[{"data":1,"prerenderedAt":-1},["ShallowReactive",2],{"health-study-detail:100658263":3},{"organization":4,"outcomesModule":7,"designInfo":58,"detailedDescription":67,"studyPopulation":63,"armGroups":68,"interventions":75,"overallOfficials":81,"centralContacts":86,"locations":96,"responsibleParty":116,"collaborators":118,"id":122,"slug":123,"hasResults":124,"nctId":125,"briefTitle":126,"officialTitle":127,"acronym":63,"eligibilityCriteria":128,"healthyVolunteers":129,"sex":130,"minAge":131,"maxAge":63,"enrollmentInfo":132,"targetDuration":63,"studyType":135,"phases":136,"briefSummary":137,"conditions":138,"keywords":150,"overallStatus":99,"whyStopped":63,"lastUpdateSubmitDate":159,"lastUpdatePostDateStruct":160,"startDateStruct":163,"completionDateStruct":165,"leadSponsor":167,"locationsCount":168},{"fullName":5,"class":6},"Eight Sleep Inc.","INDUSTRY",{"primaryOutcomes":8,"secondaryOutcomes":16,"otherOutcomes":41},[9,13],{"measure":10,"description":11,"timeFrame":12},"Gut Microbiome Composition","alpha diversity: Shannon Index, beta diversity: Bray-Curtis, F\u002FB ratio, genus-level abundance, SCFA concentrations","Preparation Period, End of Condition, End of Condition 2 (~5 weeks)",{"measure":14,"description":15,"timeFrame":12},"Systemic Inflammation (blood panel)","hsCRP levels",[17,21,25,29,33,37],{"measure":18,"description":19,"timeFrame":20},"Circadian Rhythm of Core Body Temperature","Circadian core body temperature (ingested core temperature capsule). Cosinor analysis will be performed with the data collected. The capsule will stay in the participant's system until naturally excreted (1-5 days). The data recorded will be output as a temperature value (in Celsius, °C) and at a sampling rate of one temperature reading per minute.","Participants will ingest one capsule on Night 11 (second week of Pod ON condition) and Night 28 (second week of Pod OFF condition) 60 minutes before their normal bedtime. These are to evaluate the core body temperature between ON and OFF conditions.",{"measure":22,"description":23,"timeFrame":24},"Circadian Rhythm of Blood Pressure Rhythms","Blood Pressure (BP) Rhythms (systolic, diastolic, mean arterial pressure; MAP), including both single-point measurements and 24-hour ambulatory (mobile) measurements. The single-point BP readings will be manually enacted by the participant pressing the button on the monitor. During the 24-hour ambulatory monitoring, a BP reading will be taken every 30 minutes during the daytime and every 60 minutes once asleep, as per their reported normal bedtime. All BP readings are recorded and reported in millimeters of mercury (mmHg). The 24-hour BP readings will begin automatically 60 minutes before the participant's normal bedtime. Participants will continue wearing the BP cuff and monitor (attached to each other) for readings through the following night at that same time (therefore, it is a 24 hour reading). The protocol is marked in \"Nights\", however the metrics recorded in the day (AM) follow the same numerical convention (e.g. Day 11 = Night 11, where Night 11 is the nighttime of Day 11).","24-hour BP: Night -1 (Prep), Nights 5 & 12 (Pod ON), and Nights 22 & 29 (Pod OFF). Single-point BP (takes ~1-2 minutes): Night 11 PM & Night 12 AM (Pod ON), and Night 28 PM & Night 29 AM (Pod OFF). No BP readings occur during the 3-day washout period.",{"measure":26,"description":27,"timeFrame":28},"Objective Sleep Metrics: sleep staging, wakefulness after sleep onset and sleep onset latency (minutes)","Objective sleep metrics from sleep tracking devices (biometric tracking smart ring and Eight Sleep Pod) recorded in minutes. This includes sleep staging (N1: light sleep\u002FN2: established light sleep\u002FN3: deep sleep\u002FREM: rapid eye movement) (minutes in each stage), wakefulness after sleep onset (WASO: tracks all periods of wakefulness following sleep onset, excluding the time it takes to fall asleep initially)(minutes), and sleep onset latency (the number of minutes it takes to transition from full wakefulness to the first stage of sleep).","Objective sleep metrics are collected for the entire duration of the study (5-6 weeks total). The primary comparison for this outcome is objective sleep metrics (sleep staging, WASO, and sleep onset latency) between Pod ON and Pod OFF conditions.",{"measure":30,"description":31,"timeFrame":32},"Objective sleep metrics: Sleep efficiency (overall %)","Objective sleep metrics: Sleep efficiency (overall %) from sleep tracking devices (biometric tracking smart ring and Eight Sleep Pod). Sleep efficiency is the time spent asleep out of the total time spent in bed.","Pod and biometric tracking smart ring data are collected for the entire duration of the study (5-6 weeks). The primary comparison for this outcome is objective sleep metrics (sleep efficiency, %) between Pod ON and Pod OFF conditions.",{"measure":34,"description":35,"timeFrame":36},"Objective sleep metrics: Nighttime Respiratory Rate (RR)","Nighttime Respiratory Rate (RR) from sleep tracking devices (biometric tracking smart ring and Eight Sleep Pod). RR is the number of breaths per minute while asleep (units: breaths per minute, BrPM).","The Pod data and biometric tracking smart ring are collected for the entire duration of the study, for five weeks. The primary comparison for this outcome is objective sleep metrics (RR and BrPM) between Pod ON and Pod OFF conditions.",{"measure":38,"description":39,"timeFrame":40},"Subjective sleep quality metrics: Pittsburgh Sleep Quality Index (PSQI).","The PSQI measures sleep habits, patterns, and quality to assess perceived sleep quality. This assessment includes 19 self-rated items. The 19 items combine to form seven scored component categories, with each component assigned a score from 0 (no difficulty) to 3 (severe difficulty), with higher scores indicating greater sleep disturbance. All metrics obtained from the PSQI are subjective and reflect participants' perceptions of their sleep quality. The seven categories are: sleep quality, sleep latency (how long it takes to fall asleep), sleep duration, habitual sleep efficiency, sleep disturbances, use of sleeping medication and daytime dysfunction. The PSQI assessment computes a global score ranging from 0 to 21; a total score greater than 5 indicates poor sleep quality. The PSQI will be repeatedly administered across the duration of the study. A baseline PSQI score will be collected during recruitment as we will only be enrolling people with initially poor sleep.","PSQI: Baseline during Preparatory Period (by Night 0); Pod ON at Nights 7 & 14; Pod OFF at Nights 24 & 31. No PSQI during the 3-day washout. Baseline may be completed anytime during the 5-day Prep; each PSQI reflects the preceding period.",[42,46,50,54],{"measure":43,"description":44,"timeFrame":45},"Wellbeing will be assessed by the World Health Organization Well-Being Index (WHO-5).","The WHO-5 is a validated questionnaire that measures mental well-being over the two weeks prior to completion. The WHO-5 assessment consists of five questions, each of which are rated from 0 (at no time) to 5 (all of the time). The numbers reported from those five questions are added together to get a raw total score ranging from 0-25. The final score is derived by multiplying the raw score by 4 to get a percentage (%) score of 0 to 100. This assessment is interpreted as follows: a higher score suggests better well-being, a score of 50 or below suggests poorer well-being. Clinically, this assessment is used as a screening tool to gauge quality of life rather. It is not used to provide any formal diagnoses.","Baseline score (%) during 5-day Preparatory Period (by Night 0); Pod ON at Night 14; Pod OFF at Night 31. Baseline may be completed anytime during Prep period. Pod ON\u002FOFF scores reflect well-being over the prior 2 weeks. No WHO-5 during 3-day washout.",{"measure":47,"description":48,"timeFrame":49},"Quality of life, including physical, mental and social health, will be assessed with the Patient-Reported Outcomes Measurement Information System (PROMIS) survey, a standardized and validated assessment.","PROMIS measures pain, fatigue, depression, anxiety, sleep disturbances and physical functioning. Results of the assessment will use standardized T-scores where a score of 50 represents the average (mean) of the population, with a standard deviation of 10. Higher T-scores indicate greater levels of the concept being measured. For example, a higher score in negative domains, such as fatigue, indicates greater fatigue, while a higher score in positive domains, such as physical functioning, indicates better physical functioning. Scores are interpreted based on how far they are from the population average of 50. Whether a higher or lower score indicates a greater concern depends on what is being measured, and the domain being measured.","Baseline score during 5-day Preparatory period (by Night 0); Pod ON at Night 14; Pod OFF at Night 31. Baseline may be completed anytime during Prep period. Pod ON\u002FOFF scores reflect quality of life over the prior 2 weeks. No PROMIS during 3-day washout.",{"measure":51,"description":52,"timeFrame":53},"Menopausal symptom severity will be assessed for female participants with the Menopause Rating Scale (MRS),a validated questionnaire designed to assess the severity of menopausal symptoms.","The Menopause Rating Scale (MRS) consists of 11 items, each rated from 0 (no symptoms) to 4 (very severe symptoms). Item scores are summed to produce a total score ranging from 0 to 44. Higher scores indicate greater symptom severity. This assessment is interpreted as follows; 0-4 indicates no to mild symptoms, 5-8 indicates mild symptoms, 9-15 indicates moderate symptoms, and 16 or above indicates severe symptoms. A baseline MRS score will be collected during the Preparatory Period at the participants discretion, but required to be successfully submitted by the conclusion of the Preparatory Period (Night 0).","Baseline score during 5-day Preparatory period (by Night 0); Pod ON at Night 14; Pod OFF at Night 31. Baseline may be completed anytime during Prep period. Pod ON\u002FOFF scores reflect well-being over the prior 2 weeks. No MRS during 3-day washout.",{"measure":55,"description":56,"timeFrame":57},"Fatigue will be assessed with the Functional Assessment of Chronic Illness Therapy-Fatigue (FACIT-Fatigue) scale,a validated questionnaire designed to assess fatigue and its impact on daily activities and function.","The FACIT scale consists of 13 items, each rated from 0 (not at all) to 4 (very much), reflecting the previous seven days. Item scores are summed, with reverse scoring applied to negatively worded items, to produce a total score ranging from 0 to 52. For example, a response of 4 on a negatively worded item would be scored as 0, while a response of 0 would be scored as 4. Higher scores indicate less fatigue. A baseline FACIT score will be collected during the Preparatory Period at the participants discretion, but required to be successfully submitted by the conclusion of the Preparatory Period (Night 0).","Baseline score during 5-day Preparatory period (by Night 0); Pod ON at Night 14; Pod OFF at Night 31. Baseline may be completed anytime during Preparatory period. Pod ON\u002FOFF scores reflect fatigue over the prior 2 weeks. No FACIT during 3-day washout.",{"allocation":59,"interventionModel":60,"interventionModelDescription":61,"primaryPurpose":62,"observationalModel":63,"timePerspective":63,"maskingInfo":64},"NA","SINGLE_GROUP","Within-subject\u002F single group model; Preparation Period (5 nights) -\\> Condition 1 Pod ATR ON (2 weeks) and Condition 2 Pod ATR OFF (2 weeks), separated by a 3 day washout period","BASIC_SCIENCE",null,{"masking":65,"maskingDescription":66,"whoMasked":63},"NONE","Partial Blinding of some of the study team.","The goal of this study is to test whether improved sleep quality and stronger circadian patterns can improve gut health and decrease inflammation among postmenopausal women and men of a similar age. Previous research has documented the beneficial health outcomes from improved sleep quality. However, current research has yet to look at how overnight active temperature regulation can improve gut and cardiometabolic health. We will use the Eight Sleep Pod, a temperature-regulated mattress cover, to control bed temperature overnight. We want to see if this improves the community of bacteria in your gut, lowers inflammation in your body, and improves blood pressure and core temperature's natural 24-hour rhythms. We will test this idea with a group of men and women who are middle-age and older and say they sleep poorly. The women in the study will also be postmenopausal.\n\nFor men and women, the aging process often disrupts sleep quality. Specifically among women, the menopausal transition and the hormonal changes accompanying this life phase, changes sleep quality. Estrogen, a hormone that is relatively high for most of a woman's life, levels drop. This estrogen decline changes how a woman's body maintains a comfortable temperature, including at night. It also changes the body's natural 24-hour patterns, called circadian rhythms. As a result of these changes, women may experience broken sleep, hot flashes, and lower-quality sleep. Among men and women, broken and poor-quality sleep resulting from aging and the menopausal transition also affect your gut health, including the gut microbiome. This is the community of tiny organisms living in your digestive system. Broken and poor-quality sleep are also linked to more inflammation in your body. These effects feed into each other. Specifically, when sleep is disrupted, the balance of helpful versus harmful gut bacteria can shift, which can increase inflammation. Disrupted sleep harms your gut health, and poor gut health disrupts sleep even more. We think that improving sleep quality could improve gut health on its own, which will also improve inflammation throughout your body.\n\nThe Eight Sleep Pod is a mattress cover that controls bed temperature. It works throughout the night to actively regulate temperature as you sleep. Our previous research has shown that the Pod improves objective and subjective sleep quality, which is why we want to see if the Pod can improve other health metrics. This study will collect sleep, biological, and survey data during two weeks of sleep with the Pod's temperature control turned ON and two weeks with the control turned OFF. We will compare the data between the temperature conditions (ON \\& OFF). We want to see if improving sleep quality leads to real changes in the gut microbiome, inflammation, core temperature, blood pressure, home sleep test and objective and subjective sleep quality metrics.\n\nFindings from this study will advance scientific understanding of how improving sleep without medication could benefit gut and cardiometabolic (heart and metabolism) health in postmenopausal women and age-matched men. The findings will help guide future decisions to support health in these groups.",[69],{"label":70,"type":71,"description":72,"interventionNames":73},"Overnight Active Temperature Regulation ON and then OFF","EXPERIMENTAL","All participants undergo Condition 1 (ATR ON, 2 weeks - 14 nights) followed by washout and Condition 2 (ATR OFF, 2 weeks - 14 nights).",[74],"Device: Overnight Active Temperature Regulation: Eight Sleep Pod System",[76],{"type":77,"name":78,"description":79,"armGroupLabels":80,"otherNames":63},"DEVICE","Overnight Active Temperature Regulation: Eight Sleep Pod System","Water-perfused mattress cover actively regulating temperature overnight, temperature will be ON during Condition 1 and OFF during Condition 2.",[70],[82],{"name":83,"affiliation":84,"role":85},"David He, PhD","Vice President of Research and Development,","PRINCIPAL_INVESTIGATOR",[87,92],{"name":88,"role":89,"phone":90,"phoneExt":63,"email":91},"Amelia Mitchell, BS","CONTACT","203-931-5606","amelia.mitchell@eightsleep.com",{"name":93,"role":89,"phone":94,"phoneExt":63,"email":95},"Megan Holm, MS","(617) 237-6054‬","megan@eightsleep.com",[97],{"facility":98,"status":99,"city":100,"state":101,"zip":102,"country":103,"countryCode":104,"cosmosGeoPoint":105,"geoPoint":110,"contacts":111},"Eight Sleep","RECRUITING","Newton Center","Massachusetts","02459","United States","US",{"type":106,"coordinates":107},"Point",[108,109],-71.1995,42.33065,{"lat":109,"lon":108},[112,114],{"name":88,"role":89,"phone":113,"phoneExt":63,"email":91},"2039315606",{"name":115,"role":89,"phone":63,"phoneExt":63,"email":63},"Megan L Holm, MS",{"type":117,"investigatorFullName":63,"investigatorTitle":63,"investigatorAffiliation":63,"oldNameTitle":63,"oldOrganization":63},"SPONSOR",[119],{"name":120,"class":121},"Boston University","OTHER","100658263","the-impact-of-overnight-active-temperature-regulation-on-gut-microbiome-inflammation-and-circadian-rhythm-100658263",false,"NCT07848594","The Impact of Overnight Active Temperature Regulation on Gut Microbiome, Inflammation, and Circadian Rhythm.","The Impact of Active Temperature Regulation During Sleep on Adult Gut Microbiome Composition, Systemic Inflammation, and Circadian Rhythm.","Inclusion Criteria: All Cohorts\n\n* 45 years of age or older\n* Self-reported poor sleep quality: PSQI score greater than 5\n* Within 1.5 hours driving of the Greater Boston area\n* Have never used an Eight Sleep Pod (or similar device) ever\n* Post-enrollment hsCRP ≤ 10 µg\u002FmL at Preparation Period blood panel. If Preparation Period hsCRP \\> 10 µg\u002FmL: triggers clinical review on a case by case basis; hard exclusion applies only at \\> 30 µg\u002FmL Weight ≥ 88 lbs\n* No MRI scheduled during the study period or within 1 week after study conclusion\n* No acute illness, injury, or dental procedure\u002Fcleaning within 3 months prior to study start\n* Non-smoker or previous infrequent (\\\u003C1 weekly) smoker who has ceased at least 3 months prior to study start\n* Predictable bowel movements: at least 3 weekly and no more than 3 daily bowel movements\n* Able to drive or be transported to a local lab facility at least three total times for blood panels\n* Willing to complete 3 blood panels (3-4 tubes of blood collected at each draw): no strong aversion to needles\n* Able to swallow a pill\u002Fcapsule (approximately the size of the standard vitamin capsule) for internal core temperature monitoring\n* Stable diet for a minimum of 3 months prior to enrollment, with no planned major dietary changes during the study period\n* Stable medication regimen: no medication type or dose changes within 3 months prior to study start, and no plans to change medications during the study. This includes long-term -medication like antidepressants, statins, hormones, antihypertensives, or levothyroxine.\n* Stable exercise routine for a minimum of 3 months prior to study start, with no planned changes to this routine\n* Stable dietary supplement routine for a minimum of 3 months prior to the study start: includes probiotics, synbiotics, supplemental SCFA's\n* Willing to receive, set-up, and use all required equipment: the Eight Sleep Pod Cover and Hub, biometric smart ring, urine-based hormone measurement kit, ambulatory blood pressure monitor, core temperature capsule, HST device, and stool collection kits for the required amount of time\n* Comfortable using research accounts owned by Eight Sleep for some study devices\n* Willing and able to have stool samples picked up by the research team three and up to five times during the study\n* Willing to have the research team in the home for study set-up (up to 3 hours)\n* Have a valid, government issued ID\n\nCohort A specific Inclusion: Postmenopausal women\n\n* Assigned female at birth\n* Postmenopausal: self-reported absence of menstrual period for 12 or more consecutive months prior to study start\n* No change to hormone replacement therapy (HRT) use within 3 months prior to study start or plans to change HRT status during study period\n* No changes to hormonal birth control use within 3 months prior to study start or plans to change birth control use during study period\n\nCohort B specific Inclusion: Age-Matched Men\n\n-Assigned Male at birth\n\nExclusion Criteria: All Cohorts\n\n* Currently taking any of the following medications\u002Fsupplements or have changed use status (using to not using or vice versa) within 3 months before study start.\n\n  * Antibiotics (any kind), including one-time or short-term antibiotic use\n  * Corticosteroids (oral or injection only, topical preparations included):\n  * Prednisone\n  * Prednisolone\n  * Dexamethasone\n  * Hydrocortisone\n  * Methylprednisolone (Medrol)\n  * Budesonide\n  * Betamethasone\n* Anti-TNF-α medications (biologics for arthritis, Crohn's disease, psoriasis, or other immune\u002Finflammatory conditions):\n\n  * Adalimumab (Humira)\n  * Etanercept (Enbrel)\n  * Infliximab (Remicade)\n  * Certolizumab (Cimzia)\n  * Golimumab (Simponi)\n* Changed use status (using to not using or vice versa) within 3 months before study start or plans to stop\u002Fstart the medications during the study.\n\n  --Statins (cholesterol-lowering medications):\n  * Atorvastatin (Lipitor)\n  * Rosuvastatin (Crestor)\n  * Lovastatin (Mevacor)\n  * Fluvastatin (Lescol)\n* Antihypertensive drugs (blood pressure medications):\n\n  * Angiotensoconverting enzyme (ACE) inhibitors: Lisinopril, Ramipril, Perindopril, Enalapril\n  * Angiotensin II receptor blockers (ARBs): Losartan, Valsartan, Candesartan\n  * Calcium channel blockers: Amlodipine (Norvasc), Diltiazem, Verapamil\n  * Beta-blockers: Metoprolol, Atenolol, Bisoprolol, Propranolol\n  * Diuretics: Hydrochlorothiazide, Furosemide (Lasix), Indapamide\n* Changed use status (using to not using or vice versa) within 3 months before study start or plans to start\u002Fstop during the study.\n\n  * Hormonal birth control (any form):\n\n    ---Combined oral contraceptives (estrogen + progestin) or progestin-only capsule\n    * Hormonal IUD (e.g. Mirena, Kyleena)\n    * Contraceptive implant (e.g. Nexplanon)\n    * Contraceptive injection (e.g. Depo-Provera)\n    * Contraceptive patch (e.g. Xulane, Evra)\n    * Vaginal ring (e.g. NuvaRing)\n  * Hormone replacement therapy (exceptions: systemic - local vaginal estrogen preparations are not excluded):\n\n    * Estrogen-based: oral tablets, patches, gel, cream, or vaginal ring\n    * Combined estrogen + progestogen: oral tablets or patches\n    * Progesterone-based: oral tablets or intrauterine device\n    * Testosterone: cream or gel\n    * Bioidentical: oral tablets, patches, gel, cream, pellets, or injections\n* Currently taking any of the following medications\u002Fsupplements or have changed use status (using to not using or vice versa) within 3 months before study start or plans to start\u002Fstop during the study.\n\n  --Anabolic-androgenic steroids or performance-enhancing drugs (prescribed or non-prescribed):\n  * Testosterone-based: testosterone enanthate, cypionate, propionate, Sustanon\n  * Synthetic anabolic steroids: nandrolone, stanozolol (Winstrol), oxandrolone (Anavar), methandrostenolone (Dianabol), trenbolone\n* GLP-1 receptor agonists or other glucose-lowering medications:\n\n  * GLP-1s: Semaglutide (Ozempic, Wegovy), Liraglutide (Victoza, Saxenda), Dulaglutide (Trulicity), Tirzepatide (Mounjaro, Zepbound)\n  * Other: Metformin (Glucophage), Insulin (all types), Sitagliptin (Januvia), Empagliflozin (Jardiance), Dapagliflozin (Farxiga), Glipizide, Glyburide\n* Currently taking any of the following medications\u002Fsupplements or have changed use status (using to not using or vice versa) within 3 months before study start or plans to start\u002Fstop taking these drugs during the study period.\n\n  --Sleep medications: Prescription: Zolpidem (Ambien), Zopiclone (Imovane), Eszopiclone (Lunesta), Temazepam, Nitrazepam, Trazodone (when prescribed for sleep), Suvorexant (Belsomra) Over-the-counter: Diphenhydramine (Benadryl, ZzzQuil, Unisom), Doxylamine (Unisom SleepTabs, Nytol),\n\n  --Benzodiazepines (use status change within 12 months before study start): Diazepam (Valium), Lorazepam (Ativan), Clonazepam (Klonopin), Temazepam, Nitrazepam\n  * Antidepressant medications (change within 3 months of study start or plans to start\u002Fstop taking during the study period)\n  * Stimulants affecting blood pressure:\n\n    * Methylphenidate (Ritalin, Concerta)\n    * Amphetamine\u002FDextroamphetamine (Adderall)\n    * Lisdexamfetamine (Vyvanse)\n    * Modafinil (Provigil)\n    * Pseudoephedrine (Sudafed, including other cold\u002Fdecongestant medications)\n  * Antipsychotics: Quetiapine (Seroquel), Olanzapine (Zyprexa), Risperidone\n  * Mood stabilizers: Lithium, Valproate (Depakote)\n* Changed use status (using to not using or vice versa) within 3 months before study start or during the study.\n\n  --CBT-I or pharmacological treatment for insomnia disorder\n* Changed use status (started or stopped using) within 3 months before study start.\n\n  * Probiotics, prebiotics, or synbiotics\n  * SCFAs\n  * Butyrate (Sodium butyrate, Calcium\u002Fmagnesium butyrate, Tributyrin), Acetate, Propionate\n  * Multivitamins containing any of the following minerals:\n  * Iron, Selenium, Calcium, Zinc, Phosphorus, Magnesium Note: Stable long-term multivitamin use (unchanged for ≥3 months) is not excluded Folic Acid, Vitamin C, Vitamin A, Vitamin D, or Vitamin E supplements\n  * Antioxidant supplements\n  * Omega-3 \u002F fish oil supplements\n  * Melatonin (current use excluded if unwilling to cease use during study participation)\n* Current, ongoing, or history of diagnosis or changed diagnosis status (new diagnosis, revised or reversed diagnosis) within the specified timeframe.\n\n  * Metabolic Conditions\n\n    * Diabetes mellitus: Type 1\n    * Type 2 diabetes (within the past 3 years)\n    * Diagnosed prediabetes (confirmed via Preparation Period hbA1c levels. A result between 5.7-6.4% warrants exclusion from the study)\n    * Chronic hepatitis B\u002FC\n    * Liver cirrhosis\n    * Alcoholic liver disease\n    * Non-alcoholic fatty liver disease (NAFLD) or non-alcoholic steatohepatitis (NASH) (within the past 3 years)\n    * Hepatitis A (within the past 3 years)\n    * Hypothyroidism or hyperthyroidism (including Hashimoto's thyroiditis)\n  * Cardiovascular Conditions\n\n    * Hypertension\n    * Cardiovascular disease, including:\n    * Coronary artery disease (CAD) or ischemic heart disease\n    * History of myocardial infarction (heart attack)\n    * Heart failure (any grade)\n    * Atherosclerosis\n    * History of stroke or transient ischemic attack (TIA)\n    * Peripheral arterial disease (PAD)\n    * Atrial fibrillation or other major cardiac arrhythmias\n    * Vasovagal syncope: common fainting episode caused by a sudden drop in blood pressure and heart rate\n    * Severe anemia or significant white blood cell or platelet abnormalities\n    * Surgery, severe skin disease, or fistula on the upper arm (interfering with BP cuff readings; within 3 months prior to the study start)\n  * Autoimmune Conditions\n\n    * Rheumatoid arthritis\n    * Ankylosing spondylitis\n    * Lupus erythematosus\n    * Multiple sclerosis (MS)\n    * Any other diagnosed autoimmune condition or current use of immunosuppressive medications\n  * Gastrointestinal Conditions\n\n    * Inflammatory bowel disease (IBD), Crohn's disease or ulcerative colitis\n    * Irritable bowel syndrome (IBS)\n    * Celiac disease\n    * Gastroparesis or diverticular disease\n    * History of colostomy, colon cancer, or other colon-related surgeries\n    * Recent gastrointestinal surgery (within 6 months prior to enrollment)\n  * Chronic Diseases\n\n    * Renal disease (chronic kidney disease, any stage)\n    * Hepatic disease (beyond those listed under metabolic conditions above)\n    * Respiratory or chronic lung disease\n  * Neurological and Psychological Conditions\n\n    * Dementia\n    * Alzheimer's disease\n    * Parkinson's disease\n    * Schizophrenia\n  * Sleep-Related Conditions\n\n    * Obstructive sleep apnea (OSA)\n    * Central sleep apnea\n    * Complex sleep apnea syndrome\n    * Narcolepsy or hypersomnia disorders\n    * Restless legs syndrome (RLS) \u002F Willis-Ekbom disease\n    * Periodic limb movement disorder (PLMD)\n    * Circadian rhythm sleep-wake disorders: shift work disorder (SWD), irregular sleep-wake rhythm disorder (ISWRD), or non-24-hour sleep-wake disorder (N24SWD) Note: Participants with delayed sleep-wake phase disorder (DSWPD) or advanced sleep-wake phase disorder (ASWPD) with chronically stable sleep timing may be included.\n* Participants will be excluded if they participate in any of the following behaviors or conditions within the indicated timeframe.\n\n  * Substance Use\n\n    * Current addiction to opiates\n    * Excessive alcohol consumption (more than 14 standard drinks per average 1 week)\n    * Habitual caffeine consumption exceeding 400 mg per day (approximately 4 standard cups of coffee or equivalent)\n    * Recreational frequent drug use within timeframes noted prior to study start:\n    * Cannabis \u002F marijuana (including edibles and oils): daily or near-daily use (defined as ≥5 days per week) within 3 months prior to study start\n    * Cocaine: any use within 3 months prior to study start\n    * MDMA \u002F ecstasy: any use within 3 months prior to study start\n    * Hallucinogens (LSD, psilocybin): any use within 4 weeks prior to study start\n    * Ketamine or other illicit substances: any use within 3 months prior to study start\n  * Diet and Weight\n\n    * Planning significant changes to diet or lifestyle in the 3 months prior to study start, or had significant changes to diet or lifestyle in the 3 months prior to study start\n\n      * Starting or stopping a specialized diet (ketogenic, vegan, carnivore, elimination, intermittent fasting)\n    * Significant increase or decrease in exercise load or training plan (change of ≥60 minutes per week in total exercise volume, starting or stopping a structured exercise program, or injury\u002Fillness-related activity restriction) within 3 months prior to study start\n    * Currently enrolled in an active weight-loss program, bariatric program, or medically supervised diet, or planning to start one during the study\n    * Weight loss or gain within the past 1 month of 5% of body weight or greater,, or weight loss or gain within the past 6 months of 10% body weight or greater\n  * Health Status at Enrollment\n\n    ---Acute illness or active infection at the time of recruitment or study start: includes colds, prolonged cough, fevers, etc.\n    * Active cancer diagnosis or receipt of chemotherapy or radiotherapy within 12 months prior to study start, or planned chemotherapy treatment during the study duration\n    * Hospitalization of greater than 24 hours for acute illness, major surgery, sepsis, or cardiac, pulmonary or neurological events within 6 months prior to study start\n  * Study Equipment Compatibility\n\n    * Unable or unwilling to swallow a standard-sized capsule (required for internal core temperature monitoring capsule)\n    * Currently using a pacemaker or other electromagnetic medical implant (contraindicated with core temperature capsule)\n    * MRI scheduled during the study period or within 1 week after study conclusion\n    * Have or may have a CT scan planned during the study period\n    * Allergic to nickel or aluminum\n  * Sample and Data Collection ---Unable or unwilling to\n\n    ----Collect and provide at least 3, and up to 5, stool samples\n\n    ----Store self-collected stool samples in a home freezer until shipment\u002Fpick-up (up to 1 week after collection)\n\n    ----Complete 3 blood panels (3-4 tubes of blood each), including strong aversion to needles\n\n    ----Complete required digital surveys and any requested data sharing\n    * Communicate with the research team within a timely manner throughout the duration of the study\n    * Have stool samples picked up from home\n    * Have research staff within home for study set-up for up to 3 hours\n    * Complete all data collection requirements in a timely manner\n  * Lifestyle and Compliance\n\n    * Travel planned during the study period\n    * Unstable WiFi connection at any point during the study period (to the best ability this can be predicted)\n    * Unwilling or unable to provide informed consent with sufficient mental wellness to understand the study\n    * Lived outside of the United States within 6 months prior to study start\n\nCohort A Exclusion Criteria: Postmenopausal women\n\n* Hysterectomy\n* Oophorectomy (single or double)\n* Polyendocrine metabolic ovarian syndrome (PMOS), previously known as polycystic ovarian syndrome (PCOS)\n* Diagnosed testosterone dysregulation (hyperandrogenism or androgen insufficiency) not attributable to PMOS\n* Premature ovarian insufficiency (POI) or premature ovarian failure (POF)\n* Endometriosis\n* Change to hormone replacement therapy (HRT) use within 3 months prior to study start\n* Changes to hormonal birth control use within 3 months prior to study start\n\nCohort B Exclusion Criteria: Age-Matched Men\n\n-Diagnosed testosterone dysregulation (hyperandrogenism and\u002For androgen insufficiency)",true,"ALL","45 Years",{"count":133,"type":134},100,"ESTIMATED","INTERVENTIONAL",[59],"This study examines whether two continuous weeks of overnight active temperature regulation (via the Eight Sleep Pod) use affects gut microbiome composition, inflammation, and the body's daily temperature and blood pressure rhythms in postmenopausal women and age-matched men with self-reported poor sleep.",[139,140,141,142,143,144,145,146,147,148,149],"Poor Sleep Quality","Gut Microbiome","Gut Health","Inflammation","Circadian Rhythm","Circadian Clocks","Gut Microbiota","Women's Health","Gut-Brain Axis","Blood Pressure","Systemic Inflammatory Response",[140,151,143,152,148,153,154,155,156,157,141,158],"Systemic Inflammation","Sleep Quality","Core Temperature","Poor Sleep","Postmenopausal","Active Temperature Regulation","Blood Pressure Rhythm","Gut Flora","2026-09-23",{"date":161,"type":162},"2026-09-30","ACTUAL",{"date":164,"type":134},"2026-10",{"date":166,"type":134},"2026-12",{"name":5,"class":6},1]