[{"data":1,"prerenderedAt":-1},["ShallowReactive",2],{"health-study-detail:100659340":3},{"organization":4,"outcomesModule":7,"designInfo":48,"detailedDescription":43,"studyPopulation":51,"armGroups":52,"interventions":61,"overallOfficials":43,"centralContacts":66,"locations":43,"responsibleParty":72,"collaborators":43,"id":76,"slug":77,"hasResults":78,"nctId":79,"briefTitle":80,"officialTitle":81,"acronym":43,"eligibilityCriteria":82,"healthyVolunteers":78,"sex":83,"minAge":84,"maxAge":85,"enrollmentInfo":86,"targetDuration":43,"studyType":89,"phases":43,"briefSummary":90,"conditions":91,"keywords":43,"overallStatus":93,"whyStopped":43,"lastUpdateSubmitDate":94,"lastUpdatePostDateStruct":95,"startDateStruct":98,"completionDateStruct":100,"leadSponsor":102,"locationsCount":43},{"fullName":5,"class":6},"Anhui Provincial Hospital","OTHER_GOV",{"primaryOutcomes":8,"secondaryOutcomes":40,"otherOutcomes":43},[9,13,16,19,22,25,28,31,34,37],{"measure":10,"description":11,"timeFrame":12},"Wake After Sleep Onset (WASO), measured in minutes by polysomnography","Wake after sleep onset (WASO) is defined as the total amount of time spent awake after initial sleep onset and before final awakening during the monitoring period. WASO will be measured in minutes using polysomnography (PSG). A higher WASO indicates a greater amount of wakefulness during the sleep period.","Day -1 (the day before surgery), Day 0 (the day of surgery), Postoperative Day 1, and Postoperative Day 2",{"measure":14,"description":15,"timeFrame":12},"Proportions of Rapid Eye Movement (REM) Sleep, Non-Rapid Eye Movement (NREM) Sleep, and Wakefulness measured by polysomnography","Sleep and wake states will be determined using polysomnography (PSG). The proportions of rapid eye movement (REM) sleep, non-rapid eye movement (NREM) sleep, and wakefulness will be calculated as the percentage of the total recording time spent in each state. Values will be reported as percentages (%), with higher values indicating a greater proportion of the recording period spent in the corresponding state.",{"measure":17,"description":18,"timeFrame":12},"Proportions of N1, N2, and N3 stages of non-rapid eye movement (NREM) sleep measured by polysomnography","Sleep stages will be determined using polysomnography (PSG). The proportions of N1, N2, and N3 sleep will be calculated as the percentage of total sleep time (TST) spent in each respective NREM sleep stage. Values will be reported as percentages (%). Higher values indicate a greater proportion of total sleep time spent in the corresponding sleep stage.",{"measure":20,"description":21,"timeFrame":12},"Sleep Onset Latency (SOL), measured in minutes by polysomnography","Sleep onset latency (SOL) is defined as the time from the beginning of the sleep opportunity to the onset of sleep, as determined by polysomnography (PSG). SOL will be reported in minutes. A higher value indicates a longer time required to initiate sleep.",{"measure":23,"description":24,"timeFrame":12},"Total Sleep Time (TST), measured in minutes by polysomnography","Total sleep time (TST) is defined as the total amount of time spent asleep during the monitoring period, as determined by polysomnography (PSG). TST will be reported in minutes. A higher value indicates a longer duration of sleep.",{"measure":26,"description":27,"timeFrame":12},"Sleep Efficiency (SE), measured as a percentage by polysomnography","Sleep efficiency (SE) is defined as the percentage of time spent asleep relative to the total time in bed during the monitoring period. SE will be calculated as total sleep time (TST) divided by total time in bed, multiplied by 100. Sleep efficiency will be derived from polysomnography (PSG) data and reported as a percentage (%). Higher values indicate greater sleep efficiency.",{"measure":29,"description":30,"timeFrame":12},"Serum Testosterone Concentration","Serum testosterone concentration will be measured using an automated chemiluminescence immunoassay. The result will be reported as concentration values (ng\u002FdL).",{"measure":32,"description":33,"timeFrame":12},"Serum Progesterone Concentration","Serum progesterone concentration will be measured using an automated chemiluminescence immunoassay. The result will be reported as concentration values (ng\u002FmL).",{"measure":35,"description":36,"timeFrame":12},"Serum Cortisol Concentration","Serum cortisol concentration will be measured using an automated chemiluminescence immunoassay. The result will be reported as concentration values (μg\u002FdL).",{"measure":38,"description":39,"timeFrame":12},"Serum Estradiol (E2) Concentration","Serum estradiol concentration will be measured using an automated chemiluminescence immunoassay. The result will be reported as concentration values (pg\u002FmL).",[41,45],{"measure":42,"description":43,"timeFrame":44},"Sleep satisfaction (rated on a scale of 1-10, with 1 indicating very dissatisfied and 10 indicating very satisfied)",null,"30 minutes after waking each morning",{"measure":46,"description":43,"timeFrame":47},"number of nighttime awakenings (subjectively perceived)","Every morning within 30 minutes after awakening",{"allocation":43,"interventionModel":43,"interventionModelDescription":43,"primaryPurpose":43,"observationalModel":49,"timePerspective":50,"maskingInfo":43},"CASE_CONTROL","RETROSPECTIVE","This study is a prospective observational study designed to compare the recovery trajectories of perioperative stress-related sleep disturbances between male and female patients undergoing laparoscopic cholecystectomy. All enrolled participants will be naturally assigned to either the female group or the male group according to sex, without any study-related intervention.",[53,58],{"label":54,"type":43,"description":55,"interventionNames":56},"man group","No study intervention",[57],"Other: No study intervention",{"label":59,"type":43,"description":55,"interventionNames":60},"woman group",[57],[62],{"type":63,"name":55,"description":64,"armGroupLabels":65,"otherNames":43},"OTHER","This is a retrospective observational study based on existing medical records. No intervention, treatment, or procedure is assigned or administered by the study investigators. All data are collected retrospectively from routine clinical care.",[54,59],[67],{"name":68,"role":69,"phone":70,"phoneExt":43,"email":71},"tong fu, Master","CONTACT","+8613156561090","futong5533227@126.com",{"type":73,"investigatorFullName":74,"investigatorTitle":75,"investigatorAffiliation":5,"oldNameTitle":43,"oldOrganization":43},"SPONSOR_INVESTIGATOR","Li Juan","Chief Physician","100659340","perioperative-sleep-recovery-trajectories-in-patients-of-different-sexes-undergoing-laparoscopic-cholecystectomy-100659340",false,"NCT07863804","Perioperative Sleep Recovery Trajectories in Patients of Different Sexes Undergoing Laparoscopic Cholecystectomy","A Prospective Observational Study of Perioperative Sleep Recovery Trajectories in Patients of Different Sexes Undergoing Laparoscopic Cholecystectomy","Inclusion Criteria:\n\n1. Aged 18-65 years of both genders. Alert and capable of normal communication. Voluntarily sign informed consent, complete the whole experimental procedure, and meet ethical and compliance requirements.\n2. Patients scheduled to undergo laparoscopic cholecystectomy under general anesthesia.\n3. No history of severe needle or blood phobia, and able to tolerate repeated venous blood sampling during the perioperative period.\n4. No long-term use of sedative-hypnotics, anxiolytics, antidepressants, or glucocorticoids within the past month, except for short-term use for acute illness for no more than 3 days; no other interventions that may affect sleep, such as transcranial magnetic stimulation or cognitive behavioral therapy.\n5. Stable vital signs, essentially normal function of major organs, including the heart, brain, lungs, liver, and kidneys, and no severe organic disease; able to tolerate surgery and the study procedures.\n6. Able to strictly follow the required sleep-wake schedule during the study period and cooperate with completion of sleep diaries, questionnaires, and all assessments, with good compliance.\n\nExclusion Criteria:\n\n* 1: Aged \\\u003C18 years or \\>65 years; pregnant or breastfeeding women; patients with psychiatric disorders, such as schizophrenia, mania, or depression, cognitive impairment, or inability to cooperate with the study, in order to avoid missing data or study bias due to poor cooperation.\n\n  2: Severe coagulation disorders, skin infection at the puncture site, or other conditions unsuitable for repeated blood sampling, to ensure the safety of blood collection procedures.\n\n  3: Use of sedative-hypnotics, anxiolytics, antidepressants, hormonal medications, or other sleep-related interventions within the past month that may affect the study outcomes, in order to minimize confounding factors and ensure the accuracy of the results.\n\n  4: Severe cardiovascular or cerebrovascular disease, severe hepatic or renal insufficiency, severe respiratory disease, or other conditions that may affect perioperative recovery or sleep assessment.\n\n  5: Major surgery or severe trauma within the past 3 months that may interfere with the perioperative stress response.\n\n  6: Alcohol or drug dependence, or consumption of more than three cups of coffee, strong tea, or other stimulant beverages per day with an inability to maintain relatively stable consumption habits during the study period, as substances such as caffeine may interfere with sleep.\n\n  7: Voluntary withdrawal from the study before completion, or inability to complete the study due to adverse reactions, poor compliance, or other reasons.","ALL","18 Years","65 Years",{"count":87,"type":88},58,"ESTIMATED","OBSERVATIONAL","This is an observational clinical study. It does not give new treatments to participants. Researchers want to learn how sleep gets better or worse after laparoscopic gallbladder removal surgery. Sleep problems are common after surgery. Some people may recover their sleep faster than others. Researchers will look at whether sleep recovery differs between women and men. They will also check how sex-related hormone levels connect with sleep changes.\n\nAbout 58 participants will join this study.\n\nKey requirements to take part:\n\n* Aged 18 to 65 years old\n* Scheduled for laparoscopic gallbladder removal under general anesthesia\n* Able to give informed consent and finish all study tasks\n* Can tolerate repeated blood draws\n* No long-term sleep-affecting medicine use in the past one month\n* Major organs work normally\n\nPeople cannot join if they:\n\n* Are younger than 18 years or older than 65 years\n* Are pregnant or breastfeeding\n* Have mental health or cognitive conditions that stop study participation\n* Have problems that make repeated blood collection unsafe\n* Have severe organ diseases or recent major injury or surgery\n* Have alcohol or drug dependence\n\nWhat happens for each participant:\n\n1. Before surgery: Participants sign consent forms. Staff collect basic health information. Participants wear a sleep-recording device called polysomnography (PSG) overnight. Participants fill out a short sleep diary each morning. Fasting blood samples are collected the next morning to measure hormone levels.\n2. On surgery day: Standard hospital care goes forward. Staff record surgery-related information. PSG sleep recording, sleep diary, and morning blood draw are repeated.\n3. First and second days after surgery: The same sleep recording, sleep diary, and morning fasting blood collection continue for two more nights.\n\nResearchers compare sleep measurements across four nights. These measurements come from both PSG machine readings and participants' self-reported sleep diaries. Researchers also compare hormone level changes between female and male participants.\n\nPossible benefits: Participants receive objective feedback on their own sleep and hormone results. If test values show clear concerns, researchers share these findings with their clinical care team. No direct treatment benefit is guaranteed.\n\nPossible risks: This is a low-risk study. Small risks may include mild pain, bruising at blood draw sites, or temporary light-headedness from blood collection. Filling out short diaries may bring minor tiredness. All personal data will be kept private. Participants can leave the study at any time with no penalty.",[92],"Sleep and Circadian Problems","NOT_YET_RECRUITING","2026-10-04",{"date":96,"type":97},"2026-10-07","ACTUAL",{"date":99,"type":88},"2026-09-20",{"date":101,"type":88},"2026-12-30",{"name":74,"class":6}]