[{"data":1,"prerenderedAt":-1},["ShallowReactive",2],{"health-study-detail:100659273":3},{"organization":4,"outcomesModule":7,"designInfo":137,"detailedDescription":136,"studyPopulation":136,"armGroups":143,"interventions":155,"overallOfficials":136,"centralContacts":160,"locations":167,"responsibleParty":185,"collaborators":189,"id":192,"slug":193,"hasResults":194,"nctId":195,"briefTitle":196,"officialTitle":197,"acronym":136,"eligibilityCriteria":198,"healthyVolunteers":199,"sex":200,"minAge":201,"maxAge":202,"enrollmentInfo":203,"targetDuration":136,"studyType":206,"phases":207,"briefSummary":209,"conditions":210,"keywords":212,"overallStatus":224,"whyStopped":136,"lastUpdateSubmitDate":225,"lastUpdatePostDateStruct":226,"startDateStruct":229,"completionDateStruct":231,"leadSponsor":233,"locationsCount":234},{"fullName":5,"class":6},"University of Ontario Institute of Technology","OTHER",{"primaryOutcomes":8,"secondaryOutcomes":16,"otherOutcomes":136},[9,13],{"measure":10,"description":11,"timeFrame":12},"Change in Lung Function as Measured by Forced Expiratory Volume in 1 Second (FEV1)","Spirometry will be performed using the In2itive™ (Vitalograph, UK) to assess lung function. FEV1 in mL will be used to evaluate the effects of different temperature and humidity exposures.","Measured 1-5 min before entering each temperature\u002Fhumidity condition, 1-5 min after entering the chamber, and 1-5 min after mCAFT. Day 1 is ~2 weeks after enrollment; Day 2 ~2 weeks later. Conditions are separated by 45 min washout.",{"measure":14,"description":15,"timeFrame":12},"Change in Forced Vital Capacity (FVC)","FVC in mL will be measured using the In2itive™ (Vitalograph, UK) to assess lung function.",[17,20,23,26,30,34,37,40,44,48,52,56,60,64,68,72,76,80,84,87,90,93,96,99,102,106,109,112,115,118,122,126,130,133],{"measure":18,"description":19,"timeFrame":12},"Change in Peak Expiratory Flow (PEF)","PEF in L\u002Fmin will be measured using the In2itive™ (Vitalograph, UK) to assess lung function.",{"measure":21,"description":22,"timeFrame":12},"Change in FEV1\u002FFVC Ratio","The FEV1\u002FFVC ratio (%) will be calculated from spirometry measurements using the In2itive™ (Vitalograph, UK) to assess airflow limitation.",{"measure":24,"description":25,"timeFrame":12},"Airway inflammation","Fractional exhaled nitric oxide (FeNO) will be measured using the NIOX VERO device as a non-invasive biomarker of airway inflammation, measured in parts per billion (ppb).",{"measure":27,"description":28,"timeFrame":29},"Heart Rate","Heart rate will be continuously measured using the Zephyr BioHarness and Athena physiological measurement system. Heart rate will be reported in beats per minute (bpm).","Continuously monitored beginning prior to chamber entry and throughout each temperature and humidity exposure condition, including pre-, during, and post-mCAFT. Conditions are separated by a 45-minute washout and repeated across 2 study visits.",{"measure":31,"description":32,"timeFrame":33},"Respiratory Rate","Respiratory rate will be continuously measured using the Zephyr BioHarness and Athena physiological system. Respiratory rate will be reported in breaths per minute.","Continuously monitored beginning immediately prior to chamber entry and throughout each temperature and humidity exposure condition, including the washout periods. Conditions are separated by a 45-minute washout and repeated across 2 study visits.",{"measure":35,"description":36,"timeFrame":33},"Heart Rate Variability (HRV)","HRV in milliseconds will be continuously measured using the Zephyr BioHarness and Athena platform to assess responses to temperature and humidity exposures.",{"measure":38,"description":39,"timeFrame":33},"Skin Temperature","Skin temperature will be continuously measured using the Zephyr BioHarness and Athena physiological measurement platform. Skin temperature will be reported in degree Celsius.",{"measure":41,"description":42,"timeFrame":43},"Dyspnea","Dyspnea will be assessed using the Modified Borg Scale (no units).","Measured 1-5 minutes before entering the chamber, immediately after chamber entry, 1-5 minutes before\u002Fafter the mCAFT, and after each temperature and humidity exposure. Conditions are separated by a 45-minute washout and repeated across 2 study visits.",{"measure":45,"description":46,"timeFrame":47},"Blood Pressure","Blood pressure will be measured before and after the modified Canadian Aerobic Fitness Test using a blood pressure monitor. Blood pressure will be reported in mmHg.","Measured at the beginning and end of each study visit and within 1-5 minutes before and after mCAFT during each temperature and humidity exposure. Conditions are separated by a 45-minute washout and repeated across 2 study visits.",{"measure":49,"description":50,"timeFrame":51},"Peripheral oxygen saturation (SpO2)","SpO2 will be measured using a fingertip pulse oximeter (Masimo MightySat or Rad-G).","Measured during mCAFT within each temperature and humidity exposure condition. Conditions are separated by a 45-minute washout and repeated across 2 study visits.",{"measure":53,"description":54,"timeFrame":55},"Rate of Perceived Exertion (RPE)","RPE will be assessed using Borg 6-20 scale. RPE will be reported as a score from 6-20.","Assessed 1- 5 minutes before and 1- 5 minutes after mCAFT testing. Conditions are separated by a 45-minute washout and repeated across 2 study visits.",{"measure":57,"description":58,"timeFrame":59},"Change in Estimated Peak Oxygen Uptake (VO₂peak) as Measured by the Modified Canadian Aerobic Fitness Test (mCAFT)","The Modified Canadian Aerobic Fitness Test (mCAFT) will be used to measure exercise capacity. It is a progressive submaximal step test used to estimate peak oxygen uptake (VO₂peak). Participants will complete 3-minute stepping stages of increasing intensity, with cadence and step height adjusted according to age and sex. Estimated peak oxygen uptake (VO₂peak) will be calculated and reported in mL\u002Fkg\u002Fmin.","Measured during the mCAFT within each temperature and humidity exposure condition. Assessments are repeated across two study visits approximately 2 weeks apart, with a 45-minute washout between conditions.",{"measure":61,"description":62,"timeFrame":63},"Change in Maximum Stage Achieved on the Modified Canadian Aerobic Fitness Test (mCAFT)","The Modified Canadian Aerobic Fitness Test (mCAFT) will be used to measure exercise capacity. It is a progressive submaximal step test consisting of 3-minute stepping stages of increasing intensity, with cadence and step height adjusted according to age and sex. The maximum stage successfully completed by each participant will be recorded.","Measured during the Modified Canadian Aerobic Fitness Test (mCAFT) within each temperature and humidity exposure condition. Assessments are repeated across two study visits approximately 2 weeks apart, with a 45-minute washout between conditions.",{"measure":65,"description":66,"timeFrame":67},"Respiratory Medications Used Prior to Testing","Respiratory medications used prior to each temperature and humidity exposure condition, including medication name, dose, and time of administration.","Recorded prior to each temperature and humidity exposure condition (ideal, cold-dry, cold-humid, hot-dry, and hot-humid) across 2 study visits.",{"measure":69,"description":70,"timeFrame":71},"Exposure Duration","Duration of completion of each temperature and humidity exposure condition, calculated as time between chamber entry and chamber exit. Measured in minutes.","Measured during each exposure condition (ideal, cold-dry, cold-humid, hot-dry, and hot-humid) across 2 study visits.",{"measure":73,"description":74,"timeFrame":75},"Actions Taken in the Chamber","Actions taken during\u002Fafter each temperature and humidity exposure condition, including rescue respiratory medication use, cooling chair use, provision of coverings (e.g., blankets), early exit from the chamber, and other exposure-related will be noted down by study staff.","Measured during\u002Fafter each temperature and humidity exposure condition (ideal, cold-dry, cold-humid, hot-dry, and hot-humid) across 2 study visits.",{"measure":77,"description":78,"timeFrame":79},"Participant Age","Participant age will be collected and reported in years.","Measured once during screening and baseline assessments on Day 1 (pre-test), prior to any temperature and humidity exposure conditions.",{"measure":81,"description":82,"timeFrame":83},"Sex at Birth","Participant reported sex assigned at birth will be collected and reported as categorical options.","Measured once during screening and baseline assessments on day 1 (pre-test), prior to any temperature and humidity exposure conditions.",{"measure":85,"description":86,"timeFrame":83},"Gender Identity","Participant reported gender identity will be collected and reported as categorical options.",{"measure":88,"description":89,"timeFrame":83},"Years Since Asthma Diagnosis","Time since diagnosed asthma will be collected and reported in years.",{"measure":91,"description":92,"timeFrame":83},"Asthma Triggers","Participant asthma triggers, including allergic and non-allergic triggers, will be collected and reported as categorical options and free text.",{"measure":94,"description":95,"timeFrame":83},"Height","Participant height will be measured and reported in meters (m).",{"measure":97,"description":98,"timeFrame":83},"Weight","Participant weight will be measured and reported in kilograms (kg).",{"measure":100,"description":101,"timeFrame":83},"Respiratory Medication Use","Current respiratory medication use reported as categorical options and free text.",{"measure":103,"description":104,"timeFrame":105},"Body Mass Index (BMI)","BMI will be calculated from height (m) and weight (kg) and reported in kg\u002Fm².","Calculated once during screening and baseline assessments on day 1 (pre-test), prior to any temperature and humidity exposure conditions.",{"measure":107,"description":108,"timeFrame":83},"Co-Morbidities","Participant reported co-morbid medical conditions will be collected and reported as categorical response options and free text.",{"measure":110,"description":111,"timeFrame":83},"Other Medical Diagnoses","Participant reported medical diagnoses other than asthma will be collected and reported as free text.",{"measure":113,"description":114,"timeFrame":83},"Ethnicity","Participant reported ethnicity will be collected and reported as categorical options.",{"measure":116,"description":117,"timeFrame":83},"Social Determinants of Health","Social determinants of health, including factors that may influence health outcomes and healthcare access, will be collected and reported as questionnaire responses.",{"measure":119,"description":120,"timeFrame":121},"Asthma Control Test (ACT)","Asthma control will be assessed using the ACT, a validated questionnaire that evaluates asthma symptoms, activity limitations, and overall control. Scores range from 5 to 25, with higher scores indicating better asthma control. The ACT will be used to assess changes in asthma control status throughout study participation.","Measured at screening\u002Fbaseline prior to the exposure sessions.",{"measure":123,"description":124,"timeFrame":125},"Physical Activity Questionnaire for Older Children (PAQ-C)","The PAQ-C is a self-administered questionnaire that assesses a child's general physical activity level during the previous 7 days. Higher scores indicate greater physical activity.","Measured at baseline prior to the exposures.",{"measure":127,"description":128,"timeFrame":129},"Physical Activity Questionnaire for Adolescents (PAQ-A)","The PAQ-A is a self-administered questionnaire that assesses an adolescent's general physical activity level during the previous 7 days. Higher scores indicate greater physical activity.","Measured at baseline prior to exposures.",{"measure":131,"description":132,"timeFrame":129},"Mini Pediatrics Asthma Quality of Life Questionnaire (MiniPAQLQ)","The miniPAQLQ is a self-administered questionnaire that assess asthma-related quality of life in children, including symptoms, activity limitations and emotional function. Higher scores indicate better quality of life.",{"measure":134,"description":135,"timeFrame":129},"International Study of Asthma & Allergies in Childhood (ISAAC) Core Questionnaire for Asthma","The ISAAC Core Questionnaire for Asthma will be used to assess asthma symptoms and history in control participants to confirm the absence of asthma and other respiratory conditions.",null,{"allocation":138,"interventionModel":139,"interventionModelDescription":136,"primaryPurpose":140,"observationalModel":136,"timePerspective":136,"maskingInfo":141},"NON_RANDOMIZED","CROSSOVER","BASIC_SCIENCE",{"masking":142,"maskingDescription":136,"whoMasked":136},"NONE",[144,150],{"label":145,"type":146,"description":147,"interventionNames":148},"Asthma Arm","EXPERIMENTAL","Children and youth aged 11 to 18 years with asthma will be exposed to five controlled temperature and humidity conditions (ideal, cold dry, cold humid, hot dry, and hot humid) in a climatic chamber. Lung function, breathing symptoms, exercise capacity, and physiological responses will be measured before, during, and after each exposure.",[149],"Other: Controlled Temperature and Humidity Exposure",{"label":151,"type":152,"description":153,"interventionNames":154},"Non-asthma Control Arm","ACTIVE_COMPARATOR","Age- and sex-matched children and youth without asthma will undergo the same environmental exposures and assessments as the asthma group to allow comparison of responses between groups.",[149],[156],{"type":6,"name":157,"description":158,"armGroupLabels":159,"otherNames":136},"Controlled Temperature and Humidity Exposure","Exposure to five controlled environmental conditions in a climatic chamber: ideal (18°C, 50-60% RH), cold dry (-15°C, 30-40% RH), cold humid (-15°C, 95-100% RH), hot dry (+35°C, 30-40% RH), and hot humid (+35°C, 95-100% RH). Participants undergo lung function testing, exercise testing, symptom assessments, and physiological monitoring during and after exposures.",[145,151],[161],{"name":162,"role":163,"phone":164,"phoneExt":165,"email":166},"Mika L Nonoyama","CONTACT","905-721-8668","5329","mika.nonoyama@ontariotechu.ca",[168],{"facility":169,"status":136,"city":170,"state":171,"zip":136,"country":172,"countryCode":173,"cosmosGeoPoint":174,"geoPoint":179,"contacts":180},"Ontario Tech University","Oshawa","Ontario","Canada","CA",{"type":175,"coordinates":176},"Point",[177,178],-78.84957,43.90012,{"lat":178,"lon":177},[181],{"name":162,"role":163,"phone":182,"phoneExt":183,"email":184},"416-813-7654","428064","mika.nonoyama@sickids.ca",{"type":186,"investigatorFullName":187,"investigatorTitle":188,"investigatorAffiliation":5,"oldNameTitle":136,"oldOrganization":136},"PRINCIPAL_INVESTIGATOR","Mika Nonoyama","Associate professor",[190],{"name":191,"class":6},"The Hospital for Sick Children","100659273","testing-the-effects-of-temperature--humidity-on-children-with-and-without-asthma-in-an-environmental-climatic-chamber-100659273",false,"NCT07864506","Testing the Effects of Temperature & Humidity on Children With and Without Asthma in an Environmental Climatic Chamber","Testing the Effects of Temperature & Humidity on Children With and Without Asthmas in an Environmental Climatic Chamber","Inclusion Criteria:\n\n* Children and youth aged 11 to 18 years\n* Able to provide assent\u002Fconsent, with parent or guardian consent when required\n* Diagnosed with asthma and currently stable (for the asthma group)\n* Willing to attend study visits at the ACE research facility in Oshawa, Ontario\n* For the control group: No asthma or other respiratory condition\n\nExclusion Criteria:\n\n* Does not meet all inclusion criteria\n* Parent or guardian does not provide consent when required",true,"ALL","11 Years","18 Years",{"count":204,"type":205},60,"ESTIMATED","INTERVENTIONAL",[208],"NA","The goal of this clinical study is to learn how different temperature and humidity conditions affect breathing, lung function, exercise capacity, symptoms, and other physical responses in children and youth aged 11 to 18 years with asthma, compared with age- and sex-matched children and youth without asthma.\n\nThe main questions it aims to answer are:\n\n* How do different temperature and humidity conditions affect lung function, breathing symptoms, exercise capacity, and physiological responses in children and youth with asthma?\n* Do children and youth with asthma respond differently to these environmental conditions than children and youth without asthma?\n* Do sex and gender influence these responses?\n\nResearchers will compare children and youth with asthma to age- and sex-matched children and youth without asthma to see if temperature and humidity exposures have different effects on breathing, exercise performance, symptoms, and physiological responses.\n\nParticipants will:\n\n* Attend two study visits in a climate-controlled chamber.\n* Be exposed to hot, cold, and varying humidity conditions for short periods of time.\n* Complete breathing tests and exercise testing before, during, and after each exposure.\n* Have symptoms, physical activity, and physiological responses monitored throughout the study.",[211],"Asthma",[213,214,215,216,217,218,219,220,221,222,223],"asthma","children","lungs","environmental conditions","adolescents","temperature","spirometry","lung function","weather","humidity","respiratory","NOT_YET_RECRUITING","2026-10-02",{"date":227,"type":228},"2026-10-07","ACTUAL",{"date":230,"type":205},"2026-09",{"date":232,"type":205},"2027-09",{"name":5,"class":6},1]