Ignite Creation Date:
2025-12-26 @ 10:56 AM
Ignite Modification Date:
2026-01-01 @ 2:28 AM
Study NCT ID:
NCT05826808
Status:
COMPLETED
Last Update Posted:
2025-04-23
First Post:
2023-03-15
Is NOT Gene Therapy:
True
Has Adverse Events:
False
Brief Title:
Effect of Moderate Altitude (>1000 m.a.s.l.) on Sleep Examinations (Polysomnography).
Sponsor:
Organization:
Raw JSON
{'hasResults': False, 'derivedSection': {'miscInfoModule': {'versionHolder': '2025-12-24'}, 'interventionBrowseModule': {'meshes': [{'id': 'D017286', 'term': 'Polysomnography'}], 'ancestors': [{'id': 'D008991', 'term': 'Monitoring, Physiologic'}, {'id': 'D019937', 'term': 'Diagnostic Techniques and Procedures'}, {'id': 'D003933', 'term': 'Diagnosis'}]}}, 'protocolSection': {'designModule': {'phases': ['NA'], 'studyType': 'INTERVENTIONAL', 'designInfo': {'allocation': 'RANDOMIZED', 'maskingInfo': {'masking': 'SINGLE', 'whoMasked': ['OUTCOMES_ASSESSOR']}, 'primaryPurpose': 'DIAGNOSTIC', 'interventionModel': 'CROSSOVER'}, 'enrollmentInfo': {'type': 'ACTUAL', 'count': 44}}, 'statusModule': {'overallStatus': 'COMPLETED', 'startDateStruct': {'date': '2023-06-30', 'type': 'ACTUAL'}, 'expandedAccessInfo': {'hasExpandedAccess': False}, 'statusVerifiedDate': '2025-04', 'completionDateStruct': {'date': '2024-03-16', 'type': 'ACTUAL'}, 'lastUpdateSubmitDate': '2025-04-18', 'studyFirstSubmitDate': '2023-03-15', 'studyFirstSubmitQcDate': '2023-04-12', 'lastUpdatePostDateStruct': {'date': '2025-04-23', 'type': 'ACTUAL'}, 'studyFirstPostDateStruct': {'date': '2023-04-24', 'type': 'ACTUAL'}, 'primaryCompletionDateStruct': {'date': '2024-03-16', 'type': 'ACTUAL'}}, 'outcomesModule': {'primaryOutcomes': [{'measure': 'T90 (time spent in SpO2 below 90%)', 'timeFrame': '4 nights', 'description': 'T90 is the percent of sleeping time which the participant spent in SpO2 below 90%. It provides information about the duration and degree of hypoxia during the whole sleep.'}], 'secondaryOutcomes': [{'measure': 'SpO2 (oxygen saturation)', 'timeFrame': '4 nights', 'description': 'SpO2 is the amount of haemoglobin bound to oxygen. Normal values lie above 95%. Values below 90% are considered as low and require treatment.'}, {'measure': 'AHI (apnea-hypopnea index)', 'timeFrame': '4 nights', 'description': 'AHI is defined as the number of apneas and hypopneas per hour of sleep, whereby apnea is defined as a cessation of the airflow for ≥10 seconds, while hypopnea is defined as a reduction of the airflow ≥30% with an oxygen desaturation ≥3% or an arousal.'}, {'measure': 'SWS (slow-wave sleep)', 'timeFrame': '4 nights', 'description': 'SWS includes the deep sleep phase. Deep sleep is amongst other important for energy restoration, immune system strengthening and regeneration of cells.'}, {'measure': 'AI (arousal index)', 'timeFrame': '4 nights', 'description': 'AI is the number of arousals per hour of sleep, whereby an arousal is an interruption of sleep from 3-15 seconds. They prevent suffocation in the sleep apnea by interrupting breathing pauses but are also coupled with a lot of stress for the human body.'}, {'measure': 'TcCO2 (partial pressure of carbon dioxide)', 'timeFrame': '4 nights', 'description': 'TcCO2 correlates with PaCO2 and is therefore a non-invasive alternative. A normal value of PCO2 lies between 35 and 45 mmHg. Lower values can lead to muscle cramps, abnormal heartbeat and much more.'}, {'measure': 'WASO (wakefulness after sleep onset)', 'timeFrame': '4 nights', 'description': 'WASO is the time spent awake after sleep onset. High values of WASO are for example found in sleep apnea, insomnia and restless leg syndrome.'}, {'measure': 'ODI (oxygen desaturation index)', 'timeFrame': '4 nights', 'description': 'ODI is defined as the number of oxygen decreases ≥3% per hour of sleep.'}]}, 'oversightModule': {'isUsExport': False, 'oversightHasDmc': False, 'isFdaRegulatedDrug': False, 'isFdaRegulatedDevice': False}, 'conditionsModule': {'conditions': ['Healthy']}, 'descriptionModule': {'briefSummary': 'The purpose of this study is to investigate the effect of moderate altitude (\\>1000 m.a.s.l.) on sleep examinations (polysomnography).', 'detailedDescription': 'Polysomnographies will be done for each participant for 2 consecutive nights at the sleep laboratory in Chur (CH; 600 m.a.s.l.) as well as for 2 consecutive nights at the participants home elevations (CH; \\>1000 m.a.s.l.). Between the measurements at those two different altitudes there will be a two-week washout period at \\>1000 m.a.s.l.. The sequence of altitude exposure will be randomized.'}, 'eligibilityModule': {'sex': 'ALL', 'stdAges': ['ADULT', 'OLDER_ADULT'], 'maximumAge': '70 Years', 'minimumAge': '18 Years', 'healthyVolunteers': True, 'eligibilityCriteria': 'Inclusion Criteria:\n\n* Healthy (no current medical condition or intake of regular medication, except negligible medical issues or accidents not interfering with the current health status or physical performance.)\n* Living above 1000 m.a.s.l. since at least 1 year\n* No overnight stay at altitudes \\<1000 m.a.s.l. in the previous 4 weeks\n* 18-70 years old\n* Body mass index 18,5-30 kg/m2\n* informed consent\n\nExclusion Criteria:\n\n* Active diseases or health related conditions that require treatment (sleep disorders (mainly sleep apnea), chronic rhinitis, cardiovascular and lung diseases)\n* Use of drugs that affect the respiratory center drive (sedatives, sleep inducing drugs, opioids), stimulants or illegal drugs\n* Regular consumption of recreational drugs (alcohol and nicotine included)'}, 'identificationModule': {'nctId': 'NCT05826808', 'briefTitle': 'Effect of Moderate Altitude (>1000 m.a.s.l.) on Sleep Examinations (Polysomnography).', 'organization': {'class': 'OTHER', 'fullName': 'Kantonsspital Graubünden'}, 'officialTitle': 'The Different Diagnostic Values of Polysomnographies at Low and at Moderate Altitude - A Randomized Crossover Trial', 'orgStudyIdInfo': {'id': '2023-00636'}}, 'armsInterventionsModule': {'armGroups': [{'type': 'EXPERIMENTAL', 'label': 'A', 'description': 'Polysomnographies will be done first for 2 nights at the sleep laboratory in Chur (600 m.a.s.l.) and after a two-week washout period for 2 nights at the participants home elevations (\\>1000 m.a.s.l.).', 'interventionNames': ['Diagnostic Test: Polysomnography']}, {'type': 'EXPERIMENTAL', 'label': 'B', 'description': 'Polysomnographies will be done first for 2 nights at the participants home elevations (\\>1000 m.a.s.l.). and after a two-week washout period for 2 nights at sleep laboratory in Chur (600 m.a.s.l.).', 'interventionNames': ['Diagnostic Test: Polysomnography']}], 'interventions': [{'name': 'Polysomnography', 'type': 'DIAGNOSTIC_TEST', 'description': 'The polysomnographic recordings include electroencephalogram (EEG), electrooculogram (EOG), electromyogram (EMG), electrocardiogram (ECG), pulse oximetry, transcutaneous capnography, nasal airflow and thoracic and abdominal respiratory effort.', 'armGroupLabels': ['A', 'B']}]}, 'contactsLocationsModule': {'locations': [{'city': 'Chur', 'country': 'Switzerland', 'facility': 'Kantonsspital Graubünden', 'geoPoint': {'lat': 46.84986, 'lon': 9.53287}}], 'overallOfficials': [{'name': 'Tsogyal Latshang, PD Dr. med.', 'role': 'PRINCIPAL_INVESTIGATOR', 'affiliation': 'Kantonsspital Graubünden'}]}, 'ipdSharingStatementModule': {'ipdSharing': 'NO'}, 'sponsorCollaboratorsModule': {'leadSponsor': {'name': 'Tsogyal Latshang', 'class': 'OTHER'}, 'responsibleParty': {'type': 'SPONSOR_INVESTIGATOR', 'investigatorTitle': 'Head of Pneumology', 'investigatorFullName': 'Tsogyal Latshang', 'investigatorAffiliation': 'Kantonsspital Graubünden'}}}}