Ignite Creation Date:
2025-12-24 @ 5:46 PM
Ignite Modification Date:
2026-01-01 @ 1:12 AM
Study NCT ID:
NCT04675268
Status:
RECRUITING
Last Update Posted:
2024-07-03
First Post:
2020-12-14
Is NOT Gene Therapy:
True
Has Adverse Events:
False
Brief Title:
Variability in Nocturnal Oxygen Parameters in Suspected Obstructive Sleep Apnea (OSA)
Sponsor:
Organization:
Raw JSON
{'hasResults': False, 'derivedSection': {'miscInfoModule': {'versionHolder': '2025-12-24'}, 'conditionBrowseModule': {'meshes': [{'id': 'D020181', 'term': 'Sleep Apnea, Obstructive'}], 'ancestors': [{'id': 'D012891', 'term': 'Sleep Apnea Syndromes'}, {'id': 'D001049', 'term': 'Apnea'}, {'id': 'D012120', 'term': 'Respiration Disorders'}, {'id': 'D012140', 'term': 'Respiratory Tract Diseases'}, {'id': 'D020919', 'term': 'Sleep Disorders, Intrinsic'}, {'id': 'D020920', 'term': 'Dyssomnias'}, {'id': 'D012893', 'term': 'Sleep Wake Disorders'}, {'id': 'D009422', 'term': 'Nervous System Diseases'}]}, 'interventionBrowseModule': {'meshes': [{'id': 'D010092', 'term': 'Oximetry'}], 'ancestors': [{'id': 'D001784', 'term': 'Blood Gas Analysis'}, {'id': 'D001774', 'term': 'Blood Chemical Analysis'}, {'id': 'D019963', 'term': 'Clinical Chemistry Tests'}, {'id': 'D019411', 'term': 'Clinical Laboratory Techniques'}, {'id': 'D019937', 'term': 'Diagnostic Techniques and Procedures'}, {'id': 'D003933', 'term': 'Diagnosis'}, {'id': 'D006334', 'term': 'Heart Function Tests'}, {'id': 'D003935', 'term': 'Diagnostic Techniques, Cardiovascular'}, {'id': 'D012129', 'term': 'Respiratory Function Tests'}, {'id': 'D003948', 'term': 'Diagnostic Techniques, Respiratory System'}, {'id': 'D008919', 'term': 'Investigative Techniques'}]}}, 'protocolSection': {'designModule': {'phases': ['NA'], 'studyType': 'INTERVENTIONAL', 'designInfo': {'allocation': 'NA', 'maskingInfo': {'masking': 'NONE'}, 'primaryPurpose': 'DIAGNOSTIC', 'interventionModel': 'SINGLE_GROUP'}, 'enrollmentInfo': {'type': 'ESTIMATED', 'count': 130}}, 'statusModule': {'overallStatus': 'RECRUITING', 'startDateStruct': {'date': '2021-01-26', 'type': 'ACTUAL'}, 'expandedAccessInfo': {'hasExpandedAccess': False}, 'statusVerifiedDate': '2024-07', 'completionDateStruct': {'date': '2025-11-01', 'type': 'ESTIMATED'}, 'lastUpdateSubmitDate': '2024-07-01', 'studyFirstSubmitDate': '2020-12-14', 'studyFirstSubmitQcDate': '2020-12-14', 'lastUpdatePostDateStruct': {'date': '2024-07-03', 'type': 'ACTUAL'}, 'studyFirstPostDateStruct': {'date': '2020-12-19', 'type': 'ACTUAL'}, 'primaryCompletionDateStruct': {'date': '2025-11-01', 'type': 'ESTIMATED'}}, 'outcomesModule': {'primaryOutcomes': [{'measure': 'Variability in oxygen desaturation index 3 percent', 'timeFrame': '7 nights', 'description': 'Using a CE medical approved polygraphy device (Dreamscan 2 - Medatec) the variability in number of oxygen desaturation events with desaturation higher or equal to 3% is evaluated.\n\nMean +/- SD or median (interquartile range) depending whether or not the 7 night data present a Gaussian distribution, and the coefficient of variation (CV).'}, {'measure': 'Variability in oxygen desaturation index 4 percent', 'timeFrame': '7 nights', 'description': 'Using a CE medical approved polygraphy device (Dreamscan 2 - Medatec) the variability in number of oxygen desaturation events with desaturation higher or equal to 4% is evaluated.\n\nMean +/- SD or median (interquartile range) depending whether or not the 7 night data present a Gaussian distribution, and the coefficient of variation (CV).'}, {'measure': 'Variability in mean oxygen saturation', 'timeFrame': '7 nights', 'description': 'Using a CE medical approved polygraphy device (Dreamscan 2 - Medatec) the variability in mean nocturnal oxygen saturation during 7 consecutive nights at home is evaluated.\n\nMean +/- SD or median (interquartile range) depending whether or not the 7 night data present a Gaussian distribution, and the coefficient of variation (CV).'}, {'measure': 'Variability in minimal oxygen saturation', 'timeFrame': '7 nights', 'description': 'Using a CE medical approved polygraphy device (Dreamscan 2 - Medatec) the variability in mean nocturnal oxygen saturation during 7 consecutive nights at home is evaluated.\n\nMean +/- SD or median (interquartile range) depending whether or not the 7 night data present a Gaussian distribution, and the coefficient of variation (CV).'}, {'measure': 'Variability in percentage of time oxygen saturation < 90 percent', 'timeFrame': '7 nights', 'description': 'Using a CE medical approved polygraphy device (Dreamscan 2 - Medatec) the variability in mean nocturnal oxygen saturation during 7 consecutive nights at home is evaluated.\n\nMean +/- SD or median (interquartile range) depending whether or not the 7 night data present a Gaussian distribution, and the coefficient of variation (CV).'}, {'measure': 'Variability in percentage of time oxygen saturation < 88 percent', 'timeFrame': '7 nights', 'description': 'Using a CE medical approved polygraphy device (Dreamscan 2 - Medatec) the variability in mean nocturnal oxygen saturation during 7 consecutive nights at home is evaluated.\n\nMean +/- SD or median (interquartile range) depending whether or not the 7 night data present a Gaussian distribution, and the coefficient of variation (CV).'}, {'measure': 'Variability in percentage of time oxygen saturation < 80 percent', 'timeFrame': '7 nights', 'description': 'Using a CE medical approved polygraphy device (Dreamscan 2 - Medatec) the variability in mean nocturnal oxygen saturation during 7 consecutive nights at home is evaluated.\n\nMean +/- SD or median (interquartile range) depending whether or not the 7 night data present a Gaussian distribution, and the coefficient of variation (CV).'}], 'secondaryOutcomes': [{'measure': 'Evaluation of clinical predictors (alcohol intake, sleep duration) of this variability.', 'timeFrame': '7 nights', 'description': 'Based on sleep diaries, the correlation between alcohol intake and/or sleep duration and the variability of nocturnal oxygen parameters is evaluated.'}, {'measure': 'Evaluation of clinical predictors (body position) of this variability.', 'timeFrame': '7 nights', 'description': 'Based on data of the McRoberts Move monitor, the correlation between body position and the variability of nocturnal oxygen parameters is evaluated.'}, {'measure': 'To compare nocturnal oxygen (and PPG) parameters measured at home and during a diagnostic polysomnography in hospital.', 'timeFrame': '8 nights (7 nights at home and 1 night in the hospital)', 'description': 'Comparison of the different oxygen parameters evaluated during 7 nights at home and during 1 night in the hospital'}, {'measure': 'Variability in surrogate AHI', 'timeFrame': '7 nights', 'description': 'Based on a previously developed algorithm, based on oximetry (including PPG), a surrogate AHI can be calculated. The variability in the surrogate AHI during 7 nights is evaluated.'}, {'measure': 'Variability in cardiovascular comorbidity', 'timeFrame': '7 nights', 'description': 'Based on a previously developed algorithm, based on oximetry (including PPG), the cardiovascular comorbidity can be estimated. The variability in this algorithm during 7 nights is evaluated.'}]}, 'oversightModule': {'oversightHasDmc': False, 'isFdaRegulatedDrug': False, 'isFdaRegulatedDevice': False}, 'conditionsModule': {'keywords': ['oximetry'], 'conditions': ['Obstructive Sleep Apnea']}, 'descriptionModule': {'briefSummary': 'The investigators would like to evaluate the variability of oxygen (and PPG) parameters during 7 nights at home. Oxygen (and PPG) parameters will also be evaluated during 1 night at the hospital (diagnostic polysomnography).\n\nBased on currently developed algorithms, surrogate apnea-hypopnea index (AHI), cardiovascular status and the variability of these parameters will be evaluated.', 'detailedDescription': 'The main objective of this trial is to evaluate the variability in nocturnal oxygen (and PPG) parameters during 7 consecutive nights at home and to identify clinical predictors of variability in patients with suspected OSA.\n\nData regarding sleep position, alcohol intake and sleep duration will be evaluated (these parameters could be important to explain variability).\n\nAdditional objectives are to compare the parameters measured at home with the parameters measured during an in-hospital polysomnography.\n\nThe investigators will also evaluate variability in the surrogate AHI described by the group based on the measurements at home and the impact of multi-night evaluation of oxygen (and PPG) parameters on the recently developed mICS algorithm will be explored.\n\nThis study is a first explorative approach for further (multi-site) work to define the burden of OSA associated with cardiovascular or psychofunctional problems.'}, 'eligibilityModule': {'sex': 'ALL', 'stdAges': ['ADULT', 'OLDER_ADULT'], 'minimumAge': '18 Years', 'healthyVolunteers': False, 'eligibilityCriteria': 'Inclusion Criteria:\n\n* Patients with suspected OSA with a clinical indication to perform a polysomnography\n\nExclusion Criteria:\n\n* Patients younger than 18 yrs\n* Patients not able to read or understand the informed consent content on the purpose of the study, due to visual, intellectual or language issues\n* Patients with neuromuscular disease or chest wall disease with suspected hypoventilation'}, 'identificationModule': {'nctId': 'NCT04675268', 'acronym': 'VARIOUS', 'briefTitle': 'Variability in Nocturnal Oxygen Parameters in Suspected Obstructive Sleep Apnea (OSA)', 'organization': {'class': 'OTHER', 'fullName': 'Universitaire Ziekenhuizen KU Leuven'}, 'officialTitle': 'Variability in Nocturnal Oxygen Parameters in Suspected Obstructive Sleep Apnea', 'orgStudyIdInfo': {'id': 's64296'}}, 'armsInterventionsModule': {'armGroups': [{'type': 'EXPERIMENTAL', 'label': '7 night home oximetry', 'description': 'Patients will undergo 7 nights home monitoring with oximetry.', 'interventionNames': ['Diagnostic Test: oximetry']}], 'interventions': [{'name': 'oximetry', 'type': 'DIAGNOSTIC_TEST', 'description': 'A CE medical approved polygraphy device (Dreamscan 2 - Medatec) will be used to obtain oximetry (and PPG) data', 'armGroupLabels': ['7 night home oximetry']}]}, 'contactsLocationsModule': {'locations': [{'zip': '3000', 'city': 'Leuven', 'status': 'RECRUITING', 'country': 'Belgium', 'contacts': [{'name': 'Dries Testelmans, MD, PhD', 'role': 'CONTACT', 'email': 'dries.testelmans@uzleuven.be', 'phone': '00 32 16 34 25 22'}], 'facility': 'University Hospitals Leuven', 'geoPoint': {'lat': 50.87959, 'lon': 4.70093}}], 'centralContacts': [{'name': 'Bertien Buyse, MD, PhD', 'role': 'CONTACT', 'email': 'Bertien.Buyse@uzleuven.be', 'phone': '+32 16 342522'}, {'name': 'Dries Testelmans, MD, PhD', 'role': 'CONTACT', 'email': 'Dries.Testelmans@uzleuven.be', 'phone': '+32 16 342522'}], 'overallOfficials': [{'name': 'Bertien Buyse, MD, PhD', 'role': 'PRINCIPAL_INVESTIGATOR', 'affiliation': 'Universitaire Ziekenhuizen KU Leuven'}]}, 'sponsorCollaboratorsModule': {'leadSponsor': {'name': 'Universitaire Ziekenhuizen KU Leuven', 'class': 'OTHER'}, 'responsibleParty': {'type': 'SPONSOR'}}}}