Ignite Creation Date:
2025-12-25 @ 2:47 AM
Ignite Modification Date:
2025-12-31 @ 2:41 AM
Study NCT ID:
NCT04638933
Status:
COMPLETED
Last Update Posted:
2023-11-29
First Post:
2020-11-16
Is NOT Gene Therapy:
True
Has Adverse Events:
False
Brief Title:
Effect of CPAP Therapy on Molecular Breath Patterns in Patients With 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'}]}}, 'protocolSection': {'designModule': {'studyType': 'OBSERVATIONAL', 'designInfo': {'timePerspective': 'PROSPECTIVE', 'observationalModel': 'COHORT'}, 'enrollmentInfo': {'type': 'ACTUAL', 'count': 53}, 'patientRegistry': False}, 'statusModule': {'overallStatus': 'COMPLETED', 'startDateStruct': {'date': '2020-10-06', 'type': 'ACTUAL'}, 'expandedAccessInfo': {'hasExpandedAccess': False}, 'statusVerifiedDate': '2023-11', 'completionDateStruct': {'date': '2023-01-31', 'type': 'ACTUAL'}, 'lastUpdateSubmitDate': '2023-11-28', 'studyFirstSubmitDate': '2020-11-16', 'studyFirstSubmitQcDate': '2020-11-16', 'lastUpdatePostDateStruct': {'date': '2023-11-29', 'type': 'ACTUAL'}, 'studyFirstPostDateStruct': {'date': '2020-11-20', 'type': 'ACTUAL'}, 'primaryCompletionDateStruct': {'date': '2023-01-31', 'type': 'ACTUAL'}}, 'outcomesModule': {'primaryOutcomes': [{'measure': 'Exhaled breath pattern', 'timeFrame': 'twice during 1 month', 'description': 'Change in exhaled breath pattern in response to one month of CPAP treatment'}], 'secondaryOutcomes': [{'measure': 'OSA severity parameter', 'timeFrame': 'twice during 1 month', 'description': 'Correlation of breath print with changes in OSA severity parameters on CPAP (e.g. AHI, ODI)'}, {'measure': 'Vital signs', 'timeFrame': 'twice during 1 month', 'description': 'Correlation of breath print with changes in blood pressure and heart rate'}, {'measure': 'Sleepiness', 'timeFrame': 'twice during 1 month', 'description': 'Correlation of breath print with changes in sleepiness (Epworth sleepiness scale) and Functional outcome of sleep questionnaire (FOSQ 30)'}, {'measure': 'Spirometry', 'timeFrame': 'twice during 1 month', 'description': 'Correlation of breath print with spirometry (FEV1, FVC)'}, {'measure': 'CPAP therapy', 'timeFrame': 'twice during 1 month', 'description': 'Correlation of breath print with CPAP therapy parameters (adherence and leakage)'}, {'measure': 'Therapy feedback', 'timeFrame': 'twice during 1 month', 'description': "Correlation of breath print with patients' and their partners' feedback report on CPAP machine used"}]}, 'oversightModule': {'oversightHasDmc': False, 'isFdaRegulatedDrug': False, 'isFdaRegulatedDevice': False}, 'conditionsModule': {'keywords': ['Exhaled breath analysis', 'Mass spectrometry'], 'conditions': ['Obstructive Sleep Apnea']}, 'descriptionModule': {'briefSummary': 'Determination of changes in molecular breath patterns in OSA patients, naïve for OSA treatment before and after one month of CPAP therapy by untargeted, secondary electrospray ionisation-high resolution mass spectrometry (SESI-HRMS). Furthermore, breath patterns will be assessed for correlation and association to clinical outcomes such as change in OSA severity, sleepiness, and blood pressure.'}, 'eligibilityModule': {'sex': 'ALL', 'stdAges': ['ADULT', 'OLDER_ADULT'], 'minimumAge': '18 Years', 'samplingMethod': 'PROBABILITY_SAMPLE', 'studyPopulation': 'Patients with proven OSA (apnea-hypopnea index ≥20/h, ESS \\>10, age ≥18 years) and initiation of CPAP treatment', 'eligibilityCriteria': 'Inclusion Criteria:\n\n* Recently diagnosed OSA (AHI ≥20/h)\n* Patient is willing to start CPAP therapy\n* ESS \\> 10 points\n* 18 years or above\n\nExclusion Criteria:\n\n* Moribund or severe disease prohibiting protocol adherence\n* Use of oxygen therapy or home ventilation\n* Physical or intellectual impairment precluding informed consent or protocol adherence\n* Known malignancy, acute pulmonary disease, drug or alcohol abuse, known active inflammatory diseases (e.g. autoimmune disease), relevant congenital defects e.g. amino acid metabolism defect, relevant endocrinological disease, renal failure (GFR \\< 15 mL/min)\n* Pregnant patients'}, 'identificationModule': {'nctId': 'NCT04638933', 'acronym': 'BrOSA', 'briefTitle': 'Effect of CPAP Therapy on Molecular Breath Patterns in Patients With OSA', 'organization': {'class': 'OTHER', 'fullName': 'University of Zurich'}, 'officialTitle': 'Effect of CPAP Therapy on Molecular Breath Patterns in Patients With OSA (BrOSA)', 'orgStudyIdInfo': {'id': 'BASEC-Nr. 2020-02084'}}, 'armsInterventionsModule': {'armGroups': [{'label': 'OSA patients', 'description': 'Patients with proven OSA (apnea-hypopnea index ≥20/h, ESS \\>10, age ≥18 years) and initiation of CPAP treatment', 'interventionNames': ['Other: No intervention']}], 'interventions': [{'name': 'No intervention', 'type': 'OTHER', 'description': 'No intervention', 'armGroupLabels': ['OSA patients']}]}, 'contactsLocationsModule': {'locations': [{'zip': '8091', 'city': 'Zurich', 'country': 'Switzerland', 'facility': 'University Hospital Zurich', 'geoPoint': {'lat': 47.36667, 'lon': 8.55}}]}, 'sponsorCollaboratorsModule': {'leadSponsor': {'name': 'Malcolm Kohler', 'class': 'OTHER'}, 'responsibleParty': {'type': 'SPONSOR_INVESTIGATOR', 'investigatorTitle': 'Prof. Dr. med.', 'investigatorFullName': 'Malcolm Kohler', 'investigatorAffiliation': 'University of Zurich'}}}}