Ignite Creation Date:
2025-12-24 @ 4:15 PM
Ignite Modification Date:
2025-12-28 @ 4:30 PM
Study NCT ID:
NCT04925466
Status:
COMPLETED
Last Update Posted:
2022-04-08
First Post:
2021-06-04
Is NOT Gene Therapy:
True
Has Adverse Events:
False
Brief Title:
Acceptable Pressure Range for Continuous Positive Airway Pressure(CPAP) Treatment
Sponsor:
Organization:
Raw JSON
{'hasResults': False, 'derivedSection': {'miscInfoModule': {'versionHolder': '2025-12-24'}}, 'protocolSection': {'designModule': {'phases': ['NA'], 'studyType': 'INTERVENTIONAL', 'designInfo': {'allocation': 'RANDOMIZED', 'maskingInfo': {'masking': 'NONE'}, 'primaryPurpose': 'TREATMENT', 'interventionModel': 'CROSSOVER'}, 'enrollmentInfo': {'type': 'ACTUAL', 'count': 40}}, 'statusModule': {'overallStatus': 'COMPLETED', 'startDateStruct': {'date': '2021-06-05', 'type': 'ACTUAL'}, 'expandedAccessInfo': {'hasExpandedAccess': False}, 'statusVerifiedDate': '2022-04', 'completionDateStruct': {'date': '2021-09-23', 'type': 'ACTUAL'}, 'lastUpdateSubmitDate': '2022-04-07', 'studyFirstSubmitDate': '2021-06-04', 'studyFirstSubmitQcDate': '2021-06-05', 'lastUpdatePostDateStruct': {'date': '2022-04-08', 'type': 'ACTUAL'}, 'studyFirstPostDateStruct': {'date': '2021-06-14', 'type': 'ACTUAL'}, 'primaryCompletionDateStruct': {'date': '2021-07-19', 'type': 'ACTUAL'}}, 'outcomesModule': {'primaryOutcomes': [{'measure': 'sleep structure', 'timeFrame': '4 full night', 'description': 'Assessment of the sleep efficiency (percentage is calculated by dividing Total Sleep Time by Total Time in bed)'}, {'measure': 'arousal index', 'timeFrame': '4 full night', 'description': 'total number of arousal events/total sleep time(h)'}, {'measure': 'Apnea hypopnea index', 'timeFrame': '4 full night', 'description': 'Total number of apneas and hypopneas/total sleep time (h)'}, {'measure': 'Oxygen Desaturation Index', 'timeFrame': '4 full night', 'description': 'Total number of oxygen desaturations≥3% /total sleep time(h)'}], 'secondaryOutcomes': [{'measure': 'Patients preference', 'timeFrame': '4 full night', 'description': 'Using a questionnaire named preference to record patients preference to 10cmH2O or manual titrated pressure'}]}, 'oversightModule': {'oversightHasDmc': True, 'isFdaRegulatedDrug': False, 'isFdaRegulatedDevice': False}, 'conditionsModule': {'keywords': ['OSA', 'CPAP', 'acceptable range'], 'conditions': ['Obstructive Sleep Apnea of Adult']}, 'referencesModule': {'references': [{'pmid': '40130675', 'type': 'DERIVED', 'citation': 'Wang L, Chen Y, Wei Q, Wu Y, Huang C, Liang S, Steier J, Catcheside P, Eckert D, Wellman A, Luo Y. Fixed CPAP at 10 cmH 2O May Replace Manual Titration in Moderate to Severe OSA Patients: A Preliminary Randomised Controlled Trial. Respirology. 2025 Aug;30(8):770-778. doi: 10.1111/resp.70037. Epub 2025 Mar 25.'}]}, 'descriptionModule': {'briefSummary': 'Compliance of continuous positive airway pressure （CPAP） derived from auto-titration is similar to that derived from manual titration, although pressure derived from the former was usually 2-5 cmH2O higher than the latter. Therefore the Investigators hypothesize that accurate titration maybe not necessary for successful treatment of obstructive sleep apnea (OSA) as long as CPAP pressure was not lower than the minimal effective pressure.', 'detailedDescription': 'Study Design: A randomized, cross-over and double-blind study. Objective: To compare the pressure of 10 cmH2O and minimal effective pressure derived from manual titration on the effect of CPAP treatment in OSA. Methods: Patients with suspected OSA (age, body mass index and symptom) to be referred to a sleep centre were recruited. Patients with OSA confirmed by overnight full polysomnography (PSG) were invited to do standard overnight manual titration under PSG based on the Academy of Sleep Medicine (AASM) manual guidelines. Patients whose manual titration pressure lower than 10cmH2O and willing to participate in the study were invited to repeat two more nights (3th PSG and 4th PSG) under CPAP pressure at both 10cmH2O and the pressure derived from manual titration in random order. The sleep apnea-hypopnea index (AHI), obstructive sleep apnea index (OHI), arousal index (ArI), oxygen desaturation index (ODI), sleep structure, and treatment preference were to be observed.'}, 'eligibilityModule': {'sex': 'ALL', 'stdAges': ['ADULT', 'OLDER_ADULT'], 'maximumAge': '75 Years', 'minimumAge': '18 Years', 'healthyVolunteers': False, 'eligibilityCriteria': 'Inclusion Criteria:\n\n1. reported snore, apnea and daytime sleepiness;\n2. a diagnosis of obstructive sleep apnea with polysomnography according to ASSM guideline(apnoea-hypopnea-index(AHI)≥5 events/h) and need to be treated with continuous positive airway pressure;\n3. willing to participate after informed consent.\n\nExclusion Criteria:\n\n1. Evidence of severe coronary or cerebral, cardiovascular disease and significant memory, perceptual or behavioural disorder;\n2. Severe respiratory disease defined as severe chronic obstructive pulmonary disease(ie. FEV1/FVC\\<70% and FEV1\\<50%predicted) or resting awake SaO2\\<90%\n3. Have known contraindications with CPAP, like current pneumothorax and hemoptysis, et al.\n4. Central sleep apnea\\>10 events/h；\n5. Frequent nasal congestion；\n6. Optimal treatment CPAP pressure(by manual titration) equal or higher than 10cmH2O.'}, 'identificationModule': {'nctId': 'NCT04925466', 'briefTitle': 'Acceptable Pressure Range for Continuous Positive Airway Pressure(CPAP) Treatment', 'organization': {'class': 'OTHER', 'fullName': 'State Key Laboratory of Respiratory Disease'}, 'officialTitle': 'Comparison of 10cmH2O and Manual Titrated Pressure in Treatment of Obstructive Sleep Apnea(OSA) Patients', 'orgStudyIdInfo': {'id': '2021016'}}, 'armsInterventionsModule': {'armGroups': [{'type': 'EXPERIMENTAL', 'label': 'Treatment with CPAP at 10cmH2O', 'description': 'Patients with OSA will be treated with CPAP at 10cmH2O during sleep.', 'interventionNames': ['Device: CPAP at pressure of 10 cmH2O']}, {'type': 'EXPERIMENTAL', 'label': 'Treatment with CPAP at minimal effective pressure', 'description': 'Patients with OSA will be treated with CPAP at minimal effective pressure derived from manual titration during sleep.', 'interventionNames': ['Device: CPAP at minimal effective pressure']}], 'interventions': [{'name': 'CPAP at pressure of 10 cmH2O', 'type': 'DEVICE', 'description': 'Patients used CPAP with the pressure of 10 cmH2O during overnight polysomnography', 'armGroupLabels': ['Treatment with CPAP at 10cmH2O']}, {'name': 'CPAP at minimal effective pressure', 'type': 'DEVICE', 'description': 'Patients with OSA will be treated with CPAP at minimal effective pressure derived from manual titration during sleep.', 'armGroupLabels': ['Treatment with CPAP at minimal effective pressure']}]}, 'contactsLocationsModule': {'locations': [{'zip': '510230', 'city': 'Guangzhou', 'state': 'Guangdong', 'country': 'China', 'facility': 'The First Affiliated Hospital of Guangzhou Medical University', 'geoPoint': {'lat': 23.11667, 'lon': 113.25}}], 'overallOfficials': [{'name': 'Yuanming Luo, PhD', 'role': 'PRINCIPAL_INVESTIGATOR', 'affiliation': 'The First Affiliated Hospital of Guangzhou Medical University'}]}, 'ipdSharingStatementModule': {'ipdSharing': 'UNDECIDED'}, 'sponsorCollaboratorsModule': {'leadSponsor': {'name': 'State Key Laboratory of Respiratory Disease', 'class': 'OTHER'}, 'responsibleParty': {'type': 'PRINCIPAL_INVESTIGATOR', 'investigatorTitle': 'Proffessor', 'investigatorFullName': 'Yuan-Ming Luo', 'investigatorAffiliation': 'State Key Laboratory of Respiratory Disease'}}}}