Ignite Creation Date:
2025-12-24 @ 9:21 PM
Ignite Modification Date:
2026-01-01 @ 7:42 AM
Study NCT ID:
NCT06818604
Status:
NOT_YET_RECRUITING
Last Update Posted:
2025-02-10
First Post:
2025-01-13
Is NOT Gene Therapy:
True
Has Adverse Events:
False
Brief Title:
Comparing CPAP and BiPAP for Sleep-Disordered Breathing in People with Cervical Spinal Cord Injuries
Sponsor:
Organization:
Raw JSON
{'hasResults': False, 'derivedSection': {'miscInfoModule': {'versionHolder': '2025-12-24'}, 'conditionBrowseModule': {'meshes': [{'id': 'D013119', 'term': 'Spinal Cord Injuries'}, {'id': 'D012891', 'term': 'Sleep Apnea Syndromes'}, {'id': 'D020181', 'term': 'Sleep Apnea, Obstructive'}, {'id': 'D007319', 'term': 'Sleep Initiation and Maintenance Disorders'}, {'id': 'D011782', 'term': 'Quadriplegia'}, {'id': 'D012893', 'term': 'Sleep Wake Disorders'}, {'id': 'D012133', 'term': 'Respiratory Paralysis'}, {'id': 'D020211', 'term': 'Autonomic Dysreflexia'}, {'id': 'D018908', 'term': 'Muscle Weakness'}, {'id': 'D001261', 'term': 'Pulmonary Atelectasis'}, {'id': 'D013117', 'term': 'Spinal Cord Compression'}], 'ancestors': [{'id': 'D013118', 'term': 'Spinal Cord Diseases'}, {'id': 'D002493', 'term': 'Central Nervous System Diseases'}, {'id': 'D009422', 'term': 'Nervous System Diseases'}, {'id': 'D020196', 'term': 'Trauma, Nervous System'}, {'id': 'D014947', 'term': 'Wounds and Injuries'}, {'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': 'D001523', 'term': 'Mental Disorders'}, {'id': 'D010243', 'term': 'Paralysis'}, {'id': 'D009461', 'term': 'Neurologic Manifestations'}, {'id': 'D012816', 'term': 'Signs and Symptoms'}, {'id': 'D013568', 'term': 'Pathological Conditions, Signs and Symptoms'}, {'id': 'D012131', 'term': 'Respiratory Insufficiency'}, {'id': 'D001342', 'term': 'Autonomic Nervous System Diseases'}, {'id': 'D009135', 'term': 'Muscular Diseases'}, {'id': 'D009140', 'term': 'Musculoskeletal Diseases'}, {'id': 'D020879', 'term': 'Neuromuscular Manifestations'}, {'id': 'D010335', 'term': 'Pathologic Processes'}, {'id': 'D008171', 'term': 'Lung Diseases'}]}}, 'protocolSection': {'designModule': {'phases': ['NA'], 'studyType': 'INTERVENTIONAL', 'designInfo': {'allocation': 'RANDOMIZED', 'maskingInfo': {'masking': 'NONE'}, 'primaryPurpose': 'TREATMENT', 'interventionModel': 'PARALLEL'}, 'enrollmentInfo': {'type': 'ESTIMATED', 'count': 32}}, 'statusModule': {'overallStatus': 'NOT_YET_RECRUITING', 'startDateStruct': {'date': '2025-08-01', 'type': 'ESTIMATED'}, 'expandedAccessInfo': {'hasExpandedAccess': False}, 'statusVerifiedDate': '2024-12', 'completionDateStruct': {'date': '2027-09-01', 'type': 'ESTIMATED'}, 'lastUpdateSubmitDate': '2025-02-06', 'studyFirstSubmitDate': '2025-01-13', 'studyFirstSubmitQcDate': '2025-02-06', 'lastUpdatePostDateStruct': {'date': '2025-02-10', 'type': 'ACTUAL'}, 'studyFirstPostDateStruct': {'date': '2025-02-10', 'type': 'ACTUAL'}, 'primaryCompletionDateStruct': {'date': '2026-09-01', 'type': 'ESTIMATED'}}, 'outcomesModule': {'primaryOutcomes': [{'measure': 'Adherence to PAP Therapy', 'timeFrame': '4 weeks', 'description': 'Median hours of PAP device use per night, objectively measured via device download. Additional metrics include: % days used \\>4 hrs/night, total # of days used, total # of hours used.'}], 'secondaryOutcomes': [{'measure': 'Daytime Sleepiness', 'timeFrame': '4 weeks', 'description': 'Measured using the Epworth Sleepiness Scale (ESS). ESS is a self-administered questionnaire that asks participants to rate their likelihood of dozing off or falling asleep in eight different situations that are common in daily life. Scores range from 0 to 24, with higher scores indicating greater daytime sleepiness.'}, {'measure': 'Sleep Quality', 'timeFrame': '4 weeks', 'description': 'Measured using the Pittsburgh Sleep Quality Index (PSQI). The PSQI is a self-rated questionnaire that assesses sleep quality over the past month. The PSQI yields seven component scores, each ranging from 0 to 3, which are summed to produce a global PSQI score ranging from 0 to 21. Higher global PSQI scores indicate poorer sleep quality.'}, {'measure': 'Fatigue', 'timeFrame': '4 weeks', 'description': 'Measured using the PROMIS-Fatigue (PROMIS-F) scale. The PROMIS-F is a standardized, self-reported measure of fatigue. PROMIS-F T-scores are standardized to a mean of 50 and a standard deviation of 10. Higher T-scores indicate greater fatigue.'}, {'measure': 'PAP side effects', 'timeFrame': '4 weeks', 'description': 'Assessed using a PAP therapy side effect survey. This survey will collect information about any side effects experienced by participants as a result of using the PAP devices.'}, {'measure': 'Recruitment Rate', 'timeFrame': '4 weeks', 'description': 'Helps assess the feasibility of recruiting this specific patient population for future, larger studies. Also helps us understand if there are any barriers to participation that need to be addressed in future research. Recruitment rate will be assessed as the average number of participants enrolled per month during the recruitment period.'}]}, 'oversightModule': {'isUsExport': False, 'oversightHasDmc': False, 'isFdaRegulatedDrug': False, 'isFdaRegulatedDevice': False}, 'conditionsModule': {'keywords': ['sleep disordered breathing', 'Cervical Vertebrae', 'Obstructive Sleep Apnea', 'Spinal Cord Injuries', 'Positive Pressure Respiration', 'Continuous Positive Airway Pressure', 'Sleep Quality', 'Quadriplegia', 'Polysomnography', 'Tetraplegia', 'Sleep Wake Disorders', 'Diaphragmatic Paralysis', 'Autonomic Dysreflexia', 'Muscle Weakness', 'Nocturnal Hypoventilation', 'Phrenic Nerve', 'Pulmonary Atelectasis', 'Spinal Cord Compression', 'Ventilator Weaning', 'Neurological Rehabilitation', 'Sleep Disorders', 'Activities of Daily Living'], 'conditions': ['Spinal Cord Injuries (SCI)', 'Sleep Disordered Breathing (SDB)', 'Sleep Apnea', 'Cervical Spinal Cord Injruy']}, 'descriptionModule': {'briefSummary': 'Sleep-disordered breathing (SDB) is common in individuals with cervical spinal cord injuries, with studies suggesting prevalence rates ranging from 27% to 62%. The condition often leads to daytime sleepiness, fatigue, and poor participation in rehabilitation. Positive airway pressure therapy can be used to treat the condition; however, some individuals find continuous positive airway pressure (CPAP), which applies the same pressure during inhalation and exhalation, difficult to use. Bilevel positive airway pressure (BiPAP) offers different pressures for inhalation and exhalation, which may be more comfortable and potentially improve adherence in this patient population. However, limited evidence compares CPAP and BiPAP in individuals with cervical spinal cord injuries.\n\nThis pilot study will enroll 32 adult participants with cervical spinal cord injuries who have moderate to severe SDB (defined as an AHI of 15 events/hour or greater). Participants will be randomly assigned to either CPAP or BiPAP therapy for 4 weeks. Device usage per night will be measured, and data on daytime sleepiness, fatigue, and sleep quality will be collected at baseline, 2 weeks, and 4 weeks. The investigators aim to determine whether BiPAP improves adherence and symptoms compared to CPAP in this patient population.'}, 'eligibilityModule': {'sex': 'ALL', 'stdAges': ['ADULT', 'OLDER_ADULT'], 'minimumAge': '19 Years', 'healthyVolunteers': False, 'eligibilityCriteria': 'Inclusion Criteria:\n\n* Age \\>= 19 years\n* Cervical spinal cord injury (ASIA A, B, or C). This will include patients with upper (C1-C4) and lower (C5-C7) spinal cord injuries\n* Presence of sleep disordered breathing, defined as AHI \\> =15 events/hour by home sleep apnea test (HSAT)\n\nExclusion Criteria:\n\n* On CPAP or BiPAP prior to spinal cord injury\n* Hypoventilation syndrome (elevated venous carbon dioxide, PvCO2\\>50 mm Hg)'}, 'identificationModule': {'nctId': 'NCT06818604', 'briefTitle': 'Comparing CPAP and BiPAP for Sleep-Disordered Breathing in People with Cervical Spinal Cord Injuries', 'organization': {'class': 'OTHER', 'fullName': 'University of British Columbia'}, 'officialTitle': 'Comparison Between CPAP and BiPAP for Management of Sleep Disordered Breathing in Cervical Spinal Cord Injury Patients: a Pilot Randomized Controlled Study', 'orgStudyIdInfo': {'id': 'H24-01212'}}, 'armsInterventionsModule': {'armGroups': [{'type': 'EXPERIMENTAL', 'label': 'CPAP Therapy', 'interventionNames': ['Device: CPAP']}, {'type': 'EXPERIMENTAL', 'label': 'BiPAP Therapy', 'interventionNames': ['Device: BiPAP']}], 'interventions': [{'name': 'CPAP', 'type': 'DEVICE', 'description': 'Participants randomized to this group will receive auto-CPAP therapy. The device will be initiated by a respiratory therapist at GF Strong Rehabilitation Centre. Settings will be adjusted to achieve a device efficacy index \\< 5 events per hour.', 'armGroupLabels': ['CPAP Therapy']}, {'name': 'BiPAP', 'type': 'DEVICE', 'description': 'Participants will receive BiPAP S mode therapy for 4 weeks. The device will be initiated by a respiratory therapist at GF Strong Rehabilitation Centre with initial settings of IPAP 8 cmH2O and EPAP 3 cmH2O. Settings will be modified to a maximum tolerated level to achieve a tidal volume of 8 mL/kg ideal body weight and SpO2 \\> 95%. Overnight oximetry will be performed to ensure at least 4 hours of device use, and settings will be adjusted to achieve a DEI \\< 5 events per hour.', 'armGroupLabels': ['BiPAP Therapy']}]}, 'contactsLocationsModule': {'locations': [{'zip': 'V5Z 2G9', 'city': 'Vancouver', 'state': 'British Columbia', 'country': 'Canada', 'contacts': [{'name': 'Viet Vu', 'role': 'CONTACT', 'email': 'Viet.Vu@vch.ca', 'phone': '604-734-1313'}], 'facility': 'GF Strong Rehabilitation Centre', 'geoPoint': {'lat': 49.24966, 'lon': -123.11934}}], 'centralContacts': [{'name': 'Najib Ayas', 'role': 'CONTACT', 'email': 'nayas@providencehealth.bc.ca', 'phone': '604-875-4122'}, {'name': 'Viet Vu', 'role': 'CONTACT', 'email': 'Viet.Vu@vch.ca', 'phone': '604-734-1313'}]}, 'ipdSharingStatementModule': {'ipdSharing': 'NO'}, 'sponsorCollaboratorsModule': {'leadSponsor': {'name': 'University of British Columbia', 'class': 'OTHER'}, 'responsibleParty': {'type': 'PRINCIPAL_INVESTIGATOR', 'investigatorTitle': 'Principal Investigator', 'investigatorFullName': 'Najib Ayas', 'investigatorAffiliation': 'University of British Columbia'}}}}