Comparing CPAP and BiPAP for Sleep-Disordered Breathing in People with Cervical Spinal Cord Injuries

NCT ID: NCT06818604

Last Updated: 2025-02-10

Basic Information

• Recruitment Status: NOT_YET_RECRUITING
• Clinical Phase: NA
• Total Enrollment: 32 participants
• Study Classification: INTERVENTIONAL
• Study Start Date: 2025-08-01
• Study Completion Date: 2027-09-01

Brief Summary

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.

This 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.

Conditions

Spinal Cord Injuries (SCI); Sleep Disordered Breathing (SDB); Sleep Apnea; Cervical Spinal Cord Injruy

Study Design

• Allocation Method: RANDOMIZED
• Intervention Model: PARALLEL
• Primary Study Purpose: TREATMENT
• Blinding Strategy: NONE

Study Groups

CPAP Therapy

Group Type: EXPERIMENTAL

CPAP

Intervention Type: DEVICE

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.

BiPAP Therapy

Group Type: EXPERIMENTAL

BiPAP

Intervention Type: DEVICE

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.

Interventions

CPAP

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.

Intervention Type: DEVICE

BiPAP

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.

Intervention Type: DEVICE

Eligibility Criteria

Inclusion Criteria

• Age >= 19 years
• Cervical spinal cord injury (ASIA A, B, or C). This will include patients with upper (C1-C4) and lower (C5-C7) spinal cord injuries
• Presence of sleep disordered breathing, defined as AHI > =15 events/hour by home sleep apnea test (HSAT)

Exclusion Criteria

• On CPAP or BiPAP prior to spinal cord injury
• Hypoventilation syndrome (elevated venous carbon dioxide, PvCO2>50 mm Hg)

• Minimum Eligible Age: 19 Years
• Eligible Sex: ALL
• Accepts Healthy Volunteers: No

Sponsors

University of British Columbia

OTHER

Sponsor Role: lead

Responsible Party

Najib Ayas

Principal Investigator

Responsibility Role: PRINCIPAL_INVESTIGATOR

Locations

GF Strong Rehabilitation Centre

Vancouver, British Columbia, Canada

Countries

Canada

Central Contacts

Najib Ayas

Role: CONTACT

nayas@providencehealth.bc.ca

604-875-4122

Viet Vu

Role: CONTACT

Viet.Vu@vch.ca

604-734-1313

Facility Contacts

Viet Vu

Role: primary

Viet.Vu@vch.ca

604-734-1313

Other Identifiers

H24-01212

Identifier Type: -

Identifier Source: org_study_id