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

Not Applicable

Not yet recruiting

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

• Registration Number: NCT06818604
• Lead Sponsor: University of British Columbia

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.

Detailed Description

Not available

Study Timeline

• Status Verified: 2024-12
• Study First Submitted: 2025-01-13
• Study First Submitted QC: 2025-02-06
• Last Update Submitted: 2025-02-06
• Study First Posted: 2025-02-10
• Last Update Posted: 2025-02-10
• Study Start: 2025-08-01
• Primary Completion: 2026-09-01
• Study Completion: 2027-09-01

Recruitment & Eligibility

• Status: NOT_YET_RECRUITING
• Sex: All
• Target Recruitment: 32

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)

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: PARALLEL

Primary Outcome Measures

Name	Time	Method
Adherence to PAP Therapy	4 weeks	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.

Secondary Outcome Measures

Name	Time	Method
PAP side effects	4 weeks	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.
Sleep Quality	4 weeks	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.
Daytime Sleepiness	4 weeks	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.
Fatigue	4 weeks	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.
Recruitment Rate	4 weeks	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.

Trial Locations

Locations (1)

GF Strong Rehabilitation Centre; 🇨🇦 Vancouver, British Columbia, Canada