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

University of British Columbia

Status: Not yet enrolling

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

Treatments: Device: CPAP; Device: BiPAP

Study type: Interventional

Funder types: Other

Identifiers

NCT06818604

H24-01212

Details and patient eligibility

About

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.

Enrollment: 32 estimated patients

Sex: All

Ages: 19+ years old

Volunteers: No Healthy Volunteers

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)

Trial design

Primary purpose: Treatment

Allocation: Randomized

Interventional model: Parallel Assignment

Masking: None (Open label)

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32 participants in 2 patient groups

CPAP Therapy

Experimental group

Treatment:

Device: CPAP

BiPAP Therapy

Experimental group

Treatment:

Device: BiPAP