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

Sponsor
University of British Columbia
Study ID
NCT06818604
Status
Not Yet Recruiting

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Conditions

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

Eligibility Criteria

Sex
ALL
Age
19 Years - N/A
Healthy Volunteers
Not accepted

Interventions

  • CPAP — 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 — 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.

Study Details

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.

Key Dates

First listed
Feb 10, 2025
Start date
Aug 1, 2025
Status verified
Dec 2024
Primary completion
Sep 1, 2026
Completion
Sep 1, 2027

Study Design

Enrollment
32 participants (estimated)
Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
TREATMENT

Arms

  • Experimental: CPAP Therapy
  • Experimental: BiPAP Therapy

Primary Outcome Measure

Adherence to PAP Therapy [ Time Frame: 4 weeks ]

Central Contacts

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