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

Comparison Between CPAP and BiPAP for Management of Sleep Disordered Breathing in Cervical Spinal Cord Injury Patients: a Pilot Randomized Controlled Study

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.

Study Overview

• Status: Not yet recruiting
• Conditions: Sleep Apnea; Spinal Cord Injuries (SCI); Sleep Disordered Breathing (SDB); Cervical Spinal Cord Injruy
• Intervention / Treatment: Device: CPAP; Device: BiPAP

• Study Type: Interventional
• Enrollment (Estimated): 32
• Phase: Not Applicable

Contacts and Locations

• Study Contact: Name: Najib Ayas; Phone Number: 604-875-4122; Email: nayas@providencehealth.bc.ca
• Study Contact Backup: Name: Viet Vu; Phone Number: 604-734-1313; Email: Viet.Vu@vch.ca

Study Locations

• Canada
  • British Columbia
    • Vancouver, British Columbia, Canada, V5Z 2G9
      • GF Strong Rehabilitation Centre
      • Contact: Viet Vu; Phone Number: 604-734-1313; Email: Viet.Vu@vch.ca

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: Adult; Older Adult
• Accepts Healthy Volunteers: No

Description

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 Plan

How is the study designed?

Design Details

• Primary Purpose: Treatment
• Allocation: Randomized
• Interventional Model: Parallel Assignment
• Masking: None (Open Label)

Number of Arms

2

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
Experimental: CPAP Therapy	Device: 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.
Experimental: BiPAP Therapy	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.

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Adherence to PAP Therapy	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.	4 weeks

Secondary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Daytime Sleepiness	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.	4 weeks
Sleep Quality	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.	4 weeks
Fatigue	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.	4 weeks
PAP side effects	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.	4 weeks
Recruitment Rate	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.	4 weeks

Collaborators and Investigators

• Sponsor: University of British Columbia

Study record dates

Study Major Dates

• Study Start (Estimated): August 1, 2025
• Primary Completion (Estimated): September 1, 2026
• Study Completion (Estimated): September 1, 2027

Study Registration Dates

• First Submitted: January 13, 2025
• First Submitted That Met QC Criteria: February 6, 2025
• First Posted (Actual): March 25, 2025

Study Record Updates

• Last Update Posted (Actual): March 25, 2025
• Last Update Submitted That Met QC Criteria: February 6, 2025
• Last Verified: December 1, 2024

More Information

Terms related to this study

• Keywords: Continuous Positive Airway Pressure; Obstructive Sleep Apnea; Polysomnography; Sleep Quality; Activities of Daily Living; Sleep Disorders; Ventilator Weaning; Muscle Weakness; Tetraplegia; sleep disordered breathing; Spinal Cord Injuries; Neurological Rehabilitation; Quadriplegia; Diaphragmatic Paralysis; Sleep Wake Disorders; Autonomic Dysreflexia; Spinal Cord Compression; Phrenic Nerve; Nocturnal Hypoventilation; Pulmonary Atelectasis; Positive Pressure Respiration; Cervical Vertebrae
• Additional Relevant MeSH Terms: Central Nervous System Diseases; Nervous System Diseases; Pathologic Processes; Respiratory Tract Diseases; Respiration Disorders; Sleep Wake Disorders; Apnea; Sleep Disorders, Intrinsic; Dyssomnias; Trauma, Nervous System; Spinal Cord Diseases; Wounds and Injuries; Respiratory Aspiration; Sleep Apnea Syndromes; Spinal Cord Injuries
• Other Study ID Numbers: H24-01212

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: NO

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: No
• product manufactured in and exported from the U.S.: No