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NCT Number: NCT06818604

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

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.

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Key information

Conditions

Spinal Cord Injuries (SCI) Apnea Autonomic Dysreflexia Autonomic Nervous System Diseases Central Nervous System Diseases Cervical Spinal Cord Injruy Dyssomnias Lung Diseases Mental Disorders Muscle Weakness Muscular Diseases Musculoskeletal Diseases Nervous System Diseases Neurologic Manifestations Neuromuscular Manifestations Paralysis Pathologic Processes Pathological Conditions, Signs and Symptoms Pulmonary Atelectasis Quadriplegia Respiration Disorders Respiratory Insufficiency Respiratory Paralysis Respiratory Tract Diseases Signs and Symptoms Sleep Apnea Sleep Apnea Syndromes Sleep Apnea, Obstructive Sleep Disordered Breathing (SDB) Sleep Disorders, Intrinsic Sleep Initiation and Maintenance Disorders Sleep Wake Disorders Spinal Cord Compression Spinal Cord Diseases Spinal Cord Injuries Trauma, Nervous System Wounds and Injuries

Age range

19 year and older

Sex eligibility

All sexes

Study type

Interventional

Phase

Not applicable

Primary location

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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)

Treatment and study plan

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.

Primary outcomes

  1. Adherence to PAP Therapy

    Time frame: 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 outcomes

  1. Daytime Sleepiness

    Time frame: 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.

  2. Sleep Quality

    Time frame: 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.

  3. Fatigue

    Time frame: 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.

  4. PAP side effects

    Time frame: 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.

  5. Recruitment Rate

    Time frame: 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.

Study contacts

Contact information is provided by the study sponsor or research team.

Najib Ayas

CONTACT

[email protected]

604-875-4122

Viet Vu

CONTACT

[email protected]

604-734-1313

Sponsors and collaborators

Lead sponsor

University of British Columbia

Other

Registry information

Official study title

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

Important dates

Study start
2025
Primary completion
2026
Study completion
2027
First posted
Feb 10, 2025
Registry last updated
Feb 10, 2025

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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