Clinical trial NCT06818604: Comparing CPAP and BiPAP for Sleep-Disordered Breathing in People with Cervical Spinal Cord Injuries
Official title: Comparison Between CPAP and BiPAP for Management of Sleep Disordered Breathing in Cervical Spinal Cord Injury Patients: a Pilot Randomized Controlled Study
Study type: INTERVENTIONAL
Overall status: NOT_YET_RECRUITING
Phase: NA
Conditions: Spinal Cord Injuries (SCI)
Sleep Disordered Breathing (SDB)
Sleep Apnea
Cervical Spinal Cord Injruy
Keywords: sleep disordered breathing
Cervical Vertebrae
Obstructive Sleep Apnea
Spinal Cord Injuries
Positive Pressure Respiration
Continuous Positive Airway Pressure
Sleep Quality
Quadriplegia
Polysomnography
Tetraplegia
Sleep Wake Disorders
Diaphragmatic Paralysis
Autonomic Dysreflexia
Muscle Weakness
Nocturnal Hypoventilation
Phrenic Nerve
Pulmonary Atelectasis
Spinal Cord Compression
Ventilator Weaning
Neurological Rehabilitation
Sleep Disorders
Activities of Daily Living
Lead sponsor: University of British Columbia
Sponsor class: OTHER
First posted: 2025-02-10
Enrollment: 32
Sex: ALL
Minimum age (years): 19
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: TREATMENT

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.


Eligibility criteria: 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)

Primary outcomes:
measure: Adherence to PAP Therapy
timeFrame: 4 weeks
Secondary outcomes:
measure: Daytime Sleepiness
timeFrame: 4 weeks
measure: Sleep Quality
timeFrame: 4 weeks
measure: Fatigue
timeFrame: 4 weeks
measure: PAP side effects
timeFrame: 4 weeks
measure: Recruitment Rate
timeFrame: 4 weeks
Other outcomes:
Locations:
city: Vancouver
country: Canada
facility: GF Strong Rehabilitation Centre
state: British Columbia
Study officials:
References: