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Not yet recruiting NCT06818604

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

No phase Interventional Spinal Cord Injuries (SCI) Sleep Disordered Breathing (SDB) Sleep Apnea Cervical Spinal Cord Injruy

For patients and families

In plain language

An automatic summary of structured registry data. It is an orientation aid, not a substitute for the official protocol or a physician assessment.

What is being studied
The protocol lists: CPAP, BiPAP.
Who it may be relevant to
Registry conditions: Spinal Cord Injuries (SCI), Sleep Disordered Breathing (SDB), Sleep Apnea, Cervical Spinal Cord Injruy. Basic parameters: from 19 years · All.
What needs checking
Age, condition and sex are only basic indicators. Prior treatment, laboratory values and other mandatory requirements appear in the eligibility criteria below.
Where it takes place
Canada
Next step
Save the trial, show it to the treating physician, and confirm current recruitment with the study center. Costs, documents and travel →

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Official title

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

Overview

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.

Interventions

  • 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.
  • 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.

Primary outcome measures

  • Adherence to PAP Therapy [Time frame: 4 weeks]
Secondary outcome measures (5)
  • Daytime Sleepiness [Time frame: 4 weeks]
  • Sleep Quality [Time frame: 4 weeks]
  • Fatigue [Time frame: 4 weeks]
  • PAP side effects [Time frame: 4 weeks]
  • Recruitment Rate [Time frame: 4 weeks]

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)

Criteria are shown verbatim from the registry (in English). Final eligibility is always assessed by the study center.

Healthy volunteers: No

Study design

Allocation
Randomized
Model
Parallel assignment
Masking
Open label
Primary purpose
Treatment

Study locations

Canada · 1 center
  • GF Strong Rehabilitation Centre — Vancouver

Identifiers

NCT: NCT06818604 · H24-01212

Primary sources (government registries)

View this study on ClinicalTrials.gov ↗