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

NCT06818604 | Not Yet Recruiting

• 1 other identifier: H24-01212
• Study Type: interventional
• Target: 32
• Locations: 1 country
• Sites: 1

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.

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

Outcome Measures

Primary Outcomes (1)

• 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 Outcomes (5)

• Daytime Sleepiness

  4 weeks

• Sleep Quality

  4 weeks

• Fatigue

  4 weeks

• PAP side effects

  4 weeks

• Recruitment Rate

  4 weeks

Study Arms (2)

CPAP Therapy

EXPERIMENTAL

Device: CPAP

BiPAP Therapy

EXPERIMENTAL

Device: BiPAP

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.

CPAP Therapy

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.

BiPAP Therapy

Eligibility Criteria

• Age: 19 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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)

You may not qualify if:

• On CPAP or BiPAP prior to spinal cord injury
• Hypoventilation syndrome (elevated venous carbon dioxide, PvCO2\>50 mm Hg)

Sponsors & Collaborators

• University of British Columbia: lead

Study Sites (1)

GF Strong Rehabilitation Centre

Vancouver, British Columbia, V5Z 2G9, Canada

Location

MeSH Terms

Conditions

Spinal Cord Injuries; Sleep Apnea Syndromes; Sleep Apnea, Obstructive; Sleep Initiation and Maintenance Disorders; Quadriplegia; Sleep Wake Disorders; Respiratory Paralysis; Autonomic Dysreflexia; Muscle Weakness; Pulmonary Atelectasis; Spinal Cord Compression

Condition Hierarchy (Ancestors)

Spinal Cord Diseases; Central Nervous System Diseases; Nervous System Diseases; Trauma, Nervous System; Wounds and Injuries; Apnea; Respiration Disorders; Respiratory Tract Diseases; Sleep Disorders, Intrinsic; Dyssomnias; Mental Disorders; Paralysis; Neurologic Manifestations; Signs and Symptoms; Pathological Conditions, Signs and Symptoms; Respiratory Insufficiency; Autonomic Nervous System Diseases; Muscular Diseases; Musculoskeletal Diseases; Neuromuscular Manifestations; Pathologic Processes; Lung Diseases

Central Study Contacts

Najib Ayas

CONTACT

604-875-4122; nayas@providencehealth.bc.ca

Viet Vu

CONTACT

604-734-1313; Viet.Vu@vch.ca

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: NONE
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Principal Investigator

Study Record Dates

• First Submitted: January 13, 2025
• First Posted: February 10, 2025
• Study Start: August 1, 2025
• Primary Completion (Estimated): September 1, 2026
• Study Completion (Estimated): September 1, 2027
• Last Updated: February 10, 2025

Record last verified: 2024-12

Data Sharing

• IPD Sharing: Will not share

Locations

CA (1)