Recruiting

Observational Study

Sponsor:

University Health Network, Toronto

Code:

NCT04007380

Conditions

Spinal Cord Injuries

Sleep Apnea

Eligibility Criteria

Sex: All

Age: 18+

Healthy Volunteers: Not accepted

Interventions

Continuous positive airway pressure (CPAP) therapy

Study Details

Brief summary:

This clinical trial will examine the efficacy of continuous positive airway pressure (CPAP) therapy in improving psychosocial, neurocognitive and behavioral consequences of moderate-to-severe sleep-related breathing disorders (SRBDs) in people living with spinal cord injury (SCI).

Conditions

Spinal Cord Injuries

Sleep Apnea

Study ID

NCT04007380

Start date

Sep 27, 2019

Status verified date

Dec, 2024

Completion date

Aug 30, 2025

Anticipated

Primary completion date

Aug 30, 2025

Anticipated

Eligibility Criteria

Eligibility Criteria

Sex: All

Age: 18+

Healthy Volunteers: Not accepted

Inclusion Criteria:

  • English-speaking adults 18 years of age or older
  • Have traumatic cervical/thoracic (injury level at C5 to T10), severe or moderate (AIS A, B, or C) SCI who were not diagnosed with a sleep disorder prior to the injury.
  • At least 2 months after injury
  • Clinical warning symptoms and/or signs for SRBDs

Exclusion Criteria:

  • Patients with a non-traumatic spinal cord disease at risk for neurologic progression
  • Concomitant diseases of the central nervous system
  • Preinjury chronic pain
  • Psychiatric disorders that may prevent the participant to be compliant to the study protocol requirements
  • Neuromuscular diseases
  • Current substance misuse
  • History of primary hypersomnia
  • Hypothyroidism
  • Moderate or severe iron deficiency anemia
  • Active infection
  • Kidney failure
  • Epilepsy
  • Chronic fatigue syndrome
  • Vitamin B12 deficiency

Study Design

Enrollment

24 participants

Anticipated

Intervention Model

Single group

Primary purpose

Treatment

Interventions and Outcome Measures

Arms

other: CPAP-therapy arm

This single-arm clinical trial will examine the effects of 4-month period CPAP therapy in individuals living with SCI. The CPAP will be adjusted according to the results of the auto-titrating CPAP testing for each participant.

Interventions

Continuous positive airway pressure (CPAP) therapy

The participants will undergo CPAP therapy for 4 consecutive months in the management of moderate-to-severe SRBDs

Primary outcome measure

  • Fatigue Severity Scale [ Time Frame: Change in Fatigue Severity Scale from baseline to after 4-month period of CPAP therapy ]

Central Contacts and Locations

Central contacts

Mitsue Aibe, MD

4165973422Mitsue.Aibe@uhn.ca

Julio Furlan, MD

4165973422Julio.Furlan@uhn.ca

Locations

Lyndhurst Centre, KITE - TRI UHN

Recruiting

Toronto, Ontario, Canada

Contacts

Mitsue Aibe, MD

416-597-3422Mitsue.Aibe@uhn.ca

More Information

Sponsor

University Health Network, Toronto

Last update posted

Dec 11, 2024

Last verified

Dec, 2024

Keywords

  • Spinal cord injuries
  • Sleep-related breathing disorders

Trial information was received from ClinicalTrials.gov and was last updated on 2026-09-10. This information was provided to ClinicalTrials.gov by University Health Network, Toronto on 2024-12-11.