Recruiting

Motor Impairment

Sponsor:

University Health Network, Toronto

Code:

NCT05473689

Conditions

Spinal Cord Injuries

Spine Disease

Eligibility Criteria

Sex: All

Age: 18+

Healthy Volunteers: Not accepted

Interventions

Continuous positive airway pressure (CPAP) therapy

Study Details

Brief summary:

This randomized clinical trial will compare three groups of individuals with cervical/thoracic, complete or incomplete spinal cord injury (SCI) that will undergo: (i) early CPAP therapy in the management of moderate-to-severe sleep-related breathing disorders (SRBDs) among adults at 6 weeks after SCI; (ii) delayed CPAP therapy in the management of moderate-to-severe SRBDs among adults at 22 weeks after SCI; and (iii) no treatment as they either have mild or no SRBD.

Conditions

Spinal Cord Injuries

Spine Disease

Study ID

NCT05473689

Start date

Aug 15, 2022

Status verified date

Dec, 2024

Completion date

Jul 31, 2025

Anticipated

Primary completion date

Jul 31, 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)
  • Acute (≤ 30 days after injury), cervical/thoracic (injury level at C2 to T12), complete or incomplete (AIS A to D) SCI
  • Not being treated for sleep apnea prior to the spinal cord impairment onset.

Exclusion Criteria:

  • Non-traumatic spinal cord disease at risk for neurologic progression (e.g., demyelinating spine diseases such as neuromyelitis optica and multiple sclerosis, spinal cord malignancy)
  • Concomitant diseases of the central nervous system
  • Preinjury chronic pain
  • Other pre-existing diseases of the central nervous system
  • Significant psychiatric disorders with recent episode of exacerbation
  • Neuromuscular diseases
  • Current substance misuse
  • Known history of primary hypersomnia or secondary hypersomnia of any cause except for SRBDs (e.g., hypothyroidism, moderate or severe iron deficiency anemia, infections, depression, kidney failure, chronic fatigue syndrome, neurodegenerative diseases, and myotonic dystrophy)
  • Epilepsy
  • Vitamin B12 deficiency

Study Design

Enrollment

66 participants

Anticipated

Allocation

Randomized

Intervention Model

Parallel Assignment

Primary purpose

Treatment

Interventions and Outcome Measures

Arms

experimental: Early-CPAP therapy group

Individuals diagnosed with moderate-to-severe sleep-related breathing disorders (SRBDs) who will start CPAP therapy within the first 6 weeks after SCI.

active comparator: Delayed-CPAP therapy group

Individuals diagnosed with moderate-to-severe SRBDs who will start on CPAP therapy at the 5th month after SCI.

no intervention: Non-CPAP therapy group

Individuals who are diagnosed with no or mild SRBD.

Interventions

Continuous positive airway pressure (CPAP) therapy

Continuous positive airway pressure (CPAP) therapy for moderate-to-severe sleep-related breathing disorders.

Primary outcome measure

  • Change in International Standards for Neurological Classification of SCI (ISNCSCI) motor subscore from baseline to 6 months after recruitment [ Time Frame: From baseline to 6 months after recruitment ]
  • Change in International from baseline to 6 months after recruitment Standards for Neurological Classification of SCI (ISNCSCI) sensory subscore [ Time Frame: From baseline to 6 months after recruitment ]
  • Change in Spinal Cord Independence Measure (SCIM) - version III - score from baseline to 6 months after recruitment [ Time Frame: From baseline to 6 months after recruitment ]

Central Contacts and Locations

Central contacts

Lamisa Etu, BSc

4165973422LamisaFaria.Etu@uhn.ca

Locations

KITE Toronto Research Institute

Recruiting

Toronto, Ontario, Canada, M4G 3V9

Contacts

Mitsue Aibe

4165973422Mitsue.Aibe@uhn.ca

More Information

Sponsor

University Health Network, Toronto

Last update posted

Dec 11, 2024

Last verified

Dec, 2024

Keywords

  • sleep apnea
  • 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.