RecruitingNot ApplicableNCT05473689

Outcomes Post Treatment: Impact on Motor Impairment of Sleep Efficiency in SCI (OPTIMISE SCI Trial)

Sponsor

University Health Network, Toronto

Enrollment

66 participants

Start Date

Aug 15, 2022

Study Type

INTERVENTIONAL

Conditions

Spinal Cord Injuries Spine Disease

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.

Eligibility

Min Age: 18 Years

Inclusion Criteria3

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 Criteria10

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

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