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

University Health Network, Toronto

Status: Enrolling

Conditions: Spinal Cord Injuries; Spine Disease

Treatments: Device: Continuous positive airway pressure (CPAP) therapy

Study type: Interventional

Funder types: Other

Identifiers

NCT05473689

21-6214

Details and patient eligibility

About

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.

Enrollment: 66 estimated patients

Sex: All

Ages: 18+ years old

Volunteers: No Healthy Volunteers

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

Trial design

Primary purpose: Treatment

Allocation: Randomized

Interventional model: Parallel Assignment

Masking: Single Blind

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66 participants in 3 patient groups

Early-CPAP therapy group

Experimental group

Description:

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

Treatment:

Device: Continuous positive airway pressure (CPAP) therapy

Delayed-CPAP therapy group

Active Comparator group

Description:

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

Treatment:

Device: Continuous positive airway pressure (CPAP) therapy

Non-CPAP therapy group

No Intervention group

Description:

Individuals who are diagnosed with no or mild SRBD.