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

Not Applicable

Recruiting

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.

Recruitment & Eligibility

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

Arm && Interventions

Group	Intervention	Description
Early-CPAP therapy group	Continuous positive airway pressure (CPAP) therapy	Individuals diagnosed with moderate-to-severe sleep-related breathing disorders (SRBDs) who will start CPAP therapy within the first 6 weeks after SCI.
Delayed-CPAP therapy group	Continuous positive airway pressure (CPAP) therapy	Individuals diagnosed with moderate-to-severe SRBDs who will start on CPAP therapy at the 5th month after SCI.

Primary Outcome Measures

Name	Time	Method
Change in International from baseline to 6 months after recruitment Standards for Neurological Classification of SCI (ISNCSCI) sensory subscore	From baseline to 6 months after recruitment	Sensory assessment of dermatomes in the upper and lower extremities (224: normal; 0: no sensory function)
Change in Spinal Cord Independence Measure (SCIM) - version III - score from baseline to 6 months after recruitment	From baseline to 6 months after recruitment	The SCIM scores varies from 0 to 100 and includes the following subscores: self-care (0-20); respiration and sphincter management (0-40); mobility (0-40).
Change in International Standards for Neurological Classification of SCI (ISNCSCI) motor subscore from baseline to 6 months after recruitment	From baseline to 6 months after recruitment	Motor assessment of muscles in the upper and lower extremities (100: normal; 0: complete paresis)

Secondary Outcome Measures

Name	Time	Method
Change in Fatigue Severity Scale (FSS) from baseline to 6 months after recruitment	From baseline to 6 months after recruitment	The FSS scores vary from 9 (normal) to 56 (the most severe degree of fatigue)
Change in Medical Outcomes Study Sleep Scale (MOS-SS) from baseline to 6 months after recruitment	From baseline to 6 months after recruitment	Scores for the sleep disturbance, snoring, respiratory problems, sleep adequacy, and daytime somnolence dimensions range from 0 (normal) to 100.
Change in Depression, Anxiety & Stress Scales- 21 (DASS-21) score from baseline to 6 months after recruitment	From baseline to 6 months after recruitment	The DASS-21 scores vary from 0 (normal) to 42 (most severe symptoms of depression, anxiety and stress).
Change in Patient Health Questionnaire (PHQ-9) score from baseline to 6 months after recruitment	From baseline to 6 months after recruitment	The PHQ-9 scores vary from 0 to 27, which means: 0-4 is the normal or minimal; 5-9 if the person is mildly depressed; 10-14 if the person is moderately depressed; 15-19 if the person has moderately severe depression; and 20-27 if the person is severely depressed.
Change in Montreal Cognitive Assessment (MoCA test) score from baseline to 6 months after recruitment	From baseline to 6 months after recruitment	The MoCA test scores vary from 0 to 30 (normal).