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

Study Overview
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Brief Summary
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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.

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

Conditions
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Spinal Cord Injuries, Spine Disease

Intervention / Treatment
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* Device: Continuous positive airway pressure (CPAP) therapy


Participation Criteria
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Eligibility Criteria
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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

Ages Eligible for Study
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Minimum Age: 18 Years

Sexes Eligible for Study
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All

Accepts Healthy Volunteers
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No

Study Plan
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How is the study designed?
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Design Details

Primary Purpose: Treatment
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Single


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Experimental: Early-CPAP therapy group<br>Individuals diagnosed with moderate-to-severe sleep-related breathing disorders (SRBDs) who will start CPAP therapy within the first 6 weeks after SCI. | Device: Continuous positive airway pressure (CPAP) therapy<br>* Continuous positive airway pressure (CPAP) therapy for moderate-to-severe sleep-related breathing disorders.<br>|
| Active Comparator: Delayed-CPAP therapy group<br>Individuals diagnosed with moderate-to-severe SRBDs who will start on CPAP therapy at the 5th month after SCI. | Device: Continuous positive airway pressure (CPAP) therapy<br>* Continuous positive airway pressure (CPAP) therapy for moderate-to-severe sleep-related breathing disorders.<br>|
| No Intervention: Non-CPAP therapy group<br>Individuals who are diagnosed with no or mild SRBD. | |

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Change in International Standards for Neurological Classification of SCI (ISNCSCI) motor subscore from baseline to 6 months after recruitment | Motor assessment of muscles in the upper and lower extremities (100: normal; 0: complete paresis) | 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 | Sensory assessment of dermatomes in the upper and lower extremities (224: normal; 0: no sensory function) | From baseline to 6 months after recruitment | 
| Change in Spinal Cord Independence Measure (SCIM) - version III - score 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). | From baseline to 6 months after recruitment | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Change in Fatigue Severity Scale (FSS) from baseline to 6 months after recruitment | The FSS scores vary from 9 (normal) to 56 (the most severe degree of fatigue) | From baseline to 6 months after recruitment | 
| Change in Depression, Anxiety & Stress Scales- 21 (DASS-21) score 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). | From baseline to 6 months after recruitment | 
| Change in Patient Health Questionnaire (PHQ-9) score 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. | From baseline to 6 months after recruitment | 
| Change in Medical Outcomes Study Sleep Scale (MOS-SS) 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. | From baseline to 6 months after recruitment | 
| Change in Montreal Cognitive Assessment (MoCA test) score from baseline to 6 months after recruitment | The MoCA test scores vary from 0 to 30 (normal). | From baseline to 6 months after recruitment | 

 Terms related to the study
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Keywords Provided by Centre Hospitalier Valida
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sleep apnea, sleep-related breathing disorders