Clinical trial NCT05473689: Outcomes Post Treatment: Impact on Motor Impairment of Sleep Efficiency in SCI (OPTIMISE SCI Trial)
Official title: Outcomes Post Treatment: Impact on Motor Impairment of Sleep Efficiency in SCI (OPTIMISE SCI Trial)
Study type: INTERVENTIONAL
Overall status: RECRUITING
Phase: NA
Conditions: Spinal Cord Injuries
Spine Disease
Keywords: sleep apnea
sleep-related breathing disorders
Lead sponsor: University Health Network, Toronto
Sponsor class: OTHER
Collaborators: name: Sunnybrook Health Sciences Centre
First posted: 2022-07-26
Enrollment: 66
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: TREATMENT

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.


Eligibility criteria: 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

Primary outcomes:
measure: Change in International Standards for Neurological Classification of SCI (ISNCSCI) motor subscore from baseline to 6 months after recruitment
timeFrame: From baseline to 6 months after recruitment
measure: Change in International from baseline to 6 months after recruitment Standards for Neurological Classification of SCI (ISNCSCI) sensory subscore
timeFrame: From baseline to 6 months after recruitment
measure: Change in Spinal Cord Independence Measure (SCIM) - version III - score from baseline to 6 months after recruitment
timeFrame: From baseline to 6 months after recruitment
Secondary outcomes:
measure: Change in Fatigue Severity Scale (FSS) from baseline to 6 months after recruitment
timeFrame: From baseline to 6 months after recruitment
measure: Change in Depression, Anxiety & Stress Scales- 21 (DASS-21) score from baseline to 6 months after recruitment
timeFrame: From baseline to 6 months after recruitment
measure: Change in Patient Health Questionnaire (PHQ-9) score from baseline to 6 months after recruitment
timeFrame: From baseline to 6 months after recruitment
measure: Change in Medical Outcomes Study Sleep Scale (MOS-SS) from baseline to 6 months after recruitment
timeFrame: From baseline to 6 months after recruitment
measure: Change in Montreal Cognitive Assessment (MoCA test) score from baseline to 6 months after recruitment
timeFrame: From baseline to 6 months after recruitment
Other outcomes:
Locations:
city: Toronto
country: Canada
facility: KITE Toronto Research Institute
state: Ontario
Study officials:
affiliation: KITE Research Institute, University Health Network
name: Julio C Furlan, MD, FRCPC
role: PRINCIPAL_INVESTIGATOR
References: