Outcomes Post Treatment: Impact on Motor Impairment of Sleep Efficiency in SCI (OPTIMISE SCI Trial)
Trial statusRecruiting
Trial phaseNot applicable
Trial typeInterventional
Biological sexAll
Age18+
SponsorUniversity Health Network, Toronto
About this trial
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
This trial does not accept healthy volunteersQualifiers
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.
Disqualifiers
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
Trial design
Design model
Parallel
Treatments tested in this trial
Continuous positive airway pressure (CPAP) therapy
DeviceContinuous positive airway pressure (CPAP) therapy for moderate-to-severe sleep-related breathing disorders.
Treatment groups
66 Participants
are divided into 3 treatment groupsGroup A: Early-CPAP therapy groupExperimental treatment 1 intervention
Group B: Delayed-CPAP therapy groupActive comparator 1 intervention
Group C: Non-CPAP therapy groupNo intervention 0 interventions
Trial outcomes
Primary outcomes
1
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)
Time frame
From baseline to 6 months after recruitment2
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)
Time frame
From baseline to 6 months after recruitment3
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).
Time frame
From baseline to 6 months after recruitmentSecondary outcomes
1
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)
Time frame
From baseline to 6 months after recruitment2
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).
Time frame
From baseline to 6 months after recruitment3
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.
Time frame
From baseline to 6 months after recruitment4
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.
Time frame
From baseline to 6 months after recruitmentSponsors and contacts
Click on the lead sponsor to view all of their trials.
University Health Network, Toronto
Lead sponsor
Sunnybrook Health Sciences Centre
Collaborator
Source ClinicalTrials.gov