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
Qualifiers
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
Treatments tested in this trial
- Continuous positive airway pressure (CPAP) therapy
Treatment groups
66 Participants
are divided into 3 treatment groupsSponsors and collaborators
University Health Network, Toronto
Lead sponsor
Sunnybrook Health Sciences Centre
Collaborator
Source ClinicalTrials.gov