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

Launched by UNIVERSITY HEALTH NETWORK, TORONTO · Jul 21, 2022

Keywords

ClinConnect Summary

The OPTIMISE SCI Trial is a study looking at how different treatments for sleep problems affect motor skills in adults who have recently suffered spinal cord injuries (SCI). The trial will divide participants into three groups: one group will start using a CPAP machine (a device that helps with breathing during sleep) early on, just six weeks after their injury; the second group will start using the CPAP machine later, at 22 weeks; and the third group will not receive treatment since they either have mild sleep issues or none at all.

To join the study, participants need to be adults aged 18 or older who have experienced a cervical or thoracic spinal cord injury within the last 30 days and haven't been treated for sleep apnea before their injury. Participants can expect to be monitored for their sleep and motor skills over the course of the trial. This study is important because it aims to understand the best timing for starting sleep treatment and how it might help improve movement and overall recovery after a spinal cord injury.

Gender

ALL

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