Psychosocial, Cognitive, and Behavioral Consequences of Sleep-disordered Breathing After SCI

Recruiting now · Not applicable

Conditions studied: Spinal Cord Injuries, Sleep Apnea

In brief

This clinical trial will examine the efficacy of continuous positive airway pressure (CPAP) therapy in improving psychosocial, neurocognitive and behavioral consequences of moderate-to-severe sleep-related breathing disorders (SRBDs) in people living with spinal cord injury (SCI).

Key facts

Study ID

NCT04007380

Run by

University Health Network, Toronto

People needed

24

Starts

2019-09-27

Expected to finish

2025-08-30

Last updated by the study team

2024-12-11

Who can join

Age: 18 and older. Sex: any. Healthy volunteers: not accepted.

You may qualify if…

• English-speaking adults 18 years of age or older
• Have traumatic cervical/thoracic (injury level at C5 to T10), severe or moderate (AIS A, B, or C) SCI who were not diagnosed with a sleep disorder prior to the injury.
• At least 2 months after injury
• Clinical warning symptoms and/or signs for SRBDs

You may not qualify if…

• Patients with a non-traumatic spinal cord disease at risk for neurologic progression
• Concomitant diseases of the central nervous system
• Preinjury chronic pain
• Psychiatric disorders that may prevent the participant to be compliant to the study protocol requirements
• Neuromuscular diseases
• Current substance misuse
• History of primary hypersomnia
• Hypothyroidism
• Moderate or severe iron deficiency anemia
• Active infection
• Kidney failure
• Epilepsy
• Chronic fatigue syndrome
• Vitamin B12 deficiency

Where it is running

• Lyndhurst Centre, KITE - TRI UHN — Toronto, Ontario, Canada (enrolling)

Full record on ClinicalTrials.gov

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