RECRUITINGINTERVENTIONAL
Psychosocial, Cognitive, and Behavioral Consequences of Sleep-disordered Breathing After SCI
Psychosocial, Cognitive, and Behavioral Consequences of Sleep-disordered Breathing in Spinal Cord Injured People
About This Trial
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).
Who May Be Eligible (Plain English)
Who May Qualify:
- 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
Who Should NOT Join This Trial:
- 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
Always talk to your doctor about whether this trial is right for you.
Original Eligibility Criteria
View original clinical language
Inclusion Criteria:
* 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
Exclusion Criteria:
* 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
Treatments Being Tested
OTHER
Continuous positive airway pressure (CPAP) therapy
The participants will undergo CPAP therapy for 4 consecutive months in the management of moderate-to-severe SRBDs
Locations (1)
Lyndhurst Centre, KITE - TRI UHN
Toronto, Ontario, Canada