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

Spinal Cord Injuries Clinical Trial

Official title:
Psychosocial, Cognitive, and Behavioral Consequences of Sleep-disordered Breathing in Spinal Cord Injured People

Clinical Trial Summary

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).

Clinical Trial Description

SCI is a potentially catastrophic event for individuals who may sustain motor, sensory, and autonomic deficit, as well as secondary conditions including SRBDs. The SRBDs include central, obstructive and mixed sleep apnea that can occur in up to 50% of the paraplegics and up to 91% of the motor complete tetraplegics. Although the frequency of SRBDs after SCI is much greater than in able-bodied people, this condition is still a largely under-recognized in the SCI population. With this, the investigators hypothesize that regular use of CPAP for treatment of moderate-to-severe SRBDs in individuals living with SCI significantly improve their fatigue, depressive symptoms, anxiety, cognitive impairment, quality of life, and social and work participation. This research project will include: (i) a single-arm clinical trial to evaluate the efficacy of nightly use of CPAP for 4 consecutive months in the management of moderate-to-severe SRBDs among 24 adults with subacute to chronic, cervical or thoracic, complete or incomplete SCI; and (ii) a qualitative study of the challenges experienced by the 24 people with SCI who undergo an unattended-hospital or home-based sleep study for diagnosis of SRBDs followed by CPAP therapy. Overall, this clinical study has the potential to ultimately improve fatigue, mood, cognition, quality of life, and social and work participation of people living with SCI, by examining under-explored links with the SRBDs. ;

Study Design

Related Conditions & MeSH terms

Clinical Trial Details
NCT number NCT04007380
Study type Interventional
Source University Health Network, Toronto
Contact Mitsue Aibe, MD
Phone 4165973422
Email Mitsue.Aibe@uhn.ca
Status Recruiting
Phase N/A
Start date September 27, 2019
Completion date April 30, 2024
View Details
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