NCT04007380

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

• Status: Recruiting
• Phase: N/A
• Study type: Interventional
• Enrollment: 24 (estimated)
• Sponsor: University Health Network, Toronto · Academic / Other
• Sex: All
• Age: 18 Years
• Healthy volunteers: Not accepted

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).

Detailed 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.

Conditions

• Spinal Cord Injuries
• Sleep Apnea

Interventions

Type	Name	Description
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

Timeline

• Start date: 2019-09-27
• Primary completion: 2025-08-30
• Completion: 2025-08-30
• First posted: 2019-07-05
• Last updated: 2024-12-11

Locations

1 site across 1 country: Canada