Clinical trial NCT04007380: Psychosocial, Cognitive, and Behavioral Consequences of Sleep-disordered Breathing After SCI
Official title: Psychosocial, Cognitive, and Behavioral Consequences of Sleep-disordered Breathing in Spinal Cord Injured People
Study type: INTERVENTIONAL
Overall status: RECRUITING
Phase: NA
Conditions: Spinal Cord Injuries
Sleep Apnea
Keywords: Spinal cord injuries
Sleep-related breathing disorders
Lead sponsor: University Health Network, Toronto
Sponsor class: OTHER
Collaborators: name: The Craig H. Neilsen Foundation
First posted: 2019-07-05
Enrollment: 24
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: NA
Intervention model: SINGLE_GROUP
Primary purpose: TREATMENT

Brief 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.

Eligibility criteria: 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

Primary outcomes:
measure: Fatigue Severity Scale
timeFrame: Change in Fatigue Severity Scale from baseline to after 4-month period of CPAP therapy
Secondary outcomes:
measure: Epworth Sleepiness Score
timeFrame: Change in Epworth Sleepiness Score from baseline to after 4-month period of CPAP therapy
measure: Medical Outcomes Study Sleep Scale
timeFrame: Change in Medical Outcomes Study Sleep Scale from baseline to after 4-month period of CPAP therapy
measure: Depression, Anxiety & Stress Scales- 21
timeFrame: Change in Depression, Anxiety & Stress Scales- 21 from baseline to after 4-month period of CPAP therapy
measure: Montreal Cognitive Assessment (MoCA) test
timeFrame: Change in Montreal Cognitive Assessment (MoCA) score from baseline to after 4-month period of CPAP therapy
Other outcomes:
measure: Face-to-face, 1-hour interview for qualitative analysis
timeFrame: At completion of the 4-month period of CPAP therapy
Locations:
city: Toronto
country: Canada
facility: Lyndhurst Centre, KITE - TRI UHN
state: Ontario
Study officials:
affiliation: Toronto Rehabilitation Institute
name: Julio Furlan, MD
role: PRINCIPAL_INVESTIGATOR
References: