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

University Health Network, Toronto

Status: Enrolling

Conditions: Spinal Cord Injuries; Sleep Apnea

Treatments: Other: Continuous positive airway pressure (CPAP) therapy

Study type: Interventional

Funder types: Other

Identifiers

NCT04007380

19-5072

Details and patient eligibility

About

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).

Full 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.

Enrollment: 24 estimated patients

Sex: All

Ages: 18+ years old

Volunteers: No Healthy Volunteers

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

Trial design

Primary purpose: Treatment

Allocation: N/A

Interventional model: Single Group Assignment

Masking: None (Open label)

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24 participants in 1 patient group

CPAP-therapy arm

Other group

Description:

This single-arm clinical trial will examine the effects of 4-month period CPAP therapy in individuals living with SCI. The CPAP will be adjusted according to the results of the auto-titrating CPAP testing for each participant.

Treatment:

Other: Continuous positive airway pressure (CPAP) therapy