Psychosocial, Cognitive, and Behavioral Consequences of Sleep-disordered Breathing After SCI
For patients and families
In plain language
An automatic summary of structured registry data. It is an orientation aid, not a substitute for the official protocol or a physician assessment.
- What is being studied
- The protocol lists: Continuous positive airway pressure (CPAP) therapy.
- Who it may be relevant to
- Registry conditions: Spinal Cord Injuries, Sleep Apnea. Basic parameters: from 18 years · All.
- What needs checking
- Age, condition and sex are only basic indicators. Prior treatment, laboratory values and other mandatory requirements appear in the eligibility criteria below.
- Where it takes place
- Canada
- Next step
- Save the trial, show it to the treating physician, and confirm current recruitment with the study center. Costs, documents and travel →
Unsure about the terms? Read our patient guide →
Official title
Psychosocial, Cognitive, and Behavioral Consequences of Sleep-disordered Breathing in Spinal Cord Injured People
Overview
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.
Interventions
- 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
Primary outcome measures
- Fatigue Severity Scale [Time frame: Change in Fatigue Severity Scale from baseline to after 4-month period of CPAP therapy]
Secondary outcome measures (4)
- Epworth Sleepiness Score [Time frame: Change in Epworth Sleepiness Score from baseline to after 4-month period of CPAP therapy]
- Medical Outcomes Study Sleep Scale [Time frame: Change in Medical Outcomes Study Sleep Scale from baseline to after 4-month period of CPAP therapy]
- Depression, Anxiety & Stress Scales- 21 [Time frame: Change in Depression, Anxiety & Stress Scales- 21 from baseline to after 4-month period of CPAP therapy]
- Montreal Cognitive Assessment (MoCA) test [Time frame: Change in Montreal Cognitive Assessment (MoCA) score from baseline to after 4-month period of CPAP therapy]
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
Criteria are shown verbatim from the registry (in English). Final eligibility is always assessed by the study center.
Healthy volunteers: No
Study design
- Allocation
- N/A
- Model
- Single group
- Masking
- Open label
- Primary purpose
- Treatment
Study locations
Canada · 1 center
- Lyndhurst Centre, KITE - TRI UHN — Toronto
Identifiers
NCT: NCT04007380 · 19-5072