Spinal Cord InjuriesNCT04007380
Psychosocial, Cognitive, and Behavioral Consequences of Sleep-disordered Breathing After SCI
A study testing Continuous positive airway pressure (CPAP) therapy in people with Spinal Cord Injuries and Sleep Apnea, run by University Health Network, Toronto at 1 site in Canada.
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). Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Spinal Cord Injuries, Sleep Apnea
- What is being tested?
- Continuous positive airway pressure (CPAP) therapy
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 24 participants
- Where
- 1 siteCanada
- Study dates
- 27 Sep 2019to 30 Aug 2025
- Phase
- Interventional
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 years and older
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- 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
Who cannot join
- 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
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- History of primary hypersomnia
- Hypothyroidism
- Moderate or severe iron deficiency anemia
- Active infection
- Kidney failure
- Epilepsy
- Chronic fatigue syndrome
- Vitamin B12 deficiency
Trial locations and contacts
1 site in 1 country. Contact the study team or a site near you to ask about taking part.
Canada1 site, 1 recruiting
- Recruiting
Lyndhurst Centre, KITE - TRI UHN
Toronto, Ontario
Mitsue Aibe, MD, 416-597-3422 ext. 6285, Mitsue.Aibe@uhn.ca
About this study
Official title: Psychosocial, Cognitive, and Behavioral Consequences of Sleep-disordered Breathing in Spinal Cord Injured People
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).
Read the 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
- Being tested
- Continuous positive airway pressure (CPAP) therapy
- Keywords
- Spinal cord injuries, Sleep-related breathing disorders
- Medical subject headings
- Spinal Cord Injuries, Sleep Apnea Syndromes
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Continuous positive airway pressure (CPAP) therapyOther
The participants will undergo CPAP therapy for 4 consecutive months in the management of moderate-to-severe SRBDs
| Study group | Role | What they receive |
|---|---|---|
| CPAP-therapy arm | Other | 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. Receives: Other: Continuous positive airway pressure (CPAP) therapy |
What is being measured
The primary outcome is the main question the study is designed to answer.
Fatigue Severity Scale
Self-reported (or administered by an interviewer) scale where participants choose one of seven levels of agreement for each question. Range from 9 (best outcome) to 63 (worst outcome). The primary outcome is the difference between post-intervention and pre-intervention Fatigue Severity Scales.
Measured: Change in Fatigue Severity Scale from baseline to after 4-month period of CPAP therapy
Secondary outcomes (4)
Epworth Sleepiness Score
Self-reported (or administered by an interviewer) where participants answer the 8 brief questions. Range from 0 (best outcome) to 24 (worst outcome). This secondary outcome comprises the difference between post-intervention and pre-intervention Epworth sleepiness scores.
Measured: Change in Epworth Sleepiness Score from baseline to after 4-month period of CPAP therapy
Medical Outcomes Study Sleep Scale
Self-reported scale that consists of 12 Likert-type items assessing six dimensions of sleep problems: sleep disturbance (i.e. difficulty initiating or maintaining sleep), snoring, respiratory problems, sleep quantity, sleep adequacy, and daytime somnolence). Higher scores for the domains of sleep disturbance, somnolence and sleep indices indicate worse sleep disturbances, whereas lower scores for sleep quantity and sleep adequacy indicate worse sleep disturbances.
Measured: Change in Medical Outcomes Study Sleep Scale from baseline to after 4-month period of CPAP therapy
Depression, Anxiety & Stress Scales- 21
Self-reported (or administered by an interviewer) scale where participants rate questions on depression, anxiety and stress. Depression subscale varies from 0 (best outcome) to 21 (worst outcome). Anxiety subscale varies from 0 (best outcome) to 21 (worst outcome). Stress subscale varies from 0 (best outcome) to 21 (worst outcome). This secondary outcome comprises the difference in the overall pre-intervention and post-intervention DASS-21 scores.
Measured: Change in Depression, Anxiety & Stress Scales- 21 from baseline to after 4-month period of CPAP therapy
Montreal Cognitive Assessment (MoCA) test
Cognitive test administered by an interviewer.
Measured: Change in Montreal Cognitive Assessment (MoCA) score from baseline to after 4-month period of CPAP therapy
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted5 Jul 2019
- Study start27 Sep 2019
- Primary completion30 Aug 2025 (estimated)
- Study completion30 Aug 2025 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Spinal Cord InjuriesStudies of the same condition, open and under way.
- More trials run by University Health Network, TorontoThe sponsor's other registered studies.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Treatment
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Enrolment
- 24 participants (estimated)
Sponsor and investigators
- Lead sponsor
- University Health Network, Toronto
- Sponsor type
- University, hospital or other
- Collaborators
- The Craig H. Neilsen Foundation
- Responsible party
- Sponsor
- Investigators
- Julio Furlan, MD, Principal investigator, Toronto Rehabilitation Institute
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT04007380
- Sponsor's protocol ID
- 19-5072
- Status last verified
- Dec 2024
- First submitted
- 25 Mar 2019
- Last updated
- 11 Dec 2024
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No