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
- Are there results?
- Not yet: the study is under way
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
Show all 14Show fewer
- 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
Study at a glance
From the registry record, last updated by the sponsor on 11 Dec 2024. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Psychosocial, Cognitive, and Behavioral Consequences of Sleep-disordered Breathing in Spinal Cord Injured People
- ClinicalTrials.gov ID
- NCT04007380
- Acronym / sponsor ID
- 19-5072
- Conditions
- Spinal Cord Injuries, Sleep Apnea
- Keywords
- Spinal cord injuries, Sleep-related breathing disorders
- Study type
- Interventional
- Recruitment status
- Recruiting
- Enrolment
- 24 participants (estimated)
- Lead sponsor
- University Health Network, TorontoUniversity, hospital or other
- Collaborators
- The Craig H. Neilsen Foundation
- Study start
- 27 Sep 2019 (actual)
- Primary completion
- 30 Aug 2025 (estimated)
- Study completion
- 30 Aug 2025 (estimated)
- First posted
- 5 Jul 2019 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
Study design
- Primary purpose
- Treatment
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| CPAP-therapy arm | Other | Other: Continuous positive airway pressure (CPAP) therapyThis 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. |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (4 listed)
- 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
Key exclusion criteria (14 listed)
- 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
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Continuous positive airway pressure (CPAP) therapyThe participants will undergo CPAP therapy for 4 consecutive months in the management of moderate-to-severe SRBDs | Other | CPAP-therapy arm |
Primary outcome
Fatigue Severity Scale
Time frame: Change in Fatigue Severity Scale from baseline to after 4-month period of CPAP therapy
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.
4 secondary outcomes
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
Results and safety
This study is still under way. Results are not available in the source record yet.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 11 Dec 2024.
- Individual participant dataSharing planned: No
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part.
Julio Furlan, MD principal investigator
Toronto Rehabilitation Institute
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
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.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 4 inclusion and 14 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: looking for participants now, as of the sponsor's last update on 11 Dec 2024. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in Canada. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
This study is still under way. Results are not available in the source record yet.
How can a doctor refer a patient or contact the research team?
Contact Mitsue Aibe, MD (4165973422 ext. 6285, Mitsue.Aibe@uhn.ca), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Fatigue Severity Scale (time frame: Change in Fatigue Severity Scale from baseline to after 4-month period of CPAP therapy). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 11 Dec 2024.