Spinal Cord InjuriesNCT05473689
Outcomes Post Treatment: Impact on Motor Impairment of Sleep Efficiency in SCI (OPTIMISE SCI Trial)
A study testing Continuous positive airway pressure (CPAP) therapy in people with Spinal Cord Injuries and Spine Disease, run by University Health Network, Toronto at 1 site in Canada.
Trial summary
This randomized clinical trial will compare three groups of individuals with cervical/thoracic, complete or incomplete spinal cord injury (SCI) that will undergo: (i) early CPAP therapy in the management of moderate-to-severe sleep-related breathing disorders (SRBDs) among adults at 6 weeks after SCI; (ii) delayed… Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Spinal Cord Injuries, Spine Disease
- What is being tested?
- Continuous positive airway pressure (CPAP) therapy
- Type of treatment
- Medical device
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 66 participants
- Where
- 1 siteCanada
- Study dates
- 15 Aug 2022to 31 Jul 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)
- Acute (≤ 30 days after injury), cervical/thoracic (injury level at C2 to T12), complete or incomplete (AIS A to D) SCI
- Not being treated for sleep apnea prior to the spinal cord impairment onset.
Who cannot join
- Non-traumatic spinal cord disease at risk for neurologic progression (e.g., demyelinating spine diseases such as neuromyelitis optica and multiple sclerosis, spinal cord malignancy)
- Concomitant diseases of the central nervous system
- Preinjury chronic pain
- Other pre-existing diseases of the central nervous system
- Significant psychiatric disorders with recent episode of exacerbation
- Neuromuscular diseases
Show all 10Show fewer
- Current substance misuse
- Known history of primary hypersomnia or secondary hypersomnia of any cause except for SRBDs (e.g., hypothyroidism, moderate or severe iron deficiency anemia, infections, depression, kidney failure, chronic fatigue syndrome, neurodegenerative diseases, and myotonic dystrophy)
- Epilepsy
- 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
KITE Toronto Research Institute
Toronto, Ontario, M4G 3V9
Mitsue Aibe, 4165973422 ext. 6285, Mitsue.Aibe@uhn.ca
About this study
This randomized clinical trial will compare three groups of individuals with cervical/thoracic, complete or incomplete spinal cord injury (SCI) that will undergo: (i) early CPAP therapy in the management of moderate-to-severe sleep-related breathing disorders (SRBDs) among adults at 6 weeks after SCI; (ii) delayed CPAP therapy in the management of moderate-to-severe SRBDs among adults at 22 weeks after SCI; and (iii) no treatment as they either have mild or no SRBD.
- Conditions
- Spinal Cord Injuries, Spine Disease
- Being tested
- Continuous positive airway pressure (CPAP) therapy
- Keywords
- sleep apnea, sleep-related breathing disorders
- Medical subject headings
- Spinal Cord Injuries, Spinal Diseases, 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) therapyDevice
Continuous positive airway pressure (CPAP) therapy for moderate-to-severe sleep-related breathing disorders.
| Study group | Role | What they receive |
|---|---|---|
| Early-CPAP therapy group | Experimental | Individuals diagnosed with moderate-to-severe sleep-related breathing disorders (SRBDs) who will start CPAP therapy within the first 6 weeks after SCI. Receives: Device: Continuous positive airway pressure (CPAP) therapy |
| Delayed-CPAP therapy group | Active comparator | Individuals diagnosed with moderate-to-severe SRBDs who will start on CPAP therapy at the 5th month after SCI. Receives: Device: Continuous positive airway pressure (CPAP) therapy |
| Non-CPAP therapy group | No intervention | Individuals who are diagnosed with no or mild SRBD. |
What is being measured
The primary outcome is the main question the study is designed to answer.
Change in International Standards for Neurological Classification of SCI (ISNCSCI) motor subscore from baseline to 6 months after recruitment
Motor assessment of muscles in the upper and lower extremities (100: normal; 0: complete paresis)
Measured: From baseline to 6 months after recruitment
Change in International from baseline to 6 months after recruitment Standards for Neurological Classification of SCI (ISNCSCI) sensory subscore
Sensory assessment of dermatomes in the upper and lower extremities (224: normal; 0: no sensory function)
Measured: From baseline to 6 months after recruitment
Change in Spinal Cord Independence Measure (SCIM) - version III - score from baseline to 6 months after recruitment
The SCIM scores varies from 0 to 100 and includes the following subscores: self-care (0-20); respiration and sphincter management (0-40); mobility (0-40).
Measured: From baseline to 6 months after recruitment
Secondary outcomes (5)
Change in Fatigue Severity Scale (FSS) from baseline to 6 months after recruitment
The FSS scores vary from 9 (normal) to 56 (the most severe degree of fatigue)
Measured: From baseline to 6 months after recruitment
Change in Depression, Anxiety & Stress Scales- 21 (DASS-21) score from baseline to 6 months after recruitment
The DASS-21 scores vary from 0 (normal) to 42 (most severe symptoms of depression, anxiety and stress).
Measured: From baseline to 6 months after recruitment
Change in Patient Health Questionnaire (PHQ-9) score from baseline to 6 months after recruitment
The PHQ-9 scores vary from 0 to 27, which means: 0-4 is the normal or minimal; 5-9 if the person is mildly depressed; 10-14 if the person is moderately depressed; 15-19 if the person has moderately severe depression; and 20-27 if the person is severely depressed.
Measured: From baseline to 6 months after recruitment
Change in Medical Outcomes Study Sleep Scale (MOS-SS) from baseline to 6 months after recruitment
Scores for the sleep disturbance, snoring, respiratory problems, sleep adequacy, and daytime somnolence dimensions range from 0 (normal) to 100.
Measured: From baseline to 6 months after recruitment
Change in Montreal Cognitive Assessment (MoCA test) score from baseline to 6 months after recruitment
The MoCA test scores vary from 0 to 30 (normal).
Measured: From baseline to 6 months after recruitment
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted26 Jul 2022
- Study start15 Aug 2022
- Primary completion31 Jul 2025 (estimated)
- Study completion31 Jul 2025 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (1)Papers the sponsor has linked to this study.
- 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
- Randomised
- Intervention model
- Parallel groups
- Masking
- Single blind
- Who is masked
- Outcomes assessor
- Enrolment
- 66 participants (estimated)
Sponsor and investigators
- Lead sponsor
- University Health Network, Toronto
- Sponsor type
- University, hospital or other
- Collaborators
- Sunnybrook Health Sciences Centre
- Responsible party
- Sponsor
- Investigators
- Julio C Furlan, MD, FRCPC, Principal investigator, KITE Research Institute, University Health Network
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT05473689
- Sponsor's protocol ID
- 21-6214
- Status last verified
- Dec 2024
- First submitted
- 19 Jul 2022
- Last updated
- 11 Dec 2024
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No: The UHN REB needs to approve any plan to share data from this RCT.
Publications
Furlan JC, Yao C, McKay M, Walsh S, Boulos M. Study protocol for the Outcomes Post-Treatment: Impact on Motor Impairment of Sleep Efficiency in Spinal Cord Injury (OPTIMISE SCI) - a randomised controlled trial. BMJ Open. 2025 Jun 6;15(6):e099266. doi: 10.1136/bmjopen-2025-099266.
PubMed 40480676
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
- Outcomes Post Treatment: Impact on Motor Impairment of Sleep Efficiency in SCI (OPTIMISE SCI Trial)
- ClinicalTrials.gov ID
- NCT05473689
- Acronym / sponsor ID
- 21-6214
- Conditions
- Spinal Cord Injuries, Spine Disease
- Keywords
- sleep apnea, sleep-related breathing disorders
- Study type
- Interventional
- Recruitment status
- Recruiting
- Enrolment
- 66 participants (estimated)
- Lead sponsor
- University Health Network, TorontoUniversity, hospital or other
- Collaborators
- Sunnybrook Health Sciences Centre
- Study start
- 15 Aug 2022 (actual)
- Primary completion
- 31 Jul 2025 (estimated)
- Study completion
- 31 Jul 2025 (estimated)
- First posted
- 26 Jul 2022 (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 randomized clinical trial will compare three groups of individuals with cervical/thoracic, complete or incomplete spinal cord injury (SCI) that will undergo: (i) early CPAP therapy in the management of moderate-to-severe sleep-related breathing disorders (SRBDs) among adults at 6 weeks after SCI; (ii) delayed CPAP therapy in the management of moderate-to-severe SRBDs among adults at 22 weeks after SCI; and (iii) no treatment as they either have mild or no SRBD.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Single blind (outcomes assessor)
- Number of arms
- 3
| Arm | Type | Receives |
|---|---|---|
| Early-CPAP therapy group | Experimental | Device: Continuous positive airway pressure (CPAP) therapyIndividuals diagnosed with moderate-to-severe sleep-related breathing disorders (SRBDs) who will start CPAP therapy within the first 6 weeks after SCI. |
| Delayed-CPAP therapy group | Active comparator | Device: Continuous positive airway pressure (CPAP) therapyIndividuals diagnosed with moderate-to-severe SRBDs who will start on CPAP therapy at the 5th month after SCI. |
| Non-CPAP therapy group | No intervention | –Individuals who are diagnosed with no or mild SRBD. |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (3 listed)
- English-speaking adults (18 years of age or older)
- Acute (≤ 30 days after injury), cervical/thoracic (injury level at C2 to T12), complete or incomplete (AIS A to D) SCI
- Not being treated for sleep apnea prior to the spinal cord impairment onset.
Key exclusion criteria (10 listed)
- Non-traumatic spinal cord disease at risk for neurologic progression (e.g., demyelinating spine diseases such as neuromyelitis optica and multiple sclerosis, spinal cord malignancy)
- Concomitant diseases of the central nervous system
- Preinjury chronic pain
- Other pre-existing diseases of the central nervous system
- Significant psychiatric disorders with recent episode of exacerbation
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) therapyContinuous positive airway pressure (CPAP) therapy for moderate-to-severe sleep-related breathing disorders. | Device | Delayed-CPAP therapy group, Early-CPAP therapy group |
Primary outcome
Change in International Standards for Neurological Classification of SCI (ISNCSCI) motor subscore from baseline to 6 months after recruitment
Time frame: From baseline to 6 months after recruitment
Motor assessment of muscles in the upper and lower extremities (100: normal; 0: complete paresis)
Change in International from baseline to 6 months after recruitment Standards for Neurological Classification of SCI (ISNCSCI) sensory subscore
Time frame: From baseline to 6 months after recruitment
Sensory assessment of dermatomes in the upper and lower extremities (224: normal; 0: no sensory function)
Change in Spinal Cord Independence Measure (SCIM) - version III - score from baseline to 6 months after recruitment
Time frame: From baseline to 6 months after recruitment
The SCIM scores varies from 0 to 100 and includes the following subscores: self-care (0-20); respiration and sphincter management (0-40); mobility (0-40).
5 secondary outcomes
Change in Fatigue Severity Scale (FSS) from baseline to 6 months after recruitment
Time frame: From baseline to 6 months after recruitment
Change in Depression, Anxiety & Stress Scales- 21 (DASS-21) score from baseline to 6 months after recruitment
Time frame: From baseline to 6 months after recruitment
Change in Patient Health Questionnaire (PHQ-9) score from baseline to 6 months after recruitment
Time frame: From baseline to 6 months after recruitment
Change in Medical Outcomes Study Sleep Scale (MOS-SS) from baseline to 6 months after recruitment
Time frame: From baseline to 6 months after recruitment
Change in Montreal Cognitive Assessment (MoCA test) score from baseline to 6 months after recruitment
Time frame: From baseline to 6 months after recruitment
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.
- Derived from this study: PubMed 40480676Furlan JC, Yao C, McKay M, Walsh S, Boulos M. Study protocol for the Outcomes Post-Treatment: Impact on Motor Impairment of Sleep Efficiency in Spinal Cord Injury (OPTIMISE SCI) - a randomised controlled trial. BMJ Open. 2025 Jun 6;15(6):e099266. doi: 10.1136/bmjopen-2025-099266.
- Individual participant dataSharing planned: No. The UHN REB needs to approve any plan to share data from this RCT.
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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 C Furlan, MD, FRCPC principal investigator
KITE Research Institute, University Health Network
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 Spine Disease, 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 3 inclusion and 10 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 Lamisa Etu, BSc (4165973422 ext. 6285, LamisaFaria.Etu@uhn.ca), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Change in International Standards for Neurological Classification of SCI (ISNCSCI) motor subscore from baseline to 6 months after recruitment (time frame: From baseline to 6 months after recruitment). The study lists 3 primary outcomes in all. It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT05473689, which also lists 1 linked publication.
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.