StrokeNCT06847074
Rise & Shine: Promoting Sleep Quality in Chronic Stroke With Exercise
A study testing Multimodal Exercise and Cognitve and Social Activities in people with Stroke and Poor Quality Sleep, run by University of British Columbia at 1 site in Canada.
Trial summary
health problems, such as heart disease, diabetes, cognitive impairment, and dementia. After a person suffers a stroke, they often experience difficulties in getting a good night's sleep. Approximately half of stroke survivors have insomnia, or have trouble falling and/or staying asleep. Read more about this study
- Who is it for?
- Ages 55 years and older
- Conditions the study is for
- Stroke, Poor Quality Sleep
- What is being tested?
- Multimodal Exercise and Cognitve and Social Activities
- Type of treatment
- Lifestyle or therapy programme
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 62 participants
- Where
- 1 siteCanada
- Study dates
- 15 May 2025to 30 Jun 2028
- 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 55 years and older
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- We will include community-dwelling adults who had an ischemic or hemorrhagic stroke at least one year prior to study enrolment and have poor sleep quality - defined as a sleep efficiency of < or = 85%, with allowance for minor upward deviations on individual nights consistent with known night-to-night variability and instrument accuracy limits, and a PSQI global score of > 5. Individuals must also meet these inclusion criteria: 1) aged 55 years and older; 2) a baseline MMSE score of = or > 22/30 and a MoCA score of = or > 19/30; 3) community-dwelling; 4) able to comply with scheduled assessments, classes, and other trial procedures; 5) read, write, and speak English with acceptable visual and auditory acuity; 6) not to start or stable (i.e., = or > 6 months) on a fixed dose of medication that impacts sleep (i.e., anti-arrhythmics, beta blockers, selective serotonin reuptake inhibitor, etc.) during the 26-week intervention period; 7) able to walk for a minimum of six metres with rest intervals with or without assistive devices; 8) based on interview, have an activity tolerance of 60 minutes with rest intervals; 9) not participating in any regular therapy or progressive exercise (e.g., treadmill or weight-lifting); and 10) able to safely engage in exercise as indicated by the PAR-Q+63 and written confirmation by family or study physicians.
Who cannot join
- We will exclude individuals who: 1) are diagnosed with OSA and are not using CPAP or defined as potentially having undiagnosed OSA (AHI > 20) as a result of study screening; 2) have restless leg syndrome; 3) are diagnosed with dementia of any type; 4) are diagnosed with another type of neurodegenerative or neurological condition (e.g., Parkinson's disease); 5) are planning to participate, or already enrolled in, a clinical drug trial or exercise trial concurrent to this study; 6) are at high risk for cardiac complications during exercise and/or unable to self-regulate activity or to understand recommended activity level; 7) have clinically significant peripheral neuropathy or severe musculoskeletal or joint disease that impairs mobility, as determined by his/her physician; or 8) have aphasia as judged by an inability to communicate by phone.
Trial locations and contacts
1 site in 1 country. Contact the study team or a site near you to ask about taking part.
Ryan Stein, MSc contact
Canada1 site, 1 recruiting
- Recruiting
Vancouver Coastal Health Research Institute Research Pavilion
Vancouver, British Columbia, V5Z 1L8
Nathan Wei, B.SC, 604-875-4111 ext. 69056, cogmob.research@hiphealth.ca
Teresa Liu-Ambrose, Ph.D
About this study
health problems, such as heart disease, diabetes, cognitive impairment, and dementia.
After a person suffers a stroke, they often experience difficulties in getting a good night's sleep. Approximately half of stroke survivors have insomnia, or have trouble falling and/or staying asleep. Poor sleep quality among stroke survivors increases the risk of recurrent stroke by 3-fold and the risk of early death by 76%. Hence, stroke survivors need strategies to promote better sleep.
Read more
Fortunately, evidence shows that sleep quality can be improved with exercise, even among those who struggle with insomnia. Whether exercise training can improve sleep quality in adults with chronic stroke (i.e., at least 12 months has passed since their stroke) and poor sleep quality is not known. In addition, it is unknown if improved sleep is associated with improved outcomes in those with chronic stroke.
This study will specifically evaluate the effect of twice-weekly targeted exercise training on sleep quality over a 6-month period in persons with chronic stroke and poor sleep quality. This study will also evaluate the effect of exercise on the following outcomes: 1) sleep structure; 2) fatigue; 3) daytime sleepiness; 4) mood; 5) physical function and capacity; 6) thinking abilities; 7) heart health; and 8) quality of life. Finally, this study will examine how changes in sleep quality may be related to changes in these outcomes. Our proposed research is timely as the importance of sleep to recovery, health, and wellbeing post-stroke is increasingly recognized.
Read the detailed description
Approximately half of stroke survivors have insomnia. Poor sleep quality among stroke survivors increases the risk of recurrent stroke by 3-fold and the risk of early death by 76%. Hence, stroke survivors are a target population in need of intervention strategies to promote sleep quality.
Current research and stroke rehabilitation do not address the sleep consequences of stroke - especially for those in the chronic phase (i.e., = or > 12 months since an index stroke). Adults with chronic stroke have lower sleep efficiency compared with sex- and age-matched controls. Poor sleep quality in chronic stroke is associated with depression, impaired physical function, and reduced cognitive function.
How to effectively treat insomnia in adults with chronic stroke is not well established. Intervention studies show exercise improves sleep quality and structure. Whether exercise can improve sleep quality in adults with chronic stroke and poor sleep quality is not established.
Primary Question: In adults with chronic stroke and poor sleep quality, can a 26-week multimodal exercise training program of moderate intensity (EX) improve sleep efficiency, as objectively measured by the actigraphy, compared with a 26-week cognitive and social activities program (CON; active control group)?
Secondary Question: What are additional benefits of EX vs. CON? Compared with CON, we will evaluate the effect of EX on: 1) actigraphy-measured sleep parameters of latency, duration, and wake after sleep onset; 2) sleep architecture by frontal electroencephalography; 3) subjective sleep quality; 4) fatigue; 5) daytime sleepiness; 6) mood; 7) functional capacity; 8) cognitive function; 9) cardiometabolic risk factors; and 10) quality of life.
Tertiary Question: Are changes in sleep quality associated with changes in: 1) fatigue; 2) daytime sleepiness; 3) mood; 4) cognitive function; 5) cardiometabolic risk factors; and 6) quality of life?
Pilot Data: Using actigraphy, the investigators acquired sleep data from 21 of 120 (i.e., subset) participants with chronic stroke enrolled in a RCT with cognitive function as the primary outcome. These 21 participants (mean age=69) were randomized to 26 weeks of: 1) multimodal exercise of moderate intensity (EX; n=12); or 2) cognitive and social activities (i.e., no exercise; CON; n=9). Of these 21 participants, 48% had a baseline actigraphy-measured sleep efficiency < 85%. Compared with CON, EX significantly improved actigraphy-measured sleep efficiency values (in %) at 13 weeks and 26 weeks.
Methods: A 26-week, assessor-blinded, single-site RCT of 62 community-dwelling adults with chronic stroke, WatchPAT measured sleep efficiency < 85%, Pittsburgh Sleep Quality Index global score > 5, and aged 55 years and older. Individuals will be randomized to one of two experimental groups: 1) twice-weekly EX (n=31); or 2) twice-weekly CON (n=31). Randomization will be stratified by sex and age. Measurement will occur at baseline, 13 weeks, and 26 weeks, unless otherwise stated.
- Conditions
- Stroke, Poor Quality Sleep
- Being tested
- Multimodal Exercise, Cognitve and Social Activities
- Keywords
- Exercise
- Medical subject headings
- Stroke, Motor Activity
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Multimodal ExerciseBehavioural
Each 60-minute class will include a 10-minute warm-up (i.e., stretches for the major muscles and walking on the spot), 40 minutes of training, and a 10-minute cool down (i.e., stretches and relaxation techniques).Instructors will use heart rate monitors to continuously track intensity during and across all sessions.
Cognitve and Social ActivitiesBehavioural
Each 60-minute class will include 30 minutes of cognitive enrichment activities and 30 minutes of activities that promote social interactions.
| Study group | Role | What they receive |
|---|---|---|
| Multimodal Exercise Training | Experimental | The program will consist of moderate intensity, multimodal exercise training; 2x/week; in-person, group-based. Receives: Behavioral: Multimodal Exercise |
| Cognitive and Social Activities (No Exercise) | Active comparator | The program will consist of cognitive and social activites; 2x/week; in-person, group-based Receives: Behavioral: Cognitve and Social Activities |
What is being measured
The primary outcome is the main question the study is designed to answer.
Sleep Efficiency
Sleep efficiency as measured by actigraphy over days of wear.
Measured: Baseline, 13 weeks, 26 weeks
Secondary outcomes (21)
Sleep latency, duration, and wake after sleep onset
Sleep latency, duration, and wake after sleep onset by actigraphy over days of wear.
Measured: Baseline, 13 weeks, 26 weeks
Sleep Architecture (OPTIONAL)
Sleep architecture as measured by EEG headband
Measured: Baseline, 13 weeks, 26 weeks
Subjective sleep quality
Subjective sleep quality measured by Pittsburgh Sleep Quality Index
Measured: Baseline, 13 weeks, 26 weeks
Fatigue
Fatigue measured by Fatigue Severity Scale
Measured: Baseline, 13 weeks, 26 weeks
Sleepiness
Daytime sleepiness measured by questionnaire
Measured: Baseline, 13 weeks, 26 weeks
Mood
Depressive symptoms measured by questionnaire
Measured: Baseline, 13 weeks, 26 weeks
Functional Capacity
Functional capacity, or aerobic capacity, measured by the 6-Minute Walk Test
Measured: Baseline, 13 weeks, 26 weeks
NIH Toolbox Cognitive Battery
Cognitive function measured by NIH Toolbox Cognitive Battery
Measured: Baseline, 13 weeks, 26 weeks
ADAS-Cog Plus
Cognitive function measured by ADAS-Cog Plus
Measured: Baseline, 13 weeks, 26 weeks
Executive Functions
The domain of executive functions measured by Trails A and B, Digits Forward and Backward, and Clock Drawing
Measured: Baseline, 13 weeks, 26 weeks
Verbal Fluency
Verbal fluency measured by categorical fluency
Measured: Baseline, 13 weeks, 26 weeks
Memory
Memory measured by the Rey Auditory Verbal Fluency
Measured: Baseline, 13 weeks, 26 weeks
Blood Pressure
Systolic and diastolic blood pressure
Measured: Baseline, 13 weeks, 26 weeks
Chronotype
Chronotype measured by questionnaire
Measured: Baseline, 13 weeks, 26 weeks
Blood Biomarkers (OPTIONAL)
We will draw blood to assess markers cardiometabolic health and brain health
Measured: Baseline, 13 weeks, 26 weeks
Quality of life
Quality of life measured by the EuroQol-5 Domain-5 Level (EQ-5D-5L)
Measured: Baseline, 13 weeks, 26 weeks
Current Physical Activity (Self-Report)
Physical activity outside of research study will be assessed by questionnaire
Measured: Baseline, 13 weeks, 26 weeks
Balance and Mobility
Balance and mobility measured by the Short Physical Performance Battery
Measured: Baseline, 13 weeks, 26 weeks
Activities of Daily Living
Lawton and Brody Instrumental Activities of Daily Living Scale will asssess activites of daily living
Measured: Baseline, 26 weeks
Arterial Stiffness
Arterial stiffness will be measured as pulse wave velocity
Measured: Baseline, 13 weeks, 26 weeks
Sedentary Behaviour
Time in sedentary behaviour will be measured by actigraphy over days of wear.
Measured: Baseline, 13 weeks, 26 weeks
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted26 Feb 2025
- Study start15 May 2025
- Primary completion15 May 2028 (estimated)
- Study completion30 Jun 2028 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for StrokeStudies of the same condition, open and under way.
- More trials run by University of British ColumbiaThe 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
- Triple blind
- Who is masked
- Care provider, Investigator, Outcomes assessor
- Enrolment
- 62 participants (estimated)
Sponsor and investigators
- Lead sponsor
- University of British Columbia
- Sponsor type
- University, hospital or other
- Collaborators
- Vancouver Coastal Health Research Institute
- Responsible party
- Principal investigator, Teresa Liu-Ambrose, University of British Columbia
- Investigators
- Teresa Liu-Ambrose, PhD, Principal investigator, University of British Columbia
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT06847074
- Sponsor's protocol ID
- H23-01163
- Status last verified
- Jun 2026
- First submitted
- 17 Feb 2025
- Last updated
- 11 Jun 2026
- Results posted
- No
- Data monitoring committee
- Yes
- 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 Jun 2026. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Rise & Shine: Promoting Sleep Quality in Chronic Stroke With Exercise
- ClinicalTrials.gov ID
- NCT06847074
- Acronym / sponsor ID
- H23-01163
- Conditions
- Stroke, Poor Quality Sleep
- Keywords
- Exercise
- Study type
- Interventional
- Recruitment status
- Recruiting
- Enrolment
- 62 participants (estimated)
- Lead sponsor
- University of British ColumbiaUniversity, hospital or other
- Collaborators
- Vancouver Coastal Health Research Institute
- Study start
- 15 May 2025 (actual)
- Primary completion
- 15 May 2028 (estimated)
- Study completion
- 30 Jun 2028 (estimated)
- First posted
- 26 Feb 2025 (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.
health problems, such as heart disease, diabetes, cognitive impairment, and dementia.
After a person suffers a stroke, they often experience difficulties in getting a good night's sleep. Approximately half of stroke survivors have insomnia, or have trouble falling and/or staying asleep. Poor sleep quality among stroke survivors increases the risk of recurrent stroke by 3-fold and the risk of early death by 76%. Hence, stroke survivors need strategies to promote better sleep.
Fortunately, evidence shows that sleep quality can be improved with exercise, even among those who struggle with insomnia. Whether exercise training can improve sleep quality in adults with chronic stroke (i.e., at least 12 months has passed since their stroke) and poor sleep quality is not known. In addition, it is unknown if improved sleep is associated with improved outcomes in those with chronic stroke.
This study will specifically evaluate the effect of twice-weekly targeted exercise training on sleep quality over a 6-month period in persons with chronic stroke and poor sleep quality. This study will also evaluate the effect of exercise on the following outcomes: 1) sleep structure; 2) fatigue; 3) daytime sleepiness; 4) mood; 5) physical function and capacity; 6) thinking abilities; 7) heart health; and 8) quality of life. Finally, this study will examine how changes in sleep quality may be related to changes in these outcomes. Our proposed research is timely as the importance of sleep to recovery, health, and wellbeing post-stroke is increasingly recognized.
Detailed description
Approximately half of stroke survivors have insomnia. Poor sleep quality among stroke survivors increases the risk of recurrent stroke by 3-fold and the risk of early death by 76%. Hence, stroke survivors are a target population in need of intervention strategies to promote sleep quality.
Current research and stroke rehabilitation do not address the sleep consequences of stroke - especially for those in the chronic phase (i.e., = or > 12 months since an index stroke). Adults with chronic stroke have lower sleep efficiency compared with sex- and age-matched controls. Poor sleep quality in chronic stroke is associated with depression, impaired physical function, and reduced cognitive function.
How to effectively treat insomnia in adults with chronic stroke is not well established. Intervention studies show exercise improves sleep quality and structure. Whether exercise can improve sleep quality in adults with chronic stroke and poor sleep quality is not established.
Primary Question: In adults with chronic stroke and poor sleep quality, can a 26-week multimodal exercise training program of moderate intensity (EX) improve sleep efficiency, as objectively measured by the actigraphy, compared with a 26-week cognitive and social activities program (CON; active control group)?
Secondary Question: What are additional benefits of EX vs. CON? Compared with CON, we will evaluate the effect of EX on: 1) actigraphy-measured sleep parameters of latency, duration, and wake after sleep onset; 2) sleep architecture by frontal electroencephalography; 3) subjective sleep quality; 4) fatigue; 5) daytime sleepiness; 6) mood; 7) functional capacity; 8) cognitive function; 9) cardiometabolic risk factors; and 10) quality of life.
Tertiary Question: Are changes in sleep quality associated with changes in: 1) fatigue; 2) daytime sleepiness; 3) mood; 4) cognitive function; 5) cardiometabolic risk factors; and 6) quality of life?
Pilot Data: Using actigraphy, the investigators acquired sleep data from 21 of 120 (i.e., subset) participants with chronic stroke enrolled in a RCT with cognitive function as the primary outcome. These 21 participants (mean age=69) were randomized to 26 weeks of: 1) multimodal exercise of moderate intensity (EX; n=12); or 2) cognitive and social activities (i.e., no exercise; CON; n=9). Of these 21 participants, 48% had a baseline actigraphy-measured sleep efficiency < 85%. Compared with CON, EX significantly improved actigraphy-measured sleep efficiency values (in %) at 13 weeks and 26 weeks.
Methods: A 26-week, assessor-blinded, single-site RCT of 62 community-dwelling adults with chronic stroke, WatchPAT measured sleep efficiency < 85%, Pittsburgh Sleep Quality Index global score > 5, and aged 55 years and older. Individuals will be randomized to one of two experimental groups: 1) twice-weekly EX (n=31); or 2) twice-weekly CON (n=31). Randomization will be stratified by sex and age. Measurement will occur at baseline, 13 weeks, and 26 weeks, unless otherwise stated.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Triple blind (care provider, investigator, outcomes assessor)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Multimodal Exercise Training | Experimental | Behavioral: Multimodal ExerciseThe program will consist of moderate intensity, multimodal exercise training; 2x/week; in-person, group-based. |
| Cognitive and Social Activities (No Exercise) | Active comparator | Behavioral: Cognitve and Social ActivitiesThe program will consist of cognitive and social activites; 2x/week; in-person, group-based |
Who may qualify
- Ages
- 55 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (1 listed)
- We will include community-dwelling adults who had an ischemic or hemorrhagic stroke at least one year prior to study enrolment and have poor sleep quality - defined as a sleep efficiency of < or = 85%, with allowance for minor upward deviations on individual nights consistent with known night-to-night variability and instrument accuracy limits, and a PSQI global score of > 5. Individuals must also meet these inclusion criteria: 1) aged 55 years and older; 2) a baseline MMSE score of = or > 22/30 and a MoCA score of = or > 19/30; 3) community-dwelling; 4) able to comply with scheduled assessments, classes, and other trial procedures; 5) read, write, and speak English with acceptable visual and auditory acuity; 6) not to start or stable (i.e., = or > 6 months) on a fixed dose of medication that impacts sleep (i.e., anti-arrhythmics, beta blockers, selective serotonin reuptake inhibitor, etc.) during the 26-week intervention period; 7) able to walk for a minimum of six metres with rest intervals with or without assistive devices; 8) based on interview, have an activity tolerance of 60 minutes with rest intervals; 9) not participating in any regular therapy or progressive exercise (e.g., treadmill or weight-lifting); and 10) able to safely engage in exercise as indicated by the PAR-Q+63 and written confirmation by family or study physicians.
Key exclusion criteria (1 listed)
- We will exclude individuals who: 1) are diagnosed with OSA and are not using CPAP or defined as potentially having undiagnosed OSA (AHI > 20) as a result of study screening; 2) have restless leg syndrome; 3) are diagnosed with dementia of any type; 4) are diagnosed with another type of neurodegenerative or neurological condition (e.g., Parkinson's disease); 5) are planning to participate, or already enrolled in, a clinical drug trial or exercise trial concurrent to this study; 6) are at high risk for cardiac complications during exercise and/or unable to self-regulate activity or to understand recommended activity level; 7) have clinically significant peripheral neuropathy or severe musculoskeletal or joint disease that impairs mobility, as determined by his/her physician; or 8) have aphasia as judged by an inability to communicate by phone.
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 |
|---|---|---|
| Multimodal ExerciseEach 60-minute class will include a 10-minute warm-up (i.e., stretches for the major muscles and walking on the spot), 40 minutes of training, and a 10-minute cool down (i.e., stretches and relaxation techniques).Instructors will use heart rate monitors to continuously track intensity during and across all sessions. | Behavioural | Multimodal Exercise Training |
| Cognitve and Social ActivitiesEach 60-minute class will include 30 minutes of cognitive enrichment activities and 30 minutes of activities that promote social interactions. | Behavioural | Cognitive and Social Activities (No Exercise) |
Primary outcome
Sleep Efficiency
Time frame: Baseline, 13 weeks, 26 weeks
Sleep efficiency as measured by actigraphy over days of wear.
21 secondary outcomes
Sleep latency, duration, and wake after sleep onset
Time frame: Baseline, 13 weeks, 26 weeks
Sleep Architecture (OPTIONAL)
Time frame: Baseline, 13 weeks, 26 weeks
Subjective sleep quality
Time frame: Baseline, 13 weeks, 26 weeks
Fatigue
Time frame: Baseline, 13 weeks, 26 weeks
Sleepiness
Time frame: Baseline, 13 weeks, 26 weeks
Mood
Time frame: Baseline, 13 weeks, 26 weeks
Functional Capacity
Time frame: Baseline, 13 weeks, 26 weeks
NIH Toolbox Cognitive Battery
Time frame: Baseline, 13 weeks, 26 weeks
ADAS-Cog Plus
Time frame: Baseline, 13 weeks, 26 weeks
Executive Functions
Time frame: Baseline, 13 weeks, 26 weeks
Verbal Fluency
Time frame: Baseline, 13 weeks, 26 weeks
Memory
Time frame: Baseline, 13 weeks, 26 weeks
Blood Pressure
Time frame: Baseline, 13 weeks, 26 weeks
Chronotype
Time frame: Baseline, 13 weeks, 26 weeks
Blood Biomarkers (OPTIONAL)
Time frame: Baseline, 13 weeks, 26 weeks
Quality of life
Time frame: Baseline, 13 weeks, 26 weeks
Current Physical Activity (Self-Report)
Time frame: Baseline, 13 weeks, 26 weeks
Balance and Mobility
Time frame: Baseline, 13 weeks, 26 weeks
Activities of Daily Living
Time frame: Baseline, 26 weeks
Arterial Stiffness
Time frame: Baseline, 13 weeks, 26 weeks
Sedentary Behaviour
Time frame: Baseline, 13 weeks, 26 weeks
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 Jun 2026.
- 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.
Ryan Stein, MSc contact
Teresa Liu-Ambrose, PhD principal investigator
University of British Columbia
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Multimodal Exercise and Cognitve and Social Activities in people with Stroke and Poor Quality Sleep, run by University of British Columbia 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 1 inclusion and 1 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 Jun 2026. 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 Teresa Liu-Ambrose, PhD (604-617-8047, teresa.ambrose@ubc.ca), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Sleep Efficiency (time frame: Baseline, 13 weeks, 26 weeks). 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 Jun 2026.