Parkinson DiseaseNCT05644327
Exercise to Improve Sleep in Parkinson's Disease
A study testing Cardiovascular training (CT), Resistance training (RT) and Multimodal training (MT) in people with Parkinson Disease, run by McGill University at 3 sites in Canada.
Trial summary
This study will investigate the impact of three common exercise modalities, cardiovascular, resistance, and multimodal (i.e., a combination of the previous two) training, on sleep quality and architecture in persons with Parkinson's disease (PD). Read more about this study
- Who is it for?
- Ages 40 years and older
- Conditions the study is for
- Parkinson Disease
- What is being tested?
- Cardiovascular training (CT), Resistance training (RT) and Multimodal training (MT)
- Type of treatment
- Lifestyle or therapy programme
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 150 participants
- Where
- 3 sitesCanada
- Study dates
- 1 Sep 2021to 30 Dec 2027
- 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 40 years and older
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- Persons with mild-moderate idiopathic Parkinson's Disease (Modified Hoehn \& Yahr Scale stages 0.5-3.5);
- On a stable dosage of medication during the previous month;
- Having poor sleep quality defined as a score > 15 in the PDSS-2 and/or reporting subjective sleep complaints affecting their sleep quality;
Who cannot join
- Having atypical parkinsonism, dementia, stroke, or any other neurological condition;
- Presenting severe untreated obstructive sleep apnea (OSA);
- Having a Montreal Cognitive Assessment (MoCA) score <18
- Having a Beck Depression Inventory score >31;
- Having absolute contraindications to exercise;
- Having severe osteoporosis;
- Participating in an exercise or drug trial during the period of the study;
- Exceeding the physical activity levels recommended for the general population (≥150 minutes/week of moderate-intensity or ≥75 minutes/week of vigorous-intensity cardiovascular activity) and/or strengthening activities ≥2 days/week.
Trial locations and contacts
3 sites in 1 country. Contact the study team or a site near you to ask about taking part.
Canada3 sites, 3 recruiting
- Recruiting
Jewish Rehabilitation Hospital
Laval, Quebec, H7V 1R2
Marc Roig, Ph.D., 450-688-9550 ext. 84599, marc.roigpull@mcgill.ca
Jacopo Cristini, MSc, 450-688-9550 ext. 84416, jacopo.cristini@mail.mcgill.ca
- Recruiting
Human Brain Control of Locomotion Laboratory
Montreal, Quebec, H2W 1S4
Caroline Paquette, Ph.D., 514-398-4400 ext. 00890, caroline.paquette@mcgill.ca
Alexandra Potvin-Desrochers, Ph.D., 514-398-4184 ext. 09833, alexandra.potvin-desrochers@mail.mcgill.ca
- Not yet recruiting
Cummings Centre
Montreal, Quebec, H3W 3E8
Maria Fragapane, 514.734.1797, maria.fragapane@cummingscentre.org
About this study
Official title: The Effects of Different Exercise Modalities on Sleep Quality and Architecture in People With Parkinson's Disease
This study will investigate the impact of three common exercise modalities, cardiovascular, resistance, and multimodal (i.e., a combination of the previous two) training, on sleep quality and architecture in persons with Parkinson's disease (PD). Furthermore, the project will investigate whether the potential positive exercise-induced changes in sleep are associated with improvements in different quality of life (QoL)-related aspects. Participants will perform either cardiovascular training (CT), resistance training (RT), multimodal training (MT), or will be allocated to a control condition (i.e., waiting list - CON) for 12 weeks. Training will be performed three times/week. The assessments will be conducted at baseline, post-intervention, and follow-up (i.e. 8 weeks after the intervention) by assessors blinded to the participants' group allocation.
Read the detailed description
Background: Over 100,000 Canadians are currently living with PD. Every year, 6,600 new cases are diagnosed and this number is expected to double by 2031. Almost all (98%) of those persons experience sleep problems, which can appear even before the onset of the cardinal motor symptoms of the disease, affecting multiple aspects of their QoL. Persons with PD also show alterations in sleep architecture, which are clinically relevant as they have been associated with a faster disease progression. Since medications used to reduce sleep problems in PD have potential adverse side effects, exercise has been proposed as a potential non-pharmacological alternative to improve sleep quality and architecture in people with PD. However, the most beneficial intervention to improve sleep in this clinical population is still to be determined.
Objective: 1) To conduct a 12-week RCT comparing the effects of CT, RT, MT, and CON on both objective and subjective measures of sleep quality and architecture in patients with mild-to-moderate PD; 2) To assess whether, regardless of the exercise modality, positive changes in sleep quality and architecture mediate exercise-induced improvements in aspects directly related to QoL such as cognitive and motor function.
Design: A four-arm, parallel-group, multi-site, single-blinded RCT with assessments performed at baseline (T0) and after 12 weeks of training (T1), as well as at 8 weeks post-intervention (T2), by assessors blinded to the participants' group allocation.
Methods: After completing T0, participants will be randomly allocated into four groups using a sequence created and held by a central randomization service (https://www.randomizer.at) using a 1:1:1:1 ratio. Permuted blocks of varying sizes to ensure balance over time will be used. Adherence to the training programs and training intensity progression will be monitored by trainers who will track attendance and record responses to exercise (e.g., HR) during training sessions. Participants who will miss training sessions due to valid reasons (e.g., doctor appointments) will be offered make-up sessions to complete the full 36 training sessions. Participants who do not complete 80% of the training (>27 training sessions) over the 12-week, develop injuries that preclude safety during training, or desire to stop the program, will be excluded.
Changes in objective and subjective measures of sleep quality will be assessed with polysomnography and the PD sleep scale version 2, respectively. Sleep architecture will be measured with polysomnography. Motor and cognitive function will be assessed with the Unified PD Rating Scale part III and the Scale for Outcomes in PD-Cognition, respectively. Fatigue, psychosocial functioning and QoL will be assessed with the PD Fatigue Scale, the Scale for Outcomes in PD-Psychosocial and the PD QoL Scale, respectively. The plasma concentration of different inflammatory biomarkers will be assessed using enzyme-linked immunosorbent assays (ELISA) kits following the instructions provided by the manufacturers. Cardiorespiratory fitness will be assessed with a graded exercise test (GXT) performed on a recumbent stepper.
Expected results: 1) MT will be more effective than RT, CT, and CON at improving objective and subjective sleep quality and sleep architecture; 2) Sleep architecture improvements, regardless of the type of exercise performed, will mediate enhancements in cognition and motor function; 3) Improvements in sleep quality (i.e., sleep efficiency), regardless of the type of exercise performed, will mediate enhancements in different QoL-related aspects such as fatigue and psychological functioning.
Impact: This will be the first study comparing the effect of MT, CT and RT on sleep quality and architecture and investigating whether these changes mediate improvements in cognitive and motor function as well as QoL-related aspects (e.g., fatigue). The results of the study will provide important information to design more personalized exercise-based treatments, which are patient-oriented and aimed at optimizing the effect of sleep on cognitive and motor function as well as QoL in PD.
- Conditions
- Parkinson Disease
- Being tested
- Cardiovascular training (CT), Resistance training (RT), Multimodal training (MT)
- Keywords
- Parkinson's disease, Rehabilitation, Sleep, Exercise, Cardiovascular training, Resistance training, Multimodal training, Motor function, Cognition, Quality of life
- Medical subject headings
- Parkinson Disease, Motor Activity
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Cardiovascular training (CT)Behavioural
12 weeks of CT
Resistance training (RT)Behavioural
12 weeks of RT
Multimodal training (MT)Behavioural
12 weeks of MT
| Study group | Role | What they receive |
|---|---|---|
| Cardiovascular training (CT) | Experimental | Cardiovascular training (CT) will be performed on a recumbent stepper. CT will start at low intensity, and, through a linear progression, will reach vigorous intensity; then, this intensity will be maintained until the end of the training period. Each session will include five minutes of warm-up and cool-down performed at the beginning and at the end of the training, respectively. Furthermore, five minutes of stretching will be performed after the cool-down. CT's sessions will last approximately 45 minutes (30 to 50 minutes) and will be interspersed with 48 hours of recovery. Receives: Behavioral: Cardiovascular training (CT) |
| Resistance training (RT) | Experimental | Resistance training (RT) intensity will be estimated using the percentage of one-maximal repetition (1-RM) defined as the maximal weight liftable for ten maximal repetitions with proper form. The program will include five exercises (leg press, lat machine, leg extension, leg curl, bench press) and will start at high-volume low intensity. RT will follow a periodization to reach high-intensity low-volume at the end of the intervention (week 12). The training sessions will start and end with five-minute of warm-up and cool-down, which will include exercise on a recumbent stepper and stretching, respectively. RT's sessions will last approximately 45 minutes (40 to 50 minutes) and will be interspersed with 48 hours of recovery. Receives: Behavioral: Resistance training (RT) |
| Multimodal training (MT) | Experimental | Multimodal training (MT) will combine cardiovascular and resistance training interventions using the modalities described previously, but each component will be shortened to match the overall training duration (i.e., volume) among groups. The first part of each training session will always include three resistance exercises, which will be followed by 15-20 minutes of cardiovascular training performed on the total body recumbent stepper. Periodization will follow the same progression previously described for cardiovascular and resistance training, respectively, reaching vigorous intensity towards the end of the training period. Training sessions will include a five-minute warm-up and cool-down on the total body recumbent stepper. MT's sessions will approximately last 45 minutes (40 to 50 minutes) and will be interspersed with 48 hours of recovery. Receives: Behavioral: Multimodal training (MT) |
| Control condition (CON; waiting list) | No intervention | The control condition (CON; waiting list) will receive no intervention (i.e., exercise) but usual care. Participants in the CON will be required to go about their normal life, maintaining their current physical activity levels until the end of the study. Then, they will be offered to join one of the training programs/condition. |
What is being measured
The primary outcome is the main question the study is designed to answer.
Changes in objective sleep quality
Sleep efficiency (SE) measured with polysomnography; SE (%) = Time asleep while in bed * 100; values = 0-100%; higher values reflect better SE.
Measured: 12 weeks (post-intervention) and 8 weeks (follow-up)
Changes in subjective sleep quality
PD Sleep Scale version 2 (PDSS-2); values = 0-60; higher values reflect worse sleep quality.
Measured: 12 weeks (post-intervention) and 8 weeks (follow-up)
Changes in sleep architecture
Changes in slow-wave power measured with polysomnography.
Measured: 12 weeks (post-intervention) and 8 weeks (follow-up)
Changes in sleep architecture
Changes in sleep spindles density measured with polysomnography.
Measured: 12 weeks (post-intervention) and 8 weeks (follow-up)
Changes in sleep architectures
Changes in REM sleep duration (%) measured with polysomnography.
Measured: 12 weeks (post-intervention) and 8 weeks (follow-up)
Secondary outcomes (5)
Changes in motor function
Unified PD Rating Scale part III (UPDRS part III); values = 0-132; higher values reflect worse motor function.
Measured: 12 weeks (post-intervention) and 8 weeks (follow-up)
Changes in cognitive function
Scale for Outcomes in PD-Cognition (SCOPA-COG); values = 0-43; higher values reflect better cognitive function.
Measured: 12 weeks (post-intervention) and 8 weeks (follow-up)
Changes in fatigue
PD Fatigue Scale; values = 16-80; higher values reflect worse fatigue.
Measured: 12 weeks (post-intervention) and 8 weeks (follow-up)
Changes in psychosocial functioning
Scale for Outcomes in PD-Psychosocial (SCOPA-PS); values = 0-100%; higher values (%) reflect worse psychosocial functioning.
Measured: 12 weeks (post-intervention) and 8 weeks (follow-up)
Changes in Quality of Life Scale
PD Quality of Life Scale (PDQUALIF); values = 0-100%; higher values (%) reflect worse quality of life.
Measured: 12 weeks (post-intervention) and 8 weeks (follow-up)
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted9 Dec 2022
- Study start1 Sep 2021
- Primary completion30 Dec 2027 (estimated)
- Study completion30 Dec 2027 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Parkinson DiseaseStudies of the same condition, open and under way.
- 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
- Investigator
- Enrolment
- 150 participants (estimated)
Sponsor and investigators
- Lead sponsor
- McGill University
- Sponsor type
- University, hospital or other
- Collaborators
- Jewish Rehabilitation Hospital, The Memory Lab, The Human Brain Control of Locomotion Lab (HBCL), The Cummings Centre, Canadian Institutes of Health Research (CIHR)
- Responsible party
- Principal investigator, Marc Roig, McGill University
- Investigators
- Marc Roig, Ph.D., Principal investigator, McGill University
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT05644327
- Sponsor's protocol ID
- MP5020221584
- Status last verified
- Mar 2026
- First submitted
- 18 Nov 2022
- Last updated
- 13 Mar 2026
- 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 13 Mar 2026. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- The Effects of Different Exercise Modalities on Sleep Quality and Architecture in People With Parkinson's Disease
- ClinicalTrials.gov ID
- NCT05644327
- Acronym / sponsor ID
- MP5020221584
- Conditions
- Parkinson Disease
- Keywords
- Parkinson's disease, Rehabilitation, Sleep, Exercise, Cardiovascular training, Resistance training, Multimodal training, Motor function
- Study type
- Interventional
- Recruitment status
- Recruiting
- Enrolment
- 150 participants (estimated)
- Lead sponsor
- McGill UniversityUniversity, hospital or other
- Collaborators
- Jewish Rehabilitation Hospital, The Memory Lab, The Human Brain Control of Locomotion Lab (HBCL), The Cummings Centre, Canadian Institutes of Health Research (CIHR)
- Study start
- 1 Sep 2021 (actual)
- Primary completion
- 30 Dec 2027 (estimated)
- Study completion
- 30 Dec 2027 (estimated)
- First posted
- 9 Dec 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 study will investigate the impact of three common exercise modalities, cardiovascular, resistance, and multimodal (i.e., a combination of the previous two) training, on sleep quality and architecture in persons with Parkinson's disease (PD). Furthermore, the project will investigate whether the potential positive exercise-induced changes in sleep are associated with improvements in different quality of life (QoL)-related aspects. Participants will perform either cardiovascular training (CT), resistance training (RT), multimodal training (MT), or will be allocated to a control condition (i.e., waiting list - CON) for 12 weeks. Training will be performed three times/week. The assessments will be conducted at baseline, post-intervention, and follow-up (i.e. 8 weeks after the intervention) by assessors blinded to the participants' group allocation.
Detailed description
Background: Over 100,000 Canadians are currently living with PD. Every year, 6,600 new cases are diagnosed and this number is expected to double by 2031. Almost all (98%) of those persons experience sleep problems, which can appear even before the onset of the cardinal motor symptoms of the disease, affecting multiple aspects of their QoL. Persons with PD also show alterations in sleep architecture, which are clinically relevant as they have been associated with a faster disease progression. Since medications used to reduce sleep problems in PD have potential adverse side effects, exercise has been proposed as a potential non-pharmacological alternative to improve sleep quality and architecture in people with PD. However, the most beneficial intervention to improve sleep in this clinical population is still to be determined.
Objective: 1) To conduct a 12-week RCT comparing the effects of CT, RT, MT, and CON on both objective and subjective measures of sleep quality and architecture in patients with mild-to-moderate PD; 2) To assess whether, regardless of the exercise modality, positive changes in sleep quality and architecture mediate exercise-induced improvements in aspects directly related to QoL such as cognitive and motor function.
Design: A four-arm, parallel-group, multi-site, single-blinded RCT with assessments performed at baseline (T0) and after 12 weeks of training (T1), as well as at 8 weeks post-intervention (T2), by assessors blinded to the participants' group allocation.
Methods: After completing T0, participants will be randomly allocated into four groups using a sequence created and held by a central randomization service (https://www.randomizer.at) using a 1:1:1:1 ratio. Permuted blocks of varying sizes to ensure balance over time will be used. Adherence to the training programs and training intensity progression will be monitored by trainers who will track attendance and record responses to exercise (e.g., HR) during training sessions. Participants who will miss training sessions due to valid reasons (e.g., doctor appointments) will be offered make-up sessions to complete the full 36 training sessions. Participants who do not complete 80% of the training (>27 training sessions) over the 12-week, develop injuries that preclude safety during training, or desire to stop the program, will be excluded.
Changes in objective and subjective measures of sleep quality will be assessed with polysomnography and the PD sleep scale version 2, respectively. Sleep architecture will be measured with polysomnography. Motor and cognitive function will be assessed with the Unified PD Rating Scale part III and the Scale for Outcomes in PD-Cognition, respectively. Fatigue, psychosocial functioning and QoL will be assessed with the PD Fatigue Scale, the Scale for Outcomes in PD-Psychosocial and the PD QoL Scale, respectively. The plasma concentration of different inflammatory biomarkers will be assessed using enzyme-linked immunosorbent assays (ELISA) kits following the instructions provided by the manufacturers. Cardiorespiratory fitness will be assessed with a graded exercise test (GXT) performed on a recumbent stepper.
Expected results: 1) MT will be more effective than RT, CT, and CON at improving objective and subjective sleep quality and sleep architecture; 2) Sleep architecture improvements, regardless of the type of exercise performed, will mediate enhancements in cognition and motor function; 3) Improvements in sleep quality (i.e., sleep efficiency), regardless of the type of exercise performed, will mediate enhancements in different QoL-related aspects such as fatigue and psychological functioning.
Impact: This will be the first study comparing the effect of MT, CT and RT on sleep quality and architecture and investigating whether these changes mediate improvements in cognitive and motor function as well as QoL-related aspects (e.g., fatigue). The results of the study will provide important information to design more personalized exercise-based treatments, which are patient-oriented and aimed at optimizing the effect of sleep on cognitive and motor function as well as QoL in PD.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Single blind (investigator)
- Number of arms
- 4
| Arm | Type | Receives |
|---|---|---|
| Cardiovascular training (CT) | Experimental | Behavioral: Cardiovascular training (CT)Cardiovascular training (CT) will be performed on a recumbent stepper. CT will start at low intensity, and, through a linear progression, will reach vigorous intensity; then, this intensity will be maintained until the end of the training period. Each session will include five minutes of warm-up and cool-down performed at the beginning and at the end of the training, respectively. Furthermore, five minutes of stretching will be performed after the cool-down. CT's sessions will last approximately 45 minutes (30 to 50 minutes) and will be interspersed with 48 hours of recovery. |
| Resistance training (RT) | Experimental | Behavioral: Resistance training (RT)Resistance training (RT) intensity will be estimated using the percentage of one-maximal repetition (1-RM) defined as the maximal weight liftable for ten maximal repetitions with proper form. The program will include five exercises (leg press, lat machine, leg extension, leg curl, bench press) and will start at high-volume low intensity. RT will follow a periodization to reach high-intensity low-volume at the end of the intervention (week 12). The training sessions will start and end with five-minute of warm-up and cool-down, which will include exercise on a recumbent stepper and stretching, respectively. RT's sessions will last approximately 45 minutes (40 to 50 minutes) and will be interspersed with 48 hours of recovery. |
| Multimodal training (MT) | Experimental | Behavioral: Multimodal training (MT)Multimodal training (MT) will combine cardiovascular and resistance training interventions using the modalities described previously, but each component will be shortened to match the overall training duration (i.e., volume) among groups. The first part of each training session will always include three resistance exercises, which will be followed by 15-20 minutes of cardiovascular training performed on the total body recumbent stepper. Periodization will follow the same progression previously described for cardiovascular and resistance training, respectively, reaching vigorous intensity towards the end of the training period. Training sessions will include a five-minute warm-up and cool-down on the total body recumbent stepper. MT's sessions will approximately last 45 minutes (40 to 50 minutes) and will be interspersed with 48 hours of recovery. |
| Control condition (CON; waiting list) | No intervention | –The control condition (CON; waiting list) will receive no intervention (i.e., exercise) but usual care. Participants in the CON will be required to go about their normal life, maintaining their current physical activity levels until the end of the study. Then, they will be offered to join one of the training programs/condition. |
Who may qualify
- Ages
- 40 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (3 listed)
- Persons with mild-moderate idiopathic Parkinson's Disease (Modified Hoehn \& Yahr Scale stages 0.5-3.5);
- On a stable dosage of medication during the previous month;
- Having poor sleep quality defined as a score > 15 in the PDSS-2 and/or reporting subjective sleep complaints affecting their sleep quality;
Key exclusion criteria (8 listed)
- Having atypical parkinsonism, dementia, stroke, or any other neurological condition;
- Presenting severe untreated obstructive sleep apnea (OSA);
- Having a Montreal Cognitive Assessment (MoCA) score <18
- Having a Beck Depression Inventory score >31;
- Having absolute contraindications to exercise;
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 |
|---|---|---|
| Cardiovascular training (CT)12 weeks of CT | Behavioural | Cardiovascular training (CT) |
| Resistance training (RT)12 weeks of RT | Behavioural | Resistance training (RT) |
| Multimodal training (MT)12 weeks of MT | Behavioural | Multimodal training (MT) |
Primary outcome
Changes in objective sleep quality
Time frame: 12 weeks (post-intervention) and 8 weeks (follow-up)
Sleep efficiency (SE) measured with polysomnography; SE (%) = Time asleep while in bed * 100; values = 0-100%; higher values reflect better SE.
Changes in subjective sleep quality
Time frame: 12 weeks (post-intervention) and 8 weeks (follow-up)
PD Sleep Scale version 2 (PDSS-2); values = 0-60; higher values reflect worse sleep quality.
Changes in sleep architecture
Time frame: 12 weeks (post-intervention) and 8 weeks (follow-up)
Changes in slow-wave power measured with polysomnography.
Changes in sleep architecture
Time frame: 12 weeks (post-intervention) and 8 weeks (follow-up)
Changes in sleep spindles density measured with polysomnography.
Changes in sleep architectures
Time frame: 12 weeks (post-intervention) and 8 weeks (follow-up)
Changes in REM sleep duration (%) measured with polysomnography.
5 secondary outcomes
Changes in motor function
Time frame: 12 weeks (post-intervention) and 8 weeks (follow-up)
Changes in cognitive function
Time frame: 12 weeks (post-intervention) and 8 weeks (follow-up)
Changes in fatigue
Time frame: 12 weeks (post-intervention) and 8 weeks (follow-up)
Changes in psychosocial functioning
Time frame: 12 weeks (post-intervention) and 8 weeks (follow-up)
Changes in Quality of Life Scale
Time frame: 12 weeks (post-intervention) and 8 weeks (follow-up)
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 13 Mar 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.
Marc Roig, Ph.D. principal investigator
McGill University
3 sites in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Cardiovascular training (CT), Resistance training (RT) and Multimodal training (MT) in people with Parkinson Disease, run by McGill University at 3 sites 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 8 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 13 Mar 2026. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 3 sites 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 Marc Roig, Ph.D. (514-398-4400 ext. 84599, marc.roigpull@mcgill.ca), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Changes in objective sleep quality (time frame: 12 weeks (post-intervention) and 8 weeks (follow-up)). The study lists 5 primary outcomes in all. 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 13 Mar 2026.