StrokeSnSRehabSNCT07579871
Sleep and Stroke Rehabilitation Study
An observational study of Stroke and Sleep Apnea Syndrome (OSAS), run by Malin Eleonora av Kák Gustafsson, MD, PhD at 1 site in Sweden.
Trial summary
The study aims to map sleep disorders and their impact on the ability to engage in an active daily life among people who have had a stroke, with particular focus on how sleep apnea can be identified. The study has the following objectives: 1. Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Stroke, Sleep Apnea Syndrome (OSAS), Insomnia
- How many people
- 226 participants
- Where
- 1 siteSweden
- Study dates
- 18 Mar 2026to 30 Oct 2028
- How long will I take part?
- 9 Months
- Phase
- Observational
- 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
Study population: Patients with stroke residing in the local referral area of Skåne University Hospital (SUS) or in the local referral area of the Department of Medicine at Blekinge Hospital Karlskrona.
Who may be able to join
- Ischemic stroke.
- First time stroke.
Who cannot join
- Short expected survival.
- Unable to carry HSAT equipment (e.g., gel nails; the patient is wearing other medical devices; motor or cognitive impairment without the possibility of assistance from healthcare staff or relatives).
- Reduced understanding of the project due to insufficient Swedish, which cannot be bridged with an interpreter.
Trial locations and contacts
1 site in 1 country. Contact the study team or a site near you to ask about taking part.
Sweden1 site, 1 recruiting
- Recruiting
Skånes Universitetssjukhus, SUS
Lund, Skåne County
Malin E. a. K. Gustafsson, M.D., Ph.D., 004604617 10 00, malin_e.gustafsson@med.lu.se
About this study
The study aims to map sleep disorders and their impact on the ability to engage in an active daily life among people who have had a stroke, with particular focus on how sleep apnea can be identified.
The study has the following objectives:
- To examine the occurrence of sleep apnea, insomnia, excessive daytime sleepiness, and restless legs syndrome/periodic limb movements in patients with ischemic stroke three months after onset.
- To investigate associations between these sleep disorders and physical and mental health, fatigue, quality of life, cognitive and physical function, and daily physical behavior including physical activity levels.
- To identify which clinical factors and patient reported data, including patient reported data from commercial wearable health technology, predict a diagnosis of sleep apnea.
- To examine how sleep disorders affect changes in physical and mental health, fatigue, quality of life, cognitive and physical function, and daily physical behavior including physical activity levels one year after stroke.
Read the detailed description
There is currently a lack of understanding regarding how common sleep disorders are after stroke and how extensive their impact is on physical and psychological conditions. This project will investigate how common sleep disorders are in connection with stroke and how they affect patients with stroke physically and psychologically, as well as their level of activity in everyday life.
The project will also examine how healthcare services could identify who should undergo an assessment for sleep apnea. Today, there are commercial health technology products that alert users to potential breathing problems during the night, but it is unclear whether the information a patient presents to their doctor, based on these commercial health technology products, should be included in the clinical assessment of sleep apnea risk.
The project will consecutively invite individuals with stroke from Skåne and Blekinge, Sweden. Three months after their stroke, participants will complete questionnaires, undergo actigraphy and wear a commercial health technology product in the form of a smartwatch for one week, as well as complete an overnight respiratory recording. Based on this, it will be possible to determine how many participants have a sleep disorder and how it has affected them, as well as which factors make it likely that an individual has sleep apnea.
- Keywords
- actigraphy, HSAT, Quality of life, rehabilitation, recovery, smartwatch, sleep, stroke
- Medical subject headings
- Stroke, Sleep Apnea Syndromes, Sleep Apnea, Obstructive, Sleep Initiation and Maintenance Disorders, Disorders of Excessive Somnolence
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
| Study group | Role | What they receive |
|---|---|---|
| Patients with ischemic stroke | Patients with first-time ischemic stroke in Skåne and Blekinge, Sweden. |
What is being measured
The primary outcome is the main question the study is designed to answer.
Occurrence of sleep apnea
Percent of participants with sleep apnea as assessed by Home Sleep Apnea Testing.
Measured: Three months post-stroke.
Occurrence of insomnia
Percent of participants with insomnia.
Measured: Three months post-stroke.
MoCA
MoCA (Montreal Cognitive Assessment) is a cognitive screening tool scored 0-30, where higher scores indicate better cognitive function; a score of 26 or above is considered normal, with an optional +1 point for individuals with ≤12 years of education.
Measured: Twelve months post-stroke.
MoCA
MoCA (Montreal Cognitive Assessment) is a cognitive screening tool scored 0-30, where higher scores indicate better cognitive function; a score of 26 or above is considered normal, with an optional +1 point for individuals with ≤12 years of education.
Measured: Three months post-stroke.
Occurrence of excessive daytime sleepiness
Percent of participants with excessive daytime sleepiness.
Measured: Three months post-stroke.
Physical movement behavior
Amount of time spent in different postures and activities during 24 hours.
Measured: One week of continuous accelerometer monitoring three months post-stroke.
Physical movement behavior
Amount of time spent in different postures and activities during 24 hours.
Measured: One week of continuous accelerometer monitoring twelve months post-stroke.
HADS
HADS (Hospital Anxiety and Depression Scale) includes two subscales (anxiety and depression) scored 0-21 each. 0 indicates no symptoms, and 21 indicates the most severe symptoms.
Measured: Three months post-stroke.
HADS
HADS (Hospital Anxiety and Depression Scale) includes two subscales (anxiety and depression) scored 0-21 each. 0 indicates no symptoms, and 21 indicates the most severe symptoms.
Measured: Twelve months post-stroke.
FAS
FAS (Fatigue Assessment Scale) is scored 10-50. 10 indicates no fatigue, and 50 indicates the most severe fatigue.
Measured: Three months post-stroke.
FAS
FAS (Fatigue Assessment Scale) is scored 10-50. 10 indicates no fatigue, and 50 indicates the most severe fatigue.
Measured: Twelve months post-stroke.
EQ-5D
EQ-5D produces an index score ranging from <0 to 1.
1 indicates full health, and lower values indicate worse health (with values below 0 representing health states considered worse than death).
Measured: Three months post-stroke.
EQ-5D
EQ-5D produces an index score ranging from <0 to 1.
1 indicates full health, and lower values indicate worse health (with values below 0 representing health states considered worse than death).
Measured: Twelve months post-stroke.
Level of breathing difficulties
Patient-reported breathing difficulties based on information they obtained from their commercial digital health smartwatch.
Measured: Three months post-stroke.
Secondary outcomes (3)
Hba1c
HbA1c (Hemoglobin A1c) mmol/mol. Represents the average amount of blood sugar attached to hemoglobin over the past two to three months
Measured: Baseline.
Cholesterol
Serum cholesterol in mmol/L
Measured: Baseline.
Creatinine
Serum creatinine in µmol/L.
Measured: Basline.
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted12 May 2026
- Study start18 Mar 2026
- Primary completion30 Oct 2028 (estimated)
- Study completion30 Oct 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.
- 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
- Observational
- Observational model
- Cohort
- Time perspective
- Prospective
- Enrolment
- 226 participants (estimated)
- Target duration
- 9 Months
Sponsor and investigators
- Lead sponsor
- Malin Eleonora av Kák Gustafsson, MD, PhD
- Sponsor type
- University, hospital or other
- Collaborators
- Region Skane, Lund University
- Responsible party
- Sponsor-investigator, Malin Eleonora av Kák Gustafsson, MD, PhD, Region Skane
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT07579871
- Sponsor's protocol ID
- 2025-03643-01
- Other IDs
- 2025
- Acronym
- SnSRehabS
- Status last verified
- Sep 2026
- First submitted
- 27 Feb 2026
- Last updated
- 24 Sep 2026
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- Yes: De-identified individual participant data underlying the results reported in the published article. No directly identifiable information will be shared, and all data will be processed in accordance with the EU General Data Protection Regulation (GDPR).
Study at a glance
From the registry record, last updated by the sponsor on 24 Sep 2026. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Sleep and Stroke Rehabilitation Study
- ClinicalTrials.gov ID
- NCT07579871
- Acronym / sponsor ID
- SnSRehabS / 2025-03643-01
- Keywords
- actigraphy, HSAT, Quality of life, rehabilitation, recovery, smartwatch, sleep, stroke
- Study type
- Observational
- Recruitment status
- Recruiting
- Enrolment
- 226 participants (estimated)
- Lead sponsor
- Malin Eleonora av Kák Gustafsson, MD, PhDUniversity, hospital or other
- Collaborators
- Region Skane, Lund University
- Study start
- 18 Mar 2026 (actual)
- Primary completion
- 30 Oct 2028 (estimated)
- Study completion
- 30 Oct 2028 (estimated)
- First posted
- 12 May 2026 (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.
The study aims to map sleep disorders and their impact on the ability to engage in an active daily life among people who have had a stroke, with particular focus on how sleep apnea can be identified.
The study has the following objectives:
- To examine the occurrence of sleep apnea, insomnia, excessive daytime sleepiness, and restless legs syndrome/periodic limb movements in patients with ischemic stroke three months after onset.
- To investigate associations between these sleep disorders and physical and mental health, fatigue, quality of life, cognitive and physical function, and daily physical behavior including physical activity levels.
- To identify which clinical factors and patient reported data, including patient reported data from commercial wearable health technology, predict a diagnosis of sleep apnea.
- To examine how sleep disorders affect changes in physical and mental health, fatigue, quality of life, cognitive and physical function, and daily physical behavior including physical activity levels one year after stroke.
Detailed description
There is currently a lack of understanding regarding how common sleep disorders are after stroke and how extensive their impact is on physical and psychological conditions. This project will investigate how common sleep disorders are in connection with stroke and how they affect patients with stroke physically and psychologically, as well as their level of activity in everyday life.
The project will also examine how healthcare services could identify who should undergo an assessment for sleep apnea. Today, there are commercial health technology products that alert users to potential breathing problems during the night, but it is unclear whether the information a patient presents to their doctor, based on these commercial health technology products, should be included in the clinical assessment of sleep apnea risk.
The project will consecutively invite individuals with stroke from Skåne and Blekinge, Sweden. Three months after their stroke, participants will complete questionnaires, undergo actigraphy and wear a commercial health technology product in the form of a smartwatch for one week, as well as complete an overnight respiratory recording. Based on this, it will be possible to determine how many participants have a sleep disorder and how it has affected them, as well as which factors make it likely that an individual has sleep apnea.
Study design
- Observational model
- Cohort
- Time perspective
- Prospective
- Target follow-up
- 9 Months
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| Patients with ischemic stroke | – | –Patients with first-time ischemic stroke in Skåne and Blekinge, Sweden. |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
- Study population
- Patients with stroke residing in the local referral area of Skåne University Hospital (SUS) or in the local referral area of the Department of Medicine at Blekinge Hospital Karlskrona.
Key inclusion criteria (2 listed)
- Ischemic stroke.
- First time stroke.
Key exclusion criteria (3 listed)
- Short expected survival.
- Unable to carry HSAT equipment (e.g., gel nails; the patient is wearing other medical devices; motor or cognitive impairment without the possibility of assistance from healthcare staff or relatives).
- Reduced understanding of the project due to insufficient Swedish, which cannot be bridged with an interpreter.
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Primary outcome
Occurrence of sleep apnea
Time frame: Three months post-stroke.
Percent of participants with sleep apnea as assessed by Home Sleep Apnea Testing.
Occurrence of insomnia
Time frame: Three months post-stroke.
Percent of participants with insomnia.
MoCA
Time frame: Twelve months post-stroke.
MoCA (Montreal Cognitive Assessment) is a cognitive screening tool scored 0-30, where higher scores indicate better cognitive function; a score of 26 or above is considered normal, with an optional +1 point for individuals with ≤12 years of education.
MoCA
Time frame: Three months post-stroke.
MoCA (Montreal Cognitive Assessment) is a cognitive screening tool scored 0-30, where higher scores indicate better cognitive function; a score of 26 or above is considered normal, with an optional +1 point for individuals with ≤12 years of education.
Occurrence of excessive daytime sleepiness
Time frame: Three months post-stroke.
Percent of participants with excessive daytime sleepiness.
Physical movement behavior
Time frame: One week of continuous accelerometer monitoring three months post-stroke.
Amount of time spent in different postures and activities during 24 hours.
Physical movement behavior
Time frame: One week of continuous accelerometer monitoring twelve months post-stroke.
Amount of time spent in different postures and activities during 24 hours.
HADS
Time frame: Three months post-stroke.
HADS (Hospital Anxiety and Depression Scale) includes two subscales (anxiety and depression) scored 0-21 each. 0 indicates no symptoms, and 21 indicates the most severe symptoms.
HADS
Time frame: Twelve months post-stroke.
HADS (Hospital Anxiety and Depression Scale) includes two subscales (anxiety and depression) scored 0-21 each. 0 indicates no symptoms, and 21 indicates the most severe symptoms.
FAS
Time frame: Three months post-stroke.
FAS (Fatigue Assessment Scale) is scored 10-50. 10 indicates no fatigue, and 50 indicates the most severe fatigue.
FAS
Time frame: Twelve months post-stroke.
FAS (Fatigue Assessment Scale) is scored 10-50. 10 indicates no fatigue, and 50 indicates the most severe fatigue.
EQ-5D
Time frame: Three months post-stroke.
EQ-5D produces an index score ranging from <0 to 1. 1 indicates full health, and lower values indicate worse health (with values below 0 representing health states considered worse than death).
EQ-5D
Time frame: Twelve months post-stroke.
EQ-5D produces an index score ranging from <0 to 1. 1 indicates full health, and lower values indicate worse health (with values below 0 representing health states considered worse than death).
Level of breathing difficulties
Time frame: Three months post-stroke.
Patient-reported breathing difficulties based on information they obtained from their commercial digital health smartwatch.
3 secondary outcomes
Hba1c
Time frame: Baseline.
Cholesterol
Time frame: Baseline.
Creatinine
Time frame: Basline.
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 24 Sep 2026.
- Individual participant dataSharing planned: Yes. De-identified individual participant data underlying the results reported in the published article. No directly identifiable information will be shared, and all data will be processed in accordance with the EU General Data Protection Regulation (GDPR).
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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.
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
An observational study of Stroke and Sleep Apnea Syndrome (OSAS), run by Malin Eleonora av Kák Gustafsson, MD, PhD at 1 site in Sweden.
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 2 inclusion and 3 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 24 Sep 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 Sweden. 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 Malin E. a. K. Gustafsson, M.D., Ph.D. (0046451-29 60 00, malin_e.gustafsson@med.lu.se), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Occurrence of sleep apnea (time frame: Three months post-stroke.). The study lists 14 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 24 Sep 2026.