ClinicalTrials.gg
RecruitingNCT07579871SnSRehabSUpdated Sep 24, 2026

Sleep and Stroke Rehabilitation Study

An observational study in Stroke, Sleep Apnea Syndrome (OSAS) and Insomnia, sponsored by Malin Eleonora av Kák Gustafsson, MD, PhD. Recruiting at 1 site in Sweden. Open to participants aged 18 Years and older. Per ClinicalTrials.gov, last updated 2026-09-24.

Sponsored by Malin Eleonora av Kák Gustafsson, MD, PhD · Observational

From the registry’s dates

  • Started Mar 2026; still recruiting 7 months later.

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Study type
Observational
Model
Cohort
Time perspective
Prospective
Enrollment
226
Ages
18 Years and older
Sex
All
01

Where this study stands

Counted across the records on this site · 2026-11-13

Among 158 studies in Stroke with a site in Sweden — 30 open to participants now, 42 under way, 5 of them phase 3. Stroke · Sweden.

Planned enrollment
19th of 35
226 · median 230
Started
2026
with 8 others
Observational
35 of 158
7 open now
Primary completion
2028-10
later than 31 of 41 live
Registered
150th of 158
by date

Among the 158 studies in Stroke with a site in Sweden, this one is the 19th largest by planned enrollment of the 35 observational ones that give a count, is one of 9 that started in 2026, is one of 35 observational ones, reaches primary completion later than 31 of the 41 other live ones, and was the 150th registered.

Stroke

8,258 studies on the registry are indexed under Stroke; 2,055 are open to participants now.

Browse Stroke studies →

Open to participants now

30 of the 158 studies in Stroke with a site in Sweden are open now. Recruiting first, the newest first:

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All 30 open studies →

A study can be open while its sites in Sweden have not opened yet or have stopped. Only those recruiting at a site in Sweden →

Who these studies take

Of the 1,415 Stroke studies recruiting now, 695 (49%) set no upper age limit and 280 (20%) stop at 75 or younger; 77 take children under 18; 195 take healthy volunteers.

This study: 18 Years and older · all sexes · no healthy volunteers.

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02

Study 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. 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.
  2. 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.
  3. To identify which clinical factors and patient reported data, including patient reported data from commercial wearable health technology, predict a diagnosis of sleep apnea.
  4. 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.

03

Conditions studied

  • Stroke
  • Sleep Apnea Syndrome (OSAS)
  • Insomnia
  • Excessive Daytime Sleepiness

Keywords

  • actigraphy
  • HSAT
  • Quality of life
  • rehabilitation
  • recovery
  • smartwatch
  • sleep
  • stroke
04

Who can participate

Ages eligible
18 Years and older
Sexes eligible
All
Accepts healthy volunteers
No
Sampling method
Non-probability sample

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.

Go through the criteria one by one — yes, no or not sure — and take the list to your doctor or the study team. Kept in this browser only.

Inclusion criteria

  • Ischemic stroke.
  • First time stroke.

Exclusion criteria

Exclusion Criteria:

  • 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.
05

Study design

Observational model
Cohort
Time perspective
Prospective
Enrollment
226 participants (estimated)
Target follow-up
9 Months
Patient registry
Yes

Groups and cohorts

  • Patients with ischemic stroke

    Patients with first-time ischemic stroke in Skåne and Blekinge, Sweden.

06

What researchers measure

Primary outcomes

  1. Occurrence of sleep apnea

    Percent of participants with sleep apnea as assessed by Home Sleep Apnea Testing.

    Time frame: Three months post-stroke.

  2. Occurrence of insomnia

    Percent of participants with insomnia.

    Time frame: Three months post-stroke.

  3. 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.

    Time frame: Twelve months post-stroke.

  4. 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.

    Time frame: Three months post-stroke.

  5. Occurrence of excessive daytime sleepiness

    Percent of participants with excessive daytime sleepiness.

    Time frame: Three months post-stroke.

  6. Physical movement behavior

    Amount of time spent in different postures and activities during 24 hours.

    Time frame: One week of continuous accelerometer monitoring three months post-stroke.

  7. Physical movement behavior

    Amount of time spent in different postures and activities during 24 hours.

    Time frame: One week of continuous accelerometer monitoring twelve months post-stroke.

  8. 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.

    Time frame: Three months post-stroke.

  9. 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.

    Time frame: Twelve months post-stroke.

  10. FAS

    FAS (Fatigue Assessment Scale) is scored 10-50. 10 indicates no fatigue, and 50 indicates the most severe fatigue.

    Time frame: Three months post-stroke.

  11. FAS

    FAS (Fatigue Assessment Scale) is scored 10-50. 10 indicates no fatigue, and 50 indicates the most severe fatigue.

    Time frame: Twelve months post-stroke.

  12. 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).

    Time frame: Three months post-stroke.

  13. 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).

    Time frame: Twelve months post-stroke.

  14. Level of breathing difficulties

    Patient-reported breathing difficulties based on information they obtained from their commercial digital health smartwatch.

    Time frame: Three months post-stroke.

Secondary outcomes

  1. Hba1c

    HbA1c (Hemoglobin A1c) mmol/mol. Represents the average amount of blood sugar attached to hemoglobin over the past two to three months

    Time frame: Baseline.

  2. Cholesterol

    Serum cholesterol in mmol/L

    Time frame: Baseline.

  3. Creatinine

    Serum creatinine in µmol/L.

    Time frame: Basline.

07

Study locations

1 of 1 sites recruiting
  • Skånes Universitetssjukhus, SUS
    Lund, Skåne County, Sweden
    Recruiting
08

References and documents

Individual participant data

Plan to share: 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).

Supporting information: Study protocol, Statistical analysis plan, Informed consent form, Analytic code

Time frame: Beginning after publication of the primary results and continuing for 5 years thereafter.

Access criteria: Qualified researchers affiliated with academic, clinical, or research institutions may request de-identified individual participant data underlying the results reported in the published article. Researchers may submit a reasonable request to the Principal Investigator, including a description of the proposed analysis and data protection measures. Data access will be granted upon approval of the request and completion of a data-sharing agreement.

No publications or documents are linked to this record.

09

Timeline

Tracking since Sep 25, 2026
ElapsedEstimatedEstimated, not yet reachedSimilar studies: half by the dot; the band is the middle halfHalf of similar studies reached it by the dot; the band is the middle half, from a quarter to three quarters

Started Mar 2026 (actual). Primary completion is estimated for Oct 2028, 31 months after the start.

Of 835 non-industry observational studies under Stroke, half reached primary completion within 41 months of starting (the median), counting those still running; a quarter within 18 and three quarters within 92. This study's planned 31 months is below that.

Counting every sponsor, half of 897 studies reached it within 40 months; a quarter within 18 and three quarters within 85.

How these figures are worked out, and which studies are left out of them.

Registered
Feb 27, 2026
First posted
May 12, 2026
StartActual
Mar 18, 2026
Primary completionEst.
Oct 30, 2028
CompletionEst.
Oct 30, 2028
Last update
Sep 24, 2026
What these dates mean
Start.
When the first participant enrolled; while estimated, when the study expects to open to recruitment.
Primary completion.
When the last participant was examined or treated to collect data for the study's main question, its primary outcome. A study that stopped early gives the date its data collection stopped.
Completion.
When the last participant's last visit took place, for every outcome, secondary ones and side effects included: the end of the study. Often later than primary completion, sometimes the same day.
Actual and Est.
Actual means the registry says the date has happened. Est. (estimated) is a date the sponsor plans or expects. It can still move, and the sponsor is expected to change it to actual once it has passed.
No changes since tracking began. The registry record was last updated on Sep 24, 2026, before this site started recording changes on Sep 25, 2026. Its history is on ClinicalTrials.gov ↗
10

Registry details

Key details

Study ID
NCT07579871
Lead sponsor
Malin Eleonora av Kák Gustafsson, MD, PhD
Responsible party
Malin Eleonora av Kák Gustafsson, MD, PhD (Postdoc, Region Skane) — Sponsor-investigator
First posted
May 12, 2026
Start date
Mar 18, 2026
Primary completion
Oct 30, 2028 (estimated)
Completion
Oct 30, 2028 (estimated)
Last update
Sep 24, 2026

Study contacts

Malin E. a. K. Gustafsson, M.D., Ph.D.
Contact
malin_e.gustafsson@med.lu.se
0046451-29 60 00

Oversight

Data monitoring committee
No
FDA-regulated drug
No
FDA-regulated device
No
View the source record on ClinicalTrials.gov ↗

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