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NCT Number: NCT07579871

Sleep and Stroke Rehabilitation 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:

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.

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Key information

Conditions

Stroke Apnea Brain Diseases Cardiovascular Diseases Central Nervous System Diseases Cerebrovascular Disorders Disorders of Excessive Somnolence Dyssomnias Excessive Daytime Sleepiness Insomnia Mental Disorders Nervous System Diseases Respiration Disorders Respiratory Tract Diseases Sleep Apnea Syndrome (OSAS) Sleep Apnea Syndromes Sleep Apnea, Obstructive Sleep Disorders, Intrinsic Sleep Initiation and Maintenance Disorders Sleep Wake Disorders Vascular Diseases

Age range

18 year and older

Sex eligibility

All sexes

Study type

Observational

Primary location

Skånes Universitetssjukhus, SUS

Lund, Skåne County, Sweden

Location status: Recruiting

Location contact

Malin E. a. K. Gustafsson, M.D., Ph.D.

CONTACT

[email protected]

004604617 10 00

About this study

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.

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

Inclusion criteria

  • Ischemic stroke.
  • First time stroke.

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.

Treatment and study plan

Primary outcomes

  1. Occurrence of sleep apnea

    Time frame: Three months post-stroke.

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

  2. Occurrence of insomnia

    Time frame: Three months post-stroke.

    Percent of participants with insomnia.

  3. 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.

  4. 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.

  5. Occurrence of excessive daytime sleepiness

    Time frame: Three months post-stroke.

    Percent of participants with excessive daytime sleepiness.

  6. 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.

  7. 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.

  8. 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.

  9. 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.

  10. 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.

  11. 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.

  12. 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).

  13. 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).

  14. 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.

Secondary outcomes

  1. Hba1c

    Time frame: Baseline.

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

  2. Cholesterol

    Time frame: Baseline.

    Serum cholesterol in mmol/L

  3. Creatinine

    Time frame: Basline.

    Serum creatinine in µmol/L.

Study contacts

Contact information is provided by the study sponsor or research team.

Malin E. a. K. Gustafsson, M.D., Ph.D.

CONTACT

[email protected]

0046451-29 60 00

Sponsors and collaborators

Lead sponsor

Malin Eleonora av Kák Gustafsson, MD, PhD

Other

Collaborators

  • Lund University
  • Region Skane

Registry information

Acronym: SnSRehabS

Important dates

Study start
2026
Primary completion
2028
Study completion
2028
First posted
May 12, 2026
Registry last updated
May 12, 2026

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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