Sleep and Stroke Rehabilitation Study (SnSRehabS)

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.

Study Overview

• Status: Recruiting
• Conditions: Stroke; Insomnia; Excessive Daytime Sleepiness; Sleep Apnea Syndrome (OSAS)

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 Type: Observational
• Enrollment (Estimated): 226

Contacts and Locations

• Study Contact: Name: Malin E. a. K. Gustafsson, M.D., Ph.D.; Phone Number: 0046451-29 60 00; Email: malin_e.gustafsson@med.lu.se

Study Locations

• Sweden
  • Skåne County
    • Lund, Skåne County, Sweden
      • Recruiting
      • Skånes Universitetssjukhus, SUS
      • Contact: Malin E. a. K. Gustafsson, M.D., Ph.D.; Phone Number: 004604617 10 00; Email: malin_e.gustafsson@med.lu.se

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: Adult; Older Adult
• 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.

Description

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.

Study Plan

How is the study designed?

Number of groups / cohorts

1

Cohorts and Interventions

Group / Cohort
Patients with ischemic stroke; Patients with first-time ischemic stroke in Skåne and Blekinge, Sweden.

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Occurrence of sleep apnea	Percent of participants with sleep apnea as assessed by Home Sleep Apnea Testing.	Three months post-stroke.
Occurrence of insomnia	Percent of participants with insomnia.	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.	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.	Three months post-stroke.
Occurrence of excessive daytime sleepiness	Percent of participants with excessive daytime sleepiness.	Three months post-stroke.
Physical movement behavior	Amount of time spent in different postures and activities during 24 hours.	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.	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.	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.	Twelve months post-stroke.
FAS	FAS (Fatigue Assessment Scale) is scored 10-50. 10 indicates no fatigue, and 50 indicates the most severe fatigue.	Three months post-stroke.
FAS	FAS (Fatigue Assessment Scale) is scored 10-50. 10 indicates no fatigue, and 50 indicates the most severe fatigue.	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).	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).	Twelve months post-stroke.
Level of breathing difficulties	Patient-reported breathing difficulties based on information they obtained from their commercial digital health smartwatch.	Three months post-stroke.

Secondary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Hba1c	HbA1c (Hemoglobin A1c) mmol/mol. Represents the average amount of blood sugar attached to hemoglobin over the past two to three months	Baseline.
Cholesterol	Serum cholesterol in mmol/L	Baseline.
Creatinine	Serum creatinine in µmol/L.	Basline.

Collaborators and Investigators

• Sponsor: Malin Eleonora av Kák Gustafsson, MD, PhD
• Collaborators: Lund University; Region Skane

Study record dates

Study Major Dates

• Study Start (Actual): March 18, 2026
• Primary Completion (Estimated): October 30, 2028
• Study Completion (Estimated): October 30, 2028

Study Registration Dates

• First Submitted: February 27, 2026
• First Submitted That Met QC Criteria: May 6, 2026
• First Posted (Actual): May 12, 2026

Study Record Updates

• Last Update Posted (Actual): May 12, 2026
• Last Update Submitted That Met QC Criteria: May 6, 2026
• Last Verified: April 1, 2026

More Information

Terms related to this study

• Keywords: sleep; stroke; rehabilitation; Quality of life; recovery; actigraphy; smartwatch; HSAT
• Additional Relevant MeSH Terms: Cerebrovascular Disorders; Brain Diseases; Central Nervous System Diseases; Nervous System Diseases; Vascular Diseases; Cardiovascular Diseases; Mental Disorders; Respiratory Tract Diseases; Respiration Disorders; Sleep Wake Disorders; Apnea; Sleep Disorders, Intrinsic; Dyssomnias; Stroke; Sleep Apnea Syndromes; Sleep Apnea, Obstructive; Sleep Initiation and Maintenance Disorders; Disorders of Excessive Somnolence
• Other Study ID Numbers: 2025-03643-01

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: YES
• IPD Plan Description: 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).
• IPD Sharing Time Frame: Beginning after publication of the primary results and continuing for 5 years thereafter.

IPD Sharing 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.

• IPD Sharing Supporting Information Type: STUDY_PROTOCOL; SAP; ICF; ANALYTIC_CODE

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: No