Sleep and Stroke Rehabilitation Study

NCT07579871 | Recruiting

• 1 other identifier: 2025-03643-01
• Study Type: observational
• Target: 226
• Locations: 1 country
• Sites: 1

Brief 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. 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. 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. 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. 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.

Conditions

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

Keywords

actigraphy; HSAT; Quality of life; rehabilitation; recovery; smartwatch; sleep; stroke

Outcome Measures

Primary Outcomes (14)

• 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 Outcomes (3)

• Hba1c

  Baseline.

• Cholesterol

  Baseline.

• Creatinine

  Basline.

Study Arms (1)

Patients with ischemic stroke

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

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)
• 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.

You may qualify if:

• Ischemic stroke.
• First time stroke.

You may not qualify if:

• 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.

Sponsors & Collaborators

• Malin Eleonora av Kák Gustafsson, MD, PhD: lead
• Region Skane: collaborator
• Lund University: collaborator

Study Sites (1)

Skånes Universitetssjukhus, SUS

Lund, Skåne County, Sweden

RECRUITING

MeSH Terms

Conditions

Stroke; Sleep Apnea Syndromes; Sleep Apnea, Obstructive; Sleep Initiation and Maintenance Disorders; Disorders of Excessive Somnolence

Condition Hierarchy (Ancestors)

Cerebrovascular Disorders; Brain Diseases; Central Nervous System Diseases; Nervous System Diseases; Vascular Diseases; Cardiovascular Diseases; Apnea; Respiration Disorders; Respiratory Tract Diseases; Sleep Disorders, Intrinsic; Dyssomnias; Sleep Wake Disorders; Mental Disorders

Central Study Contacts

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

CONTACT

0046451-29 60 00; malin_e.gustafsson@med.lu.se

Study Design

• Study Type: observational
• Observational Model: COHORT
• Time Perspective: PROSPECTIVE
• Target Duration: 9 Months
• Sponsor Type: OTHER
• Responsible Party: SPONSOR INVESTIGATOR
• PI Title: Postdoc

Study Record Dates

• First Submitted: February 27, 2026
• First Posted: May 12, 2026
• Study Start: March 18, 2026
• Primary Completion (Estimated): October 30, 2028
• Study Completion (Estimated): October 30, 2028
• Last Updated: May 12, 2026

Record last verified: 2026-04

Data Sharing

• IPD Sharing: Will share
• Shared Documents: STUDY PROTOCOL, SAP, ICF, 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.

Locations

SE (1)