Sleep and Stroke Rehabilitation Study
For patients and families
In plain language
An automatic summary of structured registry data. It is an orientation aid, not a substitute for the official protocol or a physician assessment.
- What is being studied
- This is an observational study: the protocol does not assign a study treatment.
- Who it may be relevant to
- Registry conditions: Stroke, Sleep Apnea Syndrome (OSAS), Insomnia, Excessive Daytime Sleepiness. Basic parameters: from 18 years · All.
- What needs checking
- Age, condition and sex are only basic indicators. Prior treatment, laboratory values and other mandatory requirements appear in the eligibility criteria below.
- Where it takes place
- Sweden
- Next step
- Save the trial, show it to the treating physician, and confirm current recruitment with the study center. Costs, documents and travel →
Unsure about the terms? Read our patient guide →
Overview
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.
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.
Primary outcome measures
- Occurrence of sleep apnea [Time frame: Three months post-stroke.]
- Occurrence of insomnia [Time frame: Three months post-stroke.]
- MoCA [Time frame: Twelve months post-stroke.]
- MoCA [Time frame: Three months post-stroke.]
- Occurrence of excessive daytime sleepiness [Time frame: Three months post-stroke.]
- Physical movement behavior [Time frame: One week of continuous accelerometer monitoring three months post-stroke.]
- Physical movement behavior [Time frame: One week of continuous accelerometer monitoring twelve months post-stroke.]
- HADS [Time frame: Three months post-stroke.]
- HADS [Time frame: Twelve months post-stroke.]
- FAS [Time frame: Three months post-stroke.]
Secondary outcome measures (3)
- Hba1c [Time frame: Baseline.]
- Cholesterol [Time frame: Baseline.]
- Creatinine [Time frame: Basline.]
Eligibility criteria
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.
Criteria are shown verbatim from the registry (in English). Final eligibility is always assessed by the study center.
Healthy volunteers: No
Study design
- Observational model
- Cohort
Study locations
Sweden · 1 center
- Skånes Universitetssjukhus, SUS — Lund
Identifiers
NCT: NCT07579871 · 2025-03643-01