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
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:
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.
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.
Exclusion Criteria:
Patients with first-time ischemic stroke in Skåne and Blekinge, Sweden.
Occurrence of sleep apnea
Percent of participants with sleep apnea as assessed by Home Sleep Apnea Testing.
Time frame: Three months post-stroke.
Occurrence of insomnia
Percent of participants with insomnia.
Time frame: 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.
Time frame: 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.
Time frame: Three months post-stroke.
Occurrence of excessive daytime sleepiness
Percent of participants with excessive daytime sleepiness.
Time frame: Three months post-stroke.
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.
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.
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.
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.
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.
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.
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.
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.
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.
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.
Cholesterol
Serum cholesterol in mmol/L
Time frame: Baseline.
Creatinine
Serum creatinine in µmol/L.
Time frame: Basline.
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, Sap, Icf, Analytic code
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