Sleep and Stroke Rehabilitation Study

Обзор

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.

Подробное описание

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.

Первичные конечные точки

• Occurrence of sleep apnea [Срок оценки: Three months post-stroke.]
• Occurrence of insomnia [Срок оценки: Three months post-stroke.]
• MoCA [Срок оценки: Twelve months post-stroke.]
• MoCA [Срок оценки: Three months post-stroke.]
• Occurrence of excessive daytime sleepiness [Срок оценки: Three months post-stroke.]
• Physical movement behavior [Срок оценки: One week of continuous accelerometer monitoring three months post-stroke.]
• Physical movement behavior [Срок оценки: One week of continuous accelerometer monitoring twelve months post-stroke.]
• HADS [Срок оценки: Three months post-stroke.]
• HADS [Срок оценки: Twelve months post-stroke.]
• FAS [Срок оценки: Three months post-stroke.]

Вторичные конечные точки (3)

• Hba1c [Срок оценки: Baseline.]
• Cholesterol [Срок оценки: Baseline.]
• Creatinine [Срок оценки: Basline.]

Критерии участия

Критерии включения

• Ischemic stroke.
• First time stroke.

Критерии исключения

• 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.

Критерии приведены из реестра в оригинале (на английском). Окончательную оценку соответствия проводит исследовательский центр.

Здоровые добровольцы: Нет

Дизайн исследования

Модель наблюдения

Когортное

Центры проведения

Швеция · 1 центр

• Skånes Universitetssjukhus, SUS — Lund

Идентификаторы

NCT: NCT07579871 · 2025-03643-01

Первоисточники (государственные реестры)

• ClinicalTrials.gov (NIH, США)

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