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:
- 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.
- 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.
- To identify which clinical factors and patient reported data, including patient reported data from commercial wearable health technology, predict a diagnosis of sleep apnea.
- 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.
Přehled studie
Postavení
Detailní popis
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.
Typ studie
Zápis (Odhadovaný)
Kontakty a umístění
Studijní kontakt
- Jméno: Malin E. a. K. Gustafsson, M.D., Ph.D.
- Telefonní číslo: 0046451-29 60 00
- E-mail: malin_e.gustafsson@med.lu.se
Studijní místa
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Skåne County
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Lund, Skåne County, Švédsko
- Nábor
- Skånes Universitetssjukhus, SUS
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Kontakt:
- Malin E. a. K. Gustafsson, M.D., Ph.D.
- Telefonní číslo: 004604617 10 00
- E-mail: malin_e.gustafsson@med.lu.se
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Kritéria účasti
Kritéria způsobilosti
Věk způsobilý ke studiu
- Dospělý
- Starší dospělý
Přijímá zdravé dobrovolníky
Metoda odběru vzorků
Studijní populace
Popis
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.
Studijní plán
Jak je studie koncipována?
Detaily designu
Kohorty a intervence
Skupina / kohorta |
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Patients with ischemic stroke
Patients with first-time ischemic stroke in Skåne and Blekinge, Sweden.
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Co je měření studie?
Primární výstupní opatření
Měření výsledku |
Popis opatření |
Časové okno |
|---|---|---|
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Occurrence of sleep apnea
Časové okno: Three months post-stroke.
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Percent of participants with sleep apnea as assessed by Home Sleep Apnea Testing.
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Three months post-stroke.
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Occurrence of insomnia
Časové okno: Three months post-stroke.
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Percent of participants with insomnia.
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Three months post-stroke.
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MoCA
Časové okno: Twelve months post-stroke.
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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.
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Twelve months post-stroke.
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MoCA
Časové okno: Three months post-stroke.
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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.
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Three months post-stroke.
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Occurrence of excessive daytime sleepiness
Časové okno: Three months post-stroke.
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Percent of participants with excessive daytime sleepiness.
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Three months post-stroke.
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Physical movement behavior
Časové okno: One week of continuous accelerometer monitoring three months post-stroke.
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Amount of time spent in different postures and activities during 24 hours.
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One week of continuous accelerometer monitoring three months post-stroke.
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Physical movement behavior
Časové okno: One week of continuous accelerometer monitoring twelve months post-stroke.
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Amount of time spent in different postures and activities during 24 hours.
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One week of continuous accelerometer monitoring twelve months post-stroke.
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HADS
Časové okno: Three months post-stroke.
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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.
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Three months post-stroke.
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HADS
Časové okno: Twelve months post-stroke.
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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.
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Twelve months post-stroke.
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FAS
Časové okno: Three months post-stroke.
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FAS (Fatigue Assessment Scale) is scored 10-50.
10 indicates no fatigue, and 50 indicates the most severe fatigue.
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Three months post-stroke.
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FAS
Časové okno: Twelve months post-stroke.
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FAS (Fatigue Assessment Scale) is scored 10-50.
10 indicates no fatigue, and 50 indicates the most severe fatigue.
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Twelve months post-stroke.
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EQ-5D
Časové okno: Three months post-stroke.
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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.
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EQ-5D
Časové okno: Twelve months post-stroke.
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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.
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Level of breathing difficulties
Časové okno: Three months post-stroke.
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Patient-reported breathing difficulties based on information they obtained from their commercial digital health smartwatch.
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Three months post-stroke.
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Sekundární výstupní opatření
Měření výsledku |
Popis opatření |
Časové okno |
|---|---|---|
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Hba1c
Časové okno: Baseline.
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HbA1c (Hemoglobin A1c) mmol/mol.
Represents the average amount of blood sugar attached to hemoglobin over the past two to three months
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Baseline.
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Cholesterol
Časové okno: Baseline.
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Serum cholesterol in mmol/L
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Baseline.
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Creatinine
Časové okno: Basline.
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Serum creatinine in µmol/L.
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Basline.
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Spolupracovníci a vyšetřovatelé
Termíny studijních záznamů
Hlavní termíny studia
Začátek studia (Aktuální)
Primární dokončení (Odhadovaný)
Dokončení studie (Odhadovaný)
Termíny zápisu do studia
První předloženo
První předloženo, které splnilo kritéria kontroly kvality
První zveřejněno (Aktuální)
Aktualizace studijních záznamů
Poslední zveřejněná aktualizace (Aktuální)
Odeslaná poslední aktualizace, která splnila kritéria kontroly kvality
Naposledy ověřeno
Více informací
Termíny související s touto studií
Klíčová slova
Další relevantní podmínky MeSH
- Cerebrovaskulární poruchy
- Onemocnění mozku
- Onemocnění centrálního nervového systému
- Nemoci nervového systému
- Cévní onemocnění
- Kardiovaskulární choroby
- Duševní poruchy
- Nemoci dýchacích cest
- Poruchy dýchání
- Poruchy spánku a bdění
- Apnoe
- Poruchy spánku, vnitřní
- Dysomnie
- Mrtvice
- Syndromy spánkové apnoe
- Spánková apnoe, obstrukční
- Poruchy iniciace a udržování spánku
- Poruchy nadměrné somnolence
Další identifikační čísla studie
- 2025-03643-01
Plán pro data jednotlivých účastníků (IPD)
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Popis plánu IPD
Časový rámec sdílení IPD
Kritéria přístupu pro sdílení IPD
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.
Typ podpůrných informací pro sdílení IPD
- PROTOKOL STUDY
- MÍZA
- ICF
- ANALYTIC_CODE
Informace o lécích a zařízeních, studijní dokumenty
Studuje lékový produkt regulovaný americkým FDA
Studuje produkt zařízení regulovaný americkým úřadem FDA
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