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Sleep and Stroke Rehabilitation Study (SnSRehabS)

6 mei 2026 bijgewerkt door: Malin Eleonora av Kák Gustafsson, MD, PhD

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.

Studie Overzicht

Toestand

Werving

Conditie

Gedetailleerde beschrijving

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.

Studietype

Observationeel

Inschrijving (Geschat)

226

Contacten en locaties

In dit gedeelte vindt u de contactgegevens van degenen die het onderzoek uitvoeren en informatie over waar dit onderzoek wordt uitgevoerd.

Studiecontact

Naam: Malin E. a. K. Gustafsson, M.D., Ph.D.
Telefoonnummer: 0046451-29 60 00
E-mail: malin_e.gustafsson@med.lu.se

Studie Locaties

Zweden
- Skåne County
  - Lund, Skåne County, Zweden
    - Werving
    - Skånes Universitetssjukhus, SUS
    - Contact:
      
      Malin E. a. K. Gustafsson, M.D., Ph.D.
      
      Telefoonnummer: 004604617 10 00
      
      E-mail: malin_e.gustafsson@med.lu.se

Deelname Criteria

Onderzoekers zoeken naar mensen die aan een bepaalde beschrijving voldoen, de zogenaamde geschiktheidscriteria. Enkele voorbeelden van deze criteria zijn iemands algemene gezondheidstoestand of eerdere behandelingen.

Geschiktheidscriteria

Leeftijden die in aanmerking komen voor studie

Volwassen
Oudere volwassene

Accepteert gezonde vrijwilligers

Nee

Bemonsteringsmethode

Niet-waarschijnlijkheidssteekproef

Studie Bevolking

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.

Beschrijving

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.

Studie plan

Dit gedeelte bevat details van het studieplan, inclusief hoe de studie is opgezet en wat de studie meet.

Hoe is de studie opgezet?

Ontwerpdetails

Aantal groepen / cohorten

Cohorten en interventies

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

Wat meet het onderzoek?

Primaire uitkomstmaten

Uitkomstmaat	Maatregel Beschrijving	Tijdsspanne
Occurrence of sleep apnea Tijdsspanne: Three months post-stroke.	Percent of participants with sleep apnea as assessed by Home Sleep Apnea Testing.	Three months post-stroke.
Occurrence of insomnia Tijdsspanne: Three months post-stroke.	Percent of participants with insomnia.	Three months post-stroke.
MoCA Tijdsspanne: Twelve months post-stroke.	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 Tijdsspanne: Three months post-stroke.	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 Tijdsspanne: Three months post-stroke.	Percent of participants with excessive daytime sleepiness.	Three months post-stroke.
Physical movement behavior Tijdsspanne: One week of continuous accelerometer monitoring three months post-stroke.	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 Tijdsspanne: One week of continuous accelerometer monitoring twelve months post-stroke.	Amount of time spent in different postures and activities during 24 hours.	One week of continuous accelerometer monitoring twelve months post-stroke.
HADS Tijdsspanne: Three months post-stroke.	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 Tijdsspanne: Twelve months post-stroke.	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 Tijdsspanne: Three months post-stroke.	FAS (Fatigue Assessment Scale) is scored 10-50. 10 indicates no fatigue, and 50 indicates the most severe fatigue.	Three months post-stroke.
FAS Tijdsspanne: Twelve months post-stroke.	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 Tijdsspanne: Three months post-stroke.	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 Tijdsspanne: Twelve months post-stroke.	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 Tijdsspanne: Three months post-stroke.	Patient-reported breathing difficulties based on information they obtained from their commercial digital health smartwatch.	Three months post-stroke.

Secundaire uitkomstmaten

Uitkomstmaat	Maatregel Beschrijving	Tijdsspanne
Hba1c Tijdsspanne: Baseline.	HbA1c (Hemoglobin A1c) mmol/mol. Represents the average amount of blood sugar attached to hemoglobin over the past two to three months	Baseline.
Cholesterol Tijdsspanne: Baseline.	Serum cholesterol in mmol/L	Baseline.
Creatinine Tijdsspanne: Basline.	Serum creatinine in µmol/L.	Basline.

Medewerkers en onderzoekers

Hier vindt u mensen en organisaties die betrokken zijn bij dit onderzoek.

Sponsor

Malin Eleonora av Kák Gustafsson, MD, PhD

Medewerkers

Lund University

Region Skane

Studie record data

Deze datums volgen de voortgang van het onderzoeksdossier en de samenvatting van de ingediende resultaten bij ClinicalTrials.gov. Studieverslagen en gerapporteerde resultaten worden beoordeeld door de National Library of Medicine (NLM) om er zeker van te zijn dat ze voldoen aan specifieke kwaliteitscontrolenormen voordat ze op de openbare website worden geplaatst.

Bestudeer belangrijke data

Studie start (Werkelijk)

18 maart 2026

Primaire voltooiing (Geschat)

30 oktober 2028

Studie voltooiing (Geschat)

30 oktober 2028

Studieregistratiedata

Eerst ingediend

27 februari 2026

Eerst ingediend dat voldeed aan de QC-criteria

6 mei 2026

Eerst geplaatst (Werkelijk)

12 mei 2026

Updates van studierecords

Laatste update geplaatst (Werkelijk)

12 mei 2026

Laatste update ingediend die voldeed aan QC-criteria

6 mei 2026

Laatst geverifieerd

1 april 2026

Meer informatie

Termen gerelateerd aan deze studie

Trefwoorden

Aanvullende relevante MeSH-voorwaarden

Andere studie-ID-nummers

2025-03643-01

Plan Individuele Deelnemersgegevens (IPD)

Bent u van plan om gegevens van individuele deelnemers (IPD) te delen?

Beschrijving IPD-plan

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).

IPD-tijdsbestek voor delen

Beginning after publication of the primary results and continuing for 5 years thereafter.

IPD-toegangscriteria voor delen

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.

IPD delen Ondersteunend informatietype

LEERPROTOCOOL
SAP
ICF
ANALYTIC_CODE

Informatie over medicijnen en apparaten, studiedocumenten

Bestudeert een door de Amerikaanse FDA gereguleerd geneesmiddel

Nee

Bestudeert een door de Amerikaanse FDA gereguleerd apparaatproduct

Nee

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