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.
Studieoversikt
Status
Detaljert beskrivelse
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
Registrering (Antatt)
Kontakter og plasseringer
Studiekontakt
- Navn: Malin E. a. K. Gustafsson, M.D., Ph.D.
- Telefonnummer: 0046451-29 60 00
- E-post: malin_e.gustafsson@med.lu.se
Studiesteder
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Skåne County
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Lund, Skåne County, Sverige
- Rekruttering
- Skånes Universitetssjukhus, SUS
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Ta kontakt med:
- Malin E. a. K. Gustafsson, M.D., Ph.D.
- Telefonnummer: 004604617 10 00
- E-post: malin_e.gustafsson@med.lu.se
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Deltakelseskriterier
Kvalifikasjonskriterier
Alder som er kvalifisert for studier
- Voksen
- Eldre voksen
Tar imot friske frivillige
Prøvetakingsmetode
Studiepopulasjon
Beskrivelse
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.
Studieplan
Hvordan er studiet utformet?
Designdetaljer
Kohorter og intervensjoner
Gruppe / Kohort |
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Patients with ischemic stroke
Patients with first-time ischemic stroke in Skåne and Blekinge, Sweden.
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Hva måler studien?
Primære resultatmål
Resultatmål |
Tiltaksbeskrivelse |
Tidsramme |
|---|---|---|
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Occurrence of sleep apnea
Tidsramme: 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
Tidsramme: 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
Tidsramme: 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.
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MoCA
Tidsramme: 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.
|
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Occurrence of excessive daytime sleepiness
Tidsramme: Three months post-stroke.
|
Percent of participants with excessive daytime sleepiness.
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Three months post-stroke.
|
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Physical movement behavior
Tidsramme: 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
Tidsramme: 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
Tidsramme: 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
Tidsramme: 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
Tidsramme: Three months post-stroke.
|
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
Tidsramme: 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
Tidsramme: 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
Tidsramme: 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
Tidsramme: 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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Sekundære resultatmål
Resultatmål |
Tiltaksbeskrivelse |
Tidsramme |
|---|---|---|
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Hba1c
Tidsramme: 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
Tidsramme: Baseline.
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Serum cholesterol in mmol/L
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Baseline.
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Creatinine
Tidsramme: Basline.
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Serum creatinine in µmol/L.
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Basline.
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Samarbeidspartnere og etterforskere
Studierekorddatoer
Studer hoveddatoer
Studiestart (Faktiske)
Primær fullføring (Antatt)
Studiet fullført (Antatt)
Datoer for studieregistrering
Først innsendt
Først innsendt som oppfylte QC-kriteriene
Først lagt ut (Faktiske)
Oppdateringer av studieposter
Sist oppdatering lagt ut (Faktiske)
Siste oppdatering sendt inn som oppfylte QC-kriteriene
Sist bekreftet
Mer informasjon
Begreper knyttet til denne studien
Ytterligere relevante MeSH-vilkår
- Cerebrovaskulære lidelser
- Hjernesykdommer
- Sykdommer i sentralnervesystemet
- Sykdommer i nervesystemet
- Vaskulære sykdommer
- Kardiovaskulære sykdommer
- Psykiske lidelser
- Sykdommer i luftveiene
- Respirasjonsforstyrrelser
- Søvnvåkenforstyrrelser
- Apné
- Søvnforstyrrelser, iboende
- Dyssomnier
- Slag
- Søvnapné syndromer
- Søvnapné, obstruktiv
- Søvninitiering og vedlikeholdsforstyrrelser
- Forstyrrelser av overdreven somnolens
Andre studie-ID-numre
- 2025-03643-01
Plan for individuelle deltakerdata (IPD)
Planlegger du å dele individuelle deltakerdata (IPD)?
IPD-planbeskrivelse
IPD-delingstidsramme
Tilgangskriterier for IPD-deling
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-deling Støtteinformasjonstype
- STUDY_PROTOCOL
- SEVJE
- ICF
- ANALYTIC_CODE
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