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.
Panoramica dello studio
Stato
Descrizione dettagliata
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.
Tipo di studio
Iscrizione (Stimato)
Contatti e Sedi
Contatto studio
- Nome: Malin E. a. K. Gustafsson, M.D., Ph.D.
- Numero di telefono: 0046451-29 60 00
- Email: malin_e.gustafsson@med.lu.se
Luoghi di studio
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Skåne County
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Lund, Skåne County, Svezia
- Reclutamento
- Skånes Universitetssjukhus, SUS
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Contatto:
- Malin E. a. K. Gustafsson, M.D., Ph.D.
- Numero di telefono: 004604617 10 00
- Email: malin_e.gustafsson@med.lu.se
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Criteri di partecipazione
Criteri di ammissibilità
Età idonea allo studio
- Adulto
- Adulto più anziano
Accetta volontari sani
Metodo di campionamento
Popolazione di studio
Descrizione
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.
Piano di studio
Come è strutturato lo studio?
Dettagli di progettazione
Coorti e interventi
Gruppo / Coorte |
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Patients with ischemic stroke
Patients with first-time ischemic stroke in Skåne and Blekinge, Sweden.
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Cosa sta misurando lo studio?
Misure di risultato primarie
Misura del risultato |
Misura Descrizione |
Lasso di tempo |
|---|---|---|
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Occurrence of sleep apnea
Lasso di tempo: 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
Lasso di tempo: 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
Lasso di tempo: 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
Lasso di tempo: 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
Lasso di tempo: 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
Lasso di tempo: 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
Lasso di tempo: 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
Lasso di tempo: 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
Lasso di tempo: 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
Lasso di tempo: 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
Lasso di tempo: 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
Lasso di tempo: 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
Lasso di tempo: 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
Lasso di tempo: 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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Misure di risultato secondarie
Misura del risultato |
Misura Descrizione |
Lasso di tempo |
|---|---|---|
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Hba1c
Lasso di tempo: 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
Lasso di tempo: Baseline.
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Serum cholesterol in mmol/L
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Baseline.
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Creatinine
Lasso di tempo: Basline.
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Serum creatinine in µmol/L.
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Basline.
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Collaboratori e investigatori
Studiare le date dei record
Studia le date principali
Inizio studio (Effettivo)
Completamento primario (Stimato)
Completamento dello studio (Stimato)
Date di iscrizione allo studio
Primo inviato
Primo inviato che soddisfa i criteri di controllo qualità
Primo Inserito (Effettivo)
Aggiornamenti dei record di studio
Ultimo aggiornamento pubblicato (Effettivo)
Ultimo aggiornamento inviato che soddisfa i criteri QC
Ultimo verificato
Maggiori informazioni
Termini relativi a questo studio
Parole chiave
Termini MeSH pertinenti aggiuntivi
- Disturbi cerebrovascolari
- Malattie del cervello
- Malattie del sistema nervoso centrale
- Malattie del sistema nervoso
- Malattie vascolari
- Malattia cardiovascolare
- Disordini mentali
- Malattie delle vie respiratorie
- Disturbi respiratori
- Disturbi del sonno e della veglia
- Apnea
- Disturbi del sonno, intrinseci
- Dissonnie
- Ictus
- Sindromi da apnee notturne
- Apnea notturna, ostruttiva
- Disturbi dell'inizio e del mantenimento del sonno
- Disturbi di eccessiva sonnolenza
Altri numeri di identificazione dello studio
- 2025-03643-01
Piano per i dati dei singoli partecipanti (IPD)
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Descrizione del piano IPD
Periodo di condivisione IPD
Criteri di accesso alla condivisione IPD
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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.
Tipo di informazioni di supporto alla condivisione IPD
- STUDIO_PROTOCOLLO
- LINFA
- ICF
- CODICE_ANALITICO
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