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.
Descripción general del estudio
Estado
Descripción detallada
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 de estudio
Inscripción (Estimado)
Contactos y Ubicaciones
Estudio Contacto
- Nombre: Malin E. a. K. Gustafsson, M.D., Ph.D.
- Número de teléfono: 0046451-29 60 00
- Correo electrónico: malin_e.gustafsson@med.lu.se
Ubicaciones de estudio
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Skåne County
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Lund, Skåne County, Suecia
- Reclutamiento
- Skånes Universitetssjukhus, SUS
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Contacto:
- Malin E. a. K. Gustafsson, M.D., Ph.D.
- Número de teléfono: 004604617 10 00
- Correo electrónico: malin_e.gustafsson@med.lu.se
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Criterios de participación
Criterio de elegibilidad
Edades elegibles para estudiar
- Adulto
- Adulto Mayor
Acepta Voluntarios Saludables
Método de muestreo
Población de estudio
Descripción
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.
Plan de estudios
¿Cómo está diseñado el estudio?
Detalles de diseño
Cohortes e Intervenciones
Grupo / Cohorte |
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Patients with ischemic stroke
Patients with first-time ischemic stroke in Skåne and Blekinge, Sweden.
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¿Qué mide el estudio?
Medidas de resultado primarias
Medida de resultado |
Medida Descripción |
Periodo de tiempo |
|---|---|---|
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Occurrence of sleep apnea
Periodo de tiempo: 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
Periodo de tiempo: 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
Periodo de tiempo: 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
Periodo de tiempo: 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
Periodo de tiempo: 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
Periodo de tiempo: 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
Periodo de tiempo: 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
Periodo de tiempo: 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
Periodo de tiempo: 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
Periodo de tiempo: 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
Periodo de tiempo: 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
Periodo de tiempo: 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
Periodo de tiempo: 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
Periodo de tiempo: 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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Medidas de resultado secundarias
Medida de resultado |
Medida Descripción |
Periodo de tiempo |
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Hba1c
Periodo de tiempo: 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
Periodo de tiempo: Baseline.
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Serum cholesterol in mmol/L
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Baseline.
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Creatinine
Periodo de tiempo: Basline.
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Serum creatinine in µmol/L.
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Basline.
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Colaboradores e Investigadores
Patrocinador
Fechas de registro del estudio
Fechas importantes del estudio
Inicio del estudio (Actual)
Finalización primaria (Estimado)
Finalización del estudio (Estimado)
Fechas de registro del estudio
Enviado por primera vez
Primero enviado que cumplió con los criterios de control de calidad
Publicado por primera vez (Actual)
Actualizaciones de registros de estudio
Última actualización publicada (Actual)
Última actualización enviada que cumplió con los criterios de control de calidad
Última verificación
Más información
Términos relacionados con este estudio
Palabras clave
Términos MeSH relevantes adicionales
- Trastornos cerebrovasculares
- Enfermedades Cerebrales
- Enfermedades del Sistema Nervioso Central
- Enfermedades del Sistema Nervioso
- Enfermedades Vasculares
- Enfermedades cardiovasculares
- Desordenes mentales
- Enfermedades de las vías respiratorias
- Trastornos de la respiración
- Trastornos del sueño y la vigilia
- Apnea
- Trastornos del Sueño Intrínsecos
- Disomnias
- Carrera
- Síndromes de apnea del sueño
- Apnea del Sueño Obstructiva
- Trastornos de iniciación y mantenimiento del sueño
- Trastornos de somnolencia excesiva
Otros números de identificación del estudio
- 2025-03643-01
Plan de datos de participantes individuales (IPD)
¿Planea compartir datos de participantes individuales (IPD)?
Descripción del plan IPD
Marco de tiempo para compartir IPD
Criterios de acceso compartido de 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.
Tipo de información de apoyo para compartir IPD
- PROTOCOLO DE ESTUDIO
- SAVIA
- CIF
- CÓDIGO_ANALÍTICO
Información sobre medicamentos y dispositivos, documentos del estudio
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Estudia un producto de dispositivo regulado por la FDA de EE. UU.
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