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.
Visão geral do estudo
Status
Descrição detalhada
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 estudo
Inscrição (Estimado)
Contactos e Locais
Contato de estudo
- Nome: Malin E. a. K. Gustafsson, M.D., Ph.D.
- Número de telefone: 0046451-29 60 00
- E-mail: malin_e.gustafsson@med.lu.se
Locais de estudo
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Skåne County
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Lund, Skåne County, Suécia
- Recrutamento
- Skånes Universitetssjukhus, SUS
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Contato:
- Malin E. a. K. Gustafsson, M.D., Ph.D.
- Número de telefone: 004604617 10 00
- E-mail: malin_e.gustafsson@med.lu.se
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Critérios de participação
Critérios de elegibilidade
Idades elegíveis para estudo
- Adulto
- Adulto mais velho
Aceita Voluntários Saudáveis
Método de amostragem
População do estudo
Descrição
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.
Plano de estudo
Como o estudo é projetado?
Detalhes do projeto
Coortes e Intervenções
Grupo / Coorte |
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Patients with ischemic stroke
Patients with first-time ischemic stroke in Skåne and Blekinge, Sweden.
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O que o estudo está medindo?
Medidas de resultados primários
Medida de resultado |
Descrição da medida |
Prazo |
|---|---|---|
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Occurrence of sleep apnea
Prazo: 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
Prazo: 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
Prazo: 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
Prazo: 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
Prazo: 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
Prazo: 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
Prazo: 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
Prazo: 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
Prazo: 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
Prazo: 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
Prazo: 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
Prazo: 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
Prazo: 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
Prazo: 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 resultados secundários
Medida de resultado |
Descrição da medida |
Prazo |
|---|---|---|
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Hba1c
Prazo: 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
Prazo: Baseline.
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Serum cholesterol in mmol/L
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Baseline.
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Creatinine
Prazo: Basline.
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Serum creatinine in µmol/L.
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Basline.
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Colaboradores e Investigadores
Patrocinador
Datas de registro do estudo
Datas Principais do Estudo
Início do estudo (Real)
Conclusão Primária (Estimado)
Conclusão do estudo (Estimado)
Datas de inscrição no estudo
Enviado pela primeira vez
Enviado pela primeira vez que atendeu aos critérios de CQ
Primeira postagem (Real)
Atualizações de registro de estudo
Última Atualização Postada (Real)
Última atualização enviada que atendeu aos critérios de controle de qualidade
Última verificação
Mais Informações
Termos relacionados a este estudo
Palavras-chave
Termos MeSH relevantes adicionais
- Distúrbios Cerebrovasculares
- Doenças Cerebrais
- Doenças do Sistema Nervoso Central
- Doenças do Sistema Nervoso
- Doenças Vasculares
- Doenças cardiovasculares
- Transtornos Mentais, Desordem Mental
- Doenças Respiratórias
- Distúrbios Respiratórios
- Distúrbios do Sono Vigília
- Apnéia
- Distúrbios do Sono Intrínsecos
- Dissônias
- Derrame
- Síndromes da Apneia do Sono
- Apnéia do Sono, Obstrutiva
- Distúrbios de Iniciação e Manutenção do Sono
- Distúrbios de Sonolência Excessiva
Outros números de identificação do estudo
- 2025-03643-01
Plano para dados de participantes individuais (IPD)
Planeja compartilhar dados de participantes individuais (IPD)?
Descrição do plano IPD
Prazo de Compartilhamento de IPD
Critérios de acesso de compartilhamento 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 informação de suporte de compartilhamento de IPD
- PROTOCOLO DE ESTUDO
- SEIVA
- CIF
- ANALYTIC_CODE
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