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Sleep and Stroke Rehabilitation Study (SnSRehabS)

2026年5月6日 更新者：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:

  1. 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.
  2. 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.
  3. To identify which clinical factors and patient reported data, including patient reported data from commercial wearable health technology, predict a diagnosis of sleep apnea.
  4. 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.

調査の概要

状態

募集

条件

詳細な説明

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.

研究の種類

観察的

入学 (推定)

226

連絡先と場所

このセクションには、調査を実施する担当者の連絡先の詳細と、この調査が実施されている場所に関する情報が記載されています。

研究連絡先

研究場所

  • スウェーデン
    • Skåne County
      • Lund、Skåne County、スウェーデン
        • 募集
        • Skånes Universitetssjukhus, SUS
        • コンタクト：

参加基準

研究者は、適格基準と呼ばれる特定の説明に適合する人を探します。これらの基準のいくつかの例は、人の一般的な健康状態または以前の治療です。

適格基準

就学可能な年齢

  • 大人
  • 高齢者

健康ボランティアの受け入れ

いいえ

サンプリング方法

非確率サンプル

調査対象母集団

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.

説明

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.

研究計画

このセクションでは、研究がどのように設計され、研究が何を測定しているかなど、研究計画の詳細を提供します。

研究はどのように設計されていますか？

デザインの詳細

コホートと介入

グループ/コホート
Patients with ischemic stroke
Patients with first-time ischemic stroke in Skåne and Blekinge, Sweden.

この研究は何を測定していますか？

主要な結果の測定

結果測定
メジャーの説明
時間枠
Occurrence of sleep apnea
時間枠：Three months post-stroke.
Percent of participants with sleep apnea as assessed by Home Sleep Apnea Testing.
Three months post-stroke.
Occurrence of insomnia
時間枠：Three months post-stroke.
Percent of participants with insomnia.
Three months post-stroke.
MoCA
時間枠：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
時間枠：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
時間枠：Three months post-stroke.
Percent of participants with excessive daytime sleepiness.
Three months post-stroke.
Physical movement behavior
時間枠：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
時間枠：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
時間枠：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
時間枠：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
時間枠：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
時間枠：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
時間枠：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
時間枠：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
時間枠：Three months post-stroke.
Patient-reported breathing difficulties based on information they obtained from their commercial digital health smartwatch.
Three months post-stroke.

二次結果の測定

結果測定
メジャーの説明
時間枠
Hba1c
時間枠：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
時間枠：Baseline.
Serum cholesterol in mmol/L
Baseline.
Creatinine
時間枠：Basline.
Serum creatinine in µmol/L.
Basline.

協力者と研究者

ここでは、この調査に関係する人々や組織を見つけることができます。

スポンサー

Malin Eleonora av Kák Gustafsson, MD, PhD

協力者

Lund University
Region Skane

研究記録日

これらの日付は、ClinicalTrials.gov への研究記録と要約結果の提出の進捗状況を追跡します。研究記録と報告された結果は、国立医学図書館 (NLM) によって審査され、公開 Web サイトに掲載される前に、特定の品質管理基準を満たしていることが確認されます。

主要日程の研究

研究開始 (実際)

2026年3月18日

一次修了 (推定)

2028年10月30日

研究の完了 (推定)

2028年10月30日

試験登録日

最初に提出

2026年2月27日

QC基準を満たした最初の提出物

2026年5月6日

最初の投稿 (実際)

2026年5月12日

学習記録の更新

投稿された最後の更新 (実際)

2026年5月12日

QC基準を満たした最後の更新が送信されました

2026年5月6日

最終確認日

2026年4月1日

詳しくは

本研究に関する用語

キーワード

追加の関連 MeSH 用語

その他の研究ID番号

  • 2025-03643-01

個々の参加者データ (IPD) の計画

個々の参加者データ (IPD) を共有する予定はありますか?

はい

IPD プランの説明

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 共有時間枠

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

IPD 共有アクセス基準

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 共有サポート情報タイプ

  • STUDY_PROTOCOL
  • SAP
  • ICF
  • ANALYTIC_CODE

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米国FDA規制機器製品の研究

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