이 페이지는 자동 번역되었으며 번역의 정확성을 보장하지 않습니다. 참조하십시오 영문판 원본 텍스트의 경우.

Sleep and Stroke Rehabilitation Study (SnSRehabS)

2026년 5월 6일 업데이트: 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.

연구 개요

상태

모병

정황

상세 설명

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.

연구 유형

관찰

등록 (추정된)

226

연락처 및 위치

이 섹션에서는 연구를 수행하는 사람들의 연락처 정보와 이 연구가 수행되는 장소에 대한 정보를 제공합니다.

연구 연락처

연구 장소

  • 스웨덴
    • Skåne County
      • Lund, Skåne County, 스웨덴
        • 모병
        • Skånes Universitetssjukhus, SUS
        • 연락하다:

참여기준

연구원은 적격성 기준이라는 특정 설명에 맞는 사람을 찾습니다. 이러한 기준의 몇 가지 예는 개인의 일반적인 건강 상태 또는 이전 치료입니다.

자격 기준

공부할 수 있는 나이

  • 성인
  • 고령자

건강한 자원 봉사자를 받아들입니다

아니

샘플링 방법

비확률 샘플

연구 인구

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.

설명

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.

공부 계획

이 섹션에서는 연구 설계 방법과 연구가 측정하는 내용을 포함하여 연구 계획에 대한 세부 정보를 제공합니다.

연구는 어떻게 설계됩니까?

디자인 세부사항

코호트 및 개입

그룹/코호트
Patients with ischemic stroke
Patients with first-time ischemic stroke in Skåne and Blekinge, Sweden.

연구는 무엇을 측정합니까?

주요 결과 측정

결과 측정
측정값 설명
기간
Occurrence of sleep apnea
기간: Three months post-stroke.
Percent of participants with sleep apnea as assessed by Home Sleep Apnea Testing.
Three months post-stroke.
Occurrence of insomnia
기간: Three months post-stroke.
Percent of participants with insomnia.
Three months post-stroke.
MoCA
기간: 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
기간: 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
기간: Three months post-stroke.
Percent of participants with excessive daytime sleepiness.
Three months post-stroke.
Physical movement behavior
기간: 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
기간: 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
기간: 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
기간: 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
기간: 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
기간: 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
기간: 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
기간: 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
기간: Three months post-stroke.
Patient-reported breathing difficulties based on information they obtained from their commercial digital health smartwatch.
Three months post-stroke.

2차 결과 측정

결과 측정
측정값 설명
기간
Hba1c
기간: 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
기간: Baseline.
Serum cholesterol in mmol/L
Baseline.
Creatinine
기간: Basline.
Serum creatinine in µmol/L.
Basline.

공동 작업자 및 조사자

여기에서 이 연구와 관련된 사람과 조직을 찾을 수 있습니다.

스폰서

Malin Eleonora av Kák Gustafsson, MD, PhD

협력자

Lund University
Region Skane

연구 기록 날짜

이 날짜는 ClinicalTrials.gov에 대한 연구 기록 및 요약 결과 제출의 진행 상황을 추적합니다. 연구 기록 및 보고된 결과는 공개 웹사이트에 게시되기 전에 특정 품질 관리 기준을 충족하는지 확인하기 위해 국립 의학 도서관(NLM)에서 검토합니다.

연구 주요 날짜

연구 시작 (실제)

2026년 3월 18일

기본 완료 (추정된)

2028년 10월 30일

연구 완료 (추정된)

2028년 10월 30일

연구 등록 날짜

최초 제출

2026년 2월 27일

QC 기준을 충족하는 최초 제출

2026년 5월 6일

처음 게시됨 (실제)

2026년 5월 12일

연구 기록 업데이트

마지막 업데이트 게시됨 (실제)

2026년 5월 12일

QC 기준을 충족하는 마지막 업데이트 제출

2026년 5월 6일

마지막으로 확인됨

2026년 4월 1일

추가 정보

이 연구와 관련된 용어

키워드

추가 관련 MeSH 약관

기타 연구 ID 번호

  • 2025-03643-01

개별 참가자 데이터(IPD) 계획

개별 참가자 데이터(IPD)를 공유할 계획입니까?

예

IPD 계획 설명

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 공유 기간

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

IPD 공유 액세스 기준

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 공유 지원 정보 유형

  • 연구_프로토콜
  • 수액
  • ICF
  • ANALYTIC_CODE

약물 및 장치 정보, 연구 문서

미국 FDA 규제 의약품 연구

아니

미국 FDA 규제 기기 제품 연구

아니

이 정보는 변경 없이 clinicaltrials.gov 웹사이트에서 직접 가져온 것입니다. 귀하의 연구 세부 정보를 변경, 제거 또는 업데이트하도록 요청하는 경우 register@clinicaltrials.gov. 문의하십시오. 변경 사항이 clinicaltrials.gov에 구현되는 즉시 저희 웹사이트에도 자동으로 업데이트됩니다. .

뇌졸중에 대한 임상 시험

유사한 임상시험 검색

스폰서 및 공동 작업자

건강 상태

약물 개입

CROs by country

CROs in Mexico

정황

희귀 질병

약물 개입

식이 보충제

스폰서 / 협력자

위치

구독하다