Health TrialsbyHealthPanel

Sleep and Stroke Rehabilitation Study

ConditionsStrokeSleep Apnea Syndrome (OSAS)InsomniaExcessive Daytime Sleepiness
Trial statusRecruiting
Trial phaseNot listed
Trial typeObservational
Biological sexAll
Age18+
SponsorMalin Eleonora av Kák Gustafsson, MD, PhD

About this trial

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.

Eligibility criteria

This trial does not accept healthy volunteers

Qualifiers

Ischemic stroke.

First time stroke.

Disqualifiers

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.

Trial population

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.

Trial design

Design model

Cohort

Time perspective

Prospective

Treatments tested in this trial

Not listed

Trial groups

226 Participants
are grouped into 1 trial group
Group A: Patients with ischemic stroke

Trial outcomes

Primary outcomes

1

Occurrence of sleep apnea

Percent of participants with sleep apnea as assessed by Home Sleep Apnea Testing.

Time frame
Three months post-stroke.
2

Occurrence of insomnia

Percent of participants with insomnia.

Time frame
Three months post-stroke.
3

MoCA

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.

Time frame
Twelve months post-stroke.
4

MoCA

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.

Time frame
Three months post-stroke.

Secondary outcomes

1

Hba1c

HbA1c (Hemoglobin A1c) mmol/mol. Represents the average amount of blood sugar attached to hemoglobin over the past two to three months

Time frame
Baseline.
2

Cholesterol

Serum cholesterol in mmol/L

Time frame
Baseline.
3

Creatinine

Serum creatinine in µmol/L.

Time frame
Basline.

Other outcomes

Sponsors and contacts

Click on the lead sponsor to view all of their trials.

Malin Eleonora av Kák Gustafsson, MD, PhD

Lead sponsor

Region Skane

Sponsor institution

Region Skane

Collaborator

Lund University

Collaborator

Source ClinicalTrials.gov
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