Sleep and Stroke Rehabilitation Study

Condition(s) studied

Study summary

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

Primary outcome measure(s)

• Occurrence of sleep apnea — Three months post-stroke.
  Percent of participants with sleep apnea as assessed by Home Sleep Apnea Testing.
• Occurrence of insomnia — Three months post-stroke.
  Percent of participants with insomnia.
• MoCA — 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.
• MoCA — 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.
• Occurrence of excessive daytime sleepiness — Three months post-stroke.
  Percent of participants with excessive daytime sleepiness.
• Physical movement behavior — One week of continuous accelerometer monitoring three months post-stroke.
  Amount of time spent in different postures and activities during 24 hours.
• Physical movement behavior — One week of continuous accelerometer monitoring twelve months post-stroke.
  Amount of time spent in different postures and activities during 24 hours.
• HADS — 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.
• HADS — 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.
• FAS — Three months post-stroke.
  FAS (Fatigue Assessment Scale) is scored 10-50. 10 indicates no fatigue, and 50 indicates the most severe fatigue.
• FAS — Twelve months post-stroke.
  FAS (Fatigue Assessment Scale) is scored 10-50. 10 indicates no fatigue, and 50 indicates the most severe fatigue.
• EQ-5D — 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).
• EQ-5D — 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).
• Level of breathing difficulties — Three months post-stroke.
  Patient-reported breathing difficulties based on information they obtained from their commercial digital health smartwatch.

Trial sites (1)

Other trials for the same condition