Sleep-Disordered Breathing in the Acute Phase After Stroke and Neuropsychiatric Outcomes

Trial statusNot yet recruiting
Trial phaseNot listed
Trial typeObservational
Biological sexAll
Age18+
SponsorBlekinge County Council Hospital

About this trial

In people who have had a stroke or a transient ischemic attack (TIA), it is common to have problems with breathing patterns during sleep, particularly a condition called obstructive sleep apnea. Another common long-term problem after a stroke is post-stroke fatigue, which affects function and quality of life after stroke. There is currently no clearly effective treatment for post-stroke fatigue. We are investigating whether there might be a connection between sleep-related breathing disturbances, and the risk of developing long-term post-stroke fatigue

The project is being conducted at Blekingesjukhuset Karlskrona, and inpatients with stroke are asked to participate. Participants are equipped with a sleep analysis pad under the mattress that measures breathing patterns during the night, as well as a wrist-worn device that measures oxygen saturation in the blood. Participants are also asked about their functional level in daily life and any symptoms of obstructive sleep apnea. One year after the stroke, participants are invited for a follow-up visit where we ask about post-stroke fatigue, depressive symptoms, and treatment and investigations related to the stroke.

We will then investigate the relationship between sleep-related breathing disturbances, measured early after stroke, and the risk of significant fatigue after the stroke. This could lead to future studies with treatment trials for obstructive sleep apnea in certain individuals with post-stroke fatigue. The study could also lead to potentially increased awareness that these conditions might be connected, which could result in a higher likelihood of detecting treatable obstructive sleep apnea in certain subgroups after stroke.

Eligibility criteria

This trial does not accept healthy volunteers

Qualifiers

Age >18 years

Stroke according to WHO definition (31) (ischemic stroke, intracerebral hemorrhage, or subarachnoid hemorrhage)

TIA with MRI-verified lesions corresponding to symptoms

Informed consent to participate

Disqualifiers

Traumatic stroke

Tumor-associated bleeding

Expected survival <3 months

Unconsciousness (RLS >3)

Trial population

Hospital-based, prospective inclusion at a single site in Karlskrona, Sweden.

Trial design

Design model

Cohort

Time perspective

Prospective

Treatments tested in this trial

Not listed

Trial groups

No trial groups listed

Trial outcomes

Primary outcomes

1

Fatigue Assessment Scale

Measurement of post-stroke fatigue at 1 year follow-up.

Time frame
1 year follow-up

Secondary outcomes

Other outcomes

1

Apnea-hypopnea index

Apnea-hypopnea index measured during hospital stay with Withings Sleep Analyzer. Used as a biomarker for sleep disordered-breathing.

Time frame
Within 72 hours of ictus
2

Nocturnal time under 90% blood oxygen saturation

Measured with pulse oximeter. Used as a biomarker of sleep-disordered breathing.

Time frame
Within 72 hours of ictus
3

Oxygen Desaturation Index

Measure of nocturnal desaturations

Time frame
Within 72 hours of ictus

Sponsors and contacts

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