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

NCT06811948 | Not Yet Recruiting

• 1 other identifier: 2024-02659-01
• Study Type: observational
• Target: 340
• Locations: 1 country
• Sites: 1

Brief Summary

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.

Conditions

Stroke; Fatigue Symptom; Obstructive Sleep Apnea; Sleep Disordered Breathing (SDB)

Outcome Measures

Primary Outcomes (1)

• Fatigue Assessment Scale

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

  1 year follow-up

Other Outcomes (3)

• Apnea-hypopnea index

  Within 72 hours of ictus

• Nocturnal time under 90% blood oxygen saturation

  Within 72 hours of ictus

• Oxygen Desaturation Index

  Within 72 hours of ictus

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)
• Sampling Method: Non-Probability Sample

Study Population

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

You may qualify if:

• 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

You may not qualify if:

• Traumatic stroke
• Tumor-associated bleeding
• Expected survival \<3 months
• Unconsciousness (RLS \>3)

Sponsors & Collaborators

• Blekinge County Council Hospital: lead

Study Sites (1)

Blekinge Hospital

Karlskrona, Blekinge County, 37130, Sweden

Location

MeSH Terms

Conditions

Stroke; Fatigue; Sleep Apnea, Obstructive; Sleep Apnea Syndromes

Condition Hierarchy (Ancestors)

Cerebrovascular Disorders; Brain Diseases; Central Nervous System Diseases; Nervous System Diseases; Vascular Diseases; Cardiovascular Diseases; Signs and Symptoms; Pathological Conditions, Signs and Symptoms; Apnea; Respiration Disorders; Respiratory Tract Diseases; Sleep Disorders, Intrinsic; Dyssomnias; Sleep Wake Disorders

Central Study Contacts

Joseph Aked, MD, PhD

CONTACT

0046767723725; joseph.aked@gmail.com

Study Design

• Study Type: observational
• Observational Model: COHORT
• Time Perspective: PROSPECTIVE
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Post-doc, Resident Physician Internal Medicine

Study Record Dates

• First Submitted: January 27, 2025
• First Posted: February 6, 2025
• Study Start: February 20, 2025
• Primary Completion (Estimated): May 20, 2027
• Study Completion (Estimated): December 20, 2027
• Last Updated: February 6, 2025

Record last verified: 2025-01

Data Sharing

• IPD Sharing: Will not share

Locations

SE (1)