Cognitive Function and Pathophysiological Mechanisms in Adults With Obstructive Sleep Apnea: Long-term Impact of Positive Airway Pressure Therapy

Status: Recruiting
Location: See location...
Study Type: Observational
SUMMARY

Obstructive sleep apnea (OSA) is the most common sleep-related breathing disorder and has been increasingly recognized as a contributor to cognitive decline and a potential risk factor for neurodegeneration. Previous studies have identified several associated comorbidities, including vascular dysfunction, metabolic alterations, and neuroinflammatory changes. However, the impact and underlying interplay of these pathophysiological mechanisms remain poorly understood due to the lack of integrated, multidimensional assessment. This prospective, observational, longitudinal cohort study aims to investigate cognition and OSA-related physiological and pathophysiological processes in 100 adults newly diagnosed with OSA, who have no history of chronic diseases (except for overweight and obesity) and are not receiving chronic medication. A subgroup of patients with moderate to severe OSA indicated for positive airway pressure (PAP) therapy will be followed to evaluate its long-term effects on cognitive function and related mechanisms. All participants will undergo polysomnography (PSG), comprehensive neuropsychological assessment, brain MRI with volumetric analysis, biomarker profiling from blood and saliva, and evaluation of endothelial function, baroreflex sensitivity, and gut microbiome composition at baseline and after 12 months. PAP adherence will be continuously monitored. The primary objective of this study is to characterize the profile of cognitive impairment associated with OSA. Secondary exploratory analyses will focus on factors contributing to neurocognitive dysfunction in OSA.

Eligibility
Participation Requirements
Sex: All
Minimum Age: 18
Maximum Age: 65
Healthy Volunteers: f
View:

• Informed consent.

• Age 18 - 65 years.

• Newly diagnosed OSA according to the criteria of the American Academy of Sleep Medicine Guidelines (overnight PSG with an AHI ≥5 events per hour, hypopneas defined by ≥ 10 seconds of airflow reduction accompanied by ≥ 3% desaturation or an arousal).

• Able to accomplish relevant tests and follow-up.

Locations
Other Locations
Slovakia
1st Department of Neurology, Faculty of Medicine, Comenius University and University Hospital Bratislava, Slovakia
RECRUITING
Bratislava
Contact Information
Primary
Branislav Kollar, prof. MD PhD. MPH.
b.kollar.md@gmail.com
+421 948 334 417
Backup
Stela Biathova, MA
sbiathova@gmail.com
+421 905 218 668
Time Frame
Start Date: 2024-11-01
Estimated Completion Date: 2027-12-31
Participants
Target number of participants: 30
Treatments
Newly diagnosed OSA
Newly diagnosed OSA according to the criteria of the American Academy of Sleep Medicine Guidelines (overnight PSG with an AHI ≥5 events per hour, hypopneas defined by ≥ 10 seconds of airflow reduction accompanied by ≥ 3% desaturation or an arousal).
Related Therapeutic Areas
Sponsors
Collaborators: Slovak Academy of Sciences, University Hospital Bratislava
Leads: Comenius University

This content was sourced from clinicaltrials.gov