Taking peopleNo phase

Cognitive Function in Obstructive Sleep Apnea

Key facts

Who runs it: Comenius University
Where: Slovakia1 site in 1 countryChoose a country to see its sites
Trial code: NCT07364318
Status: Recruiting
People taking part: 30 people, planned
Started: 1 Nov 2024
Expected to end: 31 Dec 2027
Type of study: Observational
Record updated: 23 January 2026

Who can take part

Age: 18 years to 65 years
Sex: Women and men
Healthy volunteers: Cannot take part

The registry criteria, word for word

Show all 12 criteriaShow less

Who can take part

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

Who cannot take part

Chronic use of medication or nicotine that may affect the study results
Prior neuropsychological assessment less than 6 months before the start of the research
Prior therapy for OSA (i.e., CPAP, upper airway surgery, or oral appliance)
History of any chronic disease other than overweight and obesity
Severe psychiatric condition that could affect cognitive functions
Motor or sensory deficits that would significantly complicate test administration
Patients who do not have Slovak as their native language actively used in daily communication
Considered by the study team as not suitable for enrollment based on clinical judgment

Check if you might fit

Answer for yourself. This is not a decision: only the study team can say whether you can take part.

Are you between 18 and 65 years old?

This trial has no sites in United States.

It has sites in one country. Choose a country to see its sites.

About the trial

What the trial wants to find out

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.

The group in the trial

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).