Cognitive Function in Obstructive Sleep Apnea
Trial statusRecruiting
Trial phaseNot listed
Trial typeObservational
Biological sexAll
Age18-65
SponsorComenius University
About this trial
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 criteria
This trial does not accept healthy volunteersQualifiers
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.
Disqualifiers
History of any chronic disease other than overweight and obesity.
Severe psychiatric condition that could affect cognitive functions.
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.
Trial population
Patients with newly diagnosed OSA who have no history of other chronic diseases except for overweight and obesity, are not taking any medication, and are aged between 18 and 65 years.
Trial design
Design model
Cohort
Time perspective
Prospective
Treatments tested in this trial
Not listed
Trial groups
30 Participants
are grouped into 1 trial groupGroup A: Newly diagnosed OSA
Trial outcomes
Primary outcomes
1
Rey Auditory - Verbal Learning Test (RAVLT)
Measure of verbal episodic memory, encompassing immediate recall, learning across trials, delayed recall, and recognition. Units: total number of correctly recalled words (0-75); z-score. Higher scores indicate better performance.
Time frame
Baseline2
Figure Copy Task
A visuoconstructional task used to assess visual perception, spatial planning, and visual memory. Units: score 0-24 points; z-score. Higher scores indicate better performance.
Time frame
Baseline3
Controlled Oral Word Association Test (COWAT)
A verbal fluency task requiring rapid generation of words beginning with specified letters. It assesses phonemic fluency, executive function, and lexical retrieval. Units: number of correct words generated per minute; z-score. Higher scores indicate better performance.
Time frame
Baseline4
Category Fluency Test
A semantic fluency measure where subjects list as many words from a given category. It evaluates semantic memory and executive retrieval processes. Units: number of correct words generated per minute; z-score. Higher scores indicate better performance.
Time frame
BaselineSecondary outcomes
1
Apnea-Hypopnea Index (AHI)
A polysomnographic measure representing the number of apneas and hypopneas per hour of sleep. Units: events per hour. Higher scores indicate more severe OSA.
Time frame
Baseline2
Apnea-Hypopnea Index (AHI) 12 months
A polysomnographic measure representing the number of apneas and hypopneas per hour of sleep. Units: events per hour. Higher scores indicate more severe OSA. Assessments will be performed after 12 months.
Time frame
12 months3
Positive Airway Pressure (PAP) Therapy Adherence
Objective measure of treatment compliance obtained from PAP device data. Units: average hours of use per night. Higher scores indicate better adherence to therapy. Assessments will be performed after 12 months.
Time frame
12 months4
Pittsburgh Sleep Quality Index (PSQI)
A self-rated questionnaire comprising 19 items that evaluate sleep quality and disturbances over a one-month interval. Units: global PSQI score (0-21 points); cut-off ≥ 5. Higher scores indicate poorer overall sleep quality.
Time frame
Change from baseline to 12 monthsSponsors and contacts
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Comenius University
Lead sponsor
University Hospital Bratislava
Collaborator
Slovak Academy of Sciences
Collaborator
Source ClinicalTrials.gov