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| ID | Type | Description | Link |
|---|---|---|---|
| VEGA 1/0075/25 | Other Grant/Funding Number | Ministry of education and science |
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| Name | Class |
|---|---|
| University Hospital Bratislava | OTHER |
| Slovak Academy of Sciences | OTHER_GOV |
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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.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| 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). |
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| Measure | Description | Time Frame |
|---|---|---|
| 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. | Baseline |
| 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. | Baseline |
| 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. | Baseline |
| 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. | Baseline |
| Trail Making Test (TMT) | A two-part test evaluating processing speed, visual search, attention, and task-switching. Units: completion time in seconds; z-score. Shorter completion times indicate better performance. | Baseline |
| The Stroop Color and Word Test | Measure of selective attention, processing speed, cognitive flexibility, and inhibitory control. Units: completion time in seconds; z-score. Shorter completion times indicate better performance. |
| Measure | Description | Time Frame |
|---|---|---|
| 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. | Baseline |
| Apnea-Hypopnea Index (AHI) 12 months |
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Inclusion Criteria:
Exclusion Criteria:
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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.
| Name | Role | Phone | Extension | |
|---|---|---|---|---|
| Branislav Kollar, prof. MD PhD. MPH. | Contact | +421 948 334 417 | b.kollar.md@gmail.com | |
| Stela Biathova, MA | Contact | +421 905 218 668 | sbiathova@gmail.com |
| Name | Affiliation | Role |
|---|---|---|
| Peter Turcani, prof. MD PhD. | 1st Department of Neurology, Faculty of Medicine, Comenius University and University Hospital Bratislava, Slovakia | Study Director |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| 1st Department of Neurology, Faculty of Medicine, Comenius University and University Hospital Bratislava, Slovakia | Recruiting | Bratislava | 813 72 | Slovakia |
| PubMed Identifier | Type | Citation | Retractions |
|---|---|---|---|
| 38351662 | Result | Sehr T, Akgun K, Benkert P, Kuhle J, Ziemssen T, Brandt MD. Effects of obstructive sleep apnea treatment on neurodegenerative biomarker neurofilament light chain and cognitive performance. J Sleep Res. 2024 Oct;33(5):e14164. doi: 10.1111/jsr.14164. Epub 2024 Feb 13. | |
| 39589660 | Result | Xue X, Zhao Z, Zhao LB, Gao YH, Xu WH, Cai WM, Chen SH, Li TJ, Nie TY, Rui D, Ma Y, Qian XS, Lin JL, Liu L. Gut microbiota changes in healthy individuals, obstructive sleep apnea patients, and patients treated using continuous positive airway pressure: a whole-genome metagenomic analysis. Sleep Breath. 2024 Nov 26;29(1):11. doi: 10.1007/s11325-024-03185-z. |
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The study results will present the group as a whole, not individual patient data.
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| ID | Term |
|---|---|
| D020181 | Sleep Apnea, Obstructive |
| ID | Term |
|---|---|
| D012891 | Sleep Apnea Syndromes |
| D001049 | Apnea |
| D012120 | Respiration Disorders |
| D012140 | Respiratory Tract Diseases |
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blood and saliva
| Baseline |
| Digit Span | A working memory test comprising forward and backward recall of digit sequences. Assesses attention, concentration, and short-term memory. Units: total score (0-14 points); z-score. Higher scores indicate better performance. | Baseline |
| Montreal Cognitive Assessment (MoCA) | General cognition screening targeting attention, executive function, memory, language, visuospatial abilities, and orientation. Units: total score (0-30 points); ≥26 = normal cognition. Higher scores indicate better performance. | Baseline |
| Generalized Anxiety Disorder 7-item scale (GAD - 7) | A 7-item self-report questionnaire to screen and assess the severity of generalized anxiety disorder. Items are rated on a 4-point scale. Units: total score (0-21 points); cut-off ≥ 10. Higher scores indicate greater anxiety symptom severity. | Baseline |
| Patient´s Health Questionnaire (PHQ - 9) | A 9-item scale assessing depression severity based on DSM IV criteria. Items are rated on a 4-point scale. Units: total score (0-27 points); cut-off ≥ 10. Higher scores indicate greater depressive symptom severity. | Baseline |
| Rey Auditory - Verbal Learning Test (RAVLT) 12 moths | 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. Assessments will be performed after 12 months. | Change from baseline to 12 months |
| Figure Copy Task 12 months | 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. Assessments will be performed after 12 months. | Change from baseline to 12 months |
| Controlled Oral Word Association Test (COWAT) 12 months | 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. Assessments will be performed after 12 months. | Change from baseline to 12 months |
| Category Fluency Test 12 months | 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. Assessments will be performed after 12 months. | Change from baseline to 12 months |
| Trail Making Test (TMT) 12 months. | A two-part test evaluating processing speed, visual search, attention, and task-switching. Units: completion time in seconds; z-score. Shorter completion times indicate better performance. Assessments will be performed after 12 months. | Change from baseline to 12 months |
| The Stroop Color and Word Test 12 months. | Measure of selective attention, processing speed, cognitive flexibility, and inhibitory control. Units: completion time in seconds; z-score. Shorter completion times indicate better performance. Assessments will be performed after 12 months. | Change from baseline to 12 months |
| Digit Span 12 months. | A working memory test comprising forward and backward recall of digit sequences. Assesses attention, concentration, and short-term memory. Units: total score (0-14 points); z-score. Higher scores indicate better performance. Assessments will be performed after 12 months. | Change from baseline to 12 months |
| Montreal Cognitive Assessment (MoCA) 12 months. | General cognition screening targeting attention, executive function, memory, language, visuospatial abilities, and orientation. Units: total score (0-30 points); ≥26 = normal cognition. Higher scores indicate better performance. Assessments will be performed after 12 months. | Change from baseline to 12 months |
| Generalized Anxiety Disorder 7-item scale (GAD - 7) 12 months. | A 7-item self-report questionnaire to screen and assess the severity of generalized anxiety disorder. Items are rated on a 4-point scale. Units: total score (0-21 points); cut-off ≥ 10. Higher scores indicate greater anxiety symptom severity. Assessments will be performed after 12 months. | Change from baseline to 12 months |
| Patient´s Health Questionnaire (PHQ - 9) 12 months. | A 9-item scale assessing depression severity based on DSM IV criteria. Items are rated on a 4-point scale. Units: total score (0-27 points); cut-off ≥ 10. Higher scores indicate greater depressive symptom severity. Assessments will be performed after 12 months. | Change from baseline to 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.
| 12 months |
| 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. | 12 months |
| 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. | Change from baseline to 12 months |
| Epworth Sleepiness Scale (ESS) | An 8-item self-report questionnaire measuring habitual daytime sleepiness in common situations. Units: total score (0-24 points); cut-off ≥ 10. Higher scores indicate greater daytime sleepiness. | Change from baseline to 12 months |
| Brain Volumetry | Quantitative assessment of total and regional brain volumes will include total brain volume, gray and white matter volumes, hippocampal volume, cortical thickness, and other regional volumetric measures. Units: mL; changes in volumes reflect structural brain alterations. | Change from baseline to 12 months |
| Body Mass Index (BMI) | BMI calculated as weight (kg) divided by height squared (m²). Units: kg/m². Higher values indicate greater adiposity. | Change from baseline to 12 months |
| Apolipoprotein E (APOE) | Genotype Genetic biomarker associated with neurodegenerative risk. Units: genotype category (ε2/ε2, ε2/ε3, ε2/ε4, ε3/ε3, ε3/ε4, ε4/ε4). ε4 allele presence indicates higher vulnerability to cognitive decline. | Baseline |
| Plasma Neurofilament Light Chain (pNfL) | A biomarker of neuroaxonal injury. Units: pg/mL. Higher concentrations indicate greater neuronal damage. | Change from baseline to 12 months |
| Total cholesterol | Measure of circulating total cholesterol, representing the combined cholesterol content within all lipoprotein classes. Units: mmol/L. Higher values reflect a more adverse lipid profile. | Change from baseline to 12 months |
| Trolox Equivalent Antioxidant Capacity (TEAC) | Measure of total antioxidant capacity in plasma and saliva. Units: mmol Trolox equivalents/L. Lower TEAC values indicate reduced antioxidant defense and increased susceptibility to oxidative stress. | Change from baseline to 12 months |
| Reactive Hyperemia Index (RHI) | Measure of endothelial function assessed by pulse amplitude tonometry. RHI reflects the vasodilatory response of peripheral arteries following temporary occlusion. Units: ratio. Lower values indicate worse endothelial function. | Change from baseline to 12 months |
| Baroreflex Sensitivity | Indicator of autonomic cardiovascular regulation measured via Finometer. Units: ms/mmHg. Higher values indicate better baroreflex control. | Change from baseline to 12 months |
| Gut Microbiome Composition | Analysis of microbial diversity and abundance from stool samples. Units: Shannon index and Bray-Curtis dissimilarity. Lower alpha diversity and altered beta diversity indicate dysbiosis. | Change from baseline to 12 months |
| 33590375 | Result | Silva WA, Almeida-Pititto B, Santos RB, Aielo AN, Giatti S, Parise BK, Souza SP, Vivolo SF, Lotufo PA, Bensenor IM, Drager LF. Obstructive sleep apnea is associated with lower adiponectin and higher cholesterol levels independently of traditional factors and other sleep disorders in middle-aged adults: the ELSA-Brasil cohort. Sleep Breath. 2021 Dec;25(4):1935-1944. doi: 10.1007/s11325-021-02290-7. Epub 2021 Feb 15. |
| 34797460 | Result | Salari N, Khazaie H, Abolfathi M, Ghasemi H, Shabani S, Rasoulpoor S, Mohammadi M, Rasoulpoor S, Khaledi-Paveh B. The effect of obstructive sleep apnea on the increased risk of cardiovascular disease: a systematic review and meta-analysis. Neurol Sci. 2022 Jan;43(1):219-231. doi: 10.1007/s10072-021-05765-3. Epub 2021 Nov 19. |
| 39226674 | Result | Durtette A, Dargent B, Gierski F, Barbe C, Deslee G, Perotin JM, Henry A, Launois C. Impact of continuous positive airway pressure on cognitive functions in adult patients with obstructive sleep apnea: A systematic review and meta-analysis. Sleep Med. 2024 Nov;123:7-21. doi: 10.1016/j.sleep.2024.08.019. Epub 2024 Aug 22. |
| 31881487 | Result | Bubu OM, Andrade AG, Umasabor-Bubu OQ, Hogan MM, Turner AD, de Leon MJ, Ogedegbe G, Ayappa I, Jean-Louis G G, Jackson ML, Varga AW, Osorio RS. Obstructive sleep apnea, cognition and Alzheimer's disease: A systematic review integrating three decades of multidisciplinary research. Sleep Med Rev. 2020 Apr;50:101250. doi: 10.1016/j.smrv.2019.101250. Epub 2019 Dec 12. |
| 39998447 | Result | Xu H, Liu Y, Li C, Li X, Shen L, Wang H, Liu F, Zou J, Xia Y, Huang W, Liu Y, Gao Z, Fu Y, Wang F, Huang S, Song Z, Song F, Gao Y, Peng Y, Zou J, Zhu H, Liu S, Li L, Zhu X, Xiong Y, Hu Y, Yang J, Li Y, Gao F, Guo Q, Huang H, Zhang W, Li J, Chen Y, Dong P, Yang J, Lv J, Wang P, Sun Y, Qian B, Yaffe K, Guan J, Yi H, Leng Y, Yin S. Effects of Continuous Positive Airway Pressure on Neuroimaging Biomarkers and Cognition in Adult Obstructive Sleep Apnea: A Randomized Controlled Trial. Am J Respir Crit Care Med. 2025 Apr;211(4):628-636. doi: 10.1164/rccm.202406-1170OC. |
| D020919 |
| Sleep Disorders, Intrinsic |
| D020920 | Dyssomnias |
| D012893 | Sleep Wake Disorders |
| D009422 | Nervous System Diseases |