Biological and Cognitive Marker of Neurodegeneration in Obstructive Sleep Apnea Patients

Study Overview
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Brief Summary
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The goal of this observational study is to investigate biomarkers and neurocognitive markers of neurodegenerative processes in obstructive sleep apnea patients. The main questions the study aims to answer are: Does neurodegeneration assessed by neurobiological markers and neurocognitive test performance exists in obstructive sleep apnea? Are these neurodegenerative markers are associated with the adherence to clinical prescribed positive airway pressure therapy? Newly diagnosed patients with obstructive sleep apnea will be observed during the use of clinical prescribed positive pressure therapy. Different study related investigations take place before and six months after treatment start. Researchers will compare after six months the group of adherent treatment participants with the non-adherent treatment participants group to investigate if differences in the observed neurobiological or neurocognitive parameters exist.

Official Title
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Biological and Cognitive Marker of Neurodegeneration in Obstructive Sleep Apnea Patients

Conditions
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Sleep Apnea, Obstructive

Participation Criteria
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Eligibility Criteria
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Inclusion Criteria: newly diagnosed obstructive sleep apnea clinical indication for start of positive airwas pressure therapy Age older than 18 years Exclusion Criteria: neurodegenerative disease Multiple sclerosis Stroke within last 3 months Brain injury within last 3 months MoCA &lt; 21 points higher degree chonic kidney disease (lower than 30 mL/min) regular use of sleep pills (e.g. Zopiclon, Mirtazapin, Daridorexant)

Ages Eligible for Study
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Minimum Age: 18 Years

Sexes Eligible for Study
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All

Accepts Healthy Volunteers
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No

Study Plan
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How is the study designed?
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Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Newly diagnosed sleep apnea patients, starting clinical prescribed positive airway pressure therapy<br> | |

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Concentration of neurofilament light chain | longitudinal analysis | From enrollment to the follow up time point after 6 months of treatment | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Concentration of Neurofilament light chain | in between the groups (assessed after 6 months) | From enrollment to the follow up time point after 6 months of treatment, in between the groups | 
| Concentration of Glial fibrillary acidic protein | longitudinal analysis and in between the groups (assessed after 6 months) | From enrollment to the follow up time point after 6 months of treatment | 
| Cognitive performance measured by SDMT, MoCA | Longitudinal analysis and in between the groups (assessed after 6 months) | From enrollment to the follow up time point after 6 months of treatment | 
| Objective sleep parameters measured by polysomnography or equivalent measuremt methods | Longitudinal analysis and in between the groups (assessed after 6 months). For example objective parameters like apnea-hypopnea-index per hour or sleep efficacy in %. | From enrollment to the follow up time point after 6 months of treatment | 
| Subjective sleep parameters measured by symptoms questionnaires (Epworth Sleepiness Scale, Pittsburgh Sleep Quality Index) | Longitudinal analysis and in between the groups (assessed after 6 months). For example parameters like sleepiness (ESS-questionnnaire, min to max 0 to 24 points) or sleep quality (PSQI-questionnaire, min to max 0 to 21 points). Lower score values represent fewer symptom load. | From enrollment to the follow up time point after 6 months of treatment | 

 Terms related to the study
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Keywords Provided by Centre Hospitalier Valida
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Sleep apnea, Neurodegeneration, Neurofilament light chain, Glial fibrillary acidic protein, Positive airway pressure therapy