Sleep Apnea, Obstructive
Conditions
Keywords
Sleep apnea, Neurodegeneration, Neurofilament light chain, Glial fibrillary acidic protein, Positive airway pressure therapy
Brief summary
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.
Interventions
None listed
Sponsors
Technische Universität Dresden
Study design
Observational model
COHORT
Time perspective
PROSPECTIVE
Eligibility
Sex/Gender
ALL
Age
18 Years to No maximum
Healthy volunteers
No
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 < 21 points * higher degree chonic kidney disease (lower than 30 mL/min) * regular use of sleep pills (e.g. Zopiclon, Mirtazapin, Daridorexant)
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| Concentration of neurofilament light chain | From enrollment to the follow up time point after 6 months of treatment | longitudinal analysis |
Secondary
| Measure | Time frame | Description |
|---|---|---|
| Concentration of Neurofilament light chain | From enrollment to the follow up time point after 6 months of treatment, in between the groups | in between the groups (assessed after 6 months) |
| Concentration of Glial fibrillary acidic protein | From enrollment to the follow up time point after 6 months of treatment | longitudinal analysis and in between the groups (assessed after 6 months) |
| Cognitive performance measured by SDMT, MoCA | From enrollment to the follow up time point after 6 months of treatment | Longitudinal analysis and in between the groups (assessed after 6 months) |
| Objective sleep parameters measured by polysomnography or equivalent measuremt methods | From enrollment to the follow up time point after 6 months of treatment | 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 %. |
| Subjective sleep parameters measured by symptoms questionnaires (Epworth Sleepiness Scale, Pittsburgh Sleep Quality Index) | From enrollment to the follow up time point after 6 months of treatment | 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. |
Countries
Germany
Contacts
Primary ContactTony Sehr, MD
Backup ContactMoritz D Brandt, MD
Outcome results
None listed