Biological and Cognitive Marker of Neurodegeneration in Obstructive Sleep Apnea Patients
Overview
- Phase
- N/A
- Intervention
- Not specified
- Conditions
- Sleep Apnea, Obstructive
- Sponsor
- Technische Universität Dresden
- Enrollment
- 136
- Locations
- 1
- Primary Endpoint
- Concentration of neurofilament light chain
- Status
- Recruiting
- Last Updated
- 2 years ago
Overview
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.
Investigators
Tony Sehr
Principal Investigator
Technische Universität Dresden
Eligibility Criteria
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)
Outcomes
Primary Outcomes
Concentration of neurofilament light chain
Time Frame: From enrollment to the follow up time point after 6 months of treatment
longitudinal analysis
Secondary Outcomes
- 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)
- Concentration of Glial fibrillary acidic protein(From enrollment to the follow up time point after 6 months of treatment)
- Objective sleep parameters measured by polysomnography or equivalent measuremt methods(From enrollment to the follow up time point after 6 months of treatment)
- Concentration of Neurofilament light chain(From enrollment to the follow up time point after 6 months of treatment, in between the groups)
- Cognitive performance measured by SDMT, MoCA(From enrollment to the follow up time point after 6 months of treatment)