Clinical trial NCT06167369: Biological and Cognitive Marker of Neurodegeneration in Obstructive Sleep Apnea Patients
Official title: Biological and Cognitive Marker of Neurodegeneration in Obstructive Sleep Apnea Patients
Study type: OBSERVATIONAL
Overall status: RECRUITING
Conditions: Sleep Apnea, Obstructive
Keywords: Sleep apnea
Neurodegeneration
Neurofilament light chain
Glial fibrillary acidic protein
Positive airway pressure therapy
Lead sponsor: Technische Universität Dresden
Sponsor class: OTHER
First posted: 2023-12-12
Enrollment: 136
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Observational model: COHORT
Time perspective: PROSPECTIVE
Sampling method: NON_PROBABILITY_SAMPLE
Study population: Patients that are reffered to the sleep lab of the University Hospital Dresden

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.


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 \&lt; 21 points
* higher degree chonic kidney disease (lower than 30 mL/min)
* regular use of sleep pills (e.g. Zopiclon, Mirtazapin, Daridorexant)

Primary outcomes:
measure: Concentration of neurofilament light chain
timeFrame: From enrollment to the follow up time point after 6 months of treatment
Secondary outcomes:
measure: Concentration of Neurofilament light chain
timeFrame: From enrollment to the follow up time point after 6 months of treatment, in between the groups
measure: Concentration of Glial fibrillary acidic protein
timeFrame: From enrollment to the follow up time point after 6 months of treatment
measure: Cognitive performance measured by SDMT, MoCA
timeFrame: From enrollment to the follow up time point after 6 months of treatment
measure: Objective sleep parameters measured by polysomnography or equivalent measuremt methods
timeFrame: From enrollment to the follow up time point after 6 months of treatment
measure: Subjective sleep parameters measured by symptoms questionnaires (Epworth Sleepiness Scale, Pittsburgh Sleep Quality Index)
timeFrame: From enrollment to the follow up time point after 6 months of treatment
Other outcomes:
Locations:
city: Dresden
country: Germany
facility: Technische Universität Dresden, Universitätsklinikum Dresden
state: Saxony
Study officials:
References: