Biological and Cognitive Marker of Neurodegeneration in Obstructive Sleep Apnea Patients

Recruiting

• Conditions: Sleep Apnea, Obstructive

• Registration Number: NCT06167369
• Lead Sponsor: Technische Universität 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.

Detailed Description

Not available

Study Timeline

• Study First Submitted: 2023-11-23
• Study First Submitted QC: 2023-12-04
• Study First Posted: 2023-12-12
• Study Start: 2024-01-01
• Status Verified: 2024-02
• Last Update Submitted: 2024-02-16
• Last Update Posted: 2024-02-20
• Primary Completion: 2025-12-31
• Study Completion: 2026-06

Recruitment & Eligibility

• Status: RECRUITING
• Sex: All
• Target Recruitment: 136

Inclusion Criteria

• newly diagnosed obstructive sleep apnea
• clinical indication for start of positive airwas pressure therapy
• Age older than 18 years

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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)

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Study & Design

• Study Type: OBSERVATIONAL
• Study Design: Not specified

Primary Outcome Measures

Name	Time	Method
Concentration of neurofilament light chain	From enrollment to the follow up time point after 6 months of treatment	longitudinal analysis

Secondary Outcome Measures

Name	Time	Method
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.
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)
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 %.
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)
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)

Trial Locations

Locations (1)

Technische Universität Dresden, Universitätsklinikum Dresden; 🇩🇪 Dresden, Saxony, Germany