Biological and Cognitive Marker of Neurodegeneration in Obstructive Sleep Apnea Patients

Sleep Apnea, Obstructive Clinical Trial

Official title:

Biological and Cognitive Marker of Neurodegeneration in Obstructive Sleep Apnea Patients

Clinical Trial Details — Status: Recruiting

Administrative data

• NCT number: NCT06167369
• Other study ID #: MeDDrive: BICONOS
• Status: Recruiting
• Start date: January 1, 2024
• Est. completion date: June 2026

Study information

• Verified date: February 2024
• Source: Technische Universität Dresden
• Contact: Tony Sehr, MD
• Phone: +49 351 458 19324
• Email: tony.sehr[@]ukdd.de
• Is FDA regulated: No
• Study type: Observational

Clinical Trial 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.

Recruitment information / eligibility

• Status: Recruiting
• Enrollment: 136
• Est. completion date: June 2026
• Est. primary completion date: December 31, 2025
• Accepts healthy volunteers: No
• Gender: All
• Age group: 18 Years and older

Eligibility

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)

Related Conditions & MeSH terms

• Apnea
• Nerve Degeneration
• Sleep Apnea Syndromes
• Sleep Apnea, Obstructive

Locations

Country	Name	City	State
Germany	Technische Universität Dresden, Universitätsklinikum Dresden	Dresden	Saxony

Sponsors (1)

Lead Sponsor	Collaborator
Technische Universität Dresden

Country where clinical trial is conducted

Germany, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Concentration of neurofilament light chain	longitudinal analysis	From enrollment to the follow up time point after 6 months of treatment
Secondary	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
Secondary	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
Secondary	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
Secondary	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
Secondary	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