Biological and Cognitive Marker of Neurodegeneration in Obstructive Sleep Apnea Patients

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.

Study Overview

• Status: Recruiting
• Conditions: Sleep Apnea, Obstructive

• Study Type: Observational
• Enrollment (Estimated): 136

Contacts and Locations

• Study Contact: Name: Tony Sehr, MD; Phone Number: +49 351 458 19324; Email: tony.sehr@ukdd.de
• Study Contact Backup: Name: Moritz D Brandt, MD; Email: moritz.brandt@ukdd.de

Study Locations

• Germany
  • Saxony
    • Dresden, Saxony, Germany, 01307
      • Recruiting
      • Technische Universität Dresden, Universitätsklinikum Dresden
      • Contact: Tony Sehr, MD; Phone Number: +49 351 458 0; Email: tony.sehr@ukdd.de
      • Principal Investigator: Tony Sehr, MD
      • Principal Investigator: Moritz D Brandt, MD
      • Sub-Investigator: Tjalf Ziemssen, MD
      • Sub-Investigator: Katja Akgün, MD

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: Adult; Older Adult
• Accepts Healthy Volunteers: No

• Sampling Method: Non-Probability Sample

Study Population

Patients that are reffered to the sleep lab of the University Hospital Dresden

Description

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)

Study Plan

How is the study designed?

Number of groups / cohorts

1

Cohorts and Interventions

Group / Cohort
Newly diagnosed sleep apnea patients, starting clinical prescribed positive airway pressure therapy

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Concentration of neurofilament light chain	longitudinal analysis	From enrollment to the follow up time point after 6 months of treatment

Secondary Outcome Measures

Outcome Measure	Measure Description	Time Frame
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
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
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
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
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

Collaborators and Investigators

• Sponsor: Technische Universität Dresden

Study record dates

Study Major Dates

• Study Start (Actual): January 1, 2024
• Primary Completion (Estimated): December 31, 2025
• Study Completion (Estimated): June 1, 2026

Study Registration Dates

• First Submitted: November 23, 2023
• First Submitted That Met QC Criteria: December 4, 2023
• First Posted (Actual): December 12, 2023

Study Record Updates

• Last Update Posted (Actual): February 20, 2024
• Last Update Submitted That Met QC Criteria: February 16, 2024
• Last Verified: February 1, 2024

More Information

Terms related to this study

• Keywords: Neurodegeneration; Neurofilament light chain; Sleep apnea; Positive airway pressure therapy; Glial fibrillary acidic protein
• Additional Relevant MeSH Terms: Pathologic Processes; Nervous System Diseases; Respiratory Tract Diseases; Respiration Disorders; Sleep Disorders, Intrinsic; Dyssomnias; Sleep Wake Disorders; Signs and Symptoms, Respiratory; Sleep Apnea Syndromes; Sleep Apnea, Obstructive; Apnea; Nerve Degeneration
• Other Study ID Numbers: MeDDrive: BICONOS

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: NO

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: No
• product manufactured in and exported from the U.S.: No