Biological and Cognitive Marker of Neurodegeneration in Obstructive Sleep Apnea Patients

NCT06167369 | Recruiting

• 1 other identifier: MeDDrive: BICONOS
• Study Type: observational
• Target: 136
• Locations: 1 country
• Sites: 1

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.

Conditions

Sleep Apnea, Obstructive

Keywords

Sleep apnea; Neurodegeneration; Neurofilament light chain; Glial fibrillary acidic protein; Positive airway pressure therapy

Outcome Measures

Primary Outcomes (1)

• Concentration of neurofilament light chain

  longitudinal analysis

  From enrollment to the follow up time point after 6 months of treatment

Secondary Outcomes (5)

• Concentration of Neurofilament light chain

  From enrollment to the follow up time point after 6 months of treatment, in between the groups

• Concentration of Glial fibrillary acidic protein

  From enrollment to the follow up time point after 6 months of treatment

• Cognitive performance measured by SDMT, MoCA

  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

• 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

Study Arms (1)

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

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)
• Sampling Method: Non-Probability Sample

Study Population

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

You may qualify if:

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

You may not qualify if:

• 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)

Sponsors & Collaborators

• Technische Universität Dresden: lead

Study Sites (1)

Technische Universität Dresden, Universitätsklinikum Dresden

Dresden, Saxony, 01307, Germany

RECRUITING

Biospecimen

Retention: SAMPLES WITH DNA

Serum samples for measurement of neurobiological parameters like Neurofilament light chain or Glial fibrillary acidic protein

MeSH Terms

Conditions

Sleep Apnea, Obstructive; Sleep Apnea Syndromes; Nerve Degeneration; Charcot-Marie-Tooth disease, Type 1F

Condition Hierarchy (Ancestors)

Apnea; Respiration Disorders; Respiratory Tract Diseases; Sleep Disorders, Intrinsic; Dyssomnias; Sleep Wake Disorders; Nervous System Diseases; Pathologic Processes; Pathological Conditions, Signs and Symptoms

Central Study Contacts

Tony Sehr, MD

CONTACT

+49 351 458 19324; tony.sehr@ukdd.de

Moritz D Brandt, MD

CONTACT

moritz.brandt@ukdd.de

Study Design

• Study Type: observational
• Observational Model: COHORT
• Time Perspective: PROSPECTIVE
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Principal Investigator

Study Record Dates

• First Submitted: November 23, 2023
• First Posted: December 12, 2023
• Study Start: January 1, 2024
• Primary Completion: December 31, 2025
• Study Completion (Estimated): June 1, 2026
• Last Updated: February 20, 2024

Record last verified: 2024-02

Data Sharing

• IPD Sharing: Will not share

Locations

DE (1)