Biological and Cognitive Marker of Neurodegeneration in Obstructive Sleep Apnea Patients

NCT ID: NCT06167369

Last Updated: 2024-02-20

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

RECRUITING

Total Enrollment

136 participants

Study Classification

OBSERVATIONAL

Study Start Date

2024-01-01

Study Completion Date

2026-06-30

Brief Summary

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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

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Conditions

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Sleep Apnea, Obstructive

Study Design

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Observational Model Type

COHORT

Study Time Perspective

PROSPECTIVE

Study Groups

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

No interventions assigned to this group

Eligibility Criteria

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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)
Minimum Eligible Age

18 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

No

Sponsors

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Technische Universität Dresden

OTHER

Sponsor Role lead

Responsible Party

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Tony Sehr

Principal Investigator

Responsibility Role PRINCIPAL_INVESTIGATOR

Locations

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Technische Universität Dresden, Universitätsklinikum Dresden

Dresden, Saxony, Germany

Site Status RECRUITING

Countries

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Germany

Central Contacts

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Tony Sehr, MD

Role: CONTACT

+49 351 458 19324

Moritz D Brandt, MD

Role: CONTACT

Facility Contacts

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Tony Sehr, MD

Role: primary

+49 351 458 0

Other Identifiers

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MeDDrive: BICONOS

Identifier Type: -

Identifier Source: org_study_id

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