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Biological and Cognitive Marker of Neurodegeneration in Obstructive Sleep Apnea Patients

T

Technische Universität Dresden

Status

Enrolling

Conditions

Sleep Apnea, Obstructive

Study type

Observational

Funder types

Other

Identifiers

NCT06167369
MeDDrive: BICONOS

Details and patient eligibility

About

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.

Enrollment

136 estimated patients

Sex

All

Ages

18+ years old

Volunteers

No Healthy Volunteers

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)

Trial design

136 participants in 1 patient group

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

Trial contacts and locations

1

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Central trial contact

Tony Sehr, MD; Moritz D Brandt, MD

Data sourced from clinicaltrials.gov

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