Sleep Apnea, ObstructiveNCT06167369
Biological and Cognitive Marker of Neurodegeneration in Obstructive Sleep Apnea Patients
An observational study of Sleep Apnea, Obstructive, run by Technische Universität Dresden at 1 site in Germany.
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… Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Sleep Apnea, Obstructive
- How many people
- 136 participants
- Where
- 1 siteGermany
- Study dates
- 1 Jan 2024to Jun 2026
- Phase
- Observational
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 years and older
- All sexes
- No healthy volunteers
- Adult, Older adult
Study population: Patients that are reffered to the sleep lab of the University Hospital Dresden
Who may be able to join
- newly diagnosed obstructive sleep apnea
- clinical indication for start of positive airwas pressure therapy
- Age older than 18 years
Who cannot join
- 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 locations and contacts
1 site in 1 country.
Moritz D Brandt, MD contact
Germany1 site, 1 recruiting
- Recruiting
Technische Universität Dresden, Universitätsklinikum Dresden
Dresden, Saxony, 01307
Tony Sehr, MD, +49 351 458 0, tony.sehr@ukdd.de
Tony Sehr, MD
About this study
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:
Read more
- 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
- Medical subject headings
- Sleep Apnea, Obstructive, Sleep Apnea Syndromes, Nerve Degeneration, Charcot-Marie-Tooth disease, Type 1F
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
| Study group | Role | What they receive |
|---|---|---|
| Newly diagnosed sleep apnea patients, starting clinical prescribed positive airway pressure therapy | Not described |
What is being measured
The primary outcome is the main question the study is designed to answer.
Concentration of neurofilament light chain
longitudinal analysis
Measured: From enrollment to the follow up time point after 6 months of treatment
Secondary outcomes (5)
Concentration of Neurofilament light chain
in between the groups (assessed after 6 months)
Measured: 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)
Measured: 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)
Measured: 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 %.
Measured: 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.
Measured: From enrollment to the follow up time point after 6 months of treatment
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted12 Dec 2023
- Study start1 Jan 2024
- Primary completion31 Dec 2025 (estimated)
- Study completionJun 2026 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Sleep Apnea, ObstructiveStudies of the same condition, open and under way.
- More trials run by Technische Universität DresdenThe sponsor's other registered studies.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Observational
- Observational model
- Cohort
- Time perspective
- Prospective
- Enrolment
- 136 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Technische Universität Dresden
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Tony Sehr, Technische Universität Dresden
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT06167369
- Sponsor's protocol ID
- MeDDrive: BICONOS
- Status last verified
- Feb 2024
- First submitted
- 23 Nov 2023
- Last updated
- 20 Feb 2024
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Study at a glance
From the registry record, last updated by the sponsor on 20 Feb 2024. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Biological and Cognitive Marker of Neurodegeneration in Obstructive Sleep Apnea Patients
- ClinicalTrials.gov ID
- NCT06167369
- Acronym / sponsor ID
- MeDDrive: BICONOS
- Conditions
- Sleep Apnea, Obstructive
- Keywords
- Sleep apnea, Neurodegeneration, Neurofilament light chain, Glial fibrillary acidic protein, Positive airway pressure therapy
- Study type
- Observational
- Recruitment status
- Unknown status
- Enrolment
- 136 participants (estimated)
- Lead sponsor
- Technische Universität DresdenUniversity, hospital or other
- Study start
- 1 Jan 2024 (actual)
- Primary completion
- 31 Dec 2025 (estimated)
- Study completion
- Jun 2026 (estimated)
- First posted
- 12 Dec 2023 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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 design
- Observational model
- Cohort
- Time perspective
- Prospective
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| Newly diagnosed sleep apnea patients, starting clinical prescribed positive airway pressure therapy | – | – |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
- Study population
- Patients that are reffered to the sleep lab of the University Hospital Dresden
Key inclusion criteria (3 listed)
- newly diagnosed obstructive sleep apnea
- clinical indication for start of positive airwas pressure therapy
- Age older than 18 years
Key exclusion criteria (7 listed)
- neurodegenerative disease
- Multiple sclerosis
- Stroke within last 3 months
- Brain injury within last 3 months
- MoCA \< 21 points
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Primary outcome
Concentration of neurofilament light chain
Time frame: From enrollment to the follow up time point after 6 months of treatment
longitudinal analysis
5 secondary outcomes
Concentration of Neurofilament light chain
Time frame: From enrollment to the follow up time point after 6 months of treatment, in between the groups
Concentration of Glial fibrillary acidic protein
Time frame: From enrollment to the follow up time point after 6 months of treatment
Cognitive performance measured by SDMT, MoCA
Time frame: From enrollment to the follow up time point after 6 months of treatment
Objective sleep parameters measured by polysomnography or equivalent measuremt methods
Time frame: 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)
Time frame: From enrollment to the follow up time point after 6 months of treatment
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 20 Feb 2024.
- Individual participant dataSharing planned: No
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Moritz D Brandt, MD contact
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
An observational study of Sleep Apnea, Obstructive, run by Technische Universität Dresden at 1 site in Germany.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 3 inclusion and 7 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: status not confirmed, as of the sponsor's last update on 20 Feb 2024. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in Germany. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
Results are not available in the source record.
How can a doctor refer a patient or contact the research team?
Contact Tony Sehr, MD (+49 351 458 19324, tony.sehr@ukdd.de), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Concentration of neurofilament light chain (time frame: From enrollment to the follow up time point after 6 months of treatment). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 20 Feb 2024.