Obstructive Sleep ApneaNCT06903481
Precision Sleep Medicine
An observational study of Obstructive Sleep Apnea, run by University Hospital, Basel, Switzerland at 2 sites in Switzerland.
Trial summary
This retrospective observational study aims to characterize the prevalence and clinical features of obstructive sleep apnea (OSA) phenotypes and develop a rater-independent algorithm for automated OSA phenotyping, improving diagnosis and personalized treatment. Read more about this study
- Who is it for?
- Any age
- Conditions the study is for
- Obstructive Sleep Apnea
- How many people
- 1,055 participants
- Where
- 2 sitesSwitzerland
- Study dates
- 1 Jan 2022to 31 Jul 2024
- 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 Any age
- All sexes
- No healthy volunteers
- Child, Adult, Older adult
Study population: Adults who underwent polysomnography recordings at the University Hospital Basel in 2023, as well as children and adolescents who underwent polysomnography recordings at the University Children's Hospital Basel between January 2022 and July 2024. All patients have signed the general consent of the university hospital (UBS), resp. The university children's hospital (UKBB).
Who may be able to join
- age 19 years and older (data from University Hospital Basel (USB))
- age 18 years or younger (data from University Children's Hospital Basel (UKBB))
- Epworth Sleepiness Scale (ESS) score available (USB only)
- Diagnosis available (e.g. Obstructive sleep apnea (OSA), Central Sleep Apnea (CSA), Cheyne Stokes Breathing (CSR), ...)
- signed written general consent
Who cannot join
- history of treatment of sleep apnea
- tracheostomy
- current home oxygen therapy
- decline to sign the written general consent, or absence of written general consent
Trial locations and contacts
2 sites in 1 country.
Switzerland2 sites
University Children's Hospital Basel
Basel, Canton of Basel-City, 4031
University Hospital Basel
Basel, Canton of Basel-City, 4031
About this study
Official title: Precision Sleep Medicine: Hardware and Software Innovations for the Combined Diagnosis and Treatment of Sleep Apnea at the Point-of-Care
This retrospective observational study aims to characterize the prevalence and clinical features of obstructive sleep apnea (OSA) phenotypes and develop a rater-independent algorithm for automated OSA phenotyping, improving diagnosis and personalized treatment.
Read the detailed description
Obstructive sleep apnea (OSA) is characterized by repeated upper airway blockages during sleep, but it presents with a range of phenotypic variations, each with potentially distinct clinical implications. Current clinical definitions are not always precise, making it difficult to clearly classify patients with overlapping features. This phenotypic overlap poses challenges for understanding the true prevalence of "pure" versus "mixed" OSA phenotypes and their respective clinical implications.
To comprehensively characterize the prevalence and clinical features of distinct OSA phenotypes in a large, diverse patient population, this retrospective study analyzes polysomnography (PSG) data from two publicly available National Sleep Research Resource datasets. The findings are then compared to datasets from the University Hospital Basel and University Children's Hospital Basel to assess generalizability.
Furthermore, the study employs computer-aided analysis of PSG data to develop rater-independent algorithms for objective and automated OSA phenotyping. These advancements aim to improve understanding of OSA heterogeneity, facilitating more precise diagnoses and personalized treatment strategies.
- Conditions
- Obstructive Sleep Apnea
- Keywords
- Polysomnography (PSG) recordings
- Medical subject headings
- Sleep Apnea, Obstructive
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 |
|---|---|---|
| Adults | Adults who underwent polysomnography recordings at the University Hospital Basel in 2023. | |
| Children and adolescents | Children and adolescents who underwent polysomnography recordings at the University Children's Hospital Basel between January 2022 to July 2024. |
What is being measured
The primary outcome is the main question the study is designed to answer.
Phenotype characterization
To characterize the prevalence and clinical features of distinct obstructive sleep apnea (OSA) phenotypes in a large, diverse patient population, polysomnography (PSG) recordings from two publicly available National Sleep Research Resource data collections are analyzed and compared to datasets from the University Hospital Basel (USB) and University Children's Hospital Basel (UKBB) to assess generalizability.
Measured: 2025
Secondary outcomes (1)
Computer-aided phenotyping
To evaluate the potential of computer-aided pattern recognition in improving the accuracy and efficiency of OSA phenotype identification from PSG data, an algorithm is developed that objectively and automatically identifies OSA phenotypes from PSG recordings.
Measured: 2025
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted30 Mar 2025
- Study start1 Jan 2022
- Primary completion31 Jul 2024
- Study completion31 Jul 2024
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Obstructive Sleep ApneaStudies of the same condition, open and under way.
- 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
- Retrospective
- Enrolment
- 1,055 participants (actual)
Sponsor and investigators
- Lead sponsor
- University Hospital, Basel, Switzerland
- Sponsor type
- University, hospital or other
- Collaborators
- Rekonas GmbH
- Responsible party
- Sponsor
- Investigators
- Matthias Herrmann, Dr. med., Principal investigator, University Hospital, Basel, Switzerland
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT06903481
- Sponsor's protocol ID
- 2025-00175; kt24Herrmann
- Other IDs
- 2025
- Status last verified
- Mar 2025
- First submitted
- 24 Mar 2025
- Last updated
- 30 Mar 2025
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
Study at a glance
From the registry record, last updated by the sponsor on 30 Mar 2025. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Precision Sleep Medicine: Hardware and Software Innovations for the Combined Diagnosis and Treatment of Sleep Apnea at the Point-of-Care
- ClinicalTrials.gov ID
- NCT06903481
- Acronym / sponsor ID
- 2025-00175; kt24Herrmann
- Conditions
- Obstructive Sleep Apnea
- Keywords
- Polysomnography (PSG) recordings
- Study type
- Observational
- Recruitment status
- Completed
- Enrolment
- 1,055 participants (actual)
- Lead sponsor
- University Hospital, Basel, SwitzerlandUniversity, hospital or other
- Collaborators
- Rekonas GmbH
- Study start
- 1 Jan 2022 (actual)
- Primary completion
- 31 Jul 2024 (actual)
- Study completion
- 31 Jul 2024 (actual)
- First posted
- 30 Mar 2025 (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.
This retrospective observational study aims to characterize the prevalence and clinical features of obstructive sleep apnea (OSA) phenotypes and develop a rater-independent algorithm for automated OSA phenotyping, improving diagnosis and personalized treatment.
Detailed description
Obstructive sleep apnea (OSA) is characterized by repeated upper airway blockages during sleep, but it presents with a range of phenotypic variations, each with potentially distinct clinical implications. Current clinical definitions are not always precise, making it difficult to clearly classify patients with overlapping features. This phenotypic overlap poses challenges for understanding the true prevalence of "pure" versus "mixed" OSA phenotypes and their respective clinical implications.
To comprehensively characterize the prevalence and clinical features of distinct OSA phenotypes in a large, diverse patient population, this retrospective study analyzes polysomnography (PSG) data from two publicly available National Sleep Research Resource datasets. The findings are then compared to datasets from the University Hospital Basel and University Children's Hospital Basel to assess generalizability.
Furthermore, the study employs computer-aided analysis of PSG data to develop rater-independent algorithms for objective and automated OSA phenotyping. These advancements aim to improve understanding of OSA heterogeneity, facilitating more precise diagnoses and personalized treatment strategies.
Study design
- Observational model
- Cohort
- Time perspective
- Retrospective
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Adults | – | –Adults who underwent polysomnography recordings at the University Hospital Basel in 2023. |
| Children and adolescents | – | –Children and adolescents who underwent polysomnography recordings at the University Children's Hospital Basel between January 2022 to July 2024. |
Who may qualify
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Child, Adult, Older adult
- Study population
- Adults who underwent polysomnography recordings at the University Hospital Basel in 2023, as well as children and adolescents who underwent polysomnography recordings at the University Children's Hospital Basel between January 2022 and July 2024. All patients have signed the general consent of the university hospital (UBS), resp. The university children's hospital (UKBB).
Key inclusion criteria (5 listed)
- age 19 years and older (data from University Hospital Basel (USB))
- age 18 years or younger (data from University Children's Hospital Basel (UKBB))
- Epworth Sleepiness Scale (ESS) score available (USB only)
- Diagnosis available (e.g. Obstructive sleep apnea (OSA), Central Sleep Apnea (CSA), Cheyne Stokes Breathing (CSR), ...)
- signed written general consent
Key exclusion criteria (4 listed)
- history of treatment of sleep apnea
- tracheostomy
- current home oxygen therapy
- decline to sign the written general consent, or absence of written general consent
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
Phenotype characterization
Time frame: 2025
To characterize the prevalence and clinical features of distinct obstructive sleep apnea (OSA) phenotypes in a large, diverse patient population, polysomnography (PSG) recordings from two publicly available National Sleep Research Resource data collections are analyzed and compared to datasets from the University Hospital Basel (USB) and University Children's Hospital Basel (UKBB) to assess generalizability.
1 secondary outcome
Computer-aided phenotyping
Time frame: 2025
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 30 Mar 2025.
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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.
Matthias Herrmann, Dr. med. principal investigator
University Hospital, Basel, Switzerland
2 sites in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
An observational study of Obstructive Sleep Apnea, run by University Hospital, Basel, Switzerland at 2 sites in Switzerland.
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 5 inclusion and 4 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: finished, as of the sponsor's last update on 30 Mar 2025. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 2 sites in Switzerland. 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?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Phenotype characterization (time frame: 2025). 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 30 Mar 2025.