Precision Sleep Medicine

NCT ID: NCT06903481

Last Updated: 2025-03-30

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

Get a concise snapshot of the trial, including recruitment status, study phase, enrollment targets, and key timeline milestones.

Recruitment Status

COMPLETED

Total Enrollment

1055 participants

Study Classification

OBSERVATIONAL

Study Start Date

2022-01-01

Study Completion Date

2024-07-31

Brief Summary

Review the sponsor-provided synopsis that highlights what the study is about and why it is being conducted.

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

Dive into the extended narrative that explains the scientific background, objectives, and procedures in greater depth.

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

See the medical conditions and disease areas that this research is targeting or investigating.

Obstructive Sleep Apnea

Keywords

Explore important study keywords that can help with search, categorization, and topic discovery.

Polysomnography (PSG) recordings

Study Design

Understand how the trial is structured, including allocation methods, masking strategies, primary purpose, and other design elements.

Observational Model Type

COHORT

Study Time Perspective

RETROSPECTIVE

Study Groups

Review each arm or cohort in the study, along with the interventions and objectives associated with them.

Adults

Adults who underwent polysomnography recordings at the University Hospital Basel in 2023.

No interventions assigned to this group

Children and adolescents

Children and adolescents who underwent polysomnography recordings at the University Children's Hospital Basel between January 2022 to July 2024.

No interventions assigned to this group

Eligibility Criteria

Check the participation requirements, including inclusion and exclusion rules, age limits, and whether healthy volunteers are accepted.

Inclusion Criteria

* 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

Exclusion Criteria

* history of treatment of sleep apnea
* tracheostomy
* current home oxygen therapy
* decline to sign the written general consent, or absence of written general consent
Eligible Sex

ALL

Accepts Healthy Volunteers

No

Sponsors

Meet the organizations funding or collaborating on the study and learn about their roles.

Rekonas GmbH

UNKNOWN

Sponsor Role collaborator

University Hospital, Basel, Switzerland

OTHER

Sponsor Role lead

Responsible Party

Identify the individual or organization who holds primary responsibility for the study information submitted to regulators.

Responsibility Role SPONSOR

Principal Investigators

Learn about the lead researchers overseeing the trial and their institutional affiliations.

Matthias Herrmann, Dr. med.

Role: PRINCIPAL_INVESTIGATOR

University Hospital, Basel, Switzerland

Locations

Explore where the study is taking place and check the recruitment status at each participating site.

University Children's Hospital Basel

Basel, Canton of Basel-City, Switzerland

Site Status

University Hospital Basel

Basel, Canton of Basel-City, Switzerland

Site Status

Countries

Review the countries where the study has at least one active or historical site.

Switzerland

Other Identifiers

Review additional registry numbers or institutional identifiers associated with this trial.

2025-00175; kt24Herrmann

Identifier Type: -

Identifier Source: org_study_id