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OpenTrials
Completed

NCT Number: NCT06903481

Precision Sleep Medicine

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.

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Key information

Sex eligibility

All sexes

Study type

Observational

Primary location

University Children's Hospital Basel, Basel, Canton of Basel-City, Switzerland

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About this study

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.

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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

Treatment and study plan

Primary outcomes

  1. 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.

Secondary outcomes

  1. Computer-aided phenotyping

    Time frame: 2025

    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.

Sponsors and collaborators

Lead sponsor

University Hospital, Basel, Switzerland

Other

Collaborators

  • Rekonas GmbH

Registry information

Official study title

Precision Sleep Medicine: Hardware and Software Innovations for the Combined Diagnosis and Treatment of Sleep Apnea at the Point-of-Care

Important dates

Study start
2022
Primary completion
2024
Study completion
2024
First posted
Mar 30, 2025
Registry last updated
Mar 30, 2025

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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