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Search / Trial NCT06881667

US Development and Evaluation Study of a Patch-Based PSG System

Launched by ONERA BV · Mar 11, 2025

Trial Information

Current as of April 29, 2025

Completed

Keywords

Sleep Disordered Breathing Sdb Sleep Apnea Obstructive Sleep Apnea Apnea Home Psg Psg Psg Type 2 Psg Type Ii Sleep Diagnostics Home

ClinConnect Summary

The diagnostic gold standard to detect a sleep disorder in the presence of a comorbidity is attended, inpatient, polysomnography (PSG)1. Currently, these tests are limited to the in-patient setting in the sleep laboratory, which requires a large number of personnel, and the PSG studies are time-consuming and expensive to conduct. PSG studies are also burdensome for patients, as they require each patient to sleep at the hospital for at least one night while wearing multiple electrodes and other physiological monitoring equipment attached to the head, face, torso, and legs, which makes sleepi...

Gender

ALL

Eligibility criteria

  • Inclusion Criteria:
  • 18 years and older
  • Referral for a suspected sleep disorder requiring a sleep diagnostic study
  • Exclusion Criteria:
  • Inability to provide informed consent
  • History of allergic reactions to adhesives or hydrogels or a family history of adhesive skin allergies
  • Severe skin condition at sites of patch administration such as wounds, burns or on any damaged skin
  • Has an implanted cardiac stimulator or diaphragmatic pacer
  • Has an anatomical abnormality that, in the opinion of the Principal Investigator, makes the subject ineligible for inclusion
  • Will be exposed to high-frequency surgical equipment, near strong magnetic fields or with devices such as MRIs, external cardiac stimulators during their use of the Onera device

About Onera Bv

Onera BV is an innovative clinical trial sponsor focused on advancing healthcare through the development and commercialization of cutting-edge medical technologies. With a commitment to enhancing patient outcomes, Onera specializes in the design and execution of clinical studies that leverage data-driven insights and robust methodologies. The company collaborates with healthcare professionals and industry partners to ensure that its solutions address real-world challenges, ultimately aiming to improve the quality of care and accelerate the path to market for transformative therapies.

Locations

Birmingham, Alabama, United States

St. Louis, Missouri, United States

Patients applied

0 patients applied

Timeline

First submit

Trial launched

Trial updated

Estimated completion

Not reported