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

NCT06881667 | Completed FDA Device

• 1 other identifier: CIP_Protocol_Onera_D01
• Study Type: interventional
• Target: 70
• Locations: 1 country
• Sites: 2

Brief Summary

The purpose of this study is continue the development and evaluation of the Onera system as well as the procedures and best practices for dispensing, instruction, use and reportability of results.

Conditions

Sleep Disorder (Disorder)

Keywords

sleep disordered breathing; sdb; sleep apnea; obstructive sleep apnea; apnea; home PSG; PSG; PSG type 2; PSG type II; sleep diagnostics; home

Outcome Measures

Primary Outcomes (1)

• Study Success Rate

  Number of studies and reports scored to the AASM Scoring Manual version 2.6, 2020 considered acceptable for clinical use by the lead clinician on the study. A successful sleep study that can be used for diagnostic purposes indicates that the device application and signal collection was successful to assess device feasibility.

  Assessment will be completed within one month after completion of the sleep study.

Study Arms (1)

Home PSG Assessment

EXPERIMENTAL

Testing of the Onera STS in the home environment with the current device shipment method and instructions.

Device: Home PSG Assessment

Interventions

Home PSG Assessment DEVICE

Testing of the Onera STS in the home environment with the current device shipment method and instructions.

Home PSG Assessment

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• years and older
• Referral for a suspected sleep disorder requiring a sleep diagnostic study

You may not qualify if:

• 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
• 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

Sponsors & Collaborators

• Onera BV: lead

Study Sites (2)

The Sleep Disorders Center of Alabama

Birmingham, Alabama, 35213, United States

Location

Clayton Sleep Institute

St Louis, Missouri, 63123, United States

Location

Related Publications (1)

• Uhles M, Alisic S, Brown A, Doekel R, Booth W, Ojile J. Feasibility and acceptance of self-applied home type-II PSG studies with a patch-based device. Sleep Breath. 2025 Oct 28;29(6):336. doi: 10.1007/s11325-025-03503-z.

  PMID: 41148462 DERIVED

MeSH Terms

Conditions

Sleep Wake Disorders; Sleep Apnea Syndromes; Sleep Apnea, Obstructive; Apnea

Condition Hierarchy (Ancestors)

Nervous System Diseases; Neurologic Manifestations; Signs and Symptoms; Pathological Conditions, Signs and Symptoms; Mental Disorders; Respiration Disorders; Respiratory Tract Diseases; Sleep Disorders, Intrinsic; Dyssomnias; Signs and Symptoms, Respiratory

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: NA
• Masking: NONE
• Purpose: OTHER
• Intervention Model: SINGLE GROUP
• Sponsor Type: INDUSTRY
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: February 26, 2025
• First Posted: March 18, 2025
• Study Start: August 4, 2023
• Primary Completion: September 2, 2024
• Study Completion: September 2, 2024
• Last Updated: March 18, 2025

Record last verified: 2025-03

Data Sharing

• IPD Sharing: Will not share

Locations

US (2)