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

NCT06881667 · Status: COMPLETED · Phase: NA · Type: INTERVENTIONAL · Enrollment: 70

Last updated 2025-03-18

No results posted yet for this study

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)

Interventions

DEVICE

Home PSG Assessment

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

Sponsors & Collaborators

  • Onera BV

    lead INDUSTRY

Study Design

Allocation
NA
Purpose
OTHER
Masking
NONE
Model
SINGLE_GROUP

Eligibility

Min Age
18 Years
Sex
ALL
Healthy Volunteers
No

Timeline & Regulatory

Start
2023-08-04
Primary Completion
2024-09-02
Completion
2024-09-02
FDA Device
Yes

Countries

  • United States

Study Locations

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Read the full study record

This page highlights key information. For complete eligibility criteria, study locations, investigator contacts, and the full protocol, visit the original record on ClinicalTrials.gov.

View NCT06881667 on ClinicalTrials.gov