Evaluation of a Disposable Sound Sensor for Recording Respiration During Sleep

February 28, 2022 updated by: CIDELEC
Split-night prospective monocentric study to evaluate, in real conditions, the effectiveness of a disposable tracheal sound sensor.

Study Overview

Status

Not yet recruiting

Conditions

Intervention / Treatment

Study Type

Interventional

Enrollment (Anticipated)

20

Phase

  • Not Applicable

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

18 years and older (Adult, Older Adult)

Accepts Healthy Volunteers

No

Genders Eligible for Study

All

Description

Inclusion Criteria:

  • Patients with suspected obstructive sleep apnea

Exclusion Criteria:

  • Lung infection
  • Insomnia

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: Diagnostic
  • Allocation: N/A
  • Interventional Model: Single Group Assignment
  • Masking: None (Open Label)

Arms and Interventions

Participant Group / Arm
Intervention / Treatment
Experimental: Evaluation of a disposable sound sensor for recording respiration during sleep
PneaVoX sensor, CIDELEC
Device: Sleep apnea diagnosis
Split-night

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Analyzable signal time
Time Frame: One night
Percentage of the analyzable signal duration compared to the total recorded signal duration
One night

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

CIDELEC

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start (Anticipated)

February 28, 2022

Primary Completion (Anticipated)

April 28, 2022

Study Completion (Anticipated)

April 28, 2022

Study Registration Dates

First Submitted

February 17, 2022

First Submitted That Met QC Criteria

February 28, 2022

First Posted (Actual)

March 9, 2022

Study Record Updates

Last Update Posted (Actual)

March 9, 2022

Last Update Submitted That Met QC Criteria

February 28, 2022

Last Verified

February 1, 2022

More Information

Terms related to this study

Additional Relevant MeSH Terms

Other Study ID Numbers

  • 2021-A02524-37

Drug and device information, study documents

Studies a U.S. FDA-regulated drug product

No

Studies a U.S. FDA-regulated device product

No

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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