Mandibular Movement Test as a Screening Tool for Polysomnography Candidates (dépist-By)

August 2, 2017 updated by: University Hospital, Montpellier

A Mandibular Movement Test as a Screening Tool for Polysomnography Candidates Among Patients With Sleep Apnea: a Retrospective Feasibility Study

The primary objective of this study is to determine the technical failure and inconclusive test rates when using the Brizzy device for mandibular movement tracking.

Study Overview

Status

Completed

Conditions

Intervention / Treatment

Study Type

Observational

Enrollment (Actual)

4231

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

  • Child
  • Adult
  • Older Adult

Accepts Healthy Volunteers

No

Genders Eligible for Study

All

Sampling Method

Probability Sample

Study Population

This study is re-evaluating data provided by the Brizzy register in Belgium.

Description

Inclusion Criteria:

  • Patient included in the Brizzy register
  • Mandibular movement test prescribed by practitioner
  • Patient performed a mandibular movement test (ambulatory setting) using a magnetic sensor (Brizzy, Nomics, Liege, Belgium)

Exclusion Criteria:

  • none

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

Cohorts and Interventions

Group / Cohort
Intervention / Treatment
The study population
The study population is comprised of all patients included in the Brizzy register, Belgium.
Device: Mandibular movement tracking
Patients wore the Brizzy device while sleeping. Mandibular movements (A mid-sagittal mandibular movement magnetic sensor measured the distance in mm between two parallel, coupled, resonant circuits placed on the forehead and chin.) were tracked during sleep.
Other Names:
  • Brizzy (Nomics, Liege, Belgium)

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
The exploitable data rate
Time Frame: Day 0 (retrospective cross-sectional study)
The number of usable tests / the number of tests performed.
Day 0 (retrospective cross-sectional study)

Secondary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Respiratory disturbance index based on mandibular movements
Time Frame: Day 0 (retrospective cross-sectional study)
Respiratory disturbance index based on mandibular movements (Brizzy, Nomics, Liege, Belgium)
Day 0 (retrospective cross-sectional study)
Minimal estimated total sleep time
Time Frame: Day 0 (retrospective cross-sectional study)
Minimal estimated total sleep time
Day 0 (retrospective cross-sectional study)
ODI
Time Frame: Day 0 (retrospective cross-sectional study)
The oxygen desaturation index (ODI) from oximetry.
Day 0 (retrospective cross-sectional study)
Type of prescriber (qualitative)
Time Frame: Day 0 (retrospective cross-sectional study)

Was the prescriber a (choose one from among the following):

  • cardiologist,
  • general practitioner
  • otorhinolaryngologist
  • pneumologist
  • orthodontist
  • other
Day 0 (retrospective cross-sectional study)
Identification of reasons why a given test was unusable
Time Frame: Day 0 (retrospective cross-sectional study)
Day 0 (retrospective cross-sectional study)
age
Time Frame: Day 0 (retrospective cross-sectional study)
age in years
Day 0 (retrospective cross-sectional study)

Collaborators and Investigators

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

Sponsor

University Hospital, Montpellier

Collaborators

nomics s.a.

Investigators

  • Study Director: Dany Jaffuel, MD, PhD, University Hospitals of Montpellier

Publications and helpful links

The person responsible for entering information about the study voluntarily provides these publications. These may be about anything related to the study.

General Publications

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 (Actual)

January 1, 2015

Primary Completion (Actual)

December 1, 2016

Study Completion (Actual)

December 1, 2016

Study Registration Dates

First Submitted

April 21, 2017

First Submitted That Met QC Criteria

April 21, 2017

First Posted (Actual)

April 26, 2017

Study Record Updates

Last Update Posted (Actual)

August 3, 2017

Last Update Submitted That Met QC Criteria

August 2, 2017

Last Verified

April 1, 2017

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

  • RECHMPL17_0148

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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