Mandibular Movement Test as a Screening Tool for Polysomnography Candidates

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

Status

Completed

Phases

Unknown

Study type

Observational

Source

ClinicalTrials.gov

Registry ID

NCT03129984

Acronym

dépist-By

Enrollment

4231

Registered

2017-04-26

Start date

2015-01-31

Completion date

2016-12-31

Last updated

2017-08-03

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Sleep Apnea Syndromes

Keywords

mandibular movements

Brief summary

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.

Interventions

DEVICEMandibular 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.

Study design

Observational model

CASE_ONLY

Time perspective

RETROSPECTIVE

Eligibility

Sex/Gender

ALL

Healthy volunteers

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

Design outcomes

Primary

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

Secondary

Measure	Time frame	Description
Minimal estimated total sleep time	Day 0 (retrospective cross-sectional study)	Minimal estimated total sleep time
ODI	Day 0 (retrospective cross-sectional study)	The oxygen desaturation index (ODI) from oximetry.
Respiratory disturbance index based on mandibular movements	Day 0 (retrospective cross-sectional study)	Respiratory disturbance index based on mandibular movements (Brizzy, Nomics, Liege, Belgium)
Identification of reasons why a given test was unusable	Day 0 (retrospective cross-sectional study)	—
age	Day 0 (retrospective cross-sectional study)	age in years
Type of prescriber (qualitative)	Day 0 (retrospective cross-sectional study)	Was the prescriber a (choose one from among the following): * cardiologist, * general practitioner * otorhinolaryngologist * pneumologist * orthodontist * other

Outcome results

None listed

Source: ClinicalTrials.gov · Data processed: Feb 4, 2026