Mandibular Movement Test as a Screening Tool for Polysomnography Candidates

NCT ID: NCT03129984

Last Updated: 2017-08-03

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

COMPLETED

Total Enrollment

4231 participants

Study Classification

OBSERVATIONAL

Study Start Date

2015-01-31

Study Completion Date

2016-12-31

Brief Summary

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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.

Detailed Description

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Conditions

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Sleep Apnea Syndromes

Study Design

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Observational Model Type

CASE_ONLY

Study Time Perspective

RETROSPECTIVE

Study Groups

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The study population

The study population is comprised of all patients included in the Brizzy register, Belgium.

Mandibular movement tracking

Intervention Type DEVICE

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.

Interventions

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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.

Intervention Type DEVICE

Other Intervention Names

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Brizzy (Nomics, Liege, Belgium)

Eligibility Criteria

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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
Eligible Sex

ALL

Accepts Healthy Volunteers

No

Sponsors

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nomics s.a.

UNKNOWN

Sponsor Role collaborator

University Hospital, Montpellier

OTHER

Sponsor Role lead

Responsible Party

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Responsibility Role SPONSOR

Principal Investigators

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Dany Jaffuel, MD, PhD

Role: STUDY_DIRECTOR

University Hospitals of Montpellier

References

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Rotty MC, Mallet JP, Borel JC, Suehs CM, Bourdin A, Molinari N, Jaffuel D. The feasibility of a mandibular movement test as a screening tool for polysomnography candidates. Eur Respir J. 2017 Nov 30;50(5):1701076. doi: 10.1183/13993003.01076-2017. Print 2017 Nov. No abstract available.

Reference Type DERIVED
PMID: 29191954 (View on PubMed)

Other Identifiers

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RECHMPL17_0148

Identifier Type: -

Identifier Source: org_study_id

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