Mandibular Movement Test as a Screening Tool for Polysomnography Candidates

Completed

• Conditions: Sleep Apnea Syndromes
• Interventions: Device: Mandibular movement tracking

• Registration Number: NCT03129984
• Lead Sponsor: University Hospital, Montpellier

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.

Detailed Description

Not available

Study Timeline

• Study Start: 2015-01
• Primary Completion: 2016-12
• Study Completion: 2016-12
• Status Verified: 2017-04
• Study First Submitted: 2017-04-21
• Study First Submitted QC: 2017-04-21
• Study First Posted: 2017-04-26
• Last Update Submitted: 2017-08-02
• Last Update Posted: 2017-08-03

Recruitment & Eligibility

• Status: COMPLETED
• Sex: All
• Target Recruitment: 4231

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 & Design

• Study Type: OBSERVATIONAL
• Study Design: Not specified

Arm && Interventions

Group	Intervention	Description
The study population	Mandibular movement tracking	The study population is comprised of all patients included in the Brizzy register, Belgium.

Primary Outcome Measures

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

Secondary Outcome Measures

Name	Time	Method
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
Respiratory disturbance index based on mandibular movements	Day 0 (retrospective cross-sectional study)	Respiratory disturbance index based on mandibular movements (Brizzy, Nomics, Liege, Belgium)
age	Day 0 (retrospective cross-sectional study)	age in years
ODI	Day 0 (retrospective cross-sectional study)	The oxygen desaturation index (ODI) from oximetry.
Minimal estimated total sleep time	Day 0 (retrospective cross-sectional study)	Minimal estimated total sleep time
Identification of reasons why a given test was unusable	Day 0 (retrospective cross-sectional study)