Mandibular Movement Test as a Screening Tool for Polysomnography Candidates
dépist-By
A Mandibular Movement Test as a Screening Tool for Polysomnography Candidates Among Patients With Sleep Apnea: a Retrospective Feasibility Study
1 other identifier
observational
4,231
0 countries
N/A
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.
Trial Health
Trial Health Score
Automated assessment based on enrollment pace, timeline, and geographic reach
participants targeted
Target at P75+ for all trials
Started Jan 2015
Health score is calculated from publicly available data and should be used for screening purposes only.
Trial Relationships
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Study Timeline
Key milestones and dates
Study Start
First participant enrolled
January 1, 2015
CompletedPrimary Completion
Last participant's last visit for primary outcome
December 1, 2016
CompletedStudy Completion
Last participant's last visit for all outcomes
December 1, 2016
CompletedFirst Submitted
Initial submission to the registry
April 21, 2017
CompletedFirst Posted
Study publicly available on registry
April 26, 2017
CompletedAugust 3, 2017
April 1, 2017
1.9 years
April 21, 2017
August 2, 2017
Conditions
Keywords
Outcome Measures
Primary Outcomes (1)
The exploitable data rate
The number of usable tests / the number of tests performed.
Day 0 (retrospective cross-sectional study)
Secondary Outcomes (6)
Respiratory disturbance index based on mandibular movements
Day 0 (retrospective cross-sectional study)
Minimal estimated total sleep time
Day 0 (retrospective cross-sectional study)
ODI
Day 0 (retrospective cross-sectional study)
Type of prescriber (qualitative)
Day 0 (retrospective cross-sectional study)
Identification of reasons why a given test was unusable
Day 0 (retrospective cross-sectional study)
- +1 more secondary outcomes
Study Arms (1)
The study population
The study population is comprised of all patients included in the Brizzy register, Belgium.
Interventions
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.
Eligibility Criteria
This study is re-evaluating data provided by the Brizzy register in Belgium.
You may qualify if:
- 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)
You may not qualify if:
- none
Contact the study team to confirm eligibility.
Sponsors & Collaborators
- University Hospital, Montpellierlead
- nomics s.a.collaborator
Related Publications (1)
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.
PMID: 29191954DERIVED
MeSH Terms
Conditions
Condition Hierarchy (Ancestors)
Study Officials
- STUDY DIRECTOR
Dany Jaffuel, MD, PhD
University Hospitals of Montpellier
Study Design
- Study Type
- observational
- Observational Model
- CASE ONLY
- Time Perspective
- RETROSPECTIVE
- Sponsor Type
- OTHER
- Responsible Party
- SPONSOR
Study Record Dates
First Submitted
April 21, 2017
First Posted
April 26, 2017
Study Start
January 1, 2015
Primary Completion
December 1, 2016
Study Completion
December 1, 2016
Last Updated
August 3, 2017
Record last verified: 2017-04