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Completed

NCT Number: NCT03129984

Mandibular Movement Test as a Screening Tool for Polysomnography Candidates

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.

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Key information

Conditions

Sleep Apnea Syndromes Apnea Dyssomnias Nervous System Diseases Respiration Disorders Respiratory Tract Diseases Sleep Disorders, Intrinsic Sleep Wake Disorders

Sex eligibility

All sexes

Study type

Observational

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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

Treatment and study plan

Mandibular movement tracking

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.

Other names: Brizzy (Nomics, Liege, Belgium)

Primary outcomes

  1. The exploitable data rate

    Time frame: Day 0 (retrospective cross-sectional study)

    The number of usable tests / the number of tests performed.

Secondary outcomes

  1. 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)

  2. Minimal estimated total sleep time

    Time frame: Day 0 (retrospective cross-sectional study)

    Minimal estimated total sleep time

  3. ODI

    Time frame: Day 0 (retrospective cross-sectional study)

    The oxygen desaturation index (ODI) from oximetry.

  4. 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

  5. Identification of reasons why a given test was unusable

    Time frame: Day 0 (retrospective cross-sectional study)

  6. age

    Time frame: Day 0 (retrospective cross-sectional study)

    age in years

Sponsors and collaborators

Lead sponsor

University Hospital, Montpellier

Other

Collaborators

  • nomics s.a.

Registry information

Official study title

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

Acronym: dépist-By

Important dates

Study start
2015
Primary completion
2016
Study completion
2016
First posted
Apr 26, 2017
Registry last updated
Aug 3, 2017

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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