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Sleep Respiratory Disorders in Patients With Moderate to Severe Persistent Rhinitis

NCT04012216 · Status: COMPLETED · Type: OBSERVATIONAL · Enrollment: 55

Last updated 2024-11-07

No results posted yet for this study

Summary

The general aim of this study is to demonstrate that the measurement of respiratory effort assessed by mandibular movements during sleep is a useful measure for the screening of sleep disordered breathing (SDB) in patients with moderate to severe persistent rhinitis (R). The primary objective is therefore to determine a mandibular movement respiratory disturbance index (MM-RDI) threshold associated with a polysomnography respiratory disturbance index (PSG-RDI) ≥ 15 / h in a population of patients with moderate-to-severe persistent R.

Conditions

  • Rhinitis

Interventions

DEVICE

Measure of mandibular movement using a mid-sagittal magnetic sensor (Brizzy, Jawac©) Nomics, Liege, Belgium)

A mid-sagittal MM magnetic sensor (Brizzy, Jawac©) Nomics, Liege, Belgium) measures the distance in mm between two parallel, coupled, resonant circuits placed on the forehead and on the chin. Measurements last one night.

DEVICE

Gold standard: polysomnography

Polysomnography will be performed according to the American Academy of Sleep Medicine Recommendations 2018

Sponsors & Collaborators

  • ADENE

    collaborator UNKNOWN

  • University Hospital, Montpellier

    lead OTHER

Principal Investigators

  • Dany JAFFUEL, MD, PhD · Department of Respiratory Medicine and Addiction Medicine

Eligibility

Min Age
18 Years
Sex
ALL
Healthy Volunteers
No

Timeline & Regulatory

Start
2020-01-28
Primary Completion
2024-06-25
Completion
2024-11-06

Countries

  • France

Study Locations

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Read the full study record

This page highlights key information. For complete eligibility criteria, study locations, investigator contacts, and the full protocol, visit the original record on ClinicalTrials.gov.

View NCT04012216 on ClinicalTrials.gov