Sleep Respiratory Disorders in Patients With Moderate to Severe Persistent Rhinitis

NCT ID: NCT04012216

Last Updated: 2024-11-07

Basic Information

• Recruitment Status: COMPLETED
• Total Enrollment: 55 participants
• Study Classification: OBSERVATIONAL
• Study Start Date: 2020-01-28
• Study Completion Date: 2024-11-06

Brief 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.

Detailed Description

The secondary objectives of the study are to evaluate the concordance and correlation between:

• MM-RDI,
• the respiratory effort evaluated by MM,
• polysomnography (PSG) results,
• quality of life questionnaires,
• clinical data,
• treatments.

Conditions

Rhinitis

Study Design

• Observational Model Type: COHORT
• Study Time Perspective: CROSS_SECTIONAL

Study Groups

The study population

Patients consulting for persistant, moderate-to-severe rhinitis and meeting eligibility criteria.

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

Intervention Type: DEVICE

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.

Gold standard: polysomnography

Intervention Type: DEVICE

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

Interventions

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.

Intervention Type: DEVICE

Gold standard: polysomnography

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

Intervention Type: DEVICE

Eligibility Criteria

Inclusion Criteria

• Patient consulting for persistant, moderate-to-severe rhinitis
• The patient has signed the informed consent
• The patient is a beneficiary of a social security programme (national health insurance)
• Patient living in the Montpellier region (< 30 kilometers).

Exclusion Criteria

• The patient is participating in another study that precludes participation in the present study
• The patient is in an exclusion period determined by another study
• It is impossible to correctly inform the patient
• The patient cannot fluently read French
• Vulnerable patient populations according to French Health Code article L1121-6
• Adult under guardianship or incapable of giving consent according to French Health Code article L1121-8
• Pregnancy, breastfeeding (French Health Code article L1121-5)
• Any element that renders participation in the study problematic according to the investigator

• Minimum Eligible Age: 18 Years
• Eligible Sex: ALL
• Accepts Healthy Volunteers: No

Sponsors

ADENE

UNKNOWN

Sponsor Role: collaborator

University Hospital, Montpellier

OTHER

Sponsor Role: lead

Responsible Party

Responsibility Role: SPONSOR

Principal Investigators

Dany JAFFUEL, MD, PhD

Role: PRINCIPAL_INVESTIGATOR

Department of Respiratory Medicine and Addiction Medicine

Locations

Chu Montpellier

Montpellier, Hérault, France

Countries

France

Other Identifiers

RECHMPL18_0473

Identifier Type: -

Identifier Source: org_study_id