Sleep Respiratory Disorders in Patients With Moderate to Severe Persistent Rhinitis (JawRhin1)

University Hospital Center (CHU)

Status: Completed

Conditions: Rhinitis

Treatments: Device: Gold standard: polysomnography; Device: Measure of mandibular movement using a mid-sagittal magnetic sensor (Brizzy, Jawac©) Nomics, Liege, Belgium)

Study type: Observational

Funder types: Other

Identifiers

NCT04012216

RECHMPL18_0473

Details and patient eligibility

About

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.

Full 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.

Enrollment: 55 patients

Sex: All

Ages: 18+ years old

Volunteers: No Healthy Volunteers

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

Trial design

55 participants in 1 patient group

The study population

Description:

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

Treatment:

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

Device: Gold standard: polysomnography