NCT04012216

Sleep Respiratory Disorders in Patients With Moderate to Severe Persistent Rhinitis

Sleep Respiratory Disorders in Patients With Moderate to Severe Persistent Rhinitis: a Prospective, Predictive Study

• Status: Completed
• Phase: —
• Study type: Observational
• Enrollment: 55 (actual)
• Sponsor: University Hospital, Montpellier · Academic / Other
• Sex: All
• Age: 18 Years
• Healthy volunteers: Not accepted

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

Interventions

Type	Name	Description
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

Timeline

• Start date: 2020-01-28
• Primary completion: 2024-06-25
• Completion: 2024-11-06
• First posted: 2019-07-09
• Last updated: 2024-11-07

Locations

1 site across 1 country: France