Sleep Respiratory Disorders in Patients With Moderate to Severe Persistent Rhinitis

NCT04012216 | Completed

• 1 other identifier: RECHMPL18_0473
• Study Type: observational
• Target: 55
• Locations: 1 country
• Sites: 1

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.

Conditions

Rhinitis

Outcome Measures

Primary Outcomes (2)

• The mandibular movement respiratory disturbance index

  Day 7

• The polysomnography respiratory disturbance index

  Day 7

Secondary Outcomes (64)

• Epworth scale score

  Day 1

• Epworth scale score

  Day 7

• The Karolinska questionnaire

  Day 1

• The Karolinska questionnaire

  Day 7

• The Pittsburgh Sleep Quality Index (PSQI)

  Day 7

Study Arms (1)

The study population

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

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

Interventions

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

The study population

Gold standard: polysomnography DEVICE

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

The study population

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)
• Sampling Method: Probability Sample

Study Population

Patients consulting for persistant, moderate-to-severe rhinitis.

You may qualify if:

• 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).

You may not qualify if:

• The patient is participating in another study that precludes participation in the present 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

Sponsors & Collaborators

• University Hospital, Montpellier: lead
• ADENE: collaborator

Study Sites (1)

Chu Montpellier

Montpellier, Hérault, 34295, France

Location

MeSH Terms

Conditions

Rhinitis

Condition Hierarchy (Ancestors)

Respiratory Tract Infections; Infections; Nose Diseases; Respiratory Tract Diseases; Otorhinolaryngologic Diseases

Study Officials

• Dany JAFFUEL, MD, PhD

  Department of Respiratory Medicine and Addiction Medicine

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: observational
• Observational Model: COHORT
• Time Perspective: CROSS SECTIONAL
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: June 27, 2019
• First Posted: July 9, 2019
• Study Start: January 28, 2020
• Primary Completion: June 25, 2024
• Study Completion: November 6, 2024
• Last Updated: November 7, 2024

Record last verified: 2024-11

Data Sharing

• IPD Sharing: Will share
• Shared Documents: STUDY PROTOCOL, SAP, ICF, CSR, ANALYTIC CODE
• Time Frame: As close to "real time" as possible, the following supporting information will be made public: * Study Protocol * Statistical Analysis Plan * Participant Information Materials * Clinical Study Report * Analytic code These will be posted and registered on osf.io/clinicaltrials.gov. Individual datasets will be made available to reviewers at time of submission. Full public access to data will be implemented within 4 weeks following publication acceptation.
• Access Criteria: The conditions under which members of the public will be granted access (via zenodo.org) to the uploaded files are: * The data will be used/examined in a not-for-profit manner; * The data will not be used in an attempt to identify a participant or group of participants; * The user does not work for a private insurance company; * The data will not be used in support of any kind of private insurance policy or health penalties; * The data will be used/examined for the advancement of science/teaching while respecting participant/patient privacy and rights; * The user will state why they wish to access the data.

Locations

FR (1)