Sleep Respiratory Disorders in Patients With Moderate to Severe Persistent Rhinitis

Completed

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

• Registration Number: NCT04012216
• Lead Sponsor: University Hospital, Montpellier

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.

Study Timeline

• Study First Submitted: 2019-06-27
• Study First Submitted QC: 2019-07-04
• Study First Posted: 2019-07-09
• Study Start: 2020-01-28
• Primary Completion: 2024-06-25
• Status Verified: 2024-11
• Study Completion: 2024-11-06
• Last Update Submitted: 2024-11-06
• Last Update Posted: 2024-11-07

Recruitment & Eligibility

• Status: COMPLETED
• Sex: All
• Target Recruitment: 55

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

Study & Design

• Study Type: OBSERVATIONAL
• Study Design: Not specified

Arm && Interventions

Group	Intervention	Description
The study population	Measure of mandibular movement using a mid-sagittal magnetic sensor (Brizzy, Jawac©) Nomics, Liege, Belgium)	Patients consulting for persistant, moderate-to-severe rhinitis and meeting eligibility criteria.

Primary Outcome Measures

Name	Time	Method
The polysomnography respiratory disturbance index	Day 7
The mandibular movement respiratory disturbance index	Day 7

Secondary Outcome Measures

Name	Time	Method
Hypopnea index	Day 7	From polysomnography.
Total sleep time (TST)	Day 7	From polysomnography.
PLM arousal	Day 7	From polysomnography.
Signal validity	Day 7	From mandibular movement recordings.
Forced vital capacity, % predicted	Day 1	From spirometry.
Patient reports presence/absence of concentration difficulty	Day 1
The autonomy dimension of the EQ-5D-3L Questionaire (the 3-level version of Euroqol EQ-5D)	Day 1	The Euro Quality Of Life-5 dimensions - 3 levels (EQ-5D-3L) scale is a descriptive system comprising the following five dimensions: mobility, self-care, usual activities, pain/discomfort and anxiety/depression. The responses record three levels of severity (no problems/some or moderate problems/extreme problems) within a particular EQ-5D dimension. This results in a 1-digit number that expresses the level selected for that dimension. The digits for the five dimensions can be combined into a 5-digit number that describes the patient's health state. In addition, there is a visual analogue scale (VAS) to indicate the general health status with "0" indicating the worse health and "100" indicating the best health.
Patient reports presence/absence of headaches	Day 1
Time in sleep stage	Day 7	From polysomnography.
Epworth scale score	Day 7	This questionnaire describes sleepiness with a score that ranges from 0 to 24. Higher scores indicate more sleepiness.
The Pittsburgh Sleep Quality Index (PSQI)	Day 7	The Pittsburg Sleep Quality Index (PSQI) measures the quality of sleep. It contains 19 self-rated questions and 5 questions by the bed partner or roommate (if one is available). Only self -rated questions are included in the scoring. The 19 self-rated items are combined in seven component scores each of which has a range of 0-3 points. In all the cases, a score of "0" indicates no difficulty, while a score of "3" indicates severe difficulty. The seven component scores are then added to yield one "global" score with a range of 0-21 points, "0" indicating no difficulty and "21" indicating severe difficulties in all areas. The 7 components are subjective sleep quality, sleep latency, sleep duration, habitual sleep efficiency, sleep disturbances, use of sleep medication and daytime dysfunction.
Respiratory Disturbance Index	Day 7	From polysomnography.
Time spent snoring	Day 7	From polysomnography.
Arousal index	Day 7	From polysomnography.
The pain dimension of the EQ-5D-3L Questionaire (the 3-level version of Euroqol EQ-5D)	Day 1	The Euro Quality Of Life-5 dimensions - 3 levels (EQ-5D-3L) scale is a descriptive system comprising the following five dimensions: mobility, self-care, usual activities, pain/discomfort and anxiety/depression. The responses record three levels of severity (no problems/some or moderate problems/extreme problems) within a particular EQ-5D dimension. This results in a 1-digit number that expresses the level selected for that dimension. The digits for the five dimensions can be combined into a 5-digit number that describes the patient's health state. In addition, there is a visual analogue scale (VAS) to indicate the general health status with "0" indicating the worse health and "100" indicating the best health.
The periodic limb movement (PLM) index	Day 7	From polysomnography.
List of concomitant medications	Day 1
The visual analog scale from the EQ-5D-3L Questionaire (the 3-level version of Euroqol EQ-5D)	Day 1	The Euro Quality Of Life-5 dimensions - 3 levels (EQ-5D-3L) scale is a descriptive system comprising the following five dimensions: mobility, self-care, usual activities, pain/discomfort and anxiety/depression. The responses record three levels of severity (no problems/some or moderate problems/extreme problems) within a particular EQ-5D dimension. This results in a 1-digit number that expresses the level selected for that dimension. The digits for the five dimensions can be combined into a 5-digit number that describes the patient's health state. In addition, there is a visual analogue scale (VAS) to indicate the general health status with "0" indicating the worse health and "100" indicating the best health.; "0" score is the minimum value, "100" score is the maximum value. There is no subscale. The better outcome is "100" (100 indicating the best health status)
Apnea and Hypopnea index	Day 7	From polysomnography.
Number of limb movements associated with respiratory events index	Day 7	From polysomnography.
Photoplethysmography arousal index	Day 7	From polysomnography.
The Karolinska questionnaire	Day 7	The complete name of this questionnaire is the "Karolisnska questionnaire." This questionnaire describes sleepiness when the patient is driving. No total score reported. The minimum score is 1 and the maximal score is 9. The best outcome is 1 (patient is extremely vigilant), the worst outcome is 9 (very sleepy, takes great effort to stay awake, fights against sleep).
The mobility dimension of the EQ-5D-3L Questionaire (the 3-level version of Euroqol EQ-5D)	Day 1	The Euro Quality Of Life-5 dimensions - 3 levels (EQ-5D-3L) scale is a descriptive system comprising the following five dimensions: mobility, self-care, usual activities, pain/discomfort and anxiety/depression. The responses record three levels of severity (no problems/some or moderate problems/extreme problems) within a particular EQ-5D dimension. This results in a 1-digit number that expresses the level selected for that dimension. The digits for the five dimensions can be combined into a 5-digit number that describes the patient's health state. In addition, there is a visual analogue scale (VAS) to indicate the general health status with "0" indicating the worse health and "100" indicating the best health.
The daily activities dimension of the EQ-5D-3L Questionaire (the 3-level version of Euroqol EQ-5D)	Day 1	The Euro Quality Of Life-5 dimensions - 3 levels (EQ-5D-3L) scale is a descriptive system comprising the following five dimensions: mobility, self-care, usual activities, pain/discomfort and anxiety/depression. The responses record three levels of severity (no problems/some or moderate problems/extreme problems) within a particular EQ-5D dimension. This results in a 1-digit number that expresses the level selected for that dimension. The digits for the five dimensions can be combined into a 5-digit number that describes the patient's health state. In addition, there is a visual analogue scale (VAS) to indicate the general health status with "0" indicating the worse health and "100" indicating the best health.
The anxiety-depression dimension of the EQ-5D-3L Questionaire (the 3-level version of Euroqol EQ-5D)	Day 1	The Euro Quality Of Life-5 dimensions - 3 levels (EQ-5D-3L) scale is a descriptive system comprising the following five dimensions: mobility, self-care, usual activities, pain/discomfort and anxiety/depression. The responses record three levels of severity (no problems/some or moderate problems/extreme problems) within a particular EQ-5D dimension. This results in a 1-digit number that expresses the level selected for that dimension. The digits for the five dimensions can be combined into a 5-digit number that describes the patient's health state. In addition, there is a visual analogue scale (VAS) to indicate the general health status with "0" indicating the worse health and "100" indicating the best health.
Mixed apnea index	Day 7	From polysomnography.
The Nasal Obstruction Symptom Evaluation (NOSE) questionnaire	Day 7	The NOSE questionnaire is composed of five subscales, namely: 1) nasal congestion or stuffiness; 2) nasal blockage or obstruction; 3) trouble breathing through my nose; 4) trouble sleeping; 5) unable to get enough air through my nose during exercise or exertion.; All subscales are scored using a 5-point Likert scale ranging from 0 to 4 (0=not a problem, 1=very mild problem, 2=moderate problem, 3=fairly bad problem, 4=severe problem). Each definitive subscale score is obtained after multiplying the Likert score by five. All subscales are added to give a total score (total score range from 0 (no nasal obstruction) to 100 (the most severe nasal obstruction).
Obstructive apnea index	Day 7	From polysomnography.
Apnea index	Day 7	From polysomnography.
Time below 90% SpO2	Day 7	From polysomnography.
Mean SpO2	Day 7	From polysomnography.
Wake During Sleep Period	Day 7	From polysomnography.
For asthma patients, the GINA control score	Day 1	GINA = Global Initiative for Asthma
The Allergic Rhinitis Control Test (ARCT) rhinitis questionnaire	Day 1	The Allergic Rhinitis Control Test (ARCT is a self-completion questionnaire assessing the control of chronic rhinitis. It is made up of five questions scored from 1 to 5, and these individual scores are then added up to obtain a score ranging from 5 (worse score) to 25 (best score). The five questions are: during the last 2 weeks, has your allergic rhinitis had an effect on your professional/personal activities ; during the last 2 weeks, has your allergic rhinitis made you irritable ; during the last 2 weeks, has your allergic rhinitis disturbed your sleep (going to sleep, waking at night) ; during the last 2 weeks, have you needed to use an additional treatment not prescribed by your doctor to treat your allergic rhinitis ; during the last 2 weeks, how would you assess your allergic rhinitis.
Respiratory effort related arousal index	Day 7	From polysomnography.
Oxygen desaturation ≥ 3% index	Day 7	From polysomnography.
Sleep Onset Latency	Day 7	From polysomnography.
Percentage of sleep efficiency	Day 7	From polysomnography.
Respiratory fragmentation of sleep index	Day 7	From mandibular movement recordings.
ARIA rhinitis classification	Day 1	ARIA = Allergic Rhinitis and its Impact on Asthma
Minimal SpO2 during sleep	Day 7	From polysomnography.
Time in bed	Day 7	From polysomnography.
Sleep Latency	Day 7	From polysomnography.
Random eye movement (REM) stage latency	Day 7	From polysomnography.
Percent of TST in sleep stage	Day 7	From polysomnography.
Arousal index associated with respiratory events	Day 7	From polysomnography.
TST	Day 7	From mandibular movement recordings.
WASO	Day 7	From mandibular movement recordings.
% of TST spent in respiratory effort	Day 7	From mandibular movement recordings.
Fragmentation of sleep index	Day 7	From mandibular movement recordings.
Presence/absence of asthma	Day 1	Does the patient have asthma? yes/no
Forced expiratory volume in 1 second, % predicted	Day 1	From spirometry.
Forced expiratory volume 25-75, % predicted predicted	Day 1	From spirometry.
Patient reports presence/absence of poor sleep	Day 1
Patient reports presence/absence of snoring	Day 1
% of TST below 90% of SpO2	Day 7	From polysomnography.
Wake After Sleep Onset (WASO)	Day 7	From polysomnography.
Forced expiratory volume in 1 second / Forced vital capacity (% litres/litres)predicted	Day 1	From spirometry.
Patient reports presence/absence of dry mouth	Day 1
Antecedent of public road or work accident (yes/no)	Day 1
Allergen prick test results	Day 1

Trial Locations

Locations (1)

Chu Montpellier; 🇫🇷 Montpellier, Hérault, France