Sleep Respiratory Disorders in Patients With Moderate to Severe Persistent Rhinitis

Rhinitis Clinical Trial

— JawRhin1  

Official title:

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

Clinical Trial Details — Status: Recruiting

Administrative data

• NCT number: NCT04012216
• Other study ID #: RECHMPL18_0473
• Status: Recruiting
• Start date: January 28, 2020
• Est. completion date: July 31, 2025

Study information

• Verified date: March 2024
• Source: University Hospital, Montpellier
• Contact: Pascal DEMOLY, MD PhD
• Phone: +33 4 67 33 61 18
• Email: p-demoly[@]chu-montpellier.fr
• Is FDA regulated: No
• Study type: Observational

Clinical Trial 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.

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.

Recruitment information / eligibility

• Status: Recruiting
• Enrollment: 70
• Est. completion date: July 31, 2025
• Est. primary completion date: January 28, 2025
• Accepts healthy volunteers: No
• Gender: All
• Age group: 18 Years and older

Eligibility

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

Related Conditions & MeSH terms

• Respiration Disorders
• Respiratory Tract Diseases
• Rhinitis

Intervention

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.
• Gold standard: polysomnography
Polysomnography will be performed according to the American Academy of Sleep Medicine Recommendations 2018

Locations

Country	Name	City	State
France	Chu Montpellier	Montpellier	Hérault

Sponsors (2)

Lead Sponsor	Collaborator
University Hospital, Montpellier	ADENE

Country where clinical trial is conducted

France, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	The mandibular movement respiratory disturbance index		Day 7
Primary	The polysomnography respiratory disturbance index		Day 7
Secondary	Epworth scale score	This questionnaire describes sleepiness with a score that ranges from 0 to 24. Higher scores indicate more sleepiness.	Day 1
Secondary	Epworth scale score	This questionnaire describes sleepiness with a score that ranges from 0 to 24. Higher scores indicate more sleepiness.	Day 7
Secondary	The Karolinska questionnaire	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).	Day 1
Secondary	The Karolinska questionnaire	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).	Day 7
Secondary	The Pittsburgh Sleep Quality Index (PSQI)	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.	Day 7
Secondary	The mobility dimension of the EQ-5D-3L Questionaire (the 3-level version of Euroqol EQ-5D)	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.	Day 1
Secondary	The autonomy dimension of the EQ-5D-3L Questionaire (the 3-level version of Euroqol EQ-5D)	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.	Day 1
Secondary	The daily activities dimension of the EQ-5D-3L Questionaire (the 3-level version of Euroqol EQ-5D)	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.	Day 1
Secondary	The pain dimension of the EQ-5D-3L Questionaire (the 3-level version of Euroqol EQ-5D)	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.	Day 1
Secondary	The anxiety-depression dimension of the EQ-5D-3L Questionaire (the 3-level version of Euroqol EQ-5D)	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.	Day 1
Secondary	The visual analog scale from the EQ-5D-3L Questionaire (the 3-level version of Euroqol EQ-5D)	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)	Day 1
Secondary	The Nasal Obstruction Symptom Evaluation (NOSE) questionnaire	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).	Day 1
Secondary	The Nasal Obstruction Symptom Evaluation (NOSE) questionnaire	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).	Day 7
Secondary	The Allergic Rhinitis Control Test (ARCT) rhinitis questionnaire	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.	Day 1
Secondary	Total sleep time (TST)	From polysomnography.	Day 7
Secondary	Obstructive apnea index	From polysomnography.	Day 7
Secondary	Mixed apnea index	From polysomnography.	Day 7
Secondary	Apnea index	From polysomnography.	Day 7
Secondary	Hypopnea index	From polysomnography.	Day 7
Secondary	Apnea and Hypopnea index	From polysomnography.	Day 7
Secondary	Respiratory effort related arousal index	From polysomnography.	Day 7
Secondary	Respiratory Disturbance Index	From polysomnography.	Day 7
Secondary	Time spent snoring	From polysomnography.	Day 7
Secondary	Oxygen desaturation = 3% index	From polysomnography.	Day 7
Secondary	Time below 90% SpO2	From polysomnography.	Day 7
Secondary	% of TST below 90% of SpO2	From polysomnography.	Day 7
Secondary	Mean SpO2	From polysomnography.	Day 7
Secondary	Minimal SpO2 during sleep	From polysomnography.	Day 7
Secondary	Time in bed	From polysomnography.	Day 7
Secondary	Sleep Onset Latency	From polysomnography.	Day 7
Secondary	Wake After Sleep Onset (WASO)	From polysomnography.	Day 7
Secondary	Wake During Sleep Period	From polysomnography.	Day 7
Secondary	Sleep Latency	From polysomnography.	Day 7
Secondary	Random eye movement (REM) stage latency	From polysomnography.	Day 7
Secondary	Percentage of sleep efficiency	From polysomnography.	Day 7
Secondary	Time in sleep stage	From polysomnography.	Day 7
Secondary	Percent of TST in sleep stage	From polysomnography.	Day 7
Secondary	Arousal index	From polysomnography.	Day 7
Secondary	Arousal index associated with respiratory events	From polysomnography.	Day 7
Secondary	The periodic limb movement (PLM) index	From polysomnography.	Day 7
Secondary	PLM arousal	From polysomnography.	Day 7
Secondary	Number of limb movements associated with respiratory events index	From polysomnography.	Day 7
Secondary	Photoplethysmography arousal index	From polysomnography.	Day 7
Secondary	Signal validity	From mandibular movement recordings.	Day 7
Secondary	TST	From mandibular movement recordings.	Day 7
Secondary	WASO	From mandibular movement recordings.	Day 7
Secondary	% of TST spent in respiratory effort	From mandibular movement recordings.	Day 7
Secondary	Respiratory fragmentation of sleep index	From mandibular movement recordings.	Day 7
Secondary	Fragmentation of sleep index	From mandibular movement recordings.	Day 7
Secondary	ARIA rhinitis classification	ARIA = Allergic Rhinitis and its Impact on Asthma	Day 1
Secondary	Presence/absence of asthma	Does the patient have asthma? yes/no	Day 1
Secondary	For asthma patients, the GINA control score	GINA = Global Initiative for Asthma	Day 1
Secondary	Forced expiratory volume in 1 second, % predicted	From spirometry.	Day 1
Secondary	Forced vital capacity, % predicted	From spirometry.	Day 1
Secondary	Forced expiratory volume in 1 second / Forced vital capacity (% litres/litres)predicted	From spirometry.	Day 1
Secondary	Forced expiratory volume 25-75, % predicted predicted	From spirometry.	Day 1
Secondary	Antecedent of public road or work accident (yes/no)		Day 1
Secondary	Patient reports presence/absence of poor sleep		Day 1
Secondary	Patient reports presence/absence of snoring		Day 1
Secondary	Patient reports presence/absence of dry mouth		Day 1
Secondary	Patient reports presence/absence of concentration difficulty		Day 1
Secondary	Patient reports presence/absence of headaches		Day 1
Secondary	Allergen prick test results		Day 1
Secondary	List of concomitant medications		Day 1