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.
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 Type
OBSERVATIONAL
Enrollment
55
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.
Polysomnography will be performed according to the American Academy of Sleep Medicine Recommendations 2018
Chu Montpellier
Montpellier, Hérault, France
The mandibular movement respiratory disturbance index
Time frame: Day 7
The polysomnography respiratory disturbance index
Time frame: Day 7
Epworth scale score
This questionnaire describes sleepiness with a score that ranges from 0 to 24. Higher scores indicate more sleepiness.
Time frame: Day 1
Epworth scale score
This questionnaire describes sleepiness with a score that ranges from 0 to 24. Higher scores indicate more sleepiness.
Time frame: Day 7
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).
Time frame: Day 1
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).
Time frame: Day 7
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.
This platform is for informational purposes only and does not constitute medical advice. Always consult a qualified healthcare professional.
Time frame: Day 7
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.
Time frame: Day 1
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.
Time frame: Day 1
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.
Time frame: Day 1
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.
Time frame: Day 1
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.
Time frame: Day 1
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)
Time frame: Day 1
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).
Time frame: Day 1
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).
Time frame: Day 7
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.
Time frame: Day 1
Total sleep time (TST)
From polysomnography.
Time frame: Day 7
Obstructive apnea index
From polysomnography.
Time frame: Day 7
Mixed apnea index
From polysomnography.
Time frame: Day 7
Apnea index
From polysomnography.
Time frame: Day 7
Hypopnea index
From polysomnography.
Time frame: Day 7
Apnea and Hypopnea index
From polysomnography.
Time frame: Day 7
Respiratory effort related arousal index
From polysomnography.
Time frame: Day 7
Respiratory Disturbance Index
From polysomnography.
Time frame: Day 7
Time spent snoring
From polysomnography.
Time frame: Day 7
Oxygen desaturation ≥ 3% index
From polysomnography.
Time frame: Day 7
Time below 90% SpO2
From polysomnography.
Time frame: Day 7
% of TST below 90% of SpO2
From polysomnography.
Time frame: Day 7
Mean SpO2
From polysomnography.
Time frame: Day 7
Minimal SpO2 during sleep
From polysomnography.
Time frame: Day 7
Time in bed
From polysomnography.
Time frame: Day 7
Sleep Onset Latency
From polysomnography.
Time frame: Day 7
Wake After Sleep Onset (WASO)
From polysomnography.
Time frame: Day 7
Wake During Sleep Period
From polysomnography.
Time frame: Day 7
Sleep Latency
From polysomnography.
Time frame: Day 7
Random eye movement (REM) stage latency
From polysomnography.
Time frame: Day 7
Percentage of sleep efficiency
From polysomnography.
Time frame: Day 7
Time in sleep stage
From polysomnography.
Time frame: Day 7
Percent of TST in sleep stage
From polysomnography.
Time frame: Day 7
Arousal index
From polysomnography.
Time frame: Day 7
Arousal index associated with respiratory events
From polysomnography.
Time frame: Day 7
The periodic limb movement (PLM) index
From polysomnography.
Time frame: Day 7
PLM arousal
From polysomnography.
Time frame: Day 7
Number of limb movements associated with respiratory events index
From polysomnography.
Time frame: Day 7
Photoplethysmography arousal index
From polysomnography.
Time frame: Day 7
Signal validity
From mandibular movement recordings.
Time frame: Day 7
TST
From mandibular movement recordings.
Time frame: Day 7
WASO
From mandibular movement recordings.
Time frame: Day 7
% of TST spent in respiratory effort
From mandibular movement recordings.
Time frame: Day 7
Respiratory fragmentation of sleep index
From mandibular movement recordings.
Time frame: Day 7
Fragmentation of sleep index
From mandibular movement recordings.
Time frame: Day 7
ARIA rhinitis classification
ARIA = Allergic Rhinitis and its Impact on Asthma
Time frame: Day 1
Presence/absence of asthma
Does the patient have asthma? yes/no
Time frame: Day 1
For asthma patients, the GINA control score
GINA = Global Initiative for Asthma
Time frame: Day 1
Forced expiratory volume in 1 second, % predicted
From spirometry.
Time frame: Day 1
Forced vital capacity, % predicted
From spirometry.
Time frame: Day 1
Forced expiratory volume in 1 second / Forced vital capacity (% litres/litres)predicted
From spirometry.
Time frame: Day 1
Forced expiratory volume 25-75, % predicted predicted
From spirometry.
Time frame: Day 1
Antecedent of public road or work accident (yes/no)
Time frame: Day 1
Patient reports presence/absence of poor sleep
Time frame: Day 1
Patient reports presence/absence of snoring
Time frame: Day 1
Patient reports presence/absence of dry mouth
Time frame: Day 1
Patient reports presence/absence of concentration difficulty
Time frame: Day 1
Patient reports presence/absence of headaches
Time frame: Day 1
Allergen prick test results
Time frame: Day 1
List of concomitant medications
Time frame: Day 1