Rhinitis
Conditions
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.
Interventions
DEVICEMeasure 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.
DEVICEGold standard: polysomnography
Polysomnography will be performed according to the American Academy of Sleep Medicine Recommendations 2018
Sponsors
ADENE
University Hospital, Montpellier
Study design
Observational model
COHORT
Time perspective
CROSS_SECTIONAL
Eligibility
Sex/Gender
ALL
Age
18 Years to No maximum
Healthy volunteers
No
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
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| The mandibular movement respiratory disturbance index | Day 7 |
| The polysomnography respiratory disturbance index | Day 7 |
Secondary
| Measure | Time frame | Description |
|---|---|---|
| Time below 90% SpO2 | Day 7 | From polysomnography. |
| % of TST below 90% of SpO2 | Day 7 | From polysomnography. |
| Mean SpO2 | Day 7 | From polysomnography. |
| Minimal SpO2 during sleep | Day 7 | From polysomnography. |
| Epworth scale score | Day 1 | This questionnaire describes sleepiness with a score that ranges from 0 to 24. Higher scores indicate more sleepiness. |
| The Karolinska questionnaire | Day 1 | 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 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. |
| 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 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. |
| 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 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 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. |
| 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) |
| The Nasal Obstruction Symptom Evaluation (NOSE) questionnaire | Day 1 | 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). |
| 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. |
| Total sleep time (TST) | Day 7 | From polysomnography. |
| Obstructive apnea index | Day 7 | From polysomnography. |
| Mixed apnea index | Day 7 | From polysomnography. |
| Apnea index | Day 7 | From polysomnography. |
| Hypopnea index | Day 7 | From polysomnography. |
| Apnea and Hypopnea index | Day 7 | From polysomnography. |
| Respiratory effort related arousal index | Day 7 | From polysomnography. |
| Respiratory Disturbance Index | Day 7 | From polysomnography. |
| Time in bed | Day 7 | From polysomnography. |
| Sleep Onset Latency | Day 7 | From polysomnography. |
| Wake After Sleep Onset (WASO) | Day 7 | From polysomnography. |
| Wake During Sleep Period | Day 7 | From polysomnography. |
| Sleep Latency | Day 7 | From polysomnography. |
| Random eye movement (REM) stage latency | Day 7 | From polysomnography. |
| Percentage of sleep efficiency | Day 7 | From polysomnography. |
| Time in sleep stage | Day 7 | From polysomnography. |
| Percent of TST in sleep stage | Day 7 | From polysomnography. |
| Arousal index | Day 7 | From polysomnography. |
| Arousal index associated with respiratory events | Day 7 | From polysomnography. |
| The periodic limb movement (PLM) index | Day 7 | From polysomnography. |
| PLM arousal | Day 7 | From polysomnography. |
| Number of limb movements associated with respiratory events index | Day 7 | From polysomnography. |
| Photoplethysmography arousal index | Day 7 | From polysomnography. |
| Signal validity | Day 7 | From mandibular movement recordings. |
| 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. |
| Respiratory fragmentation of sleep index | Day 7 | From mandibular movement recordings. |
| Fragmentation of sleep index | Day 7 | From mandibular movement recordings. |
| ARIA rhinitis classification | Day 1 | ARIA = Allergic Rhinitis and its Impact on Asthma |
| Presence/absence of asthma | Day 1 | Does the patient have asthma? yes/no |
| For asthma patients, the GINA control score | Day 1 | GINA = Global Initiative for Asthma |
| Forced expiratory volume in 1 second, % predicted | Day 1 | From spirometry. |
| Forced vital capacity, % predicted | Day 1 | From spirometry. |
| Forced expiratory volume in 1 second / Forced vital capacity (% litres/litres)predicted | Day 1 | From spirometry. |
| Forced expiratory volume 25-75, % predicted predicted | Day 1 | From spirometry. |
| Antecedent of public road or work accident (yes/no) | Day 1 | — |
| Patient reports presence/absence of poor sleep | Day 1 | — |
| Time spent snoring | Day 7 | From polysomnography. |
| Patient reports presence/absence of dry mouth | Day 1 | — |
| Patient reports presence/absence of concentration difficulty | Day 1 | — |
| Patient reports presence/absence of headaches | Day 1 | — |
| Allergen prick test results | Day 1 | — |
| List of concomitant medications | Day 1 | — |
| Patient reports presence/absence of snoring | Day 1 | — |
| Oxygen desaturation ≥ 3% index | Day 7 | From polysomnography. |
Countries
France
Outcome results
None listed