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Completed

NCT Number: NCT04012216

Sleep Respiratory Disorders in Patients With Moderate to Severe Persistent Rhinitis

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.

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Key information

Conditions

Rhinitis Infections Nose Diseases Otorhinolaryngologic Diseases Respiratory Tract Diseases Respiratory Tract Infections

Age range

18 year and older

Sex eligibility

All sexes

Study type

Observational

Primary location

Chu Montpellier

Montpellier, Hérault, 34295, France

About this study

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.

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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

Treatment and study plan

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.

Gold standard: polysomnography

Device

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

Primary outcomes

  1. The mandibular movement respiratory disturbance index

    Time frame: Day 7

  2. The polysomnography respiratory disturbance index

    Time frame: Day 7

Secondary outcomes

  1. Epworth scale score

    Time frame: Day 1

    This questionnaire describes sleepiness with a score that ranges from 0 to 24. Higher scores indicate more sleepiness.

  2. Epworth scale score

    Time frame: Day 7

    This questionnaire describes sleepiness with a score that ranges from 0 to 24. Higher scores indicate more sleepiness.

  3. The Karolinska questionnaire

    Time frame: 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).

  4. The Karolinska questionnaire

    Time frame: 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).

  5. The Pittsburgh Sleep Quality Index (PSQI)

    Time frame: 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.

  6. The mobility dimension of the EQ-5D-3L Questionaire (the 3-level version of Euroqol EQ-5D)

    Time frame: 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.

  7. The autonomy dimension of the EQ-5D-3L Questionaire (the 3-level version of Euroqol EQ-5D)

    Time frame: 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.

  8. The daily activities dimension of the EQ-5D-3L Questionaire (the 3-level version of Euroqol EQ-5D)

    Time frame: 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.

  9. The pain dimension of the EQ-5D-3L Questionaire (the 3-level version of Euroqol EQ-5D)

    Time frame: 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.

  10. The anxiety-depression dimension of the EQ-5D-3L Questionaire (the 3-level version of Euroqol EQ-5D)

    Time frame: 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.

  11. The visual analog scale from the EQ-5D-3L Questionaire (the 3-level version of Euroqol EQ-5D)

    Time frame: 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)

  12. The Nasal Obstruction Symptom Evaluation (NOSE) questionnaire

    Time frame: 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).

  13. The Nasal Obstruction Symptom Evaluation (NOSE) questionnaire

    Time frame: 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).

  14. The Allergic Rhinitis Control Test (ARCT) rhinitis questionnaire

    Time frame: 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.

  15. Total sleep time (TST)

    Time frame: Day 7

    From polysomnography.

  16. Obstructive apnea index

    Time frame: Day 7

    From polysomnography.

  17. Mixed apnea index

    Time frame: Day 7

    From polysomnography.

  18. Apnea index

    Time frame: Day 7

    From polysomnography.

  19. Hypopnea index

    Time frame: Day 7

    From polysomnography.

  20. Apnea and Hypopnea index

    Time frame: Day 7

    From polysomnography.

  21. Respiratory effort related arousal index

    Time frame: Day 7

    From polysomnography.

  22. Respiratory Disturbance Index

    Time frame: Day 7

    From polysomnography.

  23. Time spent snoring

    Time frame: Day 7

    From polysomnography.

  24. Oxygen desaturation ≥ 3% index

    Time frame: Day 7

    From polysomnography.

  25. Time below 90% SpO2

    Time frame: Day 7

    From polysomnography.

  26. % of TST below 90% of SpO2

    Time frame: Day 7

    From polysomnography.

  27. Mean SpO2

    Time frame: Day 7

    From polysomnography.

  28. Minimal SpO2 during sleep

    Time frame: Day 7

    From polysomnography.

  29. Time in bed

    Time frame: Day 7

    From polysomnography.

  30. Sleep Onset Latency

    Time frame: Day 7

    From polysomnography.

  31. Wake After Sleep Onset (WASO)

    Time frame: Day 7

    From polysomnography.

  32. Wake During Sleep Period

    Time frame: Day 7

    From polysomnography.

  33. Sleep Latency

    Time frame: Day 7

    From polysomnography.

  34. Random eye movement (REM) stage latency

    Time frame: Day 7

    From polysomnography.

  35. Percentage of sleep efficiency

    Time frame: Day 7

    From polysomnography.

  36. Time in sleep stage

    Time frame: Day 7

    From polysomnography.

  37. Percent of TST in sleep stage

    Time frame: Day 7

    From polysomnography.

  38. Arousal index

    Time frame: Day 7

    From polysomnography.

  39. Arousal index associated with respiratory events

    Time frame: Day 7

    From polysomnography.

  40. The periodic limb movement (PLM) index

    Time frame: Day 7

    From polysomnography.

  41. PLM arousal

    Time frame: Day 7

    From polysomnography.

  42. Number of limb movements associated with respiratory events index

    Time frame: Day 7

    From polysomnography.

  43. Photoplethysmography arousal index

    Time frame: Day 7

    From polysomnography.

  44. Signal validity

    Time frame: Day 7

    From mandibular movement recordings.

  45. TST

    Time frame: Day 7

    From mandibular movement recordings.

  46. WASO

    Time frame: Day 7

    From mandibular movement recordings.

  47. % of TST spent in respiratory effort

    Time frame: Day 7

    From mandibular movement recordings.

  48. Respiratory fragmentation of sleep index

    Time frame: Day 7

    From mandibular movement recordings.

  49. Fragmentation of sleep index

    Time frame: Day 7

    From mandibular movement recordings.

  50. ARIA rhinitis classification

    Time frame: Day 1

    ARIA = Allergic Rhinitis and its Impact on Asthma

  51. Presence/absence of asthma

    Time frame: Day 1

    Does the patient have asthma? yes/no

  52. For asthma patients, the GINA control score

    Time frame: Day 1

    GINA = Global Initiative for Asthma

  53. Forced expiratory volume in 1 second, % predicted

    Time frame: Day 1

    From spirometry.

  54. Forced vital capacity, % predicted

    Time frame: Day 1

    From spirometry.

  55. Forced expiratory volume in 1 second / Forced vital capacity (% litres/litres)predicted

    Time frame: Day 1

    From spirometry.

  56. Forced expiratory volume 25-75, % predicted predicted

    Time frame: Day 1

    From spirometry.

  57. Antecedent of public road or work accident (yes/no)

    Time frame: Day 1

  58. Patient reports presence/absence of poor sleep

    Time frame: Day 1

  59. Patient reports presence/absence of snoring

    Time frame: Day 1

  60. Patient reports presence/absence of dry mouth

    Time frame: Day 1

  61. Patient reports presence/absence of concentration difficulty

    Time frame: Day 1

  62. Patient reports presence/absence of headaches

    Time frame: Day 1

  63. Allergen prick test results

    Time frame: Day 1

  64. List of concomitant medications

    Time frame: Day 1

Sponsors and collaborators

Lead sponsor

University Hospital, Montpellier

Other

Collaborators

  • ADENE

Registry information

Official study title

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

Acronym: JawRhin1

Important dates

Study start
2020
Primary completion
2024
Study completion
2024
First posted
Jul 9, 2019
Registry last updated
Nov 7, 2024

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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