Clinical trial NCT04012216: Sleep Respiratory Disorders in Patients With Moderate to Severe Persistent Rhinitis
Official title: Sleep Respiratory Disorders in Patients With Moderate to Severe Persistent Rhinitis: a Prospective, Predictive Study
Study type: OBSERVATIONAL
Overall status: COMPLETED
Conditions: Rhinitis
Lead sponsor: University Hospital, Montpellier
Sponsor class: OTHER
Collaborators: name: ADENE
First posted: 2019-07-09
Enrollment: 55
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Observational model: COHORT
Time perspective: CROSS_SECTIONAL
Sampling method: PROBABILITY_SAMPLE
Study population: Patients consulting for persistant, moderate-to-severe rhinitis.

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.

Eligibility criteria: 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

Primary outcomes:
measure: The mandibular movement respiratory disturbance index
timeFrame: Day 7
measure: The polysomnography respiratory disturbance index
timeFrame: Day 7
Secondary outcomes:
measure: Epworth scale score
timeFrame: Day 1
measure: Epworth scale score
timeFrame: Day 7
measure: The Karolinska questionnaire
timeFrame: Day 1
measure: The Karolinska questionnaire
timeFrame: Day 7
measure: The Pittsburgh Sleep Quality Index (PSQI)
timeFrame: Day 7
measure: The mobility dimension of the EQ-5D-3L Questionaire (the 3-level version of Euroqol EQ-5D)
timeFrame: Day 1
measure: The autonomy dimension of the EQ-5D-3L Questionaire (the 3-level version of Euroqol EQ-5D)
timeFrame: Day 1
measure: The daily activities dimension of the EQ-5D-3L Questionaire (the 3-level version of Euroqol EQ-5D)
timeFrame: Day 1
measure: The pain dimension of the EQ-5D-3L Questionaire (the 3-level version of Euroqol EQ-5D)
timeFrame: Day 1
measure: The anxiety-depression dimension of the EQ-5D-3L Questionaire (the 3-level version of Euroqol EQ-5D)
timeFrame: Day 1
measure: The visual analog scale from the EQ-5D-3L Questionaire (the 3-level version of Euroqol EQ-5D)
timeFrame: Day 1
measure: The Nasal Obstruction Symptom Evaluation (NOSE) questionnaire
timeFrame: Day 1
measure: The Nasal Obstruction Symptom Evaluation (NOSE) questionnaire
timeFrame: Day 7
measure: The Allergic Rhinitis Control Test (ARCT) rhinitis questionnaire
timeFrame: Day 1
measure: Total sleep time (TST)
timeFrame: Day 7
measure: Obstructive apnea index
timeFrame: Day 7
measure: Mixed apnea index
timeFrame: Day 7
measure: Apnea index
timeFrame: Day 7
measure: Hypopnea index
timeFrame: Day 7
measure: Apnea and Hypopnea index
timeFrame: Day 7
measure: Respiratory effort related arousal index
timeFrame: Day 7
measure: Respiratory Disturbance Index
timeFrame: Day 7
measure: Time spent snoring
timeFrame: Day 7
measure: Oxygen desaturation ≥ 3% index
timeFrame: Day 7
measure: Time below 90% SpO2
timeFrame: Day 7
measure: % of TST below 90% of SpO2
timeFrame: Day 7
measure: Mean SpO2
timeFrame: Day 7
measure: Minimal SpO2 during sleep
timeFrame: Day 7
measure: Time in bed
timeFrame: Day 7
measure: Sleep Onset Latency
timeFrame: Day 7
measure: Wake After Sleep Onset (WASO)
timeFrame: Day 7
measure: Wake During Sleep Period
timeFrame: Day 7
measure: Sleep Latency
timeFrame: Day 7
measure: Random eye movement (REM) stage latency
timeFrame: Day 7
measure: Percentage of sleep efficiency
timeFrame: Day 7
measure: Time in sleep stage
timeFrame: Day 7
measure: Percent of TST in sleep stage
timeFrame: Day 7
measure: Arousal index
timeFrame: Day 7
measure: Arousal index associated with respiratory events
timeFrame: Day 7
measure: The periodic limb movement (PLM) index
timeFrame: Day 7
measure: PLM arousal
timeFrame: Day 7
measure: Number of limb movements associated with respiratory events index
timeFrame: Day 7
measure: Photoplethysmography arousal index
timeFrame: Day 7
measure: Signal validity
timeFrame: Day 7
measure: TST
timeFrame: Day 7
measure: WASO
timeFrame: Day 7
measure: % of TST spent in respiratory effort
timeFrame: Day 7
measure: Respiratory fragmentation of sleep index
timeFrame: Day 7
measure: Fragmentation of sleep index
timeFrame: Day 7
measure: ARIA rhinitis classification
timeFrame: Day 1
measure: Presence/absence of asthma
timeFrame: Day 1
measure: For asthma patients, the GINA control score
timeFrame: Day 1
measure: Forced expiratory volume in 1 second, % predicted
timeFrame: Day 1
measure: Forced vital capacity, % predicted
timeFrame: Day 1
measure: Forced expiratory volume in 1 second / Forced vital capacity (% litres/litres)predicted
timeFrame: Day 1
measure: Forced expiratory volume 25-75, % predicted predicted
timeFrame: Day 1
measure: Antecedent of public road or work accident (yes/no)
timeFrame: Day 1
measure: Patient reports presence/absence of poor sleep
timeFrame: Day 1
measure: Patient reports presence/absence of snoring
timeFrame: Day 1
measure: Patient reports presence/absence of dry mouth
timeFrame: Day 1
measure: Patient reports presence/absence of concentration difficulty
timeFrame: Day 1
measure: Patient reports presence/absence of headaches
timeFrame: Day 1
measure: Allergen prick test results
timeFrame: Day 1
measure: List of concomitant medications
timeFrame: Day 1
Other outcomes:
Locations:
city: Montpellier
country: France
facility: Chu Montpellier
state: Hérault
Study officials:
affiliation: Department of Respiratory Medicine and Addiction Medicine
name: Dany JAFFUEL, MD, PhD
role: PRINCIPAL_INVESTIGATOR
References: