RhinitisJawRhin1NCT04012216
Sleep Respiratory Disorders in Patients With Moderate to Severe Persistent Rhinitis
An observational study of Rhinitis, run by University Hospital, Montpellier at 1 site in France.
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). Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Rhinitis
- What is being tested?
- Measure of mandibular movement using a mid-sagittal magnetic sensor (Brizzy, Jawac©) Nomics, Liege, Belgium) and Gold standard: polysomnography
- Type of treatment
- Medical device
- How many people
- 55 participants
- Where
- 1 siteFrance
- Study dates
- 28 Jan 2020to 6 Nov 2024
- Phase
- Observational
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 years and older
- All sexes
- No healthy volunteers
- Adult, Older adult
Study population: Patients consulting for persistant, moderate-to-severe rhinitis.
Who may be able to join
- 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).
Who cannot join
- 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
Trial locations and contacts
1 site in 1 country.
About this study
Official title: Sleep Respiratory Disorders in Patients With Moderate to Severe Persistent Rhinitis: a Prospective, Predictive Study
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.
Read the 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.
- Conditions
- Rhinitis
- Being tested
- Measure of mandibular movement using a mid-sagittal magnetic sensor (Brizzy, Jawac©) Nomics, Liege, Belgium), Gold standard: polysomnography
- Medical subject headings
- Rhinitis
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
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: polysomnographyDevice
Polysomnography will be performed according to the American Academy of Sleep Medicine Recommendations 2018
| Study group | Role | What they receive |
|---|---|---|
| The study population | Patients consulting for persistant, moderate-to-severe rhinitis and meeting eligibility criteria. Receives: Device: Measure of mandibular movement using a mid-sagittal magnetic sensor (Brizzy, Jawac©) Nomics, Liege, Belgium); Device: Gold standard: polysomnography |
What is being measured
The primary outcome is the main question the study is designed to answer.
The mandibular movement respiratory disturbance index
Measured: Day 7
The polysomnography respiratory disturbance index
Measured: Day 7
Secondary outcomes (64)
Epworth scale score
This questionnaire describes sleepiness with a score that ranges from 0 to 24. Higher scores indicate more sleepiness.
Measured: Day 1
Epworth scale score
This questionnaire describes sleepiness with a score that ranges from 0 to 24. Higher scores indicate more sleepiness.
Measured: 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).
Measured: 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).
Measured: 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.
Measured: 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.
Measured: 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.
Measured: 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.
Measured: 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.
Measured: 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.
Measured: 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)
Measured: 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).
Measured: 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).
Measured: 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.
Measured: Day 1
Total sleep time (TST)
From polysomnography.
Measured: Day 7
Obstructive apnea index
From polysomnography.
Measured: Day 7
Mixed apnea index
From polysomnography.
Measured: Day 7
Apnea index
From polysomnography.
Measured: Day 7
Hypopnea index
From polysomnography.
Measured: Day 7
Apnea and Hypopnea index
From polysomnography.
Measured: Day 7
Respiratory effort related arousal index
From polysomnography.
Measured: Day 7
Respiratory Disturbance Index
From polysomnography.
Measured: Day 7
Time spent snoring
From polysomnography.
Measured: Day 7
Oxygen desaturation ≥ 3% index
From polysomnography.
Measured: Day 7
Time below 90% SpO2
From polysomnography.
Measured: Day 7
% of TST below 90% of SpO2
From polysomnography.
Measured: Day 7
Mean SpO2
From polysomnography.
Measured: Day 7
Minimal SpO2 during sleep
From polysomnography.
Measured: Day 7
Time in bed
From polysomnography.
Measured: Day 7
Sleep Onset Latency
From polysomnography.
Measured: Day 7
Wake After Sleep Onset (WASO)
From polysomnography.
Measured: Day 7
Wake During Sleep Period
From polysomnography.
Measured: Day 7
Sleep Latency
From polysomnography.
Measured: Day 7
Random eye movement (REM) stage latency
From polysomnography.
Measured: Day 7
Percentage of sleep efficiency
From polysomnography.
Measured: Day 7
Time in sleep stage
From polysomnography.
Measured: Day 7
Percent of TST in sleep stage
From polysomnography.
Measured: Day 7
Arousal index
From polysomnography.
Measured: Day 7
Arousal index associated with respiratory events
From polysomnography.
Measured: Day 7
The periodic limb movement (PLM) index
From polysomnography.
Measured: Day 7
PLM arousal
From polysomnography.
Measured: Day 7
Number of limb movements associated with respiratory events index
From polysomnography.
Measured: Day 7
Photoplethysmography arousal index
From polysomnography.
Measured: Day 7
Signal validity
From mandibular movement recordings.
Measured: Day 7
TST
From mandibular movement recordings.
Measured: Day 7
WASO
From mandibular movement recordings.
Measured: Day 7
% of TST spent in respiratory effort
From mandibular movement recordings.
Measured: Day 7
Respiratory fragmentation of sleep index
From mandibular movement recordings.
Measured: Day 7
Fragmentation of sleep index
From mandibular movement recordings.
Measured: Day 7
ARIA rhinitis classification
ARIA = Allergic Rhinitis and its Impact on Asthma
Measured: Day 1
Presence/absence of asthma
Does the patient have asthma? yes/no
Measured: Day 1
For asthma patients, the GINA control score
GINA = Global Initiative for Asthma
Measured: Day 1
Forced expiratory volume in 1 second, % predicted
From spirometry.
Measured: Day 1
Forced vital capacity, % predicted
From spirometry.
Measured: Day 1
Forced expiratory volume in 1 second / Forced vital capacity (% litres/litres)predicted
From spirometry.
Measured: Day 1
Forced expiratory volume 25-75, % predicted predicted
From spirometry.
Measured: Day 1
Antecedent of public road or work accident (yes/no)
Measured: Day 1
Patient reports presence/absence of poor sleep
Measured: Day 1
Patient reports presence/absence of snoring
Measured: Day 1
Patient reports presence/absence of dry mouth
Measured: Day 1
Patient reports presence/absence of concentration difficulty
Measured: Day 1
Patient reports presence/absence of headaches
Measured: Day 1
Allergen prick test results
Measured: Day 1
List of concomitant medications
Measured: Day 1
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted9 Jul 2019
- Study start28 Jan 2020
- Primary completion25 Jun 2024
- Study completion6 Nov 2024
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for RhinitisStudies of the same condition, open and under way.
- More trials run by University Hospital, MontpellierThe sponsor's other registered studies.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Observational
- Observational model
- Cohort
- Time perspective
- Cross-sectional
- Enrolment
- 55 participants (actual)
Sponsor and investigators
- Lead sponsor
- University Hospital, Montpellier
- Sponsor type
- University, hospital or other
- Collaborators
- ADENE
- Responsible party
- Sponsor
- Investigators
- Dany JAFFUEL, MD, PhD, Principal investigator, Department of Respiratory Medicine and Addiction Medicine
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT04012216
- Sponsor's protocol ID
- RECHMPL18_0473
- Acronym
- JawRhin1
- Status last verified
- Nov 2024
- First submitted
- 27 Jun 2019
- Last updated
- 7 Nov 2024
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- Yes: The general goal is to make the study data available to interested researchers as well as to provide proof of transparency for the study. Data (and an accompanying data dictionary) will be de-identified and potentially further cleaned or aggregated as the investigators deem necessary to protect participant anonymity. Data will be made available to the public on a not-for-profit, free platform that allows access control (zenodo.org). Links on osf.io/clinicaltrials.gov will point towards the upload.
Study at a glance
From the registry record, last updated by the sponsor on 7 Nov 2024. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Sleep Respiratory Disorders in Patients With Moderate to Severe Persistent Rhinitis: a Prospective, Predictive Study
- ClinicalTrials.gov ID
- NCT04012216
- Acronym / sponsor ID
- JawRhin1 / RECHMPL18_0473
- Conditions
- Rhinitis
- Study type
- Observational
- Recruitment status
- Completed
- Enrolment
- 55 participants (actual)
- Lead sponsor
- University Hospital, MontpellierUniversity, hospital or other
- Collaborators
- ADENE
- Study start
- 28 Jan 2020 (actual)
- Primary completion
- 25 Jun 2024 (actual)
- Study completion
- 6 Nov 2024 (actual)
- First posted
- 9 Jul 2019 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
Study design
- Observational model
- Cohort
- Time perspective
- Cross-sectional
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| The study population | – | Device: Measure of mandibular movement using a mid-sagittal magnetic sensor (Brizzy, Jawac©) Nomics, Liege, Belgium), Device: Gold standard: polysomnographyPatients consulting for persistant, moderate-to-severe rhinitis and meeting eligibility criteria. |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
- Study population
- Patients consulting for persistant, moderate-to-severe rhinitis.
Key inclusion criteria (4 listed)
- 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).
Key exclusion criteria (8 listed)
- 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
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| 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. | Device | The study population |
| Gold standard: polysomnographyPolysomnography will be performed according to the American Academy of Sleep Medicine Recommendations 2018 | Device | The study population |
Primary outcome
The mandibular movement respiratory disturbance index
Time frame: Day 7
The polysomnography respiratory disturbance index
Time frame: Day 7
64 secondary outcomes
Epworth scale score
Time frame: Day 1
Epworth scale score
Time frame: Day 7
The Karolinska questionnaire
Time frame: Day 1
The Karolinska questionnaire
Time frame: Day 7
The Pittsburgh Sleep Quality Index (PSQI)
Time frame: Day 7
The mobility dimension of the EQ-5D-3L Questionaire (the 3-level version of Euroqol EQ-5D)
Time frame: Day 1
The autonomy dimension of the EQ-5D-3L Questionaire (the 3-level version of Euroqol EQ-5D)
Time frame: Day 1
The daily activities dimension of the EQ-5D-3L Questionaire (the 3-level version of Euroqol EQ-5D)
Time frame: Day 1
The pain dimension of the EQ-5D-3L Questionaire (the 3-level version of Euroqol EQ-5D)
Time frame: Day 1
The anxiety-depression dimension of the EQ-5D-3L Questionaire (the 3-level version of Euroqol EQ-5D)
Time frame: Day 1
The visual analog scale from the EQ-5D-3L Questionaire (the 3-level version of Euroqol EQ-5D)
Time frame: Day 1
The Nasal Obstruction Symptom Evaluation (NOSE) questionnaire
Time frame: Day 1
The Nasal Obstruction Symptom Evaluation (NOSE) questionnaire
Time frame: Day 7
The Allergic Rhinitis Control Test (ARCT) rhinitis questionnaire
Time frame: Day 1
Total sleep time (TST)
Time frame: Day 7
Obstructive apnea index
Time frame: Day 7
Mixed apnea index
Time frame: Day 7
Apnea index
Time frame: Day 7
Hypopnea index
Time frame: Day 7
Apnea and Hypopnea index
Time frame: Day 7
Respiratory effort related arousal index
Time frame: Day 7
Respiratory Disturbance Index
Time frame: Day 7
Time spent snoring
Time frame: Day 7
Oxygen desaturation ≥ 3% index
Time frame: Day 7
Time below 90% SpO2
Time frame: Day 7
% of TST below 90% of SpO2
Time frame: Day 7
Mean SpO2
Time frame: Day 7
Minimal SpO2 during sleep
Time frame: Day 7
Time in bed
Time frame: Day 7
Sleep Onset Latency
Time frame: Day 7
Wake After Sleep Onset (WASO)
Time frame: Day 7
Wake During Sleep Period
Time frame: Day 7
Sleep Latency
Time frame: Day 7
Random eye movement (REM) stage latency
Time frame: Day 7
Percentage of sleep efficiency
Time frame: Day 7
Time in sleep stage
Time frame: Day 7
Percent of TST in sleep stage
Time frame: Day 7
Arousal index
Time frame: Day 7
Arousal index associated with respiratory events
Time frame: Day 7
The periodic limb movement (PLM) index
Time frame: Day 7
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 7 Nov 2024.
- Individual participant dataSharing planned: Yes. The general goal is to make the study data available to interested researchers as well as to provide proof of transparency for the study. Data (and an accompanying data dictionary) will be de-identified and potentially further cleaned or aggregated as the investigators deem necessary to protect participant anonymity. Data will be made available to the public on a not-for-profit, free platform that allows access control (zenodo.org). Links on osf.io/clinicaltrials.gov will point towards the upload.
Related trials for Rhinitis
Not yet recruitingPhase 1
Safety and Tolerability of Fluticasone Propionate 10% Nasal Insert in Participants With Chronic Allergic Rhinitis
Chronic Allergic Rhinitis
RecruitingObservational study
A Study to Evaluate Treating Watery Noses With Cryotherapy in the Clinic Setting. This is Cold Therapy, Freezing the Issues at the Back of the Nose to Ease Symptoms.
Chronic Rhinitis
Active, not recruitingPhase 3
A Study to Investigate Changes in Symptoms in Adult Participants With Chronic Rhinosinusitis With Nasal Polyposis Initiating Treatment With Tezepelumab
Chronic Rhinosinusitis With Nasal Polyps
RecruitingPhase 3
Specific Immunotherapy With Mannan-Conjugated Allergoids for HDM-Allergic Rhinitis/Rhinoconjunctivitis_MM09-SIT-063.
Allergic Rhinitis, Allergic Rhinoconjunctivitis
RecruitingPhase 3
Specific Immunotherapy With Mannan-Conjugated Allergoids for HDM-Allergic Rhinitis/Rhinoconjunctivitis. MM09-SIT-063.
Allergic Rhinitis, Allergic Rhinoconjunctivitis
Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Dany JAFFUEL, MD, PhD principal investigator
Department of Respiratory Medicine and Addiction Medicine
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
An observational study of Rhinitis, run by University Hospital, Montpellier at 1 site in France.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 4 inclusion and 8 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 7 Nov 2024. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in France. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
The mandibular movement respiratory disturbance index (time frame: Day 7). The study lists 2 primary outcomes in all. It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 7 Nov 2024.