Method of Early Diagnosis of Laryngopharyngeal Reflux

Study Overview
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Brief Summary
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The investigator will issue a Patient Information Consent for the participant in the study. 1.Patients will be asked to complete the Reflux Symptom Index questionnaire. Clinical survey, medical history. 2. Objective methods for assessing the patient's condition: - examination of ENT organs. 3. Laboratory and instrumental research methods: Endoscopic laryngoscopy and video laryngoscopy, pH-metry, acoustic voice analysis. 4.Sociological method. 5. Subjective methods for assessing the condition of the larynx. 6. Аnalysis of the received data

Detailed Description
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The investigator will issue a Patient Information Consent for the participant in the study. 1.Patients will be asked to complete the Reflux Symptom Index questionnaire. Clinical survey, medical history 2. Objective methods for assessing the patient's condition: - examination of ENT organs: rhinoscopy, otoscopy, pharyngoscopy and laryngoscopy 3. Laboratory and instrumental research methods - Endoscopic laryngoscopy and video laryngoscopy. pH-metry: The collection of mucus from the laryngopharynx for the determination of acid-base values. Acoustic voice analysis: objective assessment of the voice condition 4.Sociological method: determination of lifestyle, nutrition, the presence or absence of bad habits. 5. Subjective methods for assessing the condition of the larynx - Questionnaires. 6. Аnalysis of the received data

Official Title
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Method of Early Diagnosis of Laryngopharyngeal Reflux in an Outpatient Appointment of an Otorhinolaryngologist

Conditions
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Laryngopharyngeal Reflux, Laryngopharyngitis Chronic, Gastro Esophageal Reflux, Laryngitis

Intervention / Treatment
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* Diagnostic Test: pH metry
* Diagnostic Test: Filling out the questionnaire
* Device: Endoscopic laryngoscopy
* Device: Acoustic voice analysis


Participation Criteria
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Eligibility Criteria
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Inclusion Criteria: Patient's informed consent Age: 18-75 years old No serious somatic diseases. Patients with complaints of sore throat, coughing, burning sensation in the throat, coughing, frequent sore throat, difficulty swallowing, lump in the throat, foreign body feeling in the throat, voice changes, heartburn and belching. Diagnosis: Chronic pharyngitis Chronic laryngitis Exclusion Criteria: Disagreement to participate in scientific research Age: under 18 and over 76 Severe somatic diseases, organic lesions of the gastrointestinal tract and ENT organs Patients with pulmonary pathologies Patients with allergic manifestations (seasonal hay fever, asthma, etc.) With diagnoses: Acute respiratory diseases Patients with general neuralgic disorders

Ages Eligible for Study
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Minimum Age: 18 Years
Maximum Age: 65 Years

Sexes Eligible for Study
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All

Accepts Healthy Volunteers
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Accepts Healthy Volunteers

Study Plan
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How is the study designed?
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Design Details

Primary Purpose: Diagnostic
Allocation: Non-Randomized
Intervention Model: Parallel Assignment
Masking: None (Open Label)


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Experimental: Main group<br>Patients with complaints of sore throat, coughing, burning sensation in the throat, cough, frequent sore throat, difficulty swallowing, lump in the throat, feeling of a foreign body in the throat, voice change, heartburn, belching. | Diagnostic Test: pH metry<br>* The collection of mucus from the laryngopharynx to determine the acid-base values through pH-metry.<br>Diagnostic Test: Filling out the questionnaire<br>* Completion of the questionnaire index of reflux symptoms. An analysis of the results of the effectiveness of this method in patients with complaints of sore throat, coughing, burning sensation in the throat, cough, frequent sore throat, difficulty swallowing, lump in the throat, feeling of a foreign body in the throat, voice change, heartburn, belching will be carried out. Evaluation results range from 0 to 5, where 0 is an indicator of no problem, and 5 is an indicator of a serious problem<br>Device: Endoscopic laryngoscopy<br>* Video laryngoscopy and assessment of the presence / severity of the symptoms. Evaluation results range from 0 to 4, where 0 is an indicator of no problem, and 4 is an indicator of a serious problem<br>Device: Acoustic voice analysis<br>* acoustic analysis of the voice was performed in singers with voice disorders before and after treatment using program of the Lingwaves<br>|
| Experimental: Control group 1<br>Patients with an early diagnosis of Gastroesophageal reflux disease | Diagnostic Test: pH metry<br>* The collection of mucus from the laryngopharynx to determine the acid-base values through pH-metry.<br>Diagnostic Test: Filling out the questionnaire<br>* Completion of the questionnaire index of reflux symptoms. An analysis of the results of the effectiveness of this method in patients with complaints of sore throat, coughing, burning sensation in the throat, cough, frequent sore throat, difficulty swallowing, lump in the throat, feeling of a foreign body in the throat, voice change, heartburn, belching will be carried out. Evaluation results range from 0 to 5, where 0 is an indicator of no problem, and 5 is an indicator of a serious problem<br>Device: Endoscopic laryngoscopy<br>* Video laryngoscopy and assessment of the presence / severity of the symptoms. Evaluation results range from 0 to 4, where 0 is an indicator of no problem, and 4 is an indicator of a serious problem<br>|
| Experimental: Control group 2<br>Patients without complaints of sore throat, coughing, burning sensation in the throat, cough, frequent sore throat, difficulty swallowing, lump in the throat, feeling of a foreign body in the throat, voice change, heartburn, belching. | Diagnostic Test: pH metry<br>* The collection of mucus from the laryngopharynx to determine the acid-base values through pH-metry.<br>Diagnostic Test: Filling out the questionnaire<br>* Completion of the questionnaire index of reflux symptoms. An analysis of the results of the effectiveness of this method in patients with complaints of sore throat, coughing, burning sensation in the throat, cough, frequent sore throat, difficulty swallowing, lump in the throat, feeling of a foreign body in the throat, voice change, heartburn, belching will be carried out. Evaluation results range from 0 to 5, where 0 is an indicator of no problem, and 5 is an indicator of a serious problem<br>Device: Endoscopic laryngoscopy<br>* Video laryngoscopy and assessment of the presence / severity of the symptoms. Evaluation results range from 0 to 4, where 0 is an indicator of no problem, and 4 is an indicator of a serious problem<br>|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Acidity level of the main group, Week 0 | The acidity level of the larynx is assessed using litmus paper. The range of acidity levels is from 4.5 to 9.0, where below 6.5 indicates the acidity of the environment, above 7.5 - alkalinity. | at the inclusion to the study | 
| Acidity level of the control group 1, Week 0 | The acidity level of the larynx is assessed using litmus paper. The range of acidity levels is from 4.5 to 9.0, where below 6.5 indicates the acidity of the environment, above 7.5 - alkalinity. | at the inclusion to the study | 
| Acidity level of the control group 2, Week 0 | The acidity level of the larynx is assessed using litmus paper. The range of acidity levels is from 4.5 to 9.0, where below 6.5 indicates the acidity of the environment, above 7.5 - alkalinity. | at the inclusion to the study | 
| Index of reflux symptoms of the main group, Week 0 | Patients will be asked to complete the Reflux Symptom Index questionnaire. An analysis of the results of the effectiveness of this method in patients with complaints of sore throat, coughing, burning sensation in the throat, cough, frequent sore throat, difficulty swallowing, lump in the throat, feeling of a foreign body in the throat, voice change, heartburn, belching will be carried out. The severity of the problem is calculated as the summation of all points. The problem is absent if the summation of points is 0. The problem is serious if the summation of points is 5. | at the inclusion to the study | 
| Index of reflux symptoms of the control group 1, Week 0 | Patients will be asked to complete the Reflux Symptom Index questionnaire. An analysis of the results of the effectiveness of this method in patients with complaints of sore throat, coughing, burning sensation in the throat, cough, frequent sore throat, difficulty swallowing, lump in the throat, feeling of a foreign body in the throat, voice change, heartburn, belching will be carried out. The severity of the problem is calculated as the summation of all points. The problem is absent if the summation of points is 0. The problem is serious if the summation of points is 5. | at the inclusion to the study | 
| Index of reflux symptoms of the control group 2, Week 0 | Patients will be asked to complete the Reflux Symptom Index questionnaire. An analysis of the results of the effectiveness of this method in patients with complaints of sore throat, coughing, burning sensation in the throat, cough, frequent sore throat, difficulty swallowing, lump in the throat, feeling of a foreign body in the throat, voice change, heartburn, belching will be carried out. The severity of the problem is calculated as the summation of all points. The problem is absent if the summation of points is 0. The problem is serious if the summation of points is 5. | at the inclusion to the study | 
| Endoscopic laryngoscopy of the main group, Week 0 | Assessment of the state of the larynx on the scale of reflux symptoms. Where the presence and severity of the sign is assessed in points from 0 to 4. Where 0 is an indicator of no problem, and 4 is an indicator of a serious problem. | at the inclusion to the study | 
| Endoscopic laryngoscopy of the control group 1, Week 0 | Assessment of the state of the larynx on the scale of reflux symptoms. Where the presence and severity of the sign is assessed in points from 0 to 4. Where 0 is an indicator of no problem, and 4 is an indicator of a serious problem. | at the inclusion to the study | 
| Endoscopic laryngoscopy of the control group 2, Week 0 | Assessment of the state of the larynx on the scale of reflux symptoms. Where the presence and severity of the sign is assessed in points from 0 to 4. Where 0 is an indicator of no problem, and 4 is an indicator of a serious problem. | at the inclusion to the study | 
| Acoustic voice analysis of the main group, Week 0 | Acoustic analysis of the voice was performed in patients with a voice profession who had a voice disorder using computer program of the Lingwaves. | at the inclusion to the study | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Acidity level of the main group, Week 4 | The acidity level of the larynx is assessed using litmus paper. The range of acidity levels is from 4.5 to 9.0, where above 7.5 indicates the alkalinity of the medium, below 6.5 - acidic. | at 4 weeks after initial treatment | 
| Acidity level of the control group 1, Week 4 | The acidity level of the larynx is assessed using litmus paper. The range of acidity levels is from 4.5 to 9.0, where above 7.5 indicates the alkalinity of the medium, below 6.5 - acidic. | at 4 weeks after initial treatment | 
| Acidity level of the control group 2, Week 4 | The acidity level of the larynx is assessed using litmus paper. The range of acidity levels is from 4.5 to 9.0, where above 7.5 indicates the alkalinity of the medium, below 6.5 - acidic. | at 4 weeks after initial treatment | 
| Index of reflux symptoms of the main group, Week 4 | Patients will be asked to complete the Reflux Symptom Index questionnaire. An analysis of the results of the effectiveness of this method in patients with complaints of sore throat, coughing, burning sensation in the throat, cough, frequent sore throat, difficulty swallowing, lump in the throat, feeling of a foreign body in the throat, voice change, heartburn, belching will be carried out. The severity of the problem is calculated as the summation of all points. The problem is absent if the summation of points is 0. The problem is serious if the summation of points is 5. | at 4 weeks after initial treatment | 
| Index of reflux symptoms of the control group 1, Week 4 | Patients will be asked to complete the Reflux Symptom Index questionnaire. An analysis of the results of the effectiveness of this method in patients with complaints of sore throat, coughing, burning sensation in the throat, cough, frequent sore throat, difficulty swallowing, lump in the throat, feeling of a foreign body in the throat, voice change, heartburn, belching will be carried out. The severity of the problem is calculated as the summation of all points. The problem is absent if the summation of points is 0. The problem is serious if the summation of points is 5. | at 4 weeks after initial treatment | 
| Index of reflux symptoms of the control group 2, Week 4 | Patients will be asked to complete the Reflux Symptom Index questionnaire. An analysis of the results of the effectiveness of this method in patients with complaints of sore throat, coughing, burning sensation in the throat, cough, frequent sore throat, difficulty swallowing, lump in the throat, feeling of a foreign body in the throat, voice change, heartburn, belching will be carried out. The severity of the problem is calculated as the summation of all points. The problem is absent if the summation of points is 0. The problem is serious if the summation of points is 5. | at 4 weeks after initial treatment | 
| Endoscopic laryngoscopy of the main group, Week 4 | Assessment of the state of the larynx on the scale of reflux symptoms. Where the presence and severity of the sign is assessed in points from 0 to 4. Where 0 is an indicator of no problem, and 4 is an indicator of a serious problem. | at 4 weeks after initial treatment | 
| Endoscopic laryngoscopy of the control group 1, Week 4 | Assessment of the state of the larynx on the scale of reflux symptoms. Where the presence and severity of the sign is assessed in points from 0 to 4. Where 0 is an indicator of no problem, and 4 is an indicator of a serious problem. | at 4 weeks after initial treatment | 
| Endoscopic laryngoscopy of the control group 2, Week 4 | Assessment of the state of the larynx on the scale of reflux symptoms. Where the presence and severity of the sign is assessed in points from 0 to 4. Where 0 is an indicator of no problem, and 4 is an indicator of a serious problem. | at 4 weeks after initial treatment | 
| Acoustic voice analysis of the main group, Week 4 | Acoustic analysis of the voice was performed in patients with a voice profession who had a voice disorder using computer program of the Lingwaves | at 4 weeks after initial treatment | 

 Terms related to the study
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Keywords Provided by Centre Hospitalier Valida
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Laryngopharyngeal Reflux, Laryngopharyngitis Chronic, Gastro Esophageal Reflux, Laryngitis, pH monitoring, pH metric, acoustic voice analysis