Method of Early Diagnosis of Laryngopharyngeal Reflux (LPR)

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

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

Study Overview

• Status: Completed
• Conditions: Gastro Esophageal Reflux; Laryngopharyngeal Reflux; Laryngitis; Laryngopharyngitis Chronic
• Intervention / Treatment: Diagnostic test: pH metry; Diagnostic test: Filling out the questionnaire; Device: Endoscopic laryngoscopy; Device: Acoustic voice analysis

Detailed Description

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

• Study Type: Interventional
• Enrollment (Actual): 385
• Phase: Not Applicable

Contacts and Locations

Study Locations

• Kazakhstan
  • Almaty, Kazakhstan
    • SOS Medical Assistance
  • Almaty, Kazakhstan
    • V-ent

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 18 years to 65 years (Adult, Older Adult)
• Accepts Healthy Volunteers: No
• Genders Eligible for Study: All

Description

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

Study Plan

How is the study designed?

Design Details

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

Number of Arms

3

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
Experimental: Main group; 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; The collection of mucus from the laryngopharynx to determine the acid-base values through pH-metry.; Diagnostic test: Filling out the questionnaire; 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; Device: Endoscopic laryngoscopy; 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; Device: Acoustic voice analysis; acoustic analysis of the voice was performed in singers with voice disorders before and after treatment using program of the Lingwaves
Experimental: Control group 1; Patients with an early diagnosis of Gastroesophageal reflux disease	Diagnostic test: pH metry; The collection of mucus from the laryngopharynx to determine the acid-base values through pH-metry.; Diagnostic test: Filling out the questionnaire; 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; Device: Endoscopic laryngoscopy; 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
Experimental: Control group 2; 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; The collection of mucus from the laryngopharynx to determine the acid-base values through pH-metry.; Diagnostic test: Filling out the questionnaire; 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; Device: Endoscopic laryngoscopy; 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

What is the study measuring?

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

Collaborators and Investigators

• Sponsor: Kazakh Medical University of Continuing Education

Study record dates

Study Major Dates

• Study Start (Actual): January 10, 2021
• Primary Completion (Actual): February 15, 2022
• Study Completion (Actual): February 15, 2022

Study Registration Dates

• First Submitted: February 23, 2021
• First Submitted That Met QC Criteria: February 23, 2021
• First Posted (Actual): February 25, 2021

Study Record Updates

• Last Update Posted (Estimate): January 10, 2023
• Last Update Submitted That Met QC Criteria: January 6, 2023
• Last Verified: April 1, 2022

More Information

Terms related to this study

• Keywords: Laryngopharyngeal Reflux; pH monitoring; Laryngitis; Laryngopharyngitis Chronic; Gastro Esophageal Reflux; pH metric; acoustic voice analysis
• Additional Relevant MeSH Terms: Digestive System Diseases; Infections; Respiratory Tract Infections; Respiratory Tract Diseases; Gastrointestinal Diseases; Otorhinolaryngologic Diseases; Esophageal Motility Disorders; Deglutition Disorders; Esophageal Diseases; Laryngeal Diseases; Gastroesophageal Reflux; Laryngopharyngeal Reflux; Laryngitis; Croup
• Other Study ID Numbers: 14-2020 (Other Identifier: KazMUCE)

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: No

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: No