Method of Early Diagnosis of Laryngopharyngeal Reflux

Not Applicable

Completed

• Conditions: Laryngitis; Laryngopharyngitis Chronic; Gastro Esophageal Reflux; Laryngopharyngeal Reflux

• Registration Number: NCT04771221
• Lead Sponsor: Kazakh Medical University of Continuing Education

Brief Summary

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

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 Timeline

• Study Start: 2021-01-10
• Study First Submitted: 2021-02-23
• Study First Submitted QC: 2021-02-23
• Study First Posted: 2021-02-25
• Primary Completion: 2022-02-15
• Study Completion: 2022-02-15
• Status Verified: 2022-04
• Last Update Submitted: 2023-01-06
• Last Update Posted: 2023-01-10

Recruitment & Eligibility

• Status: COMPLETED
• Sex: All
• Target Recruitment: 385

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 & Design

• Study Type: INTERVENTIONAL
• Study Design: PARALLEL

Primary Outcome Measures

Name	Time	Method
Acidity level of the main group, Week 0	at the inclusion to the study	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.
Acidity level of the control group 1, Week 0	at the inclusion to the study	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.
Endoscopic laryngoscopy of the main group, Week 0	at the inclusion to the study	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.
Endoscopic laryngoscopy of the control group 2, Week 0	at the inclusion to the study	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.
Acidity level of the control group 2, Week 0	at the inclusion to the study	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.
"Index of reflux symptoms" of the main group, Week 0	at the inclusion to the study	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.
"Index of reflux symptoms" of the control group 1, Week 0	at the inclusion to the study	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.
"Index of reflux symptoms" of the control group 2, Week 0	at the inclusion to the study	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.
Acoustic voice analysis of the main group, Week 0	at the inclusion to the study	Acoustic analysis of the voice was performed in patients with a voice profession who had a voice disorder using computer program of the Lingwaves.
Endoscopic laryngoscopy of the control group 1, Week 0	at the inclusion to the study	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.

Secondary Outcome Measures

Name	Time	Method
Endoscopic laryngoscopy of the control group 1, Week 4	at 4 weeks after initial treatment	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.
Acidity level of the main group, Week 4	at 4 weeks after initial treatment	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.
Acidity level of the control group 1, Week 4	at 4 weeks after initial treatment	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.
"Index of reflux symptoms" of the main group, Week 4	at 4 weeks after initial treatment	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.
Endoscopic laryngoscopy of the control group 2, Week 4	at 4 weeks after initial treatment	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.
Acidity level of the control group 2, Week 4	at 4 weeks after initial treatment	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.
"Index of reflux symptoms" of the control group 1, Week 4	at 4 weeks after initial treatment	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.
"Index of reflux symptoms" of the control group 2, Week 4	at 4 weeks after initial treatment	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.
Acoustic voice analysis of the main group, Week 4	at 4 weeks after initial treatment	Acoustic analysis of the voice was performed in patients with a voice profession who had a voice disorder using computer program of the Lingwaves
Endoscopic laryngoscopy of the main group, Week 4	at 4 weeks after initial treatment	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.

Trial Locations

Locations (2)

SOS Medical Assistance; 🇰🇿 Almaty, Kazakhstan

V-ent; 🇰🇿 Almaty, Kazakhstan