Method of Early Diagnosis of Laryngopharyngeal Reflux

NCT04771221 | Completed DMC

• 1 other identifier: 14-2020
• Study Type: interventional
• Target: 385
• Locations: 1 country
• Sites: 2

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

Conditions

Laryngopharyngeal Reflux; Laryngopharyngitis Chronic; Gastro Esophageal Reflux; Laryngitis

Keywords

Laryngopharyngeal Reflux; Laryngopharyngitis Chronic; Gastro Esophageal Reflux; Laryngitis; pH monitoring; pH metric; acoustic voice analysis

Outcome Measures

Primary Outcomes (10)

• 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 Outcomes (10)

• Acidity level of the main group, Week 4

  at 4 weeks after initial treatment

• Acidity level of the control group 1, Week 4

  at 4 weeks after initial treatment

• Acidity level of the control group 2, Week 4

  at 4 weeks after initial treatment

• "Index of reflux symptoms" of the main group, Week 4

  at 4 weeks after initial treatment

• "Index of reflux symptoms" of the control group 1, Week 4

  at 4 weeks after initial treatment

Study Arms (3)

Main group

EXPERIMENTAL

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; Diagnostic Test: Filling out the questionnaire; Device: Endoscopic laryngoscopy; Device: Acoustic voice analysis

Control group 1

EXPERIMENTAL

Patients with an early diagnosis of Gastroesophageal reflux disease

Diagnostic Test: pH metry; Diagnostic Test: Filling out the questionnaire; Device: Endoscopic laryngoscopy

Control group 2

EXPERIMENTAL

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; Diagnostic Test: Filling out the questionnaire; Device: Endoscopic laryngoscopy

Interventions

pH metry DIAGNOSTIC_TEST

The collection of mucus from the laryngopharynx to determine the acid-base values through pH-metry.

Control group 1; Control group 2; Main group

Filling out the questionnaire DIAGNOSTIC_TEST

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

Control group 1; Control group 2; Main group

Endoscopic laryngoscopy DEVICE

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

Control group 1; Control group 2; Main group

Acoustic voice analysis DEVICE

acoustic analysis of the voice was performed in singers with voice disorders before and after treatment using program of the Lingwaves

Main group

Eligibility Criteria

• Age: 18 Years - 65 Years
• Sex: all
• Healthy Volunteers: Yes
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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

You may not qualify if:

• 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

Sponsors & Collaborators

• Kazakh Medical University of Continuing Education: lead

Study Sites (2)

SOS Medical Assistance

Almaty, Kazakhstan

Location

V-ent

Almaty, Kazakhstan

Location

MeSH Terms

Conditions

Laryngopharyngeal Reflux; Gastroesophageal Reflux; Laryngitis

Condition Hierarchy (Ancestors)

Esophageal Motility Disorders; Deglutition Disorders; Esophageal Diseases; Gastrointestinal Diseases; Digestive System Diseases; Laryngeal Diseases; Respiratory Tract Diseases; Respiratory Tract Infections; Infections; Otorhinolaryngologic Diseases

Study Officials

• Nukusbekova

  Doctor

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: NON RANDOMIZED
• Masking: NONE
• Purpose: DIAGNOSTIC
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: February 23, 2021
• First Posted: February 25, 2021
• Study Start: January 10, 2021
• Primary Completion: February 15, 2022
• Study Completion: February 15, 2022
• Last Updated: January 10, 2023

Record last verified: 2022-04

Data Sharing

• IPD Sharing: Will not share

Locations

KA (2)