Method of Early Diagnosis of Laryngopharyngeal Reflux

Gastro Esophageal Reflux Clinical Trial

— LPR  

Official title:

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

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT04771221
• Other study ID #: 14-2020
• Secondary ID: 14-2020
• Status: Completed
• Phase: N/A
• Start date: January 10, 2021
• Est. completion date: February 15, 2022

Study information

• Verified date: April 2022
• Source: Kazakh Medical University of Continuing Education
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial 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

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

Recruitment information / eligibility

• Status: Completed
• Enrollment: 385
• Est. completion date: February 15, 2022
• Est. primary completion date: February 15, 2022
• Accepts healthy volunteers: Accepts Healthy Volunteers
• Gender: All
• Age group: 18 Years to 65 Years

Eligibility

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

Related Conditions & MeSH terms

• Croup
• Gastro Esophageal Reflux
• Gastroesophageal Reflux
• Laryngitis
• Laryngopharyngeal Reflux
• Laryngopharyngitis Chronic

Intervention

Diagnostic Test:
• pH metry
The collection of mucus from the laryngopharynx to determine the acid-base values through pH-metry.
• 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
• Acoustic voice analysis
acoustic analysis of the voice was performed in singers with voice disorders before and after treatment using program of the Lingwaves

Locations

Country	Name	City	State
Kazakhstan	SOS Medical Assistance	Almaty
Kazakhstan	V-ent	Almaty

Sponsors (1)

Lead Sponsor	Collaborator
Kazakh Medical University of Continuing Education

Country where clinical trial is conducted

Kazakhstan, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	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
Primary	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
Primary	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
Primary	"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
Primary	"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
Primary	"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
Primary	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
Primary	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
Primary	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
Primary	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	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
Secondary	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
Secondary	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
Secondary	"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
Secondary	"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
Secondary	"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
Secondary	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
Secondary	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
Secondary	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
Secondary	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