Back to resultsMethod of Early Diagnosis of Laryngopharyngeal Reflux (LPR)
Primary Purpose
Laryngopharyngeal Reflux, Laryngopharyngitis Chronic, Gastro Esophageal Reflux
Status
Completed
Phase
Not Applicable
Locations
Kazakhstan
Study Type
Interventional
Intervention
pH metry
Filling out the questionnaire
Endoscopic laryngoscopy
Acoustic voice analysis
Sponsored by
About this trial
This is an interventional diagnostic trial for Laryngopharyngeal Reflux focused on measuring Laryngopharyngeal Reflux, Laryngopharyngitis Chronic, Gastro Esophageal Reflux, Laryngitis, pH monitoring, pH metric, acoustic voice analysis
Eligibility Criteria
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
Sites / Locations
- SOS Medical Assistance
- V-ent
Arms of the Study
Arm 1
Arm 2
Arm 3
Arm Type
Experimental
Experimental
Experimental
Arm Label
Main group
Control group 1
Control group 2
Arm Description
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.
Patients with an early diagnosis of Gastroesophageal reflux disease
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.
Outcomes
Primary Outcome Measures
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.
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.
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.
"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.
"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.
"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.
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.
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.
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.
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.
Secondary Outcome Measures
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.
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.
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.
"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.
"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.
"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.
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.
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.
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.
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
Full Information
NCT ID
NCT04771221
First Posted
February 23, 2021
Last Updated
January 6, 2023
Sponsor
Kazakh Medical University of Continuing Education
1. Study Identification
Unique Protocol Identification Number
NCT04771221
Brief Title
Method of Early Diagnosis of Laryngopharyngeal Reflux
Acronym
LPR
Official Title
Method of Early Diagnosis of Laryngopharyngeal Reflux in an Outpatient Appointment of an Otorhinolaryngologist
Study Type
Interventional
2. Study Status
Record Verification Date
April 2022
Overall Recruitment Status
Completed
Study Start Date
January 10, 2021 (Actual)
Primary Completion Date
February 15, 2022 (Actual)
Study Completion Date
February 15, 2022 (Actual)
3. Sponsor/Collaborators
Responsible Party, by Official Title
Sponsor
Name of the Sponsor
Kazakh Medical University of Continuing Education
4. Oversight
Studies a U.S. FDA-regulated Drug Product
No
Studies a U.S. FDA-regulated Device Product
No
Data Monitoring Committee
Yes
5. Study Description
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
6. Conditions and Keywords
Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Laryngopharyngeal Reflux, Laryngopharyngitis Chronic, Gastro Esophageal Reflux, Laryngitis
Keywords
Laryngopharyngeal Reflux, Laryngopharyngitis Chronic, Gastro Esophageal Reflux, Laryngitis, pH monitoring, pH metric, acoustic voice analysis
7. Study Design
Primary Purpose
Diagnostic
Study Phase
Not Applicable
Interventional Study Model
Parallel Assignment
Masking
None (Open Label)
Allocation
Non-Randomized
Enrollment
385 (Actual)
8. Arms, Groups, and Interventions
Arm Title
Main group
Arm Type
Experimental
Arm Description
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.
Arm Title
Control group 1
Arm Type
Experimental
Arm Description
Patients with an early diagnosis of Gastroesophageal reflux disease
Arm Title
Control group 2
Arm Type
Experimental
Arm Description
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.
Intervention Type
Diagnostic Test
Intervention Name(s)
pH metry
Intervention Description
The collection of mucus from the laryngopharynx to determine the acid-base values through pH-metry.
Intervention Type
Diagnostic Test
Intervention Name(s)
Filling out the questionnaire
Intervention Description
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
Intervention Type
Device
Intervention Name(s)
Endoscopic laryngoscopy
Intervention Description
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
Intervention Type
Device
Intervention Name(s)
Acoustic voice analysis
Intervention Description
acoustic analysis of the voice was performed in singers with voice disorders before and after treatment using program of the Lingwaves
Primary Outcome Measure Information:
Title
Acidity level of the main group, Week 0
Description
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.
Time Frame
at the inclusion to the study
Title
Acidity level of the control group 1, Week 0
Description
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.
Time Frame
at the inclusion to the study
Title
Acidity level of the control group 2, Week 0
Description
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.
Time Frame
at the inclusion to the study
Title
"Index of reflux symptoms" of the main group, Week 0
Description
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.
Time Frame
at the inclusion to the study
Title
"Index of reflux symptoms" of the control group 1, Week 0
Description
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.
Time Frame
at the inclusion to the study
Title
"Index of reflux symptoms" of the control group 2, Week 0
Description
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.
Time Frame
at the inclusion to the study
Title
Endoscopic laryngoscopy of the main group, Week 0
Description
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.
Time Frame
at the inclusion to the study
Title
Endoscopic laryngoscopy of the control group 1, Week 0
Description
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.
Time Frame
at the inclusion to the study
Title
Endoscopic laryngoscopy of the control group 2, Week 0
Description
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.
Time Frame
at the inclusion to the study
Title
Acoustic voice analysis of the main group, Week 0
Description
Acoustic analysis of the voice was performed in patients with a voice profession who had a voice disorder using computer program of the Lingwaves.
Time Frame
at the inclusion to the study
Secondary Outcome Measure Information:
Title
Acidity level of the main group, Week 4
Description
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.
Time Frame
at 4 weeks after initial treatment
Title
Acidity level of the control group 1, Week 4
Description
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.
Time Frame
at 4 weeks after initial treatment
Title
Acidity level of the control group 2, Week 4
Description
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.
Time Frame
at 4 weeks after initial treatment
Title
"Index of reflux symptoms" of the main group, Week 4
Description
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.
Time Frame
at 4 weeks after initial treatment
Title
"Index of reflux symptoms" of the control group 1, Week 4
Description
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.
Time Frame
at 4 weeks after initial treatment
Title
"Index of reflux symptoms" of the control group 2, Week 4
Description
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.
Time Frame
at 4 weeks after initial treatment
Title
Endoscopic laryngoscopy of the main group, Week 4
Description
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.
Time Frame
at 4 weeks after initial treatment
Title
Endoscopic laryngoscopy of the control group 1, Week 4
Description
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.
Time Frame
at 4 weeks after initial treatment
Title
Endoscopic laryngoscopy of the control group 2, Week 4
Description
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.
Time Frame
at 4 weeks after initial treatment
Title
Acoustic voice analysis of the main group, Week 4
Description
Acoustic analysis of the voice was performed in patients with a voice profession who had a voice disorder using computer program of the Lingwaves
Time Frame
at 4 weeks after initial treatment
10. Eligibility
Sex
All
Minimum Age & Unit of Time
18 Years
Maximum Age & Unit of Time
65 Years
Accepts Healthy Volunteers
Accepts Healthy Volunteers
Eligibility Criteria
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
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Nukusbekova
Organizational Affiliation
Doctor
Official's Role
Principal Investigator
Facility Information:
Facility Name
SOS Medical Assistance
City
Almaty
Country
Kazakhstan
Facility Name
V-ent
City
Almaty
Country
Kazakhstan
12. IPD Sharing Statement
Plan to Share IPD
No
Learn more about this trial
Method of Early Diagnosis of Laryngopharyngeal Reflux
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