Skip to content

Method of Early Diagnosis of Laryngopharyngeal Reflux

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

Status
Completed
Phases
NA
Study type
Interventional
Source
ClinicalTrials.gov
Registry ID
NCT04771221
Acronym
LPR
Enrollment
385
Registered
2021-02-25
Start date
2021-01-10
Completion date
2022-02-15
Last updated
2023-01-10

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Gastro Esophageal Reflux, Laryngitis, Laryngopharyngeal Reflux, Laryngopharyngitis Chronic

Keywords

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

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

Interventions

DIAGNOSTIC_TESTpH metry

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

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

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

Sponsors

Kazakh Medical University of Continuing Education
Lead SponsorOTHER

Study design

Allocation
NON_RANDOMIZED
Intervention model
PARALLEL
Primary purpose
DIAGNOSTIC
Masking
NONE

Eligibility

Sex/Gender
ALL
Age
18 Years to 65 Years
Healthy volunteers
Yes

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

Design outcomes

Primary

MeasureTime frameDescription
Acoustic voice analysis of the main group, Week 0at the inclusion to the studyAcoustic analysis of the voice was performed in patients with a voice profession who had a voice disorder using computer program of the Lingwaves.
Acidity level of the main group, Week 0at the inclusion to the studyThe 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 0at the inclusion to the studyThe 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 0at the inclusion to the studyThe 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 0at the inclusion to the studyPatients 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 0at the inclusion to the studyPatients 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 0at the inclusion to the studyPatients 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 0at the inclusion to the studyAssessment 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 0at the inclusion to the studyAssessment 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 0at the inclusion to the studyAssessment 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

MeasureTime frameDescription
Acidity level of the main group, Week 4at 4 weeks after initial treatmentThe 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 4at 4 weeks after initial treatmentThe 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 4at 4 weeks after initial treatmentThe 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 4at 4 weeks after initial treatmentPatients 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 4at 4 weeks after initial treatmentPatients 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 4at 4 weeks after initial treatmentPatients 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 4at 4 weeks after initial treatmentAssessment 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 4at 4 weeks after initial treatmentAssessment 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 4at 4 weeks after initial treatmentAssessment 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 4at 4 weeks after initial treatmentAcoustic analysis of the voice was performed in patients with a voice profession who had a voice disorder using computer program of the Lingwaves

Countries

Kazakhstan

Outcome results

None listed

Source: ClinicalTrials.gov · Data processed: Feb 4, 2026