Method of Early Diagnosis of Laryngopharyngeal Reflux

NCT ID: NCT04771221

Last Updated: 2023-01-10

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

Get a concise snapshot of the trial, including recruitment status, study phase, enrollment targets, and key timeline milestones.

Recruitment Status

COMPLETED

Clinical Phase

NA

Total Enrollment

385 participants

Study Classification

INTERVENTIONAL

Study Start Date

2021-01-10

Study Completion Date

2022-02-15

Brief Summary

Review the sponsor-provided synopsis that highlights what the study is about and why it is being conducted.

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

Dive into the extended narrative that explains the scientific background, objectives, and procedures in greater depth.

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

Conditions

See the medical conditions and disease areas that this research is targeting or investigating.

Laryngopharyngeal Reflux Laryngopharyngitis Chronic Gastro Esophageal Reflux Laryngitis

Study Design

Understand how the trial is structured, including allocation methods, masking strategies, primary purpose, and other design elements.

Allocation Method

NON_RANDOMIZED

Intervention Model

PARALLEL

Primary Study Purpose

DIAGNOSTIC

Blinding Strategy

NONE

Study Groups

Review each arm or cohort in the study, along with the interventions and objectives associated with them.

Main group

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.

Group Type EXPERIMENTAL

pH metry

Intervention Type DIAGNOSTIC_TEST

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

Filling out the questionnaire

Intervention Type 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

Endoscopic laryngoscopy

Intervention Type 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

Acoustic voice analysis

Intervention Type DEVICE

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

Control group 1

Patients with an early diagnosis of Gastroesophageal reflux disease

Group Type EXPERIMENTAL

pH metry

Intervention Type DIAGNOSTIC_TEST

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

Filling out the questionnaire

Intervention Type 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

Endoscopic laryngoscopy

Intervention Type 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 2

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.

Group Type EXPERIMENTAL

pH metry

Intervention Type DIAGNOSTIC_TEST

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

Filling out the questionnaire

Intervention Type 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

Endoscopic laryngoscopy

Intervention Type 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

Interventions

Learn about the drugs, procedures, or behavioral strategies being tested and how they are applied within this trial.

pH metry

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

Intervention Type DIAGNOSTIC_TEST

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

Intervention Type DIAGNOSTIC_TEST

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

Intervention Type DEVICE

Acoustic voice analysis

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

Intervention Type DEVICE

Eligibility Criteria

Check the participation requirements, including inclusion and exclusion rules, age limits, and whether healthy volunteers are accepted.

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
Minimum Eligible Age

18 Years

Maximum Eligible Age

65 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

Yes

Sponsors

Meet the organizations funding or collaborating on the study and learn about their roles.

Kazakh Medical University of Continuing Education

OTHER

Sponsor Role lead

Responsible Party

Identify the individual or organization who holds primary responsibility for the study information submitted to regulators.

Responsibility Role SPONSOR

Principal Investigators

Learn about the lead researchers overseeing the trial and their institutional affiliations.

Nukusbekova

Role: PRINCIPAL_INVESTIGATOR

Doctor

Locations

Explore where the study is taking place and check the recruitment status at each participating site.

SOS Medical Assistance

Almaty, , Kazakhstan

Site Status

V-ent

Almaty, , Kazakhstan

Site Status

Countries

Review the countries where the study has at least one active or historical site.

Kazakhstan

Other Identifiers

Review additional registry numbers or institutional identifiers associated with this trial.

14-2020

Identifier Type: OTHER

Identifier Source: secondary_id

14-2020

Identifier Type: -

Identifier Source: org_study_id

More Related Trials

Additional clinical trials that may be relevant based on similarity analysis.