Method of Early Diagnosis of Laryngopharyngeal Reflux (LPR)

Kazakh Medical University of Continuing Education

Status: Completed

Conditions: Laryngopharyngitis Chronic; Laryngitis; Gastro Esophageal Reflux; Laryngopharyngeal Reflux

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

Study type: Interventional

Funder types: Other

Identifiers

NCT04771221

14-2020 (Other Identifier)

Details and patient eligibility

About

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

Full 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

Enrollment: 385 patients

Sex: All

Ages: 18 to 65 years old

Volunteers: Accepts Healthy Volunteers

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

Trial design

Primary purpose: Diagnostic

Allocation: Non-Randomized

Interventional model: Parallel Assignment

Masking: None (Open label)

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385 participants in 3 patient groups

Main group

Experimental group

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.

Treatment:

Device: Acoustic voice analysis

Diagnostic Test: Filling out the questionnaire

Diagnostic Test: pH metry

Device: Endoscopic laryngoscopy

Control group 1

Experimental group

Description:

Patients with an early diagnosis of Gastroesophageal reflux disease

Treatment:

Diagnostic Test: Filling out the questionnaire

Diagnostic Test: pH metry

Device: Endoscopic laryngoscopy

Control group 2

Experimental group

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.

Treatment:

Diagnostic Test: Filling out the questionnaire

Diagnostic Test: pH metry

Device: Endoscopic laryngoscopy