Clinical trial NCT04771221: Method of Early Diagnosis of Laryngopharyngeal Reflux
Official title: Method of Early Diagnosis of Laryngopharyngeal Reflux in an Outpatient Appointment of an Otorhinolaryngologist
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: Laryngopharyngeal Reflux
Laryngopharyngitis Chronic
Gastro Esophageal Reflux
Laryngitis
Keywords: Laryngopharyngeal Reflux
Laryngopharyngitis Chronic
Gastro Esophageal Reflux
Laryngitis
pH monitoring
pH metric
acoustic voice analysis
Lead sponsor: Kazakh Medical University of Continuing Education
Sponsor class: OTHER
First posted: 2021-02-25
Enrollment: 385
Sex: ALL
Minimum age (years): 18
Maximum age (years): 65
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: yes
Allocation: NON_RANDOMIZED
Intervention model: PARALLEL
Primary purpose: DIAGNOSTIC

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

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

Primary outcomes:
measure: Acidity level of the main group, Week 0
timeFrame: at the inclusion to the study
measure: Acidity level of the control group 1, Week 0
timeFrame: at the inclusion to the study
measure: Acidity level of the control group 2, Week 0
timeFrame: at the inclusion to the study
measure: "Index of reflux symptoms" of the main group, Week 0
timeFrame: at the inclusion to the study
measure: "Index of reflux symptoms" of the control group 1, Week 0
timeFrame: at the inclusion to the study
measure: "Index of reflux symptoms" of the control group 2, Week 0
timeFrame: at the inclusion to the study
measure: Endoscopic laryngoscopy of the main group, Week 0
timeFrame: at the inclusion to the study
measure: Endoscopic laryngoscopy of the control group 1, Week 0
timeFrame: at the inclusion to the study
measure: Endoscopic laryngoscopy of the control group 2, Week 0
timeFrame: at the inclusion to the study
measure: Acoustic voice analysis of the main group, Week 0
timeFrame: at the inclusion to the study
Secondary outcomes:
measure: Acidity level of the main group, Week 4
timeFrame: at 4 weeks after initial treatment
measure: Acidity level of the control group 1, Week 4
timeFrame: at 4 weeks after initial treatment
measure: Acidity level of the control group 2, Week 4
timeFrame: at 4 weeks after initial treatment
measure: "Index of reflux symptoms" of the main group, Week 4
timeFrame: at 4 weeks after initial treatment
measure: "Index of reflux symptoms" of the control group 1, Week 4
timeFrame: at 4 weeks after initial treatment
measure: "Index of reflux symptoms" of the control group 2, Week 4
timeFrame: at 4 weeks after initial treatment
measure: Endoscopic laryngoscopy of the main group, Week 4
timeFrame: at 4 weeks after initial treatment
measure: Endoscopic laryngoscopy of the control group 1, Week 4
timeFrame: at 4 weeks after initial treatment
measure: Endoscopic laryngoscopy of the control group 2, Week 4
timeFrame: at 4 weeks after initial treatment
measure: Acoustic voice analysis of the main group, Week 4
timeFrame: at 4 weeks after initial treatment
Other outcomes:
Locations:
city: Almaty
country: Kazakhstan
facility: SOS Medical Assistance
city: Almaty
country: Kazakhstan
facility: V-ent
Study officials:
affiliation: Doctor
name: Nukusbekova
role: PRINCIPAL_INVESTIGATOR
References: