Method of Early Diagnosis of Laryngopharyngeal Reflux in an Outpatient Appointment of an Otorhinolaryngologist
Trial Snapshot
- Phase
- Not Applicable
- Status
- Completed
- Sponsor
- Enrollment
- 385
- Locations
- 2
- Primary Endpoint
- Acidity level of the main group, Week 0
Study Overview
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
Study Design
- Study Type
- Interventional
- Allocation
- Non Randomized
- Intervention Model
- Parallel
- Primary Purpose
- Diagnostic
- Masking
- None
Eligibility Criteria
- Ages
- 18 Years to 65 Years (Adult, Older Adult)
- Sex
- All
- Accepts 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
Arms & Interventions
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.
Intervention: pH metry (Diagnostic Test)
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.
Intervention: Filling out the questionnaire (Diagnostic Test)
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.
Intervention: Endoscopic laryngoscopy (Device)
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.
Intervention: Acoustic voice analysis (Device)
Control group 1
Patients with an early diagnosis of Gastroesophageal reflux disease
Intervention: Filling out the questionnaire (Diagnostic Test)
Control group 1
Patients with an early diagnosis of Gastroesophageal reflux disease
Intervention: pH metry (Diagnostic Test)
Control group 1
Patients with an early diagnosis of Gastroesophageal reflux disease
Intervention: Endoscopic laryngoscopy (Device)
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.
Intervention: pH metry (Diagnostic Test)
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.
Intervention: Filling out the questionnaire (Diagnostic Test)
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.
Intervention: Endoscopic laryngoscopy (Device)
Outcomes
Primary Outcomes
Acidity level of the main group, Week 0
Time Frame: at the inclusion to the study
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
Time Frame: at the inclusion to the study
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.
Endoscopic laryngoscopy of the main group, Week 0
Time Frame: at the inclusion to the study
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
Time Frame: at the inclusion to the study
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.
Acidity level of the control group 2, Week 0
Time Frame: at the inclusion to the study
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
Time Frame: at the inclusion to the study
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
Time Frame: at the inclusion to the study
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
Time Frame: at the inclusion to the study
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.
Acoustic voice analysis of the main group, Week 0
Time Frame: at the inclusion to the study
Acoustic analysis of the voice was performed in patients with a voice profession who had a voice disorder using computer program of the Lingwaves.
Endoscopic laryngoscopy of the control group 1, Week 0
Time Frame: at the inclusion to the study
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.
Secondary Outcomes
- Endoscopic laryngoscopy of the control group 1, Week 4(at 4 weeks after initial treatment)
- Acidity level of the main group, Week 4(at 4 weeks after initial treatment)
- Acidity level of the control group 1, Week 4(at 4 weeks after initial treatment)
- "Index of reflux symptoms" of the main group, Week 4(at 4 weeks after initial treatment)
- Endoscopic laryngoscopy of the main group, Week 4(at 4 weeks after initial treatment)
- Endoscopic laryngoscopy of the control group 2, Week 4(at 4 weeks after initial treatment)
- Acidity level of the control group 2, Week 4(at 4 weeks after initial treatment)
- "Index of reflux symptoms" of the control group 1, Week 4(at 4 weeks after initial treatment)
- "Index of reflux symptoms" of the control group 2, Week 4(at 4 weeks after initial treatment)
- Acoustic voice analysis of the main group, Week 4(at 4 weeks after initial treatment)