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Completed

NCT Number: NCT04771221

Method of Early Diagnosis of Laryngopharyngeal Reflux

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

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Key information

Conditions

Laryngopharyngeal Reflux Deglutition Disorders Digestive System Diseases Esophageal Diseases Esophageal Motility Disorders Gastro Esophageal Reflux Gastroesophageal Reflux Gastrointestinal Diseases Infections Laryngeal Diseases Laryngitis Laryngopharyngitis Chronic Otorhinolaryngologic Diseases Respiratory Tract Diseases Respiratory Tract Infections

Age range

18 year–65 year

Sex eligibility

All sexes

Study type

Interventional

Phase

Not applicable

Primary location

SOS Medical Assistance, Almaty, Kazakhstan

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About this study

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.
  • Subjective methods for assessing the condition of the larynx - Questionnaires.
  • Аnalysis of the received data

Who can participate

Healthy volunteers accepted: Yes

Only the study team can determine whether someone qualifies for participation.

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

Treatment and study plan

pH metry

Diagnostic Test

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

Filling out the questionnaire

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

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

Device

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

Primary outcomes

  1. 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.

  2. 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.

  3. 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.

  4. "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.

  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.

  6. "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.

  7. 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.

  8. 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.

  9. 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.

  10. 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.

Secondary outcomes

  1. Acidity level of the main group, Week 4

    Time frame: at 4 weeks after initial treatment

    The 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.

  2. Acidity level of the control group 1, Week 4

    Time frame: at 4 weeks after initial treatment

    The 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.

  3. Acidity level of the control group 2, Week 4

    Time frame: at 4 weeks after initial treatment

    The 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.

  4. "Index of reflux symptoms" of the main group, Week 4

    Time frame: at 4 weeks after initial treatment

    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.

  5. "Index of reflux symptoms" of the control group 1, Week 4

    Time frame: at 4 weeks after initial treatment

    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.

  6. "Index of reflux symptoms" of the control group 2, Week 4

    Time frame: at 4 weeks after initial treatment

    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.

  7. Endoscopic laryngoscopy of the main group, Week 4

    Time frame: at 4 weeks after initial treatment

    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.

  8. Endoscopic laryngoscopy of the control group 1, Week 4

    Time frame: at 4 weeks after initial treatment

    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.

  9. Endoscopic laryngoscopy of the control group 2, Week 4

    Time frame: at 4 weeks after initial treatment

    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.

  10. Acoustic voice analysis of the main group, Week 4

    Time frame: at 4 weeks after initial treatment

    Acoustic analysis of the voice was performed in patients with a voice profession who had a voice disorder using computer program of the Lingwaves

Sponsors and collaborators

Lead sponsor

Kazakh Medical University of Continuing Education

Other

Registry information

Official study title

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

Acronym: LPR

Important dates

Study start
2021
Primary completion
2022
Study completion
2022
First posted
Feb 25, 2021
Registry last updated
Jan 10, 2023

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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