Laryngopharyngeal Reflux SymptomsNCT05296655

Kazakh Version of Reflux Symptom Index

An observational study of Laryngopharyngeal Reflux Symptoms and Laryngopharyngitis Chronic, run by Kazakh Medical University of Continuing Education at 2 sites in Kazakhstan.

Completed

Finished. The study has ended and is not enrolling. Results may be posted on the official record.

Official record

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Trial summary

Who is it for?: Ages 18 to 74 yearsHealthy volunteers can take part
Conditions the study is for: Laryngopharyngeal Reflux Symptoms, Laryngopharyngitis Chronic, Gastro Esophageal Reflux Disease
What is being tested?: Reflux Symptom Index Inventory (diagnostic survey) and Reflux finding score
How many people: 248 participants
Where: 2 sitesKazakhstan
Study dates: 1 Mar 2020to 16 Feb 2022
Phase: Observational
Are there results?: None posted in the registry

Key requirements

Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.

Ages 18 to 74 years
All sexes
Healthy volunteers accepted
Adult, Older adult

Study population: Adult female patients between 18 to 74 years of age with a laryngopharengeal symptoms and patients without symptoms of laryngopharyngeal reflux who applied for an appointment with an otorhinolaryngologist/

Who may be able to join

Patient's informed consent;
Age: 18-74 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.

Who cannot join

Disagreement to participate in scientific research;
Age: under 18 and over 74;
Severe somatic diseases, organic lesions of the gastrointestinal tract and ENT organs;
Patients with pulmonary pathologies;
Patients with allergic manifestations (chronic or allergic rhinosinusitis and nasal polyposis);
With diagnoses: Acute respiratory diseases;

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Patients with general neuralgic disorders;
Pregnancy;
Benign lesions of the vocal cords;
Acid-suppressive therapy within 4 weeks prior to recruitment

Trial locations and contacts

2 sites in 1 country.

Kazakhstan2 sites

SOS Medical Assistance
Almaty
V-ent
Almaty

Other trials in Kazakhstan

About this study

Official title: Validity and Reliability of a Kazakh Version of Reflux Symptom Index

Reflux symptoms index (RSI) were developed to identify a clinical index of suspicion for laryngopharyngeal reflux (LPR) in patients with ear, nose, and throat symptoms. RSI is an efficient diagnostic tool for LPR/ It is easy to use, even for those who know little about LPR. It does not require special equipment or examinations and is inexpensive. Thus, it can be considered highly efficient and cost-effective. The study will focus on translating and testing the RSI into Kazakh language and comparing its results in healthy people and people with laryngopharyngeal reflux.

Conditions: Laryngopharyngeal Reflux Symptoms, Laryngopharyngitis Chronic, Gastro Esophageal Reflux Disease
Being tested: Reflux Symptom Index Inventory (diagnostic survey), Reflux finding score
Keywords: Laryngopharyngeal Reflux, Laryngopharyngeal Reflux Symptoms, Laryngitis, Laryngopharyngitis Chronic, Gastro Esophageal Reflux
Medical subject headings: Gastroesophageal Reflux, Laryngopharyngeal Reflux, Laryngitis

What participants receive

What participants receive. In a randomised study each person is assigned to one group by chance.

Reflux Symptom Index Inventory (diagnostic survey)Other
Also called RSI
Kazakh versions of the Reflux Symptom Index Inventory will be filled patients
Reflux finding scoreOther
Also called RFS
laryngoscopy with a score RFS

Study groups in NCT05296655
Study group	Role	What they receive
Laryngopharegeal reflux symptoms patients		patients with symptoms of laryngopharyngeal reflux detected at an outpatient appointment with an ENT doctor Receives: Other: Reflux Symptom Index Inventory (diagnostic survey); Other: Reflux finding score
Asymptomatic laryngopharegeal reflux patients		patients without symptoms of laryngopharyngeal reflux who applied for an appointment with an otorhinolaryngologist Receives: Other: Reflux Symptom Index Inventory (diagnostic survey)

What is being measured

The primary outcome is the main question the study is designed to answer.

RSI Score at Baseline:
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. Total score ranges from 0-45; of which 0-12 is considered no laryngopharengeal reflux, above 13 points for the presence of laryngopharyngeal reflux.
Measured: RSI Score at Baseline
RSI Score at Days 10-14
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. Total score ranges from 0-45; of which 0-12 is considered no laryngopharengeal reflux, above 13 points for the presence of laryngopharyngeal reflux.
Measured: Days 10-14
RFS Score at Baseline:
Device: Endoscopic laryngoscopy Video laryngoscopy and assessment of the presence / severity of the symptoms- Reflux finding score. Evaluation results range from 0 to 4, where 0 is an indicator of no problem, and 4 is an indicator of a serious problem. Total score ranges from 0-48; of which 0-6 is considered no laryngopharengeal reflux, above 7 points for the presence of laryngopharyngeal reflux.
Measured: RFS Score at Baseline
RFS Score at Days 10-14
Device: Endoscopic laryngoscopy Video laryngoscopy and assessment of the presence / severity of the symptoms - Reflux finding score and will be used as a gold standard of diagnosis of laryngopharengeal reflux. Evaluation results range from 0 to 4, where 0 is an indicator of no problem, and 4 is an indicator of a serious problem. Total score ranges from 0-48; of which 0-6 is considered no laryngopharengeal reflux, above 7 points for the presence of laryngopharyngeal reflux.
Measured: Days 10-14
Reliability and validity of RSI at Baseline:
Reliability and validity of RSI at Baseline using Cronbach's alpha test to check the internal consistency for all the 9 items. Total score ranges from 0-45; of which 0-12 is considered no laryngopharengeal reflux, above 13 points for the presence of laryngopharyngeal reflux.
Measured: RSI Score at Baseline
Reliability and validity of RSI at Days 10-14.
Reliability and validity of RSI at Days 10-14 using Cronbach's alpha test to check the internal consistency for all the 9 items. Total score ranges from 0-45; of which 0-12 is considered no laryngopharengeal reflux, above 13 points for the presence of laryngopharyngeal reflux.
Measured: Days 10-14
Laryngopharyngeal reflux diagnosis at baseline
Video laryngoscopy and assessment of the presence / severity of the symptoms- Reflux finding score. Evaluation results range from 0 to 4, where 0 is an indicator of no problem, and 4 is an indicator of a serious problem. Total score ranges from 0-48; of which 0-6 is considered no laryngopharengeal reflux, above 7 points for the presence of laryngopharyngeal reflux.
Measured: Baseline
Laryngopharyngeal reflux diagnosis at Days 10-14.
Video laryngoscopy and assessment of the presence / severity of the symptoms- Reflux finding score. Evaluation results range from 0 to 4, where 0 is an indicator of no problem, and 4 is an indicator of a serious problem. Total score ranges from 0-48; of which 0-6 is considered no laryngopharengeal reflux, above 7 points for the presence of laryngopharyngeal reflux.
Measured: Days 10-14
Test - retest reliability of the RSI questtionaire
Test - retest reliability of the RSI questtionaire at Days 10-14. Test-retest reliability coefficients vary between 0 and 1, where:
1 : perfect reliability,
0.9: excellent reliability, 0.8 < 0.9: good reliability, 0.7 < 0.8: acceptable reliability, 0.6 < 0.7: questionable reliability, 0.5 < 0.6: poor reliability, < 0.5: unacceptable reliability, 0: no reliability. On this scale, a correlation of .9(90%) would indicate a very high correlation (good reliability) and a value of 10% a very low one (poor reliability).
Measured: Days 10-14
Test - retest reliability of the RFS
Test - retest reliability of the RFS questtionaire at Days 10-14. Test-retest reliability coefficients vary between 0 and 1, where:
1 : perfect reliability,
0.9: excellent reliability, 0.8 < 0.9: good reliability, 0.7 < 0.8: acceptable reliability, 0.6 < 0.7: questionable reliability, 0.5 < 0.6: poor reliability, < 0.5: unacceptable reliability, 0: no reliability. On this scale, a correlation of .9(90%) would indicate a very high correlation (good reliability) and a value of 10% a very low one (poor reliability).
Measured: Days 10-14

Timeline

From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.

1 Mar 202016 Feb 2022

First posted25 Mar 2022
Study start1 Mar 2020
Primary completion15 Feb 2022
Study completion16 Feb 2022

Resources

Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
Other trials for Laryngopharyngeal Reflux SymptomsStudies of the same condition, open and under way.
What the trial phases meanHow a treatment moves from first tests in people to approval.

More details

For doctors and researchers: how the study is designed, who runs it, and its registry IDs.

Study design

Study type: Observational
Observational model: Case only
Time perspective: Prospective
Enrolment: 248 participants (actual)

IDs, dates and publications

ClinicalTrials.gov ID: NCT05296655
Sponsor's protocol ID: 14-2020/1
Status last verified: May 2022
First submitted: 17 Mar 2022
Last updated: 23 May 2022
Results posted: No
Data monitoring committee: Yes
FDA-regulated drug: No
FDA-regulated device: No
Individual data sharing: Yes: Non-identifiable IPD will be shared upon request with all required information

Want to know more?

The sponsor has not listed a contact. The official record may have more details.

Talk to your doctor first and take this page with you. Only the study team can confirm whether you can join.

Questions to ask the study team

What is the study trying to find out?
What would I need to do, and how often would I visit?
Could I receive a placebo instead of the treatment?
What are the possible risks and benefits for me?
Will it cost me anything? Are travel or time paid for?
Can I keep seeing my own doctor during the study?
What happens when the study ends?

See locations

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All Laryngopharyngeal Reflux Symptoms trials

Study at a glance

From the registry record, last updated by the sponsor on 23 May 2022. Recruitment status is as the sponsor reported it: confirm with the study team.

Official title: Validity and Reliability of a Kazakh Version of Reflux Symptom Index
ClinicalTrials.gov ID: NCT05296655
Acronym / sponsor ID: 14-2020/1
Conditions: Laryngopharyngeal Reflux Symptoms, Laryngopharyngitis Chronic, Gastro Esophageal Reflux Disease
Keywords: Laryngopharyngeal Reflux, Laryngopharyngeal Reflux Symptoms, Laryngitis, Laryngopharyngitis Chronic, Gastro Esophageal Reflux
Study type: Observational
Recruitment status: Completed
Enrolment: 248 participants (actual)
Lead sponsor: Kazakh Medical University of Continuing EducationUniversity, hospital or other
Collaborators: Asfendiyarov Kazakh National Medical University
Study start: 1 Mar 2020 (actual)
Primary completion: 15 Feb 2022 (actual)
Study completion: 16 Feb 2022 (actual)
First posted: 25 Mar 2022 (actual)
Results: Not posted in the source record

Clinical summary

The research question as the sponsor registered it. This describes what the study plans to test, not what it found.

Study design

Observational model: Case only
Time perspective: Prospective
Number of arms: 2

Arm	Type	Receives
Laryngopharegeal reflux symptoms patients	–	Other: Reflux Symptom Index Inventory (diagnostic survey), Other: Reflux finding scorepatients with symptoms of laryngopharyngeal reflux detected at an outpatient appointment with an ENT doctor
Asymptomatic laryngopharegeal reflux patients	–	Other: Reflux Symptom Index Inventory (diagnostic survey)patients without symptoms of laryngopharyngeal reflux who applied for an appointment with an otorhinolaryngologist

Who may qualify

Ages: 18 to 74 years
Sex: All
Healthy volunteers: Accepted
Age groups: Adult, Older adult
Study population: Adult female patients between 18 to 74 years of age with a laryngopharengeal symptoms and patients without symptoms of laryngopharyngeal reflux who applied for an appointment with an otorhinolaryngologist/

Key inclusion criteria (6 listed)

Patient's informed consent;
Age: 18-74 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;

Key exclusion criteria (10 listed)

Disagreement to participate in scientific research;
Age: under 18 and over 74;
Severe somatic diseases, organic lesions of the gastrointestinal tract and ENT organs;
Patients with pulmonary pathologies;
Patients with allergic manifestations (chronic or allergic rhinosinusitis and nasal polyposis);

Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.

Interventions

Intervention	Type	Arms
Reflux Symptom Index Inventory (diagnostic survey)Also: RSIKazakh versions of the Reflux Symptom Index Inventory will be filled patients	Other	Asymptomatic laryngopharegeal reflux patients, Laryngopharegeal reflux symptoms patients
Reflux finding scoreAlso: RFSlaryngoscopy with a score RFS	Other	Laryngopharegeal reflux symptoms patients

Primary outcome

RSI Score at Baseline:
Time frame: RSI Score at Baseline
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. Total score ranges from 0-45; of which 0-12 is considered no laryngopharengeal reflux, above 13 points for the presence of laryngopharyngeal reflux.
RSI Score at Days 10-14
Time frame: Days 10-14
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. Total score ranges from 0-45; of which 0-12 is considered no laryngopharengeal reflux, above 13 points for the presence of laryngopharyngeal reflux.
RFS Score at Baseline:
Time frame: RFS Score at Baseline
Device: Endoscopic laryngoscopy Video laryngoscopy and assessment of the presence / severity of the symptoms- Reflux finding score. Evaluation results range from 0 to 4, where 0 is an indicator of no problem, and 4 is an indicator of a serious problem. Total score ranges from 0-48; of which 0-6 is considered no laryngopharengeal reflux, above 7 points for the presence of laryngopharyngeal reflux.
RFS Score at Days 10-14
Time frame: Days 10-14
Device: Endoscopic laryngoscopy Video laryngoscopy and assessment of the presence / severity of the symptoms - Reflux finding score and will be used as a gold standard of diagnosis of laryngopharengeal reflux. Evaluation results range from 0 to 4, where 0 is an indicator of no problem, and 4 is an indicator of a serious problem. Total score ranges from 0-48; of which 0-6 is considered no laryngopharengeal reflux, above 7 points for the presence of laryngopharyngeal reflux.
Reliability and validity of RSI at Baseline:
Time frame: RSI Score at Baseline
Reliability and validity of RSI at Baseline using Cronbach's alpha test to check the internal consistency for all the 9 items. Total score ranges from 0-45; of which 0-12 is considered no laryngopharengeal reflux, above 13 points for the presence of laryngopharyngeal reflux.
Reliability and validity of RSI at Days 10-14.
Time frame: Days 10-14
Reliability and validity of RSI at Days 10-14 using Cronbach's alpha test to check the internal consistency for all the 9 items. Total score ranges from 0-45; of which 0-12 is considered no laryngopharengeal reflux, above 13 points for the presence of laryngopharyngeal reflux.
Laryngopharyngeal reflux diagnosis at baseline
Time frame: Baseline
Video laryngoscopy and assessment of the presence / severity of the symptoms- Reflux finding score. Evaluation results range from 0 to 4, where 0 is an indicator of no problem, and 4 is an indicator of a serious problem. Total score ranges from 0-48; of which 0-6 is considered no laryngopharengeal reflux, above 7 points for the presence of laryngopharyngeal reflux.
Laryngopharyngeal reflux diagnosis at Days 10-14.
Time frame: Days 10-14
Video laryngoscopy and assessment of the presence / severity of the symptoms- Reflux finding score. Evaluation results range from 0 to 4, where 0 is an indicator of no problem, and 4 is an indicator of a serious problem. Total score ranges from 0-48; of which 0-6 is considered no laryngopharengeal reflux, above 7 points for the presence of laryngopharyngeal reflux.
Test - retest reliability of the RSI questtionaire
Time frame: Days 10-14
Test - retest reliability of the RSI questtionaire at Days 10-14. Test-retest reliability coefficients vary between 0 and 1, where: 1 : perfect reliability, 0.9: excellent reliability, 0.8 < 0.9: good reliability, 0.7 < 0.8: acceptable reliability, 0.6 < 0.7: questionable reliability, 0.5 < 0.6: poor reliability, < 0.5: unacceptable reliability, 0: no reliability. On this scale, a correlation of .9(90%) would indicate a very high correlation (good reliability) and a value of 10% a very low one (poor reliability).
Test - retest reliability of the RFS
Time frame: Days 10-14
Test - retest reliability of the RFS questtionaire at Days 10-14. Test-retest reliability coefficients vary between 0 and 1, where: 1 : perfect reliability, 0.9: excellent reliability, 0.8 < 0.9: good reliability, 0.7 < 0.8: acceptable reliability, 0.6 < 0.7: questionable reliability, 0.5 < 0.6: poor reliability, < 0.5: unacceptable reliability, 0: no reliability. On this scale, a correlation of .9(90%) would indicate a very high correlation (good reliability) and a value of 10% a very low one (poor reliability).

Results and safety

The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.

Research links

Official record on ClinicalTrials.govLast updated by the sponsor 23 May 2022.
Individual participant dataSharing planned: Yes. Non-identifiable IPD will be shared upon request with all required information

Related trials for Laryngopharyngeal Reflux Symptoms

Enrolling by invitationObservational study
Effect of Glucagon-like Peptide-1 Receptor Agonists (GLP-1 RA) on Gastric Emptying
Gastric Emptying, Glucagon-Like Peptide-1 Receptor Agonists
Recruiting
New Topical tReatment Options for Symptomatic patiEnts With Nonerosive gastroesophageaL Reflux dIsease (The RELIEF Trial)
GERD (Gastroesophageal Reflux Disease), NERD
Recruiting
Effect of Fasting Recommendations Among Patients Using GLP-1 Receptor Agonists
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Referral and contact

AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.

Nukusbekova principal investigator

Doctor

2 sites in 1 country: see every site and its status.

Questions about this trial

What is this clinical trial studying?

An observational study of Laryngopharyngeal Reflux Symptoms and Laryngopharyngitis Chronic, run by Kazakh Medical University of Continuing Education at 2 sites in Kazakhstan.

The full registered description is in the About this study section and the official record.

Who may be eligible to take part?

The sponsor lists 6 inclusion and 10 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.

Is this clinical trial currently recruiting?

The record says: finished, as of the sponsor's last update on 23 May 2022. Status can change between updates, so confirm with the study contact before making plans.

Where is the study taking place?

The record lists 2 sites in Kazakhstan. Whether a site is taking part right now should be confirmed with that site. See every site.

What are the possible benefits and risks?

They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.

Are results available for this study?

The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.

How can a doctor refer a patient or contact the research team?

The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.

What does the primary outcome measure?

RSI Score at Baseline: (time frame: RSI Score at Baseline). The study lists 10 primary outcomes in all. It is what the study was designed to measure, not a finding.

Where can I read the original study information?

On the ClinicalTrials.gov record for NCT05296655.

Does a listing mean the treatment is approved or proven to work?

No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.

How often is this information updated?

AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 23 May 2022.