| CTRI Number |
CTRI/2025/07/091440 [Registered on: 22/07/2025] Trial Registered Prospectively |
| Last Modified On: |
18/07/2025 |
| Post Graduate Thesis |
Yes |
| Type of Trial |
Observational |
|
Type of Study
|
Cross Sectional Study |
| Study Design |
Other |
|
Public Title of Study
|
Occurrence of Acidity and Swallowing difficulty in persons with voice problems visiting a tertiary care hospital |
|
Scientific Title of Study
|
Prevalence of Laryngopharyngeal Reflux and Dysphagia in Persons with Voice Disorders visiting a Tertiary Care Hospital |
| Trial Acronym |
NIL |
|
Secondary IDs if Any
|
| Secondary ID |
Identifier |
| NIL |
NIL |
|
|
Details of Principal Investigator or overall Trial Coordinator (multi-center study)
|
| Name |
Amatullah Salik |
| Designation |
Post Graduate student pursuing Msc. in Speech Language Pathology |
| Affiliation |
Manipal College of Health Professions, Manipal Academy of Higher Education |
| Address |
Department of Speech and Hearing, Manipal College of Health Professions, Manipal Academy of Higher Education, Manipal
Udupi
KARNATAKA
576104
India |
| Phone |
9977997848 |
| Fax |
|
| Email |
amatullah.mchpmpl2024@learner.manipal.edu |
|
Details of Contact Person
Scientific Query
|
| Name |
Dr Usha Devadas |
| Designation |
Additional Professor and Head |
| Affiliation |
Manipal College of Health Professions, Manipal Academy of Higher Education |
| Address |
Department of Speech and Hearing, Manipal College of Health Professions, Manipal Academy of Higher Education, Manipal
Udupi
KARNATAKA
576104
India |
| Phone |
9448930882 |
| Fax |
|
| Email |
usha.d@manipal.edu |
|
Details of Contact Person
Public Query
|
| Name |
Dr Suresh Pillai |
| Designation |
Professor and Head |
| Affiliation |
Kasturba Medical College, Manipal |
| Address |
Department of Head and Neck Surgery, Kasturba Medical College, Madhav Nagar, Manipal
Udupi
KARNATAKA
576104
India |
| Phone |
9901728977 |
| Fax |
|
| Email |
suresh.pillai@manipal.edu |
|
|
Source of Monetary or Material Support
|
| Department of Speech and Hearing, Manipal College of Health Professions, Manipal Academy of Higher Education, Manipal, Udupi, Karnataka 576104 |
|
|
Primary Sponsor
|
| Name |
Amatullah Salik |
| Address |
Department of Speech and Hearing, Manipal College of Health Professions, Manipal Academy of Higher Education, Manipal, Udupi, Karnataka 576104 |
| Type of Sponsor |
Other [Self] |
|
|
Details of Secondary Sponsor
|
|
|
Countries of Recruitment
|
India |
|
Sites of Study
|
| No of Sites = 1 |
| Name of Principal
Investigator |
Name of Site |
Site Address |
Phone/Fax/Email |
| Dr Usha Devadas |
Kasturba Hospital |
Department of Speech and Hearing, 3rd floor, Baliga Block, Kasturba Hospital, Manipal, Udupi, Karnataka 576104
Udupi
KARNATAKA |
9448930882
usha.d@manipal.edu |
|
|
Details of Ethics Committee
|
| No of Ethics Committees= 1 |
| Name of Committee |
Approval Status |
| Kasturba Medical College and Kasturba Hospital Institutional Ethics Committee - 2 (Student Research) |
Approved |
|
|
Regulatory Clearance Status from DCGI
|
|
|
Health Condition / Problems Studied
|
| Health Type |
Condition |
| Patients |
(1) ICD-10 Condition: J383||Other diseases of vocal cords, |
|
|
Intervention / Comparator Agent
|
| Type |
Name |
Details |
| Comparator Agent |
NIL |
NIL |
| Intervention |
NIL |
NIL |
|
|
Inclusion Criteria
|
| Age From |
18.00 Year(s) |
| Age To |
90.00 Year(s) |
| Gender |
Both |
| Details |
Adults above 18 years of age with confirmed diagnosis of vocal pathology by otolaryngologist using video laryngoscopy.
Patients with a known diagnosis of Laryngopharyngeal reflux who are seeking treatment for the same.
Patients who can read and understand Kannada language. |
|
| ExclusionCriteria |
| Details |
Patients with known neurological disorders, head and neck cancer conditions having voice and swallowing disorders.
Patients with acute infections of the larynx lasting up to one week. |
|
|
Method of Generating Random Sequence
|
Not Applicable |
|
Method of Concealment
|
Not Applicable |
|
Blinding/Masking
|
Not Applicable |
|
Primary Outcome
|
| Outcome |
TimePoints |
| Prevalence of Laryngopharyngeal reflux and Dysphagia in persons with voice disorders |
48 weeks |
|
|
Secondary Outcome
|
| Outcome |
TimePoints |
| Relationship between Dysphagia & Laryngopharyngeal reflux symptoms with voice disorder |
48 weeks |
|
|
Target Sample Size
|
Total Sample Size="90"
Sample Size from India="90"
Final Enrollment numbers achieved (Total)= "Applicable only for Completed/Terminated trials"
Final Enrollment numbers achieved (India)="Applicable only for Completed/Terminated trials" |
|
Phase of Trial
|
N/A |
|
Date of First Enrollment (India)
|
11/08/2025 |
| Date of Study Completion (India) |
Applicable only for Completed/Terminated trials |
| Date of First Enrollment (Global) |
Date Missing |
| Date of Study Completion (Global) |
Applicable only for Completed/Terminated trials |
|
Estimated Duration of Trial
|
Years="0"
Months="10"
Days="0" |
|
Recruitment Status of Trial (Global)
|
Not Applicable |
| Recruitment Status of Trial (India) |
Not Yet Recruiting |
|
Publication Details
|
N/A |
|
Individual Participant Data (IPD) Sharing Statement
|
Will individual participant data (IPD) be shared publicly (including data dictionaries)?
Response - NO
|
|
Brief Summary
|
Justification for the study:Voice disorders significantly affect an individual’s communicative effectiveness, emotional well-being, and quality of life. They may co-occur with other disorders like Dysphagia and Laryngopharyngeal reflux (LPR). Dysphagia is recognized in both organic and functional voice disorders, possibly dur to the shared anatomical and physiological structures between the voice and swallowing systems. Similarly, LPR is a common contributor to voice disorders and may also impact swallowing due to the mucosal irritation in the laryngopharynx. Despite these overlaps, the interrelationship between these three conditions - Voice disorders, LPR and Dysphagia is poorly understood in the clinical literature. While previous research has independently examined the prevalence of dysphagia in voice disorders and the role of LPR in voice disorders, few studies have explored the simultaneous presence of both dysphagia and LPR in individuals with voice disorders. This creates a risk of over-reliance on LPR-targeted treatments without accurate symptom differentiation, leading to ineffective management. Furthermore, dysphagia is often underreported in this population. By studying the co-occurrence and relationship between LPR and Dysphagia symptoms in individuals with voice disorders, the research seeks to fill a critical gap. The study will employ self-reported tool and clinical assessments to understand the symptom overlap and guide early diagnosis and intervention. This can ultimately enhance patient outcomes, prevent complications such as aspiration and malnutrition, and support overall social and communication participation.
Aims and objectives of the study: Aim: To investigate the prevalence of Dysphagia and Laryngopharyngeal reflux in persons with voice disorders visiting a tertiary care hospital.
Objective(s): To investigate the prevalence of Dysphagia and Laryngopharyngeal reflux in persons with voice disorders; To determine the relationship between Dysphagia and Laryngopharyngeal reflux symptoms with voice disorder. |