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CTRI Number  CTRI/2025/02/080497 [Registered on: 13/02/2025] Trial Registered Prospectively
Last Modified On: 12/02/2025
Post Graduate Thesis  Yes 
Type of Trial  Interventional 
Type of Study   Other (Specify) [Voice Therapy]  
Study Design  Single Arm Study 
Public Title of Study   Outcome of Resonant Voice Therapy on Post Menopausal Teachers Voice Changes Teachers 
Scientific Title of Study   Efficacy of Resonant Voice Therapy on Post Menopausal Voice Changes in Teachers 
Trial Acronym  NIL 
Secondary IDs if Any  
Secondary ID  Identifier 
NIL  NIL 
 
Details of Principal Investigator or overall Trial Coordinator (multi-center study)  
Name  Avani K V 
Designation  Student 
Affiliation  Nitte Institute of Speech and Hearing 
Address  Nitte Institute of Speech and Hearing Nithyananda Nagar, Derelakatte, Mangalore, Karnataka

Dakshina Kannada
KARNATAKA
575017
India 
Phone  7306212214  
Fax    
Email  avani.23shlp06@student.nitte.edu.in  
 
Details of Contact Person
Scientific Query  
Name  Bennet Elsa Jose 
Designation  Assistant Professor 
Affiliation  Nitte Institute of Speech and Hearing 
Address  Department of Nitte institute of speech and Hearing, room number 22, Medical Science Complex P.O Derlaktte, manglore, 575018

Dakshina Kannada
KARNATAKA
575017
India 
Phone  9967750287  
Fax    
Email  bennetelsa@nitte.edu.in  
 
Details of Contact Person
Public Query  
Name  Avani K V 
Designation  Student 
Affiliation  Nitte Institute of Speech and Hearing 
Address  Department of Nitte institute of speech and Hearing, room number 22, Medical Science Complex P.O Derlaktte, manglore, 575018

Dakshina Kannada
KARNATAKA
575017
India 
Phone  7306212214  
Fax    
Email  avani.23shlp06@student.nitte.edu.in  
 
Source of Monetary or Material Support  
NItte institute of speech and hearing, Derelakatte,Manglore, Karnataka 575018 
 
Primary Sponsor  
Name  Avani K V 
Address  NItte institute of speech and hearing, Derelakatte,Manglore, Karnataka 575018 
Type of Sponsor  Other [Self funded] 
 
Details of Secondary Sponsor  
Name  Address 
NIL  NIL 
 
Countries of Recruitment     India  
Sites of Study  
No of Sites = 1  
Name of Principal Investigator  Name of Site  Site Address  Phone/Fax/Email 
Avani K V  Justice K S Hegde Charitable Hospital Mangalore  Department of Nitte institute of speech and Hearing, room number 22, Medical Science Complex P.O Derlaktte, manglore, 575018
Dakshina Kannada
KARNATAKA 		 7306212214

avani.23shlp06@student.nitte.edu.in 
 
Details of Ethics Committee  
No of Ethics Committees= 1  
Name of Committee  Approval Status 
K S HEGDE MEDICAL ACADEMY INSTITUTIONAL ETHICS COMMITTEE (NITTE Deemed to be University)  Approved 
 
Regulatory Clearance Status from DCGI  
Status 
Not Applicable 
 
Health Condition / Problems Studied  
Health Type  Condition 
Healthy Human Volunteers  female active teachers in postmenopausal category with vocal symptoms but otherwise Healthy  
 
Intervention / Comparator Agent  
Type  Name  Details 
Comparator Agent  NA  NA 
Intervention  Resonant Voice therapy  The participant will undergo 3 months of voice therapy intervention using the RVT technique. The RVT technique includes exercises such as basic training for gestures RT, All voiced, voiced, and voiceless contrasts  
 
Inclusion Criteria  
Age From  45.00 Year(s)
Age To  60.00 Year(s)
Gender  Female 
Details  1. Post menapasue women who have not experienced bleeding for a minimum of one year without any intervention that could lead to amenorrhea
2. Duration of voice uses should be less than 2 hours
3. At least five vocal symptoms were reported post-menopause 
 
ExclusionCriteria 
Details  1. Any general disability as per WHO disability assessment schedule 2.0
2. Undergoing Hormonal Replacement Therapy (HRT).
3. Any structural or functional abnormalities of vocal folds on laryngoscopy
unrelated to menopause or history of phono surgery.
4. Individual with a history of respiratory infections/ allergic episodes in the past
two weeks. 
 
Method of Generating Random Sequence   Not Applicable 
Method of Concealment   Not Applicable 
Blinding/Masking   Not Applicable 
Primary Outcome  
Outcome  TimePoints 
Assessing whether there is improvement in the voice quality or production on voice analysis comparison of voice after 3 months intervention with the baseline.

Assessment includes perceptual, acoustic, and aerodynamic measures of voice.

Acoustic analysis will include measures such as Mean Intensity, Mean pitch, Standard Deviation of pitch, Harmonics to noise Ratio, Jitter percentage, shimmer, Cepstral peak prominence, and Acoustic Voice Quality Index(AVQI).

Aerodynamic measures will include Maximum phonation duration. 		 baseline, 1 month, 3rd month
 
 
Secondary Outcome  
Outcome  TimePoints 
NIL  NIL 
 
Target Sample Size   Total Sample Size="23"
Sample Size from India="23" 
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   Phase 3 
Date of First Enrollment (India)   24/02/2025 
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="2"
Months="0"
Days="0" 
Recruitment Status of Trial (Global)   Not Yet Recruiting 
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   To evaluate the efficacy of Resonant Voice Therapy (RVT) in the management of voice problems in post-menopausal teachers and to evaluate the knowledge, attitude, and practice prevalent among postmenopausal teachers. Detailed voice analysis will be carried out at the beginning of the intervention (baseline recording), after 1 month, and third month of the intervention. The participants will receive training in RVT and will be instructed to carry out the exercises twice daily for three months. The outcome measures are: acoustic analysis (fundamental frequency, intensity, cepstral measures, acoustic voice quality index), aerodynamic measures (maximum phonation duration, s/z ratio) and perceptual evaluation. 
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