| CTRI Number |
CTRI/2025/02/081381 [Registered on: 27/02/2025] Trial Registered Prospectively |
| Last Modified On: |
10/02/2025 |
| 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 Semi-Occluded Vocal Tract Exercise on Post-Menopausal Voice Changes in Teachers |
|
Scientific Title of Study
|
Efficacy of Semi-Occluded Vocal Tract Exercise 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 |
Arpitha Mariam Aji |
| Designation |
Student |
| Affiliation |
Nitte Institute of Speech and Hearing |
| Address |
Department of Audiology and Speech Language Pathology,
Department No. 22,
Justice K.S. Hegde Hospital
Nitte Institute of Speech and Hearing,
Nithyananda Nagar, Derelakatte, Mangalore, Karnataka - 575018
Dakshina Kannada
KARNATAKA
575017
India |
| Phone |
7559978015 |
| Fax |
|
| Email |
arpitha.23shlp04@student.nitte.edu.in |
|
Details of Contact Person
Scientific Query
|
| Name |
Bennet Elsa Joseph |
| Designation |
Assistant Professor |
| Affiliation |
Nitte Institute of Speech and Hearing |
| Address |
Nitte Institute of Speech and Hearing, Nithyananda Nagar, Derelakatte, Mangalore, Karnataka - 575018
Dakshina Kannada
KARNATAKA
575017
India |
| Phone |
7559978015 |
| Fax |
|
| Email |
bennetelsa@nitte.edu.in |
|
Details of Contact Person
Public Query
|
| Name |
Arpitha Mariam Aji |
| Designation |
Student |
| Affiliation |
Nitte Institute of Speech and Hearing |
| Address |
Department of Audiology and Speech Language Pathology,Department no. 22,
Justice K.S. Hegde Hospital,
Nitte Institute of Speech and Hearing, Nithyananda Nagar, Derelakatte, Mangalore, Karnataka - 575018
Dakshina Kannada
KARNATAKA
575017
India |
| Phone |
7559978015 |
| Fax |
|
| Email |
arpitha.23shlp04@student.nitte.edu.in |
|
|
Source of Monetary or Material Support
|
| Nitte Institute of Speech and Hearing, Derelakatte, Mangalore, Karnataka - 575018 |
|
|
Primary Sponsor
|
| Name |
Arpitha Mariam Aji |
| Address |
Nitte Institute of Speech and Hearing, Nithyanandanagar, Derelakatte, Mangalore -Dakshina Kannada - 575018 |
| Type of Sponsor |
Other [Self-funded] |
|
|
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 |
| Arpitha Mariam Aji |
Justice K.S Hegde Charitable Hospital, Nitte Institute of Speech and Hearing |
Department of Audiology and Speech Language Pathology, no. 22
Dakshina Kannada
KARNATAKA |
7559978015
arpitha.23shlp04@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
|
|
|
Health Condition / Problems Studied
|
| Health Type |
Condition |
| Healthy Human Volunteers |
Female active teachers in post-menopausal category with vocal symptoms but otherwise healthy |
|
|
Intervention / Comparator Agent
|
| Type |
Name |
Details |
| Comparator Agent |
NOT APPLICABLE |
NOT APPLICABLE |
| Intervention |
Semi-Occluded Vocal Tract Exercises (SOVTE) |
The participants will undergo a 3-months voice therapy intervention using SOVTE technique.
The SOVTE technique includes exercises such as lip trills/ tongue trills, straw phonation without water and straw phonation with water.
Each exercises are to be carried out the exercises twice a day, each step 5 times. |
|
|
Inclusion Criteria
|
| Age From |
45.00 Year(s) |
| Age To |
65.00 Year(s) |
| Gender |
Female |
| Details |
1. Postmenopausal women: should not have had menstrual bleeding for at least 1 year in the absence of any interventions that may cause amenorrhea (such as oral contraceptives)
2. Must be teachers with more than 2 hours of professional voice use per day
3. Must report at least five vocal symptoms post menopause
|
|
| ExclusionCriteria |
| Details |
1. Must not have any general disability as per WHO disability assessment schedule 2.0
2. Must not be undergoing Hormonal Replacement Therapy (HRT)
3. Must not have any structural or functional abnormalities of vocal folds on laryngoscopy unrelated to menopause or history of phonosurgery.
4. Must not have a history of respiratory infections or allergies in the past 2 weeks
|
|
|
Method of Generating Random Sequence
|
|
|
Method of Concealment
|
|
|
Blinding/Masking
|
|
|
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 and s/z Ratio.
|
Baseline, 1st month and 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)
|
06/03/2025 |
| 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 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
|
To evaluate the efficacy of Semi-occluded vocal tract exercises (SOVTE) in management of voice problems in post-menopausal teachers and to evaluate the knowledge, attitude and practice prevalent among the 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 SOVTE 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. |