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Clinical Trials/CTRI/2025/02/080497
CTRI/2025/02/080497Not yet recruitingPhase 3

Efficacy of Resonant Voice Therapy on Post Menopausal Voice Changes in Teachers

Avani K V1 site in 1 country23 target enrollmentStarted: February 24, 2025Last updated:

Trial Snapshot

Phase
Phase 3
Status
Not yet recruiting
Sponsor
Enrollment
23
Locations
1
Primary Endpoint
Assessing whether there is improvement in the voice quality or production on voice analysis comparison of voice after 3 months intervention with the baseline.

Study Overview

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.

Study Design

Study Type
Interventional
Allocation
Na
Masking
None

Eligibility Criteria

Ages
45.00 Year(s) to 60.00 Year(s) (—)
Sex
Female

Inclusion Criteria

  • Post menapasue women who have not experienced bleeding for a minimum of one year without any intervention that could lead to amenorrhea
  • Duration of voice uses should be less than 2 hours
  • At least five vocal symptoms were reported post-menopause.

Exclusion Criteria

  • Any general disability as per WHO disability assessment schedule 2.0
  • Undergoing Hormonal Replacement Therapy (HRT).
  • Any structural or functional abnormalities of vocal folds on laryngoscopy unrelated to menopause or history of phono surgery.
  • Individual with a history of respiratory infections/ allergic episodes in the past two weeks.

Outcomes

Primary Outcomes

Assessing whether there is improvement in the voice quality or production on voice analysis comparison of voice after 3 months intervention with the baseline.

Time Frame: baseline, 1 month, 3rd month

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

Time Frame: baseline, 1 month, 3rd month

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).

Time Frame: baseline, 1 month, 3rd month

Aerodynamic measures will include Maximum phonation duration.

Time Frame: baseline, 1 month, 3rd month

Secondary Outcomes

No secondary outcomes reported

Investigators

Sponsor
Avani K V
Sponsor Class
Other [Self funded]
Responsible Party
Principal Investigator
Principal Investigator

Avani K V

Nitte Institute of Speech and Hearing

Study Sites (1)

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