Voice Analysis in Women With Polycystic Ovary Syndrome

October 12, 2023 updated by: Wafaa Helmy Abdelhakeem, Minia University

Polycystic ovary syndrome (PCOS) is a common endocrine disorder affecting up to one in five reproductive-aged women.

It is associated with clinical and/or biochemical hyperandrogenism, oligomenorrhea, and polycystic appearance of ovaries in ultrasonography. Voice changes have been traditionally recognized as a feature of PCOS for years. However, voice analyses of patients with PCOS are limited. The human larynx is a highly hormone-sensitive target with the presence of hormonal receptors within the vocal folds, and vocal changes occur in relation to the fluctuations in the sex hormones. During the reproductive years and throughout the menstrual cycle, vocal changes have been reported in almost one-third of nonprofessional voice users.The aim of this work is to evaluate the voice characteristics among women with PCOS

Study Overview

Status

Not yet recruiting

Conditions

Intervention / Treatment

Detailed Description

Polycystic ovary syndrome (PCOS) is a common endocrine disorder affecting up to one in five reproductive-aged women.

It is associated with clinical and/or biochemical hyperandrogenism, oligomenorrhea, and polycystic appearance of ovaries in ultrasonography. Voice changes have been traditionally recognized as a feature of PCOS for years. However, voice analyses of patients with PCOS are limited. The human larynx is a highly hormone-sensitive target with the presence of hormonal receptors within the vocal folds, and vocal changes occur in relation to the fluctuations in the sex hormones. During the reproductive years and throughout the menstrual cycle, vocal changes have been reported in almost one-third of nonprofessional voice users. Hyperandrogenism is a landmark in the diagnosis of PCOS, and androgen-related voice changes in women have been recognized.The aim of this work is to evaluate the voice characteristics among women with PCOS The study will include 50 women with and without PCOS. They will divided into 2 groups. Group I will comprise of the 25 women in the clinical group diagnosed with PCOS on ultrasound, while Group II will comprise of 25 typical women as controls Patients will be selected from Obstetric gynecological clinics of El Minna University Hospital .This study is approved by the ethics committee in the Faculty of medicine, Minna university hospital, and concents will be obtained from subjects.

Methods

  1. History taking.
  2. Abdominal ultrasonography
  3. voice sample by recording (in sustained vowel |a| )
  4. Auditory Perceptual Assessment (APA)
  5. Arabic voice handicap index (VHI): For measurement of the voice severity with the Arabic version of VHI
  6. laryngoscopic examination Patients will taken to a room with a tower on which the 8.5 mm 70 rigid laryngoscopic (KARL STORZ - endoscope) (Tele pack X LED).
  7. Acoustic analysis: The voice sample will be subjected to computerized acoustic analysis using Multidimensional voice program software(MDVP).

The results will be presented in tables and charts.Statistical analysis:Parametric and non-parametric tests included in statistical package for social science version 19 .The level of significance for this study is at 0.05.

Study Type

Observational

Enrollment (Estimated)

50

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Contact

Study Contact Backup

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

  • Adult

Accepts Healthy Volunteers

Yes

Sampling Method

Probability Sample

Study Population

50 women with and without PCOS They will divided into 2 groups. Group I will comprise of the 25 women in the clinical group diagnosed with PCOS on ultrasound, while Group II will comprise of 25 typical women as controls

Description

Inclusion Criteria:

  • Group I participants:

    • women with polycystic ovaries on ultrasound.

  • Group II will be:

    • women have a regular menstrual cycles and no PCOS on ultrasound

Exclusion Criteria:

  • Women with hypersensitive gag reflex,
  • alcohol consumption,
  • Smoking,
  • reflux symptoms and vocal abuse will be excluded in both groups.

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

Cohorts and Interventions

Group / Cohort
Intervention / Treatment
Group I
Group I (women with PCOs on ultrasound)
Diagnostic test: Acoustic Analysis by MDVP
Acoustic measurements: Acoustic analysis using Multidimensional voice program software (MDVP) will be carried out with the sustained /a/vowel for 9 seconds, for measuring frequency, jitter, shimmer and harmonic to noise ratio of the voice
Group II
group II(Group II will be women rated to have a normal voice as assessed using Auditory-Perceptual Evaluation of Voice, these women have a regular menstrual cycles and no PCOS on ultrasound)
Diagnostic test: Acoustic Analysis by MDVP
Acoustic measurements: Acoustic analysis using Multidimensional voice program software (MDVP) will be carried out with the sustained /a/vowel for 9 seconds, for measuring frequency, jitter, shimmer and harmonic to noise ratio of the voice

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
frequency
Time Frame: baseline
frequency in hertz
baseline
jitter
Time Frame: baseline
jitter in percentage%
baseline
shimmer
Time Frame: baseline
shimmer in decibel
baseline
Harmonic to noise ratio
Time Frame: baseline
Harmonic to noise ratio in decibel
baseline

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Minia University

Investigators

  • Study Chair: Hany G Eissawy, MD, Minia University

Publications and helpful links

The person responsible for entering information about the study voluntarily provides these publications. These may be about anything related to the study.

General Publications

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start (Estimated)

December 1, 2023

Primary Completion (Estimated)

January 1, 2024

Study Completion (Estimated)

February 1, 2024

Study Registration Dates

First Submitted

August 20, 2023

First Submitted That Met QC Criteria

October 12, 2023

First Posted (Actual)

October 16, 2023

Study Record Updates

Last Update Posted (Actual)

October 16, 2023

Last Update Submitted That Met QC Criteria

October 12, 2023

Last Verified

October 1, 2023

More Information

Terms related to this study

Additional Relevant MeSH Terms

Other Study ID Numbers

  • voice character in PCO

Drug and device information, study documents

Studies a U.S. FDA-regulated drug product

No

Studies a U.S. FDA-regulated device product

No

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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