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Trial Title:
Voice Analysis in Women With Polycystic Ovary Syndrome
NCT ID:
NCT06085170
Condition:
Voice Change
Conditions: Official terms:
Polycystic Ovary Syndrome
Study type:
Observational
Overall status:
Not yet recruiting
Study design:
Time perspective:
Prospective
Intervention:
Intervention type:
Diagnostic Test
Intervention name:
Acoustic Analysis by MDVP
Description:
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
Arm group label:
Group I
Arm group label:
Group II
Summary:
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
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.
Criteria for eligibility:
Study pop:
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
Sampling method:
Probability Sample
Criteria:
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.
Gender:
Female
Minimum age:
20 Years
Maximum age:
35 Years
Healthy volunteers:
Accepts Healthy Volunteers
Start date:
December 2023
Completion date:
February 2024
Lead sponsor:
Agency:
Minia University
Agency class:
Other
Source:
Minia University
Record processing date:
ClinicalTrials.gov processed this data on November 12, 2024
Source: ClinicalTrials.gov page:
https://clinicaltrials.gov/ct2/show/NCT06085170
