Clinical trial NCT06085170: Voice Analysis in Women With Polycystic Ovary Syndrome
Official title: Voice Analysis in Women With Polycystic Ovary Syndrome
Study type: OBSERVATIONAL
Overall status: NOT_YET_RECRUITING
Conditions: Voice Change
Lead sponsor: Minia University
Sponsor class: OTHER
First posted: 2023-10-16
Enrollment: 50
Sex: FEMALE
Minimum age (years): 20
Maximum age (years): 35
Standard ages: ADULT
Accepts healthy volunteers: yes
Observational model: CASE_CONTROL
Time perspective: PROSPECTIVE
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

Brief 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.

Eligibility 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.

Primary outcomes:
measure: frequency
timeFrame: baseline
measure: jitter
timeFrame: baseline
measure: shimmer
timeFrame: baseline
measure: Harmonic to noise ratio
timeFrame: baseline
Secondary outcomes:
Other outcomes:
Locations:
Study officials:
affiliation: Minia University
name: Hany G Eissawy, MD
role: STUDY_CHAIR
References:
citation: Hannoun A, Zreik T, Husseini ST, Mahfoud L, Sibai A, Hamdan AL. Vocal changes in patients with polycystic ovary syndrome. J Voice. 2011 Jul;25(4):501-4. doi: 10.1016/j.jvoice.2009.12.005. Epub 2010 May 26.
citation: Aydin K, Akbulut S, Demir MG, Demir S, Ozderya A, Temizkan S, Sargin M. Voice characteristics associated with polycystic ovary syndrome. Laryngoscope. 2016 Sep;126(9):2067-72. doi: 10.1002/lary.25818. Epub 2015 Dec 23.