Voice Analysis in Women With Polycystic Ovary Syndrome

• Sponsor: Minia University (Other)
• Overall Status: Not yet recruiting
• CT.gov ID: NCT06085170
• Collaborator: (none)
• Enrollment: 50
• Anticipated Duration (Months): 2

Study Details

Study Description

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

Condition or Disease	Intervention/Treatment	Phase
Voice Change	Diagnostic Test: Acoustic Analysis by MDVP

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 Design

• Study Type: Observational
• Anticipated Enrollment: 50 participants
• Observational Model: Case-Control
• Time Perspective: Prospective
• Official Title: Voice Analysis in Women With Polycystic Ovary Syndrome
• Anticipated Study Start Date: Dec 1, 2023
• Anticipated Primary Completion Date: Jan 1, 2024
• Anticipated Study Completion Date: Feb 1, 2024

Arms and Interventions

Arm	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

Outcome Measures

Primary Outcome Measures

1. frequency [baseline]

   frequency in hertz

2. jitter [baseline]

   jitter in percentage%

3. shimmer [baseline]

   shimmer in decibel

4. Harmonic to noise ratio [baseline]

   Harmonic to noise ratio in decibel

Eligibility Criteria

Criteria

• Ages Eligible for Study: 20 Years to 35 Years
• Sexes Eligible for Study: Female
• Accepts Healthy Volunteers: Yes

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.

Contacts and Locations

Locations

No locations specified.

Sponsors and Collaborators

• Minia University

Investigators

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

Study Documents (Full-Text)

None provided.

More Information

Publications

• 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.

• Responsible Party: Wafaa Helmy Abdelhakeem, Principal Investigator, Minia University
• ClinicalTrials.gov Identifier: NCT06085170
• Other Study ID Numbers: voice character in PCO
• First Posted: Oct 16, 2023
• Last Update Posted: Oct 16, 2023
• Last Verified: Oct 1, 2023

• Studies a U.S. FDA-regulated Drug Product: No
• Studies a U.S. FDA-regulated Device Product: No
• Additional relevant MeSH terms: Polycystic Ovary Syndrome

Study Results

No Results Posted as of Oct 16, 2023