Voice Analysis in Women With Polycystic Ovary Syndrome

NCT06085170 | Unknown

• 1 other identifier: voice character in PCO
• Study Type: observational
• Target: 50
• Locations: 0 countries
• Sites: N/A

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

Conditions

Voice Change

Outcome Measures

Primary Outcomes (4)

• frequency

  frequency in hertz

  baseline

• jitter

  jitter in percentage%

  baseline

• shimmer

  shimmer in decibel

  baseline

• Harmonic to noise ratio

  Harmonic to noise ratio in decibel

  baseline

Study Arms (2)

Group I

Group I (women with PCOs on ultrasound)

Diagnostic Test: Acoustic Analysis by MDVP

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

Interventions

Acoustic Analysis by MDVP DIAGNOSTIC_TEST

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 I; Group II

Eligibility Criteria

• Age: 20 Years - 35 Years
• Sex: female
• Healthy Volunteers: Yes
• Age Groups: Adult (18-64)
• 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

You may qualify if:

• Group I participants:
• women with polycystic ovaries on ultrasound.
• Group II will be:
• women have a regular menstrual cycles and no PCOS on ultrasound

You may not qualify if:

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

Sponsors & Collaborators

• Minia University: lead

Related Publications (2)

• 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.

  PMID: 20537860 BACKGROUND

• 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.

  PMID: 26700739 RESULT

MeSH Terms

Conditions

Dysphonia

Condition Hierarchy (Ancestors)

Voice Disorders; Laryngeal Diseases; Respiratory Tract Diseases; Otorhinolaryngologic Diseases; Neurologic Manifestations; Nervous System Diseases; Signs and Symptoms; Pathological Conditions, Signs and Symptoms

Study Officials

• Hany G Eissawy, MD

  Minia University

  STUDY CHAIR

Central Study Contacts

Wafaa H Abdelhakeem, MD

CONTACT

01091813874; dr.fofahma@gmail.com

Hamza M Abdelmohsen, MD

CONTACT

01004187816; dr.hany3ssawy@gmail.com

Study Design

• Study Type: observational
• Observational Model: CASE CONTROL
• Time Perspective: PROSPECTIVE
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Principal Investigator

Study Record Dates

• First Submitted: August 20, 2023
• First Posted: October 16, 2023
• Study Start: December 1, 2023
• Primary Completion: January 1, 2024
• Study Completion: February 1, 2024
• Last Updated: October 16, 2023

Record last verified: 2023-10