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临床试验/NCT06085170
NCT06085170尚未招募不适用

Voice Analysis in Women With Polycystic Ovary Syndrome

Minia University0 个研究点目标入组 50 人开始时间: 2023年12月最近更新:
适应症

试验速览

阶段
不适用
状态
尚未招募
发起方
入组人数
50
主要终点
frequency

研究概览

简要总结

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

详细描述

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.

研究设计

研究类型
Observational
观察模型
Case Control
时间视角
Prospective

入排标准

年龄范围
20 Years 至 35 Years(Adult)
性别
Female
接受健康志愿者

入选标准

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

排除标准

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

结局指标

主要结局

frequency

时间窗: baseline

frequency in hertz

Harmonic to noise ratio

时间窗: baseline

Harmonic to noise ratio in decibel

shimmer

时间窗: baseline

shimmer in decibel

jitter

时间窗: baseline

jitter in percentage%

次要结局

未报告次要终点

研究者

发起方
Minia University
申办方类型
Other
责任方
Principal Investigator
主要研究者

Wafaa Helmy Abdelhakeem

Principal Investigator

Minia University

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