Voice ChangeNCT06085170
Voice Analysis in Women With Polycystic Ovary Syndrome
An observational study of Voice Change, run by Minia University.
Trial 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. Read more about this study
- Who is it for?
- Ages 20 to 35 years, women onlyHealthy volunteers can take part
- Conditions the study is for
- Voice Change
- What is being tested?
- Acoustic Analysis by MDVP
- How many people
- 50 participants
- Where
- No sites listed yet
- Study dates
- Dec 2023to Feb 2024
- Phase
- Observational
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 20 to 35 years
- Women only
- Healthy volunteers accepted
- Adult
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
Who may be able to join
- Group I participants:
- women with polycystic ovaries on ultrasound.
- Group II will be:
- women have a regular menstrual cycles and no PCOS on ultrasound
Who cannot join
- Women with hypersensitive gag reflex,
- alcohol consumption,
- Smoking,
- reflux symptoms and vocal abuse will be excluded in both groups.
Trial locations and contacts
No sites are listed yet.
About this study
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
Read the 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
- History taking.
- Abdominal ultrasonography
- voice sample by recording (in sustained vowel |a| )
- Auditory Perceptual Assessment (APA)
- Arabic voice handicap index (VHI): For measurement of the voice severity with the Arabic version of VHI
- 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).
- 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.
- Conditions
- Voice Change
- Being tested
- Acoustic Analysis by MDVP
- Medical subject headings
- Dysphonia
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Acoustic Analysis by MDVPDiagnostic 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
| Study group | Role | What they receive |
|---|---|---|
| Group I | Group I (women with PCOs on ultrasound) Receives: 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) Receives: Diagnostic Test: Acoustic Analysis by MDVP |
What is being measured
The primary outcome is the main question the study is designed to answer.
frequency
frequency in hertz
Measured: baseline
jitter
jitter in percentage%
Measured: baseline
shimmer
shimmer in decibel
Measured: baseline
Harmonic to noise ratio
Harmonic to noise ratio in decibel
Measured: baseline
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted16 Oct 2023
- Study startDec 2023 (estimated)
- Primary completionJan 2024 (estimated)
- Study completionFeb 2024 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (2)Papers the sponsor has linked to this study.
- Other trials for Voice ChangeStudies of the same condition, open and under way.
- More trials run by Minia UniversityThe sponsor's other registered studies.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Observational
- Observational model
- Case-control
- Time perspective
- Prospective
- Enrolment
- 50 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Minia University
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Wafaa Helmy Abdelhakeem, Minia University
- Investigators
- Hany G Eissawy, MD, Study chair, Minia University
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT06085170
- Sponsor's protocol ID
- voice character in PCO
- Status last verified
- Oct 2023
- First submitted
- 20 Aug 2023
- Last updated
- 16 Oct 2023
- Results posted
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
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.
PubMed 20537860Aydin 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.
PubMed 26700739
Study at a glance
From the registry record, last updated by the sponsor on 16 Oct 2023. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Voice Analysis in Women With Polycystic Ovary Syndrome
- ClinicalTrials.gov ID
- NCT06085170
- Acronym / sponsor ID
- voice character in PCO
- Conditions
- Voice Change
- Study type
- Observational
- Recruitment status
- Unknown status
- Enrolment
- 50 participants (estimated)
- Lead sponsor
- Minia UniversityUniversity, hospital or other
- Study start
- Dec 2023 (estimated)
- Primary completion
- Jan 2024 (estimated)
- Study completion
- Feb 2024 (estimated)
- First posted
- 16 Oct 2023 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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
- History taking.
- Abdominal ultrasonography
- voice sample by recording (in sustained vowel |a| )
- Auditory Perceptual Assessment (APA)
- Arabic voice handicap index (VHI): For measurement of the voice severity with the Arabic version of VHI
- 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).
- 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
- Observational model
- Case-control
- Time perspective
- Prospective
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Group I | – | Diagnostic Test: Acoustic Analysis by MDVPGroup I (women with PCOs on ultrasound) |
| Group II | – | Diagnostic Test: Acoustic Analysis by MDVPgroup 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) |
Who may qualify
- Ages
- 20 to 35 years
- Sex
- Female only
- Healthy volunteers
- Accepted
- Age groups
- Adult
- 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
Key inclusion criteria (4 listed)
- Group I participants:
- Group II will be:
Key exclusion criteria (4 listed)
- Women with hypersensitive gag reflex,
- alcohol consumption,
- Smoking,
- reflux symptoms and vocal abuse will be excluded in both groups.
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Acoustic Analysis by MDVPAcoustic 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 | Diagnostic test | Group I, Group II |
Primary outcome
frequency
Time frame: baseline
frequency in hertz
jitter
Time frame: baseline
jitter in percentage%
shimmer
Time frame: baseline
shimmer in decibel
Harmonic to noise ratio
Time frame: baseline
Harmonic to noise ratio in decibel
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 16 Oct 2023.
- Background: PubMed 20537860Hannoun 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.
- Results publication: PubMed 26700739Aydin 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.
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Hany G Eissawy, MD study chair
Minia University
Questions about this trial
What is this clinical trial studying?
An observational study of Voice Change, run by Minia University.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 4 inclusion and 4 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: status not confirmed, as of the sponsor's last update on 16 Oct 2023. Status can change between updates, so confirm with the study contact before making plans.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
Results are not available in the source record.
How can a doctor refer a patient or contact the research team?
Contact Wafaa H Abdelhakeem, MD (01091813874, dr.fofahma@gmail.com), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
frequency (time frame: baseline). The study lists 4 primary outcomes in all. It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT06085170, which also lists 2 linked publications.
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 16 Oct 2023.