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NCT03070808 Clinical Trial

The Influence of Significant Weight Lost on the Quality of Voice

Obesity, Morbid Clinical Trial

Official title:
The Influence of Significant Weight Lost on the Quality of Voice

Clinical Trial Details — Status: Not yet recruiting

Administrative data
NCT number NCT03070808
Other study ID # 0005-17-KMC
Secondary ID
Status Not yet recruiting
Phase N/A
First received February 21, 2017
Last updated March 3, 2017
Start date March 15, 2017
Est. completion date September 15, 2018

Study information
Verified date February 2017
Source Kaplan Medical Center
Contact n/a
Is FDA regulated No
Health authority
Study type Observational

Clinical Trial Summary

The rate of obesity and bariatric surgery is rising steadily. Though Bariatric Surgery Influences on aspects such as endocrin analysis, finance, etc are well tested, quantitative and quality voice impacts have not been evaluated. The aim of the study is to recruit 50 patients who underwent bariatric surgery and compare voice quality in each of these patients before and after surgery.

Recruitment information / eligibility
Status Not yet recruiting
Enrollment 50
Est. completion date September 15, 2018
Est. primary completion date March 15, 2018
Accepts healthy volunteers No
Gender All
Age group 18 Years and older
Eligibility Inclusion Criteria:

- Morbid obese

- Candidates for bariatric Surgery

Exclusion Criteria:

- History of benign \ malignant disease of the larynx.

- History of head and neck tumors

- History of radiation therapy of the neck

- BMI under 30 pre-surgery

Study Design

Related Conditions & MeSH terms

Locations
Country Name City State
n/a

Sponsors (1)
Lead Sponsor Collaborator
Kaplan Medical Center

Outcome
Type Measure Description Time frame Safety issue
Primary Stroboscopic evaluation of the larynx A visual examination of the larynx 2/16-2/20
Secondary Dysphagia handicap Index Validitated questioners for dysphagia which result in a score 2/16-2/20
Secondary EAT 10 Validitated questioners for dysphagia which result in a score 2/16-2/20
Secondary Voice Handicap Index Validitated questioners for dysphagia which result in a score 2/16-2/20
Secondary Average Fundamental frequency part of voice assessment, in Hertz 2/16-2/20
Secondary Mean Fundamental frequency part of voice assessment, in Hertz 2/16-2/20
Secondary Highest Fundamental frequency part of voice assessment, in Hertz 2/16-2/20
Secondary Lowest Fundamental frequency part of voice assessment, in Hertz 2/16-2/20
Secondary Standard deviation of Fundamental frequency part of voice assessment, in numbers 2/16-2/20
Secondary Noise to harmonic ratio part of voice assessment, a descripitive measure of voice quality 2/16-2/20
Secondary Voice turbulence Index part of voice assessment 2/16-2/20
Secondary Absolute gitter Variability of frequency 2/16-2/20
Secondary Jitter percent assessment of voice variability 2/16-2/20
Secondary Shimmer percent assessment of voice variability 2/16-2/20
Secondary Shimmer in dB variability of voice volume 2/16-2/20
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