The Influence of Significant Weight Lost on the Quality of Voice

• Conditions: Voice Alteration; Obesity, Morbid

• Registration Number: NCT03070808
• Lead Sponsor: Kaplan Medical Center

Brief 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.

Detailed Description

Not available

Study Timeline

• Status Verified: 2017-02
• Study First Submitted: 2017-02-21
• Study First Submitted QC: 2017-03-03
• Last Update Submitted: 2017-03-03
• Study First Posted: 2017-03-06
• Last Update Posted: 2017-03-06
• Study Start: 2017-03-15
• Primary Completion: 2018-03-15
• Study Completion: 2018-09-15

Recruitment & Eligibility

• Status: UNKNOWN
• Sex: All
• Target Recruitment: 50

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

• Study Type: OBSERVATIONAL
• Study Design: Not specified

Primary Outcome Measures

Name	Time	Method
Stroboscopic evaluation of the larynx	2/16-2/20	A visual examination of the larynx

Secondary Outcome Measures

Name	Time	Method
Average Fundamental frequency	2/16-2/20	part of voice assessment, in Hertz
Mean Fundamental frequency	2/16-2/20	part of voice assessment, in Hertz
Highest Fundamental frequency	2/16-2/20	part of voice assessment, in Hertz
Absolute gitter	2/16-2/20	Variability of frequency
Shimmer in dB	2/16-2/20	variability of voice volume
Voice Handicap Index	2/16-2/20	Validitated questioners for dysphagia which result in a score
Dysphagia handicap Index	2/16-2/20	Validitated questioners for dysphagia which result in a score
EAT 10	2/16-2/20	Validitated questioners for dysphagia which result in a score
Lowest Fundamental frequency	2/16-2/20	part of voice assessment, in Hertz
Standard deviation of Fundamental frequency	2/16-2/20	part of voice assessment, in numbers
Noise to harmonic ratio	2/16-2/20	part of voice assessment, a descripitive measure of voice quality
Voice turbulence Index	2/16-2/20	part of voice assessment
Jitter percent	2/16-2/20	assessment of voice variability
Shimmer percent	2/16-2/20	assessment of voice variability