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Clinical Trials/NCT03070808
NCT03070808
Unknown
Not Applicable

The Influence of Significant Weight Lost on the Quality of Voice

Kaplan Medical Center0 sites50 target enrollmentMarch 15, 2017

Overview

Phase
Not Applicable
Intervention
Not specified
Conditions
Obesity, Morbid
Sponsor
Kaplan Medical Center
Enrollment
50
Primary Endpoint
Stroboscopic evaluation of the larynx
Last Updated
9 years ago

Overview

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.

Registry
clinicaltrials.gov
Start Date
March 15, 2017
End Date
September 15, 2018
Last Updated
9 years ago
Study Type
Observational
Sex
All

Investigators

Sponsor
Kaplan Medical Center
Responsible Party
Principal Investigator
Principal Investigator

Dr Oded Cohen

Doctor

Kaplan Medical Center

Eligibility Criteria

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

Outcomes

Primary Outcomes

Stroboscopic evaluation of the larynx

Time Frame: 2/16-2/20

A visual examination of the larynx

Secondary Outcomes

  • Shimmer in dB(2/16-2/20)
  • Shimmer percent(2/16-2/20)
  • Absolute gitter(2/16-2/20)
  • Voice turbulence Index(2/16-2/20)
  • Jitter percent(2/16-2/20)
  • Dysphagia handicap Index(2/16-2/20)
  • EAT 10(2/16-2/20)
  • Voice Handicap Index(2/16-2/20)
  • Average Fundamental frequency(2/16-2/20)
  • Mean Fundamental frequency(2/16-2/20)
  • Highest Fundamental frequency(2/16-2/20)
  • Lowest Fundamental frequency(2/16-2/20)
  • Standard deviation of Fundamental frequency(2/16-2/20)
  • Noise to harmonic ratio(2/16-2/20)

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