The Influence of Significant Weight Lost on the Quality of Voice

March 3, 2017 updated by: Dr Oded Cohen, Kaplan Medical Center
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.

Study Overview

Status

Unknown

Study Type

Observational

Enrollment (Anticipated)

50

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

18 years and older (Adult, Older Adult)

Accepts Healthy Volunteers

No

Genders Eligible for Study

All

Sampling Method

Non-Probability Sample

Study Population

Adults, 18 years and over, entended for Bariatric Surgery at Kaplan Medicle Center.

Description

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 Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Observational Models: Other
  • Time Perspectives: Prospective

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Stroboscopic evaluation of the larynx
Time Frame: 2/16-2/20
A visual examination of the larynx
2/16-2/20

Secondary Outcome Measures

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

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start (Anticipated)

March 15, 2017

Primary Completion (Anticipated)

March 15, 2018

Study Completion (Anticipated)

September 15, 2018

Study Registration Dates

First Submitted

February 21, 2017

First Submitted That Met QC Criteria

March 3, 2017

First Posted (Actual)

March 6, 2017

Study Record Updates

Last Update Posted (Actual)

March 6, 2017

Last Update Submitted That Met QC Criteria

March 3, 2017

Last Verified

February 1, 2017

More Information

Terms related to this study

Keywords

Other Study ID Numbers

  • 0005-17-KMC

Plan for Individual participant data (IPD)

Plan to Share Individual Participant Data (IPD)?

Undecided

Drug and device information, study documents

Studies a U.S. FDA-regulated drug product

No

Studies a U.S. FDA-regulated device product

No

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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