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The Influence of Significant Weight Lost on the Quality of Voice

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ClinicalTrials.gov Identifier: NCT03070808
Recruitment Status : Unknown
Verified February 2017 by Dr Oded Cohen, Kaplan Medical Center.
Recruitment status was:  Not yet recruiting
First Posted : March 6, 2017
Last Update Posted : March 6, 2017
Sponsor:
Information provided by (Responsible Party):
Dr Oded Cohen, 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.

Condition or disease
Obesity, Morbid Voice Alteration

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Study Type : Observational
Estimated Enrollment : 50 participants
Observational Model: Other
Time Perspective: Prospective
Official Title: The Influence of Significant Weight Lost on the Quality of Voice
Estimated Study Start Date : March 15, 2017
Estimated Primary Completion Date : March 15, 2018
Estimated Study Completion Date : September 15, 2018



Primary Outcome Measures :
  1. Stroboscopic evaluation of the larynx [ Time Frame: 2/16-2/20 ]
    A visual examination of the larynx


Secondary Outcome Measures :
  1. Dysphagia handicap Index [ Time Frame: 2/16-2/20 ]
    Validitated questioners for dysphagia which result in a score

  2. EAT 10 [ Time Frame: 2/16-2/20 ]
    Validitated questioners for dysphagia which result in a score

  3. Voice Handicap Index [ Time Frame: 2/16-2/20 ]
    Validitated questioners for dysphagia which result in a score

  4. Average Fundamental frequency [ Time Frame: 2/16-2/20 ]
    part of voice assessment, in Hertz

  5. Mean Fundamental frequency [ Time Frame: 2/16-2/20 ]
    part of voice assessment, in Hertz

  6. Highest Fundamental frequency [ Time Frame: 2/16-2/20 ]
    part of voice assessment, in Hertz

  7. Lowest Fundamental frequency [ Time Frame: 2/16-2/20 ]
    part of voice assessment, in Hertz

  8. Standard deviation of Fundamental frequency [ Time Frame: 2/16-2/20 ]
    part of voice assessment, in numbers

  9. Noise to harmonic ratio [ Time Frame: 2/16-2/20 ]
    part of voice assessment, a descripitive measure of voice quality

  10. Voice turbulence Index [ Time Frame: 2/16-2/20 ]
    part of voice assessment

  11. Absolute gitter [ Time Frame: 2/16-2/20 ]
    Variability of frequency

  12. Jitter percent [ Time Frame: 2/16-2/20 ]
    assessment of voice variability

  13. Shimmer percent [ Time Frame: 2/16-2/20 ]
    assessment of voice variability

  14. Shimmer in dB [ Time Frame: 2/16-2/20 ]
    variability of voice volume



Information from the National Library of Medicine

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Ages Eligible for Study:   18 Years and older   (Adult, Older Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
Sampling Method:   Non-Probability Sample
Study Population
Adults, 18 years and over, entended for Bariatric Surgery at Kaplan Medicle Center.
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
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Responsible Party: Dr Oded Cohen, Doctor, Kaplan Medical Center
ClinicalTrials.gov Identifier: NCT03070808    
Other Study ID Numbers: 0005-17-KMC
First Posted: March 6, 2017    Key Record Dates
Last Update Posted: March 6, 2017
Last Verified: February 2017
Individual Participant Data (IPD) Sharing Statement:
Plan to Share IPD: Undecided

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Studies a U.S. FDA-regulated Drug Product: No
Studies a U.S. FDA-regulated Device Product: No
Keywords provided by Dr Oded Cohen, Kaplan Medical Center:
obesity
voice
Additional relevant MeSH terms:
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Obesity, Morbid
Obesity
Overnutrition
Nutrition Disorders
Overweight
Body Weight