- ICH GCP
- US Clinical Trials Registry
- Clinical Trial NCT03070808
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
Conditions
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.
Sponsor
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
Additional Relevant MeSH Terms
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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