Obesity, MorbidNCT03070808
The Influence of Significant Weight Lost on the Quality of Voice
An observational study of Obesity, Morbid and Voice Alteration, run by Kaplan Medical Center.
Trial 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. Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Obesity, Morbid, Voice Alteration
- How many people
- 50 participants
- Where
- No sites listed yet
- Study dates
- 15 Mar 2017to 15 Sep 2018
- Phase
- Observational
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 years and older
- All sexes
- No healthy volunteers
- Adult, Older adult
Study population: Adults, 18 years and over, entended for Bariatric Surgery at Kaplan Medicle Center.
Who may be able to join
- Morbid obese
- Candidates for bariatric Surgery
Who cannot join
- 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
About this study
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.
- Conditions
- Obesity, Morbid, Voice Alteration
- Keywords
- obesity, voice
- Medical subject headings
- Obesity, Morbid, Dysphonia, Obesity
What is being measured
The primary outcome is the main question the study is designed to answer.
Stroboscopic evaluation of the larynx
A visual examination of the larynx
Measured: 2/16-2/20
Secondary outcomes (14)
Dysphagia handicap Index
Validitated questioners for dysphagia which result in a score
Measured: 2/16-2/20
EAT 10
Validitated questioners for dysphagia which result in a score
Measured: 2/16-2/20
Voice Handicap Index
Validitated questioners for dysphagia which result in a score
Measured: 2/16-2/20
Average Fundamental frequency
part of voice assessment, in Hertz
Measured: 2/16-2/20
Mean Fundamental frequency
part of voice assessment, in Hertz
Measured: 2/16-2/20
Highest Fundamental frequency
part of voice assessment, in Hertz
Measured: 2/16-2/20
Lowest Fundamental frequency
part of voice assessment, in Hertz
Measured: 2/16-2/20
Standard deviation of Fundamental frequency
part of voice assessment, in numbers
Measured: 2/16-2/20
Noise to harmonic ratio
part of voice assessment, a descripitive measure of voice quality
Measured: 2/16-2/20
Voice turbulence Index
part of voice assessment
Measured: 2/16-2/20
Absolute gitter
Variability of frequency
Measured: 2/16-2/20
Jitter percent
assessment of voice variability
Measured: 2/16-2/20
Shimmer percent
assessment of voice variability
Measured: 2/16-2/20
Shimmer in dB
variability of voice volume
Measured: 2/16-2/20
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted6 Mar 2017
- Study start15 Mar 2017 (estimated)
- Primary completion15 Mar 2018 (estimated)
- Study completion15 Sep 2018 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Obesity, MorbidStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Observational
- Observational model
- Other
- Time perspective
- Prospective
- Enrolment
- 50 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Kaplan Medical Center
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Dr Oded Cohen, Kaplan Medical Center
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT03070808
- Sponsor's protocol ID
- 0005-17-KMC
- Status last verified
- Feb 2017
- First submitted
- 21 Feb 2017
- Last updated
- 6 Mar 2017
- Results posted
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- Undecided
Study at a glance
From the registry record, last updated by the sponsor on 6 Mar 2017. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- The Influence of Significant Weight Lost on the Quality of Voice
- ClinicalTrials.gov ID
- NCT03070808
- Acronym / sponsor ID
- 0005-17-KMC
- Conditions
- Obesity, Morbid, Voice Alteration
- Keywords
- obesity, voice
- Study type
- Observational
- Recruitment status
- Unknown status
- Enrolment
- 50 participants (estimated)
- Lead sponsor
- Kaplan Medical CenterUniversity, hospital or other
- Study start
- 15 Mar 2017 (estimated)
- Primary completion
- 15 Mar 2018 (estimated)
- Study completion
- 15 Sep 2018 (estimated)
- First posted
- 6 Mar 2017 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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 design
- Observational model
- Other
- Time perspective
- Prospective
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
- Study population
- Adults, 18 years and over, entended for Bariatric Surgery at Kaplan Medicle Center.
Key inclusion criteria (2 listed)
- Morbid obese
- Candidates for bariatric Surgery
Key exclusion criteria (4 listed)
- 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
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Primary outcome
Stroboscopic evaluation of the larynx
Time frame: 2/16-2/20
A visual examination of the larynx
14 secondary outcomes
Dysphagia handicap Index
Time frame: 2/16-2/20
EAT 10
Time frame: 2/16-2/20
Voice Handicap Index
Time frame: 2/16-2/20
Average Fundamental frequency
Time frame: 2/16-2/20
Mean Fundamental frequency
Time frame: 2/16-2/20
Highest Fundamental frequency
Time frame: 2/16-2/20
Lowest Fundamental frequency
Time frame: 2/16-2/20
Standard deviation of Fundamental frequency
Time frame: 2/16-2/20
Noise to harmonic ratio
Time frame: 2/16-2/20
Voice turbulence Index
Time frame: 2/16-2/20
Absolute gitter
Time frame: 2/16-2/20
Jitter percent
Time frame: 2/16-2/20
Shimmer percent
Time frame: 2/16-2/20
Shimmer in dB
Time frame: 2/16-2/20
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 6 Mar 2017.
- Individual participant dataSharing planned: Undecided
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
The record lists no contact. Use the official record to reach the sponsor.
Questions about this trial
What is this clinical trial studying?
An observational study of Obesity, Morbid and Voice Alteration, run by Kaplan Medical Center.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 2 inclusion and 4 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: status not confirmed, as of the sponsor's last update on 6 Mar 2017. Status can change between updates, so confirm with the study contact before making plans.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
Results are not available in the source record.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Stroboscopic evaluation of the larynx (time frame: 2/16-2/20). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 6 Mar 2017.