- ICH GCP
- US Clinical Trials Registry
- Clinical Trial NCT03568240
Voice Acoustic Properties in People With Obstructive Sleep Apnea Syndrome (OSAS)
July 4, 2018 updated by: Hillel Yaffe Medical Center
Voice Acoustic Properties in People With OSAS (Obstructive Sleep Apnea Syndrome)
The aim of this study is to examine whether voice acoustic properties has an influence on sleep apnea.
Sleep apnea syndrome is defined as a sudden stop of more than ten seconds multiple times during sleep.
The syndrome is common especially among men and occurs in 2%-4% of the population aged 30-60.
The syndrome diagnosis is performed by an ENT (Ear, Nose and Throat) physician.
The diagnosis is based on evaluation of anatomical structures in the sound path (nose and throat, jaw, pharynx and oral cavity) and a Polysomnography (PSG) test which quantifies the number and duration of breathing pauses during night sleep and additional parameters that monitor sleep.
The syndrome has many negative consequences for those who suffer from it, including fatigue , lack of concentration, hypertension, diabetes ,heart disease, stroke and even death.
Therefore, early diagnosis is important.
Study Overview
Status
Unknown
Conditions
Intervention / Treatment
Study Type
Observational
Enrollment (Anticipated)
60
Contacts and Locations
This section provides the contact details for those conducting the study, and information on where this study is being conducted.
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 to 120 years (Adult, Older Adult)
Accepts Healthy Volunteers
Yes
Genders Eligible for Study
Male
Sampling Method
Non-Probability Sample
Study Population
60 men patients
Description
Inclusion Criteria:
- 18 years and older men who meet the criteria for disorders such as apnea.
- 18 years old men and older who meet the criteria of snores based on screening questionnaires.
- 18 years old men and older who don't suffer from disorders such as apnea and do not suffer from snoring.
Exclusion Criteria:
- Smoking Patients or smoked in the past.
- Having neurological disorders.
- Having swallowing trouble.
- Having Respiratory problems.
- Having Neuroendocrine problems.
- Having Voice disorders.
- Patients who were previously head or/and neck operated
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
Cohorts and Interventions
Group / Cohort |
Intervention / Treatment |
---|---|
30 men suffering from apnea
|
PSG test
|
15 men defined as snorers
|
PSG test
|
15 men without complaints
|
PSG test
|
What is the study measuring?
Primary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
---|---|---|
Compare differences in acoustic properties of phonetics i,a,u, n,m
Time Frame: half hour
|
Subjects will be recorded in a variety of positions expressing the phonetics i,a,u, n,m.
and the results will be documented and compared.
|
half hour
|
Collaborators and Investigators
This is where you will find people and organizations involved with this study.
Sponsor
Investigators
- Principal Investigator: Itzhak Braverman, MD, Hillel Yaffe Medical Center
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)
July 1, 2018
Primary Completion (Anticipated)
July 1, 2019
Study Completion (Anticipated)
July 1, 2019
Study Registration Dates
First Submitted
May 30, 2018
First Submitted That Met QC Criteria
June 20, 2018
First Posted (Actual)
June 26, 2018
Study Record Updates
Last Update Posted (Actual)
July 6, 2018
Last Update Submitted That Met QC Criteria
July 4, 2018
Last Verified
July 1, 2018
More Information
Terms related to this study
Additional Relevant MeSH Terms
Other Study ID Numbers
- 0019-18-HYMC
Plan for Individual participant data (IPD)
Plan to Share Individual Participant Data (IPD)?
NO
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.
Clinical Trials on Obstructive Sleep Apnea of Adult
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Cryosa, Inc.Active, not recruitingObstructive Sleep Apnea of AdultPanama, Paraguay
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State Key Laboratory of Respiratory DiseaseCompletedObstructive Sleep Apnea of AdultChina
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Instituto Nacional de Ciencias Medicas y Nutricion...Emory University; Universidad Nacional Autonoma de MexicoRecruitingObstructive Sleep Apnea of AdultMexico
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Northwestern UniversitySibel Health Inc.Completed
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Arizona State UniversityMayo Clinic; National Institute of Nursing Research (NINR)CompletedObstructive Sleep Apnea of AdultUnited States
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Cryosa, Inc.RecruitingObstructive Sleep Apnea of AdultPanama
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Idorsia Pharmaceuticals Ltd.CompletedObstructive Sleep Apnea of AdultGermany
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Essam FathiCompletedObstructive Sleep Apnea of AdultEgypt
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Nyxoah S.A.Nyxoah Pty. Ltd.Not yet recruitingObstructive Sleep Apnea of AdultAustralia
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University Hospital, MontpellierCompletedRecent Acute Myocardial InfarctionFrance
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Taipei Veterans General Hospital, TaiwanMinistry of Science and Technology, TaiwanNot yet recruiting
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