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Voice Acoustic Properties in People With Obstructive Sleep Apnea Syndrome (OSAS)

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ClinicalTrials.gov Identifier: NCT03568240
Recruitment Status : Unknown
Verified July 2018 by Hillel Yaffe Medical Center.
Recruitment status was:  Not yet recruiting
First Posted : June 26, 2018
Last Update Posted : July 6, 2018
Sponsor:
Information provided by (Responsible Party):
Hillel Yaffe Medical Center

Study Description
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Brief Summary:
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.

Condition or disease Intervention/treatment
Obstructive Sleep Apnea of Adult Diagnostic Test: Patients suffering from Sleep apnea

Study Design
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Study Type : Observational
Estimated Enrollment : 60 participants
Observational Model: Cohort
Time Perspective: Prospective
Official Title: Voice Acoustic Properties in People With OSAS (Obstructive Sleep Apnea Syndrome)
Estimated Study Start Date : July 2018
Estimated Primary Completion Date : July 2019
Estimated Study Completion Date : July 2019

Resource links provided by the National Library of Medicine

MedlinePlus related topics: Sleep Apnea

Groups and Cohorts
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Group/Cohort Intervention/treatment
30 men suffering from apnea Diagnostic Test: Patients suffering from Sleep apnea
PSG test
15 men defined as snorers Diagnostic Test: Patients suffering from Sleep apnea
PSG test
15 men without complaints Diagnostic Test: Patients suffering from Sleep apnea
PSG test


Outcome Measures
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Primary Outcome Measures :
  1. 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.


Eligibility Criteria
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Ages Eligible for Study:   18 Years to 120 Years   (Adult, Older Adult)
Sexes Eligible for Study:   Male
Accepts Healthy Volunteers:   Yes
Sampling Method:   Non-Probability Sample
Study Population
60 men patients
Criteria

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
Contacts and Locations
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Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT03568240


Contacts
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Contact: Beata Greenberg, B.sc Biology 0545355084 ext +972 BeataG@hy.health.gov.il
Contact: Adi Klein, M.A 0522147213 ext +972 AdiK@hy.health.gov.il

Sponsors and Collaborators
Hillel Yaffe Medical Center
Investigators
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Principal Investigator: Itzhak Braverman, MD Hillel Yaffe Medical Center
More Information
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Responsible Party: Hillel Yaffe Medical Center
ClinicalTrials.gov Identifier: NCT03568240    
Other Study ID Numbers: 0019-18-HYMC
First Posted: June 26, 2018    Key Record Dates
Last Update Posted: July 6, 2018
Last Verified: July 2018
Individual Participant Data (IPD) Sharing Statement:
Plan to Share IPD: No

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Studies a U.S. FDA-regulated Drug Product: No
Studies a U.S. FDA-regulated Device Product: No
Additional relevant MeSH terms:
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Apnea
Sleep Apnea Syndromes
Sleep Apnea, Obstructive
Respiration Disorders
Respiratory Tract Diseases
 Signs and Symptoms, Respiratory
Sleep Disorders, Intrinsic
Dyssomnias
Sleep Wake Disorders
Nervous System Diseases