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

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.

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

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.

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