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Clinical Trial Details — Status: Not yet recruiting

Administrative data

NCT number NCT03568240
Other study ID # 0019-18-HYMC
Secondary ID
Status Not yet recruiting
Phase
First received
Last updated
Start date July 2018
Est. completion date July 2019

Study information

Verified date July 2018
Source Hillel Yaffe Medical Center
Contact Beata Greenberg, B.sc Biology
Phone 0545355084
Email BeataG@hy.health.gov.il
Is FDA regulated No
Health authority
Study type Observational

Clinical Trial 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.


Recruitment information / eligibility

Status Not yet recruiting
Enrollment 60
Est. completion date July 2019
Est. primary completion date July 2019
Accepts healthy volunteers Accepts Healthy Volunteers
Gender Male
Age group 18 Years to 120 Years
Eligibility 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 Design


Intervention

Diagnostic Test:
Patients suffering from Sleep apnea
PSG test

Locations

Country Name City State
n/a

Sponsors (1)

Lead Sponsor Collaborator
Hillel Yaffe Medical Center

Outcome

Type Measure Description Time frame Safety issue
Primary Compare differences in acoustic properties of phonetics i,a,u, n,m 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
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