NCT03568240

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.

Trial Health

35
At Risk

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Trial has exceeded expected completion date
Enrollment
60

participants targeted

Target at P25-P50 for all trials

Timeline
Completed

Started Jul 2018

Shorter than P25 for all trials

Status
unknown

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

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Study Timeline

Key milestones and dates

First Submitted

Initial submission to the registry

May 30, 2018

Completed
27 days until next milestone

First Posted

Study publicly available on registry

June 26, 2018

Completed
5 days until next milestone

Study Start

First participant enrolled

July 1, 2018

Completed
1 year until next milestone

Primary Completion

Last participant's last visit for primary outcome

July 1, 2019

Completed
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

July 1, 2019

Completed
Last Updated

July 6, 2018

Status Verified

July 1, 2018

Enrollment Period

1 year

First QC Date

May 30, 2018

Last Update Submit

July 4, 2018

Conditions

Outcome Measures

Primary Outcomes (1)

  • 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

Study Arms (3)

30 men suffering from apnea

Diagnostic Test: Patients suffering from Sleep apnea

15 men defined as snorers

Diagnostic Test: Patients suffering from Sleep apnea

15 men without complaints

Diagnostic Test: Patients suffering from Sleep apnea

Interventions

PSG test

15 men defined as snorers15 men without complaints30 men suffering from apnea

Eligibility Criteria

Age18 Years - 120 Years
Sexmale
Healthy VolunteersYes
Age GroupsAdult (18-64), Older Adult (65+)
Sampling MethodNon-Probability Sample
Study Population

60 men patients

You may qualify if:

  • years and older men who meet the criteria for disorders such as apnea.
  • years old men and older who meet the criteria of snores based on screening questionnaires.
  • years old men and older who don't suffer from disorders such as apnea and do not suffer from snoring.

You may not qualify if:

  • 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

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Officials

  • Itzhak Braverman, MD

    Hillel Yaffe Medical Center

    PRINCIPAL INVESTIGATOR

Central Study Contacts

Beata Greenberg, B.sc Biology

CONTACT

Adi Klein, M.A

CONTACT

Study Design

Study Type
observational
Observational Model
COHORT
Time Perspective
PROSPECTIVE
Sponsor Type
OTHER GOV
Responsible Party
SPONSOR

Study Record Dates

First Submitted

May 30, 2018

First Posted

June 26, 2018

Study Start

July 1, 2018

Primary Completion

July 1, 2019

Study Completion

July 1, 2019

Last Updated

July 6, 2018

Record last verified: 2018-07

Data Sharing

IPD Sharing
Will not share