Obstructive Sleep Apnea of AdultNCT03568240
Voice Acoustic Properties in People With Obstructive Sleep Apnea Syndrome (OSAS)
An observational study of Obstructive Sleep Apnea of Adult, run by Hillel Yaffe Medical Center.
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. Read more about this study
- Who is it for?
- Ages 18 to 120 years, men onlyHealthy volunteers can take part
- Conditions the study is for
- Obstructive Sleep Apnea of Adult
- What is being tested?
- Patients suffering from Sleep apnea
- How many people
- 60 participants
- Where
- No sites listed yet
- Study dates
- Jul 2018to Jul 2019
- Phase
- Observational
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 to 120 years
- Men only
- Healthy volunteers accepted
- Adult, Older adult
Study population: 60 men patients
Who may be able to join
- 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.
Who cannot join
- 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
Trial locations and contacts
No sites are listed yet.
About this study
Official title: 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.
- Conditions
- Obstructive Sleep Apnea of Adult
- Being tested
- Patients suffering from Sleep apnea
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Patients suffering from Sleep apneaDiagnostic test
PSG test
| Study group | Role | What they receive |
|---|---|---|
| 30 men suffering from apnea | Not described Receives: Diagnostic Test: Patients suffering from Sleep apnea | |
| 15 men defined as snorers | Not described Receives: Diagnostic Test: Patients suffering from Sleep apnea | |
| 15 men without complaints | Not described Receives: Diagnostic Test: Patients suffering from Sleep apnea |
What is being measured
The primary outcome is the main question the study is designed to answer.
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.
Measured: half hour
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted26 Jun 2018
- Study startJul 2018 (estimated)
- Primary completionJul 2019 (estimated)
- Study completionJul 2019 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Obstructive Sleep Apnea of AdultStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Observational
- Observational model
- Cohort
- Time perspective
- Prospective
- Enrolment
- 60 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Hillel Yaffe Medical Center
- Sponsor type
- Other government
- Responsible party
- Sponsor
- Investigators
- Itzhak Braverman, MD, Principal investigator, Hillel Yaffe Medical Center
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT03568240
- Sponsor's protocol ID
- 0019-18-HYMC
- Status last verified
- Jul 2018
- First submitted
- 30 May 2018
- Last updated
- 6 Jul 2018
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Study at a glance
From the registry record, last updated by the sponsor on 6 Jul 2018. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Voice Acoustic Properties in People With OSAS (Obstructive Sleep Apnea Syndrome)
- ClinicalTrials.gov ID
- NCT03568240
- Acronym / sponsor ID
- 0019-18-HYMC
- Conditions
- Obstructive Sleep Apnea of Adult
- Study type
- Observational
- Recruitment status
- Unknown status
- Enrolment
- 60 participants (estimated)
- Lead sponsor
- Hillel Yaffe Medical CenterOther government
- Study start
- Jul 2018 (estimated)
- Primary completion
- Jul 2019 (estimated)
- Study completion
- Jul 2019 (estimated)
- First posted
- 26 Jun 2018 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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 design
- Observational model
- Cohort
- Time perspective
- Prospective
- Number of arms
- 3
| Arm | Type | Receives |
|---|---|---|
| 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 |
Who may qualify
- Ages
- 18 to 120 years
- Sex
- Male only
- Healthy volunteers
- Accepted
- Age groups
- Adult, Older adult
- Study population
- 60 men patients
Key inclusion criteria (3 listed)
- 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.
Key exclusion criteria (7 listed)
- Smoking Patients or smoked in the past.
- Having neurological disorders.
- Having swallowing trouble.
- Having Respiratory problems.
- Having Neuroendocrine problems.
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Patients suffering from Sleep apneaPSG test | Diagnostic test | 15 men defined as snorers, 15 men without complaints, 30 men suffering from apnea |
Primary outcome
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.
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 6 Jul 2018.
- Individual participant dataSharing planned: No
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Itzhak Braverman, MD principal investigator
Hillel Yaffe Medical Center
Questions about this trial
What is this clinical trial studying?
An observational study of Obstructive Sleep Apnea of Adult, run by Hillel Yaffe Medical Center.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 3 inclusion and 7 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: status not confirmed, as of the sponsor's last update on 6 Jul 2018. Status can change between updates, so confirm with the study contact before making plans.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
Results are not available in the source record.
How can a doctor refer a patient or contact the research team?
Contact Beata Greenberg, B.sc Biology (0545355084 ext. +972, BeataG@hy.health.gov.il), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Compare differences in acoustic properties of phonetics i,a,u, n,m (time frame: half hour). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 6 Jul 2018.