Obstructive Sleep ApneaNCT03832244
The Role of Sub-mental Ultrasonography in Diagnosing Obstructive Sleep Apnea and Its Correlation With Subjective Scales
An observational study of Obstructive Sleep Apnea and Diagnostic Imaging, run by Bartin State Hospital at 1 site in Turkey (Türkiye).
Trial summary
The investigators hypothesize that sub-mental ultrasonography measures are strongly correlated with the severity of Obstructive Sleep Apnea Syndrome and the related specific subjective scales. Read more about this study
- Who is it for?
- Ages 18 years and olderHealthy volunteers can take part
- Conditions the study is for
- Obstructive Sleep Apnea, Diagnostic Imaging, Ultrasound
- What is being tested?
- Sub-mental ultrasonography
- How many people
- 199 participants
- Where
- 1 siteTurkey (Türkiye)
- Study dates
- 22 Apr 2019to 24 Jan 2021
- 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 years and older
- All sexes
- Healthy volunteers accepted
- Adult, Older adult
Study population: * For study group: Patients who have been diagnosed as having obstructive sleep apnea on polysomnography * For control group: Patients who have a negative polysomnography or normal scores from subjective scales
Who may be able to join
- Patient who consented for sub-mental ultrasound
Who cannot join
- Any pharyngo laryngeal anatomic abnormality
- Previous history of Obstructive sleep apnea treatment
- Previous history of surgical intervention to the pharyngo laryngeal anatomic area
Trial locations and contacts
1 site in 1 country.
About this study
The investigators hypothesize that sub-mental ultrasonography measures are strongly correlated with the severity of Obstructive Sleep Apnea Syndrome and the related specific subjective scales.
Read the detailed description
Polysomnography (PSG) is the gold-standard diagnose tool for Obstructive Sleep Apnea (OSA). However, the availability of PSG is limited, particularly in developing and / or least developed countries. Sub-mental ultrasonography is stepped forward with its practical and cheap nature and its widespread use.
The investigators aimed to perform sub-mental ultrasonography to the patients who underwent to PSG by a blind-to-the-PSG-results radiologist and analyse the correlation between ultrasound measures, Apnea-Hypopnea Index (measured by Polysomnography) and subjective OSA scales.
- Conditions
- Obstructive Sleep Apnea, Diagnostic Imaging, Ultrasound
- Being tested
- Sub-mental ultrasonography
- Keywords
- sub-mental ultrasonography, obstructive sleep apnea
- Medical subject headings
- Sleep Apnea, Obstructive
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Sub-mental ultrasonographyDiagnostic test
Sub-mental ultrasonography including tongue-base thickness, retropalatal distance and the distance between lingual arteries
| Study group | Role | What they receive |
|---|---|---|
| Simple snoring | Patients undergoing to Sub-mental ultrasonography with Normal sleep: Fewer than 5 events per hour measured in over-night polysomnography Receives: Diagnostic Test: Sub-mental ultrasonography | |
| Mild OSA | Patients undergoing to Sub-mental ultrasonography with Mild sleep apnea: 5 to 14 events per hour measured in over-night polysomnography Receives: Diagnostic Test: Sub-mental ultrasonography | |
| Moderate OSA | Patients undergoing to Sub-mental ultrasonography with Moderate sleep apnea: 15 to 29 events per hour measured in over-night polysomnography Receives: Diagnostic Test: Sub-mental ultrasonography | |
| Severe OSA | Patients undergoing to Sub-mental ultrasonography with Severe sleep apnea: 30 or more events per hour measured in over-night polysomnography Receives: Diagnostic Test: Sub-mental ultrasonography |
What is being measured
The primary outcome is the main question the study is designed to answer.
Tongue base thickness
The closest distance between tongue base and the skin in the sagittal plane
Measured: Baseline
Retropalatal distance
The diameter of retropalatal space in the transverse dimension
Measured: Baseline
Distance between lingual arteries
Distance between lingual arteries in the transverse plane
Measured: Baseline
Secondary outcomes (5)
Stop-Bang questionnaire
This questionnaire evaluates the risk of sleep apnea. Low risk of OSA: Yes to 0-2 questions Intermediate risk of OSA: Yes to 3-4 questions High risk of OSA: Yes to 5-8 questions or Yes to 2 or more of 4 STOP questions + male gender or Yes to 2 or more of 4 STOP questions + BMI > 35 kg/m2 or Yes to 2 or more of 4 STOP questions + neck circumference.
Measured: Baseline
Berlin Questionnaire
The questionnaire consists of 3 categories related to the risk of having sleep apnea.
Category 1 is positive if the total score is 2 or more points. Category 2 is positive if the total score is 2 or more points. Category 3 is positive if the answer to item 10 is 'Yes' or if the BMI of the patient is greater than 30kg/m2. (BMI is defined as weight (kg) divided by height (m) squared, i.e.., kg/m2). Patients can be classified into High Risk or Low Risk based on their responses to the individual items and their overall scores in the symptom categories. High Risk: if there are 2 or more categories where the score is positive. Low Risk: if there is only 1 or no categories where the score is positive. Total score is ranged between 0-3.
Measured: Baseline
Pittsburgh Sleep Quality Index (PSQI)
The order of the PSQI items has been modified from the original order in order to fit the first 9 items (which are the only items that contribute to the total score) on a single page. Item 10, which is the second page of the scale, does not contribute to the PSQI score. In scoring the PSQI, seven component scores are derived, each scored 0 (no difficulty) to 3 (severe difficulty). The component scores are summed to produce a global score (range 0 to 21). Higher scores indicate worse sleep quality.
Measured: Baseline
Neck circumference
Neck circumference was measured with the head erect and eyes facing forward, horizontally at the upper margin of the thyroid cartilage (to the nearest 0.1 cm)
Measured: Baseline
The thyromental distance
The thyromental distance is defined as the distance from the chin (mentum) to the top of the notch of the thyroid cartilage with the head fully extended. It is measured with a ruler
Measured: Baseline
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted6 Feb 2019
- Study start22 Apr 2019
- Primary completion20 Apr 2020
- Study completion24 Jan 2021
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (1)Papers the sponsor has linked to this study.
- Other trials for Obstructive Sleep ApneaStudies 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
- Cross-sectional
- Enrolment
- 199 participants (actual)
Sponsor and investigators
- Lead sponsor
- Bartin State Hospital
- Sponsor type
- Other government
- Responsible party
- Principal investigator, Ozgeyagcioglu Yassa, Bartin State Hospital
- Investigators
- Ozge Yagcioglu Yassa, M.D., Principal investigator, Coordinator of Sleep Disorders Centre of Bartin State Hospital
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT03832244
- Sponsor's protocol ID
- BartinUyku
- Status last verified
- Jan 2021
- First submitted
- 3 Feb 2019
- Last updated
- 26 Jan 2021
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Publications
Shu CC, Lee P, Lin JW, Huang CT, Chang YC, Yu CJ, Wang HC. The use of sub-mental ultrasonography for identifying patients with severe obstructive sleep apnea. PLoS One. 2013 May 10;8(5):e62848. doi: 10.1371/journal.pone.0062848. Print 2013.
PubMed 23675433
Study at a glance
From the registry record, last updated by the sponsor on 26 Jan 2021. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- The Role of Sub-mental Ultrasonography in Diagnosing Obstructive Sleep Apnea and Its Correlation With Subjective Scales
- ClinicalTrials.gov ID
- NCT03832244
- Acronym / sponsor ID
- BartinUyku
- Conditions
- Obstructive Sleep Apnea, Diagnostic Imaging, Ultrasound
- Keywords
- sub-mental ultrasonography, obstructive sleep apnea
- Study type
- Observational
- Recruitment status
- Completed
- Enrolment
- 199 participants (actual)
- Lead sponsor
- Bartin State HospitalOther government
- Study start
- 22 Apr 2019 (actual)
- Primary completion
- 20 Apr 2020 (actual)
- Study completion
- 24 Jan 2021 (actual)
- First posted
- 6 Feb 2019 (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 investigators hypothesize that sub-mental ultrasonography measures are strongly correlated with the severity of Obstructive Sleep Apnea Syndrome and the related specific subjective scales.
Detailed description
Polysomnography (PSG) is the gold-standard diagnose tool for Obstructive Sleep Apnea (OSA). However, the availability of PSG is limited, particularly in developing and / or least developed countries. Sub-mental ultrasonography is stepped forward with its practical and cheap nature and its widespread use.
The investigators aimed to perform sub-mental ultrasonography to the patients who underwent to PSG by a blind-to-the-PSG-results radiologist and analyse the correlation between ultrasound measures, Apnea-Hypopnea Index (measured by Polysomnography) and subjective OSA scales.
Study design
- Observational model
- Cohort
- Time perspective
- Cross-sectional
- Number of arms
- 4
| Arm | Type | Receives |
|---|---|---|
| Simple snoring | – | Diagnostic Test: Sub-mental ultrasonographyPatients undergoing to Sub-mental ultrasonography with Normal sleep: Fewer than 5 events per hour measured in over-night polysomnography |
| Mild OSA | – | Diagnostic Test: Sub-mental ultrasonographyPatients undergoing to Sub-mental ultrasonography with Mild sleep apnea: 5 to 14 events per hour measured in over-night polysomnography |
| Moderate OSA | – | Diagnostic Test: Sub-mental ultrasonographyPatients undergoing to Sub-mental ultrasonography with Moderate sleep apnea: 15 to 29 events per hour measured in over-night polysomnography |
| Severe OSA | – | Diagnostic Test: Sub-mental ultrasonographyPatients undergoing to Sub-mental ultrasonography with Severe sleep apnea: 30 or more events per hour measured in over-night polysomnography |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Adult, Older adult
- Study population
- * For study group: Patients who have been diagnosed as having obstructive sleep apnea on polysomnography * For control group: Patients who have a negative polysomnography or normal scores from subjective scales
Key inclusion criteria (1 listed)
- Patient who consented for sub-mental ultrasound
Key exclusion criteria (3 listed)
- Any pharyngo laryngeal anatomic abnormality
- Previous history of Obstructive sleep apnea treatment
- Previous history of surgical intervention to the pharyngo laryngeal anatomic area
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 |
|---|---|---|
| Sub-mental ultrasonographySub-mental ultrasonography including tongue-base thickness, retropalatal distance and the distance between lingual arteries | Diagnostic test | Mild OSA, Moderate OSA, Severe OSA, Simple snoring |
Primary outcome
Tongue base thickness
Time frame: Baseline
The closest distance between tongue base and the skin in the sagittal plane
Retropalatal distance
Time frame: Baseline
The diameter of retropalatal space in the transverse dimension
Distance between lingual arteries
Time frame: Baseline
Distance between lingual arteries in the transverse plane
5 secondary outcomes
Stop-Bang questionnaire
Time frame: Baseline
Berlin Questionnaire
Time frame: Baseline
Pittsburgh Sleep Quality Index (PSQI)
Time frame: Baseline
Neck circumference
Time frame: Baseline
The thyromental distance
Time frame: Baseline
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 26 Jan 2021.
- Results publication: PubMed 23675433Shu CC, Lee P, Lin JW, Huang CT, Chang YC, Yu CJ, Wang HC. The use of sub-mental ultrasonography for identifying patients with severe obstructive sleep apnea. PLoS One. 2013 May 10;8(5):e62848. doi: 10.1371/journal.pone.0062848. Print 2013.
- Individual participant dataSharing planned: No
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A Study to Learn About the Monthly Dosing Study Medicine Called Berobenatide in Adults With Breathing Problems During Sleep and Overweight or Obesity Who Do Not Use a Breathing Machine (PAP) (VESPER-OSA 2)
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Not yet recruitingPhase 2
Supplemental Oxygen for Sleep-Disordered Breathing in Adults With Chronic Opioid Use.
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Nightly Wearable Monitoring During Home-Based Submental Electrical Stimulation for Obstructive Sleep Apnea
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Obstructive Sleep Apnea
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.
Ozge Yagcioglu Yassa, M.D. principal investigator
Coordinator of Sleep Disorders Centre of Bartin State Hospital
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
An observational study of Obstructive Sleep Apnea and Diagnostic Imaging, run by Bartin State Hospital at 1 site in Turkey (Türkiye).
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 1 inclusion and 3 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: finished, as of the sponsor's last update on 26 Jan 2021. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in Turkey (Türkiye). Whether a site is taking part right now should be confirmed with that site. See every site.
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?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Tongue base thickness (time frame: Baseline). The study lists 3 primary outcomes in all. It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT03832244, which also lists 1 linked publication.
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 26 Jan 2021.