Obstructive Sleep Apnea of AdultNCT03463785
Does Race Make a Difference in Obstructive Sleep Apnea?
An observational study of Obstructive Sleep Apnea of Adult, run by Academic Centre for Dentistry in Amsterdam at 2 sites in 2 countries.
Trial summary
Obstructive sleep apnea (OSA) is a sleep-related breathing disorder, often associated with a compromised upper airway space and an increase in upper airway collapsibility. The anatomical and functional abnormalities of the upper airway play an important role in the pathogenesis of OSA. Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Obstructive Sleep Apnea of Adult
- What is being tested?
- cone beam computed tomography
- How many people
- 58 participants
- Where
- 2 sitesin 2 countries
- Study dates
- 1 May 2017to 31 Dec 2024
- 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
- No healthy volunteers
- Adult, Older adult
Study population: the mild or moderate OSA patients with different racial background
Who may be able to join
- 18 years and older;
- Ability to speak, read, and write Dutch/Chinese;
- Ability to follow-up;
- Ability to use a computer with internet connection for online questionnaires;
- Diagnosis with symptomatic mild or moderate OSA (5 ≤ apnea-hypopnea index (AHI) < 30);
- Expected to maintain current lifestyle (sports, medicine, diet, etc.).
Who cannot join
- Untreated periodontal problems, dental pain, and a lack of retention possibilities for a MAD;
- Medication used/related to sleeping disorders;
- Evidence of respiratory/sleep disorders other than OSA (eg. central sleep apnea syndrome);
- Systemic disorders (based on medical history and examination; e.g. rheumatoid arthritis);
- Temporomandibular disorders (based on the function examination of the masticatory system);
- Medical history of known causes of tiredness by day, or severe sleep disruption (Insomnia, PLMS, Narcolepsy);
Show all 11Show fewer
- Known medical history of mental retardation, memory disorders, or psychiatric disorders.
- Reversible morphological upper airway abnormalities (e.g. enlarged tonsils);
- Inability to provide informed consent;
- simultaneous use of other modalities to treat OSA;
- Previous treatment with a MAD.
Trial locations and contacts
2 sites in 2 countries.
2 sites in 2 countries
About this study
Official title: The Role of Race in the Pathogenesis of Obstructive Sleep Apnea: Asians Versus Caucasians
Obstructive sleep apnea (OSA) is a sleep-related breathing disorder, often associated with a compromised upper airway space and an increase in upper airway collapsibility. The anatomical and functional abnormalities of the upper airway play an important role in the pathogenesis of OSA. It is hypothesized that there is racial variation in the craniofacial characteristics among OSA patients. However, inter-race comparisons based on previous studies can be problematic due to variation in measurements, OSA definitions and the sample size. Besides, to our best knowledge, there is no studies that made direct inter-race comparisons in the upper airway anatomy. Therefore, studies on inter-race comparisons of the upper airway characteristics are needed to further understand the role of race in the upper airway anatomy of the OSA patients. This would provide more insights into the pathophysiology of OSA, and could result in the development of new effective treatment strategies for OSA patients.
Read the detailed description
- Patient recruitment In The Netherlands, the participants will be recruited from the sleep center of the Sint Lucas Andreas hospital in Amsterdam. The protocol of recruiting the patients from The Netherlands is approved by Medical Ethic Committee of AMC with the reference number NL44085.018.13/COSH. In China, the participants will be recruited from the sleep disorder center of dental school of Shandong University. The protocol of recruiting patients from China is approved by Medical Ethic Committee of Shandong University. Patients that fit the inclusion criteria will be approached to participate in the study in both The Netherlands and China.
- Polysomnography (PSG) For the diagnosis of OSA, all the Chinese patients included in this study will undergo an overnight PSG recording (SOMNOscreenTM Plus PSG, Randersacker, Germany) at Qilu Hospital in Jinan, while all Dutch patients included in this study will undergo an overnight PSG recording (SOMNOscreenTM Plus PSG, Randersacker, Germany) in Amsterdam. PSG included the following variables: electroencephalogram, electro-oculogram, leg and chin electromyograms, electrocardiogram, pulse oximetry, body position, neck microphone, nasal cannula pressure transducer, and inductive plethysmography by means of thoracic and abdominal bands. The PSG recordings will be scored manually in a standard fashion. Apnea is defined as cession of airflow ≥90% for at least 10 seconds. Hypopnea is defined as a decrease in airflow of more than 30% for at least 10 seconds, and an oxygen desaturation greater than 4%. The mean apnea-hypopnea index (AHI) of the OSA group, defined as the number of apneas and hypopneas per hour of sleep.
- Cone beam computed tomography (CBCT) In The Netherlands, CBCT scans of the OSA patients will be made at the department of Oral Radiology at ACTA. In China, CBCT scans of the OSA patients will be made at the department of Oral Radiology at Shandong University. The protocol for CBCT images in The Netherlands and China will be identical and is as follows: CBCT scans will be taken in the participants with the Frankfort plane perpendicular to the floor during their awake periods. The participants will be instructed not to swallow, speak, or do any motor response other than breathing during the CBCT procedure. The image detector and beam are positioned to maximize coverage of the upper airway from the level of nasal choanae to approximately the inferior edge of the fourth cervical vertebra.
- Anatomical modeling of the upper airway Using Amira® (v4.1, Visage Imaging Inc., Carlsbad, CA, USA), the automatic process of the upper airway segmentation will be performed following the same protocol as in previous study. First, a voxel set is built to include all of the information of the upper airway; second, a new mask is built with its thresholds ranging from -1000 to -400; and third, the superior boundary (i.e., the plane across the PNS parallel to the FH plane) and the inferior boundary (i.e., the plane across the base of the epiglottis parallel to the FH plane) of the upper airway are selected in the corresponding axial planes and put into the voxel set. Finally, all of the slices between the upper and lower boundaries are selected and put into the voxel set.
- Statistical analysis Whether the data are normally distributed was tested by the Shapiro-Wilk W Test. The Mann-Whitney-U test (for non-normally distributed variables) or Chi-squared test (for categorical variables) and the independent t-test (for normally distributed variables) are used to compare the differences in the demographic characteristics between the Chinese and Caucasian OSA patients. Patient characteristics that are significantly different between the two groups will be used as covariate(s) in the following between-group analysis. One-way multivariate analysis of covariance (MANCOVA) is used to compare the differences in anatomical and aerodynamic characteristics between the Chinese and Caucasian OSA patients. A significance level is set at p<0.05.
- Conditions
- Obstructive Sleep Apnea of Adult
- Being tested
- cone beam computed tomography
- Keywords
- obstructive sleep apnea, race, upper airway, cone beam computed tomography
- 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.
cone beam computed tomographyOther
Also called Mandibular advancement device (MAD)
The CBCT data sets of both the Chinese and Dutch OSA patients will be obtained using a NewTom 5G CBCT system (QR systems, Verona, Italy), according to the standard imaging protocol. The OSA patients will be treated with mandibular advancement device.
| Study group | Role | What they receive |
|---|---|---|
| Chinese | Chinese mild or moderate OSA patients Receives: Other: cone beam computed tomography | |
| Dutch | Dutch mild or moderate OSA patients Receives: Other: cone beam computed tomography |
What is being measured
The primary outcome is the main question the study is designed to answer.
the minimum cross-sectional area of the upper airway
measurement of the smallest area on the cross-sectional plane
Measured: within a week after taking CBCT scan of the patient
Secondary outcomes (4)
the anterior-posterior dimension of CSAmin
the longest distance of CSAmin anterior-posteriorly
Measured: within a week after taking CBCT scan of the patient
the lateral dimension of CSAmin
the longest distance of CSAmin laterally
Measured: within a week after taking CBCT scan of the patient
the volume of the upper airway
the volume of the upper airway (from hard palate to the base of epiglottis)
Measured: within a week after taking CBCT scan of the patient
the length of the upper airway
the length of the upper airway (from hard palate to the base of epiglottis)
Measured: within a week after taking CBCT scan of the patient
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted13 Mar 2018
- Study start1 May 2017
- Primary completion31 Dec 2024
- Study completion31 Dec 2024
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 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
- 58 participants (actual)
Sponsor and investigators
- Lead sponsor
- Academic Centre for Dentistry in Amsterdam
- Sponsor type
- University, hospital or other
- Collaborators
- Shandong University
- Responsible party
- Principal investigator, Hui Chen, Academic Centre for Dentistry in Amsterdam
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT03463785
- Sponsor's protocol ID
- projectnummer 530-5CDP12
- Status last verified
- Jan 2025
- First submitted
- 7 Mar 2018
- Last updated
- 29 Jan 2025
- Results posted
- No
- Data monitoring committee
- Yes
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- Yes: all collected IPD, all IPD that underlie results in a publication will be shared.
Publications
Shi X, Chen H, Lobbezoo F, de Lange J, van der Stelt P, Berkhout E, Guo J, Ge S, Li G, Li Y, Aarab G. Comparison of the upper airway morphology between Dutch and Chinese adults with obstructive sleep apnea. Sleep Breath. 2023 Dec;27(6):2223-2230. doi: 10.1007/s11325-023-02834-z. Epub 2023 Apr 24.
PubMed 37093512
Study at a glance
From the registry record, last updated by the sponsor on 29 Jan 2025. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- The Role of Race in the Pathogenesis of Obstructive Sleep Apnea: Asians Versus Caucasians
- ClinicalTrials.gov ID
- NCT03463785
- Acronym / sponsor ID
- projectnummer 530-5CDP12
- Conditions
- Obstructive Sleep Apnea of Adult
- Keywords
- obstructive sleep apnea, race, upper airway, cone beam computed tomography
- Study type
- Observational
- Recruitment status
- Completed
- Enrolment
- 58 participants (actual)
- Lead sponsor
- Academic Centre for Dentistry in AmsterdamUniversity, hospital or other
- Collaborators
- Shandong University
- Study start
- 1 May 2017 (actual)
- Primary completion
- 31 Dec 2024 (actual)
- Study completion
- 31 Dec 2024 (actual)
- First posted
- 13 Mar 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.
Obstructive sleep apnea (OSA) is a sleep-related breathing disorder, often associated with a compromised upper airway space and an increase in upper airway collapsibility. The anatomical and functional abnormalities of the upper airway play an important role in the pathogenesis of OSA. It is hypothesized that there is racial variation in the craniofacial characteristics among OSA patients. However, inter-race comparisons based on previous studies can be problematic due to variation in measurements, OSA definitions and the sample size. Besides, to our best knowledge, there is no studies that made direct inter-race comparisons in the upper airway anatomy. Therefore, studies on inter-race comparisons of the upper airway characteristics are needed to further understand the role of race in the upper airway anatomy of the OSA patients. This would provide more insights into the pathophysiology of OSA, and could result in the development of new effective treatment strategies for OSA patients.
Detailed description
- Patient recruitment In The Netherlands, the participants will be recruited from the sleep center of the Sint Lucas Andreas hospital in Amsterdam. The protocol of recruiting the patients from The Netherlands is approved by Medical Ethic Committee of AMC with the reference number NL44085.018.13/COSH. In China, the participants will be recruited from the sleep disorder center of dental school of Shandong University. The protocol of recruiting patients from China is approved by Medical Ethic Committee of Shandong University. Patients that fit the inclusion criteria will be approached to participate in the study in both The Netherlands and China.
- Polysomnography (PSG) For the diagnosis of OSA, all the Chinese patients included in this study will undergo an overnight PSG recording (SOMNOscreenTM Plus PSG, Randersacker, Germany) at Qilu Hospital in Jinan, while all Dutch patients included in this study will undergo an overnight PSG recording (SOMNOscreenTM Plus PSG, Randersacker, Germany) in Amsterdam. PSG included the following variables: electroencephalogram, electro-oculogram, leg and chin electromyograms, electrocardiogram, pulse oximetry, body position, neck microphone, nasal cannula pressure transducer, and inductive plethysmography by means of thoracic and abdominal bands. The PSG recordings will be scored manually in a standard fashion. Apnea is defined as cession of airflow ≥90% for at least 10 seconds. Hypopnea is defined as a decrease in airflow of more than 30% for at least 10 seconds, and an oxygen desaturation greater than 4%. The mean apnea-hypopnea index (AHI) of the OSA group, defined as the number of apneas and hypopneas per hour of sleep.
- Cone beam computed tomography (CBCT) In The Netherlands, CBCT scans of the OSA patients will be made at the department of Oral Radiology at ACTA. In China, CBCT scans of the OSA patients will be made at the department of Oral Radiology at Shandong University. The protocol for CBCT images in The Netherlands and China will be identical and is as follows: CBCT scans will be taken in the participants with the Frankfort plane perpendicular to the floor during their awake periods. The participants will be instructed not to swallow, speak, or do any motor response other than breathing during the CBCT procedure. The image detector and beam are positioned to maximize coverage of the upper airway from the level of nasal choanae to approximately the inferior edge of the fourth cervical vertebra.
- Anatomical modeling of the upper airway Using Amira® (v4.1, Visage Imaging Inc., Carlsbad, CA, USA), the automatic process of the upper airway segmentation will be performed following the same protocol as in previous study. First, a voxel set is built to include all of the information of the upper airway; second, a new mask is built with its thresholds ranging from -1000 to -400; and third, the superior boundary (i.e., the plane across the PNS parallel to the FH plane) and the inferior boundary (i.e., the plane across the base of the epiglottis parallel to the FH plane) of the upper airway are selected in the corresponding axial planes and put into the voxel set. Finally, all of the slices between the upper and lower boundaries are selected and put into the voxel set.
- Statistical analysis Whether the data are normally distributed was tested by the Shapiro-Wilk W Test. The Mann-Whitney-U test (for non-normally distributed variables) or Chi-squared test (for categorical variables) and the independent t-test (for normally distributed variables) are used to compare the differences in the demographic characteristics between the Chinese and Caucasian OSA patients. Patient characteristics that are significantly different between the two groups will be used as covariate(s) in the following between-group analysis. One-way multivariate analysis of covariance (MANCOVA) is used to compare the differences in anatomical and aerodynamic characteristics between the Chinese and Caucasian OSA patients. A significance level is set at p<0.05.
Study design
- Observational model
- Cohort
- Time perspective
- Prospective
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Chinese | – | Other: cone beam computed tomographyChinese mild or moderate OSA patients |
| Dutch | – | Other: cone beam computed tomographyDutch mild or moderate OSA patients |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
- Study population
- the mild or moderate OSA patients with different racial background
Key inclusion criteria (6 listed)
- 18 years and older;
- Ability to speak, read, and write Dutch/Chinese;
- Ability to follow-up;
- Ability to use a computer with internet connection for online questionnaires;
- Diagnosis with symptomatic mild or moderate OSA (5 ≤ apnea-hypopnea index (AHI) < 30);
Key exclusion criteria (11 listed)
- Untreated periodontal problems, dental pain, and a lack of retention possibilities for a MAD;
- Medication used/related to sleeping disorders;
- Evidence of respiratory/sleep disorders other than OSA (eg. central sleep apnea syndrome);
- Systemic disorders (based on medical history and examination; e.g. rheumatoid arthritis);
- Temporomandibular disorders (based on the function examination of the masticatory system);
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 |
|---|---|---|
| cone beam computed tomographyAlso: Mandibular advancement device (MAD)The CBCT data sets of both the Chinese and Dutch OSA patients will be obtained using a NewTom 5G CBCT system (QR systems, Verona, Italy), according to the standard imaging protocol. The OSA patients will be treated with mandibular advancement device. | Other | Chinese, Dutch |
Primary outcome
the minimum cross-sectional area of the upper airway
Time frame: within a week after taking CBCT scan of the patient
measurement of the smallest area on the cross-sectional plane
4 secondary outcomes
the anterior-posterior dimension of CSAmin
Time frame: within a week after taking CBCT scan of the patient
the lateral dimension of CSAmin
Time frame: within a week after taking CBCT scan of the patient
the volume of the upper airway
Time frame: within a week after taking CBCT scan of the patient
the length of the upper airway
Time frame: within a week after taking CBCT scan of the patient
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 29 Jan 2025.
- Derived from this study: PubMed 37093512Shi X, Chen H, Lobbezoo F, de Lange J, van der Stelt P, Berkhout E, Guo J, Ge S, Li G, Li Y, Aarab G. Comparison of the upper airway morphology between Dutch and Chinese adults with obstructive sleep apnea. Sleep Breath. 2023 Dec;27(6):2223-2230. doi: 10.1007/s11325-023-02834-z. Epub 2023 Apr 24.
- Individual participant dataSharing planned: Yes. all collected IPD, all IPD that underlie results in a publication will be shared.
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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.
The record lists no contact. Use the official record to reach the sponsor.
2 sites in 2 countries: see every site and its status.
Questions about this trial
What is this clinical trial studying?
An observational study of Obstructive Sleep Apnea of Adult, run by Academic Centre for Dentistry in Amsterdam at 2 sites in 2 countries.
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 6 inclusion and 11 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 29 Jan 2025. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 2 sites in China, Netherlands. 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?
the minimum cross-sectional area of the upper airway (time frame: within a week after taking CBCT scan of the patient). 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 NCT03463785, 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 29 Jan 2025; AzTrials last refreshed its copy on 27 Oct 2026.