Clinical Trials Logo

Clinical Trial Details — Status: Recruiting

Administrative data

NCT number NCT03463785
Other study ID # projectnummer 530-5CDP12
Secondary ID
Status Recruiting
Phase
First received
Last updated
Start date May 1, 2017
Est. completion date October 1, 2023

Study information

Verified date January 2023
Source Academic Centre for Dentistry in Amsterdam
Contact Hui Chen, PhD
Phone +8615562661031
Email huichen1989313@163.com
Is FDA regulated No
Health authority
Study type Observational

Clinical 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. 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.


Description:

1. 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. 2. 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. 3. 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. 4. 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. 5. 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.


Recruitment information / eligibility

Status Recruiting
Enrollment 50
Est. completion date October 1, 2023
Est. primary completion date July 1, 2023
Accepts healthy volunteers No
Gender All
Age group 18 Years and older
Eligibility Inclusion Criteria: 1. 18 years and older; 2. Ability to speak, read, and write Dutch/Chinese; 3. Ability to follow-up; 4. Ability to use a computer with internet connection for online questionnaires; 5. Diagnosis with symptomatic mild or moderate OSA (5 = apnea-hypopnea index (AHI) < 30); 6. Expected to maintain current lifestyle (sports, medicine, diet, etc.). Exclusion Criteria: 1. Untreated periodontal problems, dental pain, and a lack of retention possibilities for a MAD; 2. Medication used/related to sleeping disorders; 3. Evidence of respiratory/sleep disorders other than OSA (eg. central sleep apnea syndrome); 4. Systemic disorders (based on medical history and examination; e.g. rheumatoid arthritis); 5. Temporomandibular disorders (based on the function examination of the masticatory system); 6. Medical history of known causes of tiredness by day, or severe sleep disruption (Insomnia, PLMS, Narcolepsy); 7. Known medical history of mental retardation, memory disorders, or psychiatric disorders. 8. Reversible morphological upper airway abnormalities (e.g. enlarged tonsils); 9. Inability to provide informed consent; 10. simultaneous use of other modalities to treat OSA; 11. Previous treatment with a MAD.

Study Design


Intervention

Other:
cone beam computed tomography
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.

Locations

Country Name City State
China Dentistry Jinan Shandong
Netherlands Dentistry Amsterdam

Sponsors (2)

Lead Sponsor Collaborator
Academic Centre for Dentistry in Amsterdam Shandong University

Countries where clinical trial is conducted

China,  Netherlands, 

Outcome

Type Measure Description Time frame Safety issue
Primary the minimum cross-sectional area of the upper airway measurement of the smallest area on the cross-sectional plane within a week after taking CBCT scan of the patient
Secondary the anterior-posterior dimension of CSAmin the longest distance of CSAmin anterior-posteriorly within a week after taking CBCT scan of the patient
Secondary the lateral dimension of CSAmin the longest distance of CSAmin laterally within a week after taking CBCT scan of the patient
Secondary the volume of the upper airway the volume of the upper airway (from hard palate to the base of epiglottis) within a week after taking CBCT scan of the patient
Secondary the length of the upper airway the length of the upper airway (from hard palate to the base of epiglottis) within a week after taking CBCT scan of the patient
See also
  Status Clinical Trial Phase
Recruiting NCT05489562 - Use of Intraoral Suction and Its Effects on Obstructive Sleep Apnea N/A
Recruiting NCT05717959 - Efficacy of Oropharyngeal Exercises for Patients With Obstructive Sleep Apnea Using Mandibular Advancement Device N/A
Recruiting NCT06008626 - Clinical Trial of the Cryosa System for the Treatment of Obstructive Sleep Apnea N/A
Completed NCT03122639 - Endothelial Function in Obstructive Sleep Apnea Early Phase 1
Completed NCT03940781 - Effects of Rehabilitation for Patients With Obstructive Sleep Apnea N/A
Recruiting NCT05289063 - Vascular Endothelial Dysfunction in Sleep Apnea Phase 1
Not yet recruiting NCT05268471 - Cost-effectiveness Analysis and Conditional Response to the Effect of Positional Devices in Obstructive Sleep Apnea N/A
Active, not recruiting NCT04864652 - Safety and Dosing Study of the CHILLS Cryotherapy for the Treatment of OSA N/A
Enrolling by invitation NCT05433883 - The Relationship Between Obstructive Sleep Apnea and Alzheimer's Disease: Evidence and Effectiveness N/A
Recruiting NCT06103630 - Efficacy of Oropharyngeal Exercises for Patients With Obstructive Sleep Apnea Using Mandibular Advancement Device N/A
Recruiting NCT06283095 - Management of Obstructive Sleep Apnea Syndrome by Expansion Palatoplasty N/A
Completed NCT03156283 - SleepWell24: An Innovative Smartphone Application to Improve PAP Adherence N/A
Completed NCT03362385 - OSA-ACS Project: Association of OSA and CPAP Therapy With Outcomes in ACS Patients
Completed NCT04643782 - Comparative Study of the ANNE™ One System to Diagnose Obstructive Sleep Apnea N/A
Recruiting NCT03618719 - Impact of Intermittent Hypoxia on the Function of the Phagocytes
Completed NCT03048604 - BiLAteral Hypoglossal Nerve Stimulation for Treatment of Obstructive Sleep Apnoea (BLAST OSA) N/A
Recruiting NCT05290350 - Long COVID-19 Fatigue and Obstructive Sleep Apnea
Recruiting NCT05739617 - Comprehensive Respiratory Training Exercise Program in Obstructive Sleep Apnea N/A
Completed NCT03980158 - Change in Tongue Strength and Fatigue After Upper Airway Stimulation Therapy
Completed NCT04925466 - Acceptable Pressure Range for Continuous Positive Airway Pressure(CPAP) Treatment N/A