Does Race Make a Difference in Obstructive Sleep Apnea?

NCT03463785 | Completed DMC

• 1 other identifier: projectnummer 530-5CDP12
• Study Type: observational
• Target: 58
• Locations: 2 countries
• Sites: 2

Brief 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.

Conditions

Obstructive Sleep Apnea of Adult

Keywords

obstructive sleep apnea; race; upper airway; cone beam computed tomography

Outcome Measures

Primary Outcomes (1)

• 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 Outcomes (4)

• the anterior-posterior dimension of CSAmin

  within a week after taking CBCT scan of the patient

• the lateral dimension of CSAmin

  within a week after taking CBCT scan of the patient

• the volume of the upper airway

  within a week after taking CBCT scan of the patient

• the length of the upper airway

  within a week after taking CBCT scan of the patient

Study Arms (2)

Chinese

Chinese mild or moderate OSA patients

Other: cone beam computed tomography

Dutch

Dutch mild or moderate OSA patients

Other: cone beam computed tomography

Interventions

cone beam computed tomography OTHER

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.

Also known as: Mandibular advancement device (MAD)

Chinese; Dutch

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)
• Sampling Method: Probability Sample

Study Population

the mild or moderate OSA patients with different racial background

You may qualify if:

• 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.).

You may not qualify if:

• 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);
• 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.

Sponsors & Collaborators

• Academic Centre for Dentistry in Amsterdam: lead
• Shandong University: collaborator

Study Sites (2)

Dentistry

Jinan, Shandong, 250012, China

Location

Dentistry

Amsterdam, 4081LA, Netherlands

Location

Related Publications (1)

• 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.

  PMID: 37093512 DERIVED

MeSH Terms

Conditions

Sleep Apnea, Obstructive

Interventions

Occlusal Splints

Condition Hierarchy (Ancestors)

Sleep Apnea Syndromes; Apnea; Respiration Disorders; Respiratory Tract Diseases; Sleep Disorders, Intrinsic; Dyssomnias; Sleep Wake Disorders; Nervous System Diseases

Intervention Hierarchy (Ancestors)

Orthotic Devices; Orthopedic Equipment; Surgical Equipment; Equipment and Supplies

Study Design

• Study Type: observational
• Observational Model: COHORT
• Time Perspective: PROSPECTIVE
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Dr.

Study Record Dates

• First Submitted: March 7, 2018
• First Posted: March 13, 2018
• Study Start: May 1, 2017
• Primary Completion: December 31, 2024
• Study Completion: December 31, 2024
• Last Updated: January 29, 2025

Record last verified: 2025-01

Data Sharing

• IPD Sharing: Will share
• Shared Documents: STUDY PROTOCOL, SAP, ICF
• Time Frame: After the papers are accepted.
• Access Criteria: The data will be shared with the researchers, who is interested in our project. The types of analyses used in the projected will be share via email to the corresponding authors.

Locations

CN (1); NL (1)