Status:
COMPLETED
Does Race Make a Difference in Obstructive Sleep Apnea?
Lead Sponsor:
Academic Centre for Dentistry in Amsterdam
Collaborating Sponsors:
Shandong University
Conditions:
Obstructive Sleep Apnea of Adult
Eligibility:
All Genders
18+ years
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 functiona...
Detailed 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 Ne...
Eligibility Criteria
Inclusion
- 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.).
Exclusion
- 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.
Key Trial Info
Start Date :
May 1 2017
Trial Type :
OBSERVATIONAL
Allocation :
ACTUAL
End Date :
December 31 2024
Estimated Enrollment :
58 Patients enrolled
Trial Details
Trial ID
NCT03463785
Start Date
May 1 2017
End Date
December 31 2024
Last Update
January 29 2025
Active Locations (2)
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1
Dentistry
Jinan, Shandong, China, 250012
2
Dentistry
Amsterdam, Netherlands, 4081LA