Comparison of two mandibular advancement devices in mild to moderate obstructive sleep apnea (OSA) patients: a randomized crossover trial

• Conditions: Slaapstoornissen, slaapapneu; OSA; OSAS

• Registration Number: NL-OMON52245
• Lead Sponsor: niversiteit van Amsterdam

Brief Summary

Not available

Detailed Description

Not available

Study Timeline

• Last Update Posted: 15 April 2024

Recruitment & Eligibility

• Status: Pending
• Sex: Not specified
• Target Recruitment: 80

Inclusion Criteria

• 18 years or older;
• Sufficient understanding of Dutch language in speaking, reading, and writing;
• Ability to follow-up;
• Ability to use a computer with internet connection for online questionnaires;
• Diagnosis with symptomatic mild or moderate OSA (5 <= AHI < 30).
• Dentition is adequate for both MADs (e.g., normal dental crown height, normal
dental arch)

Exclusion Criteria

• Reversible morphological upper airway abnormalities (e.g. enlarged tonsils);
• Previous treatment with an MAD;
• Inability to provide informed consent;
• Simultaneous use of other modalities to treat OSA;
• Known medical history of mental retardation, memory disorders, or psychiatric
disorders;
• Evidence of respiratory/sleep disorders other than OSA (e.g., central sleep
apnea (CSA));
• Medication usage that has an effect on sleep;
• Untreated periodontal problems, dental pain, and a lack of retention
possibilities for both MADs;
• Severe temporomandibular disorders (based on the function examination of the
masticatory system).

Study & Design

• Study Type: Interventional
• Study Design: Not specified