Effectiveness of a Newly designed digital interlocking Mandibular Advancement Device for Mild to Moderate Obstructive Sleep Apnea: A Quasi-experimental study

UMIN ID: UMIN000056614

Registered date:02/01/2025

Basic Information

• Recruitment status: Complete: follow-up continuing
• Health condition(s) or Problem(s) studied: Mild to moderate obstructive sleep apnea
• Date of first enrollment: 2024/03/13
• Target sample size: 21
• Countries of recruitment: Asia(except Japan)
• Study type: Interventional
• Intervention(s): Novel fully digital designed MAD

Outcome(s)

• Primary Outcome: The newly designed digital interlocking MAD presents a promising alternative for managing mild to moderate OSA treatment.
• Secondary Outcome: The newly designed digital interlocking MAD offers acceptable effectiveness, reduced waiting times and lower costs.

Key inclusion & exclusion criteria

• Age minimum: 18years-old
• Age maximum: 59years-old
• Gender: Male and Female
• Exclude criteria: History of allergy to polymer-based resin/polymer, Unstable health condition e.g. pregnant, regular use of narcotics, sedative, psychiatric disorders, Other sleep related breathing disorders e.g. central sleep apnea, sleep-related hypoventilation, and sleep-related hypoxemia disorder, Acute or chronic painful TMD, Craniofacial anomaly, Heavy sleep bruxism, Refuse to follow a study protocol

Related Information

• Primary Sponsor: National Science, Research and Innovation Fund (NSRF)
• Source(s) of Monetary Support: National Science, Research and Innovation Fund (NSRF)