Evaluation of an anti-snoring device featuring a Ni–Ti alloy elastic linkage in a simulated clinical environment

Background/purpose: Obstructive sleep apnea (OSA) is a common sleep-related breathing disorder that is often treated by mandibular advancement devices (MADs). However, conventional MADs are frequently associated with discomfort, rigidity, and limited patient compliance. This study aimed to design and evaluate a custom-made anti-snoring device featuring a nickel-titanium (Ni–Ti) alloy elastic connector to improve comfort, durability, and clinical performance. Materials and methods: The device consisted of dual-layer upper and lower trays and was connected via Ni–Ti alloy rods. Finite element analysis (FEA) was conducted to compare the stress and deformation characteristics of three materials (Ni–Ti, stainless steel, and polycarbonate). Fatigue testing was also performed to simulate the long-term use. A clinical simulation involving seven adult participants diagnosed with mild to moderate OSA was conducted, including a seven-day trial and a post-trial questionnaire that evaluated comfort, fit, and effectiveness. Results: FEA revealed that the Ni–Ti connector exhibited the most uniform stress distribution and the highest deformation capacity, indicating superior elasticity and resilience. Fatigue tests confirmed the structural stability after 5 million cycles. Subjective evaluations indicated the high user satisfaction and effective symptom relief; however, some discomfort related to oral dryness and temporomandibular joint (TMJ) pressure was reported. Conclusion: The Ni–Ti-based anti-snoring device demonstrated favorable biomechanical properties and clinical usability. It offers a promising alternative to traditional MADs, potentially enhancing a long-term patient compliance and therapeutic outcomes. Further clinical validation is warranted.