Pilot Study of a New Mandibular Advancement Device

Area of Science:

• Sleep Medicine
• Medical Devices
• Respiratory Medicine

Background:

• Obstructive sleep apnea (OSA) is a common respiratory disorder.
• Mandibular advancement devices (MADs) are an established treatment for OSA.
• Customized MADs may offer improved efficacy and patient compliance.

Purpose of the Study:

• To evaluate the efficacy of a novel customized mandibular advancement device (NOA® MAD) in treating patients with obstructive sleep apnea (OSA).
• To assess the impact of the NOA® MAD on polysomnography (PSG) parameters in OSA patients.

Main Methods:

• Eight patients diagnosed with OSA (Apnea-Hypopnea Index [AHI] > 5) were enrolled.
• Patients used the NOA® MAD for at least 3 months.
• Polysomnography (PSG) was performed at baseline (T0) and after 3 months of treatment (T1) to measure AHI, supine AHI, ODI, SpO2 < 90%, and MeanSpO2%.

Main Results:

• Significant improvements were observed in overall AHI (21.33 to 8.6) and supine AHI (35.64 to 11.21) after NOA® MAD treatment.
• The device demonstrated effectiveness across patients with mild, moderate, and severe OSA.
• Key PSG parameters related to breathing events and oxygenation showed positive changes.

Conclusions:

• The customized NOA® MAD is a potentially effective treatment option for obstructive sleep apnea.
• The device led to statistically significant improvements in objective sleep apnea measures.
• Further research may support the NOA® MAD as a valuable alternative for OSA management.