A randomized prospective long-term study of two oral appliances for sleep apnoea treatment.

Various types of mandibular protrusive appliances have revealed different treatment success in mild-to-moderate obstructive sleep apnoea (OSA). The present study compared the long-term effect of two different appliances in the treatment of OSA. A total of 103 patients with OSA were randomized and treated with an IST((R)) or Thornton Anterior Positioner (TAP()) appliance. They were followed-up after a short-term treatment period of 6 months and long-term treatment period of over 24 months. Sleep studies in the sleep laboratory were conducted with and without the appliances, and various questionnaires assessing subjective daytime sleepiness, sleep quality, quality of life and symptom scores were administered at each time interval. Quality of life, sleep quality, sleepiness, symptoms and sleep outcome showed significant improvement in the short-term evaluation with both appliances, but the TAP() appliance revealed a significantly greater effect. After more than 2 years of treatment, sleep outcomes revealed an equal effect with both appliances. The subjective benefits achieved initially lessened significantly. This study illustrates that both the IST((R)) and the TAP() appliances are effective therapeutic devices for OSA after a period of over 24 months. Lack of compliance may be due to insufficient improvement in anticipated subjective symptoms and/or a recurrence of symptoms over time.

RCT Entities:   Population Interventions Outcomes