ORal Appliance Network on Global Effectiveness (ORANGE) : start-up and design description
Faculty of Medicine and Health Sciences
Journal of dental sleep mediine
, p. 1-11
University of Antwerp
Oral appliance (OA) therapy is the main non-surgical alternative to CPAP treatment in patients with obstructive sleep apnea (OSA). There are clear benefits from OA when compared to placebo, but a larger variability compared to CPAP has been documented for the reduction of OSA. These results are based on less than 30 randomized controlled trials. In addition, an important variability regarding study design and methodology has been observed in these studies published over the past 15 years. Therefore, a need for more knowledge in larger studies with standardized data collection is required to better understand the role and effectiveness of OA in patients with OSA. Study Objectives: Fifteen academic researchers from nine countries have founded a network focused on OA long-term outcomes. The primary aim of this network called ORANGE (ORal Appliance Network on Global Effectiveness) is to evaluate the long-term effectiveness of OA therapy in OSA patients and assess long-term health outcomes of OA therapy related to cardiovascular disease. Exploratory aims include: assessment of objective adherence and tolerance; incidence of cardio-vascular events and related cardio- and cerebrovascular mortality; exploration of health care costs associated with this type of therapy across different countries; assessment of the cost-effectiveness of treatment, evaluation of side-effects; examination of the impact of OA on quality of life; compare differences between OA types and titration methods; evaluate the incidence of OA contra-indications. Methods: In March 2012, researchers attended the first strategic meeting, funded by the American Academy of Dental Sleep Medicine (AADSM) in Chicago. During the meeting, objectives and feasibility of the cohort were discussed. Subcommittees were created to decide on data collection priorities and standardization, which were divided into anthropometrics, medical history, sleep test data, questionnaires, dental variables, side-effects, adherence and titration factors. Consecutive patients who consent to participate will be included and the data will be entered in a web-based software called REDCap (Research Electronic Data Capture). The finalized data to be included in the cohort were discussed and determined in June 2012, in Boston. The network met again in April 2013 in Paris to finalize patient data entry needs, charts and ethical board requirements. Conclusion: ORANGE is a multinational observational cohort study, creating an unique opportunity to explore effectiveness and cardiovascular outcomes of OA therapy in OSA patients.