Oral appliance network on global effectiveness (ORANGE)
Research type
Research Study
Full title
Long-term Oral Appliance Therapy Effectiveness for Obstructive Sleep Apnoea Syndrome: A multicentre cohort study
IRAS ID
184663
Contact name
Fernanda Almeida
Contact email
Sponsor organisation
University of British Columbia
Duration of Study in the UK
10 years, 0 months, 1 days
Research summary
Oral Appliance on Global Effectiveness (ORANGE) is a multinational cohort study evaluating the long-term effectiveness of Oral Appliance (OA) therapy in Obstructive Sleep Apnea (OSA) patients and assessing long term health outcomes of this therapy on cardiovascular disease.
The purpose of this study is to gather detailed data across different countries to gain an understanding of:
* adherence and tolerance of OA treatment
* incidence of cardiovascular events and related cardiovascular and cerebrovascular (blood circulation to the brain) mortality
* exploration of health care costs associated with this type of therapy
* assessment of the cost effectiveness of treatment
* evaluation of side effects
* assessment of the impact of OA therapy on quality of life
* comparison of differences between OA types and adjustment methods
* evaluation of the incidence of OA contraindications.Patients will be recruited in to the study through Dr Quinnell’s Sleep Disorder Clinic (SDC) in the Respiratory Support and Sleep Centre (RSSC). The study will span five years and involve data collection at baseline, 3 and 6 months, 1,3 and 5 years; plus two telephone follow ups at 2 and 4 years. Data collection will include basic clinical measures (including dental), OA characteristics and adherence, patient demographics, quality of life and sleep assessment questionnaires. The data will be collected by SDC doctors, researchers and dentists. All data will be entered into an online multi-national database, managed by collaborators at the lead site, University of British Columbia. Each recruitment site only has access to patient data collected at their own site.
REC name
North of Scotland Research Ethics Committee 1
REC reference
15/NS/0122
Date of REC Opinion
9 Nov 2015
REC opinion
Favourable Opinion