THETA announces launch of SIESTA study to examine ApneaDx
From the Toronto Health Economics and Technology Assessment Collaborative website:
“SIESTA Home Sleep Study with ApneaDx™ for the Diagnosis and Management of Obstructive Sleep Apnea proposes to examine the validity, effectiveness, and cost-effectiveness of ApneaDx™, a new single-channel portable monitor designed to capture and analyze breath sounds to detect sleep apnea versus in-laboratory overnight sleep study with polysomnography – the gold standard for the diagnosis and management of obstructive sleep apnea.
SIESTA is both a multi-centre prospective validation study, as well as a pragmatic randomized single-blinded two armed non-inferiority trial. With a planned sample size of 330 participants, SIESTA will take approximately two years to complete. SIESTA is currently at the recruitment stage at the Kingston and Hamilton study sites. Dr. Mike Fitzpatrick is the lead Clinical Investigator at the Kingston Sleep Disorders Laboratory, with Nancy Myers as the onsite Study Coordinator. At the Hamilton Sleep Disorders Clinic, we have Dr. Ray Gottschalk as the Clinical Investigator and Jason Myers as the onsite Study Coordinator. REB submission is underway for our third site, Sleep & Apnea Assessment Unit in London Health Sciences Centre – Victoria Hospital with Dr. Charlie George.
ApneaDX™ is one of the first three companies selected by the MaRS Excellence in Clinical Innovation and Technology Evaluation (“EXCITE”) program.”