POCC Trial Summary

PAP - OAT - CBT - COMISA Trial: a Pilot Study This Pilot Studies main objective is to evaluate the clinical utility of OAT in COMISA patients by assessing the effectiveness of OAT in patients suffering with COMISA, that are resistant or intolerant to PAP therapy.
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Recent literature documents high prevalence of co-morbid insomnia and OSA (COMISA) that approach’s 16% of the general population. PAP adherence for patients suffering with COMISA is 30% lower than OSA alone, approximately 35% a year post prescription. This leaves approximately 2/3’s of diagnosed patients unmanaged for their OSA, and as a result, likely to have difficulty managing their Insomnia. In contrast, oral appliance therapy (OAT), which has a similar Mean Disease Alleviation to PAP, experiences a very high adherence, in the 90% range for non-COMISA patients. The question we cannot currently answer is, “Does high OAT adherence position it as the preferred treatment alternative for patients suffering with COMISA?”  This Pilot Studies main objective is to evaluate the clinical utility of OAT in COMISA patients by assessing the effectiveness of OAT in patients suffering with COMISA, that are resistant or intolerant to PAP therapy.

The POCC Trial is a patient management protocol with formal care pathway, it is not a randomized trial. The goal is to offer the protocol to consecutive patients in Ontario, Canada sleep clinics. There are no significant risks to participants, with potential gains in formalized care, systematic scheduling and compiling of patient-centred and laboratory outcomes; in addition, the participants who complete all steps will have cost savings related to their treatment of sleep apnea. There is no ‘experiment’ strictly speaking (there is no control condition nor randomization) but the formalized sequence of offering OAT after a prescription of PAP is not a universally implemented for the care of OSA or more specifically COMISA and there are benefits from documenting the results of this protocol. Our intention is to publish in Abstract and Poster form ASAP. (late 2025), followed by a full journal publication.

 

For questions please contact:

POCCTrial@DrViviano.com 905 212 7732

sherif.elsaraj@mcgill.ca 613 518-1888

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Sleep Disorders
Life Sciences > Biological Sciences > Neuroscience > Neurophysiology > Circadian Rhythms and Sleep > Sleep Disorders
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