Sleep Apnea Clinical Trial
Official title:
Investigation of the Substantial Equivalence of a Novel Mandibular Advancement Device, iSlpr™, With SomnoDent® Classic, in a Non-inferiority Study, in the Treatment of Snoring and Mild to Moderate Obstructive Sleep Apnoea.
The study is a thirty three week, prospective, open-label, randomized, parallel-group
non-inferiority study.
The study aims to investigate the Substantial Equivalence of a novel mandibular device called
iSlpr™, produced by BioAnalytics, to a currently approved device, SomnoDent® Classic, in the
treatment of mild to moderate Obstructive Sleep Apnoea (OSA) and snoring.
The objective of this study is to determine if the BioAnalytics device, iSlpr™, has a similar
safety and efficacy profile to a commonly used device, SomnoDent® Classic, in the treatment
of snoring and mild to moderate Obstructive Sleep Apnoea.
The target population will be males and females aged from 18 years to less than 75 years, who
have been diagnosed with snoring and mild to moderate sleep apnoea.
Participants will remain on study from screening visit to end of study visit; a total of
approximately 33 weeks.
This study includes -
- a screening period of up to 28 days
- a 2 week device initiation period
- a 24 week treatment period
;
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