NCT04250584

Substantial Equivalence of iSlpr™ and SomnoDent® Classic in the Treatment of Snoring and Mild to Moderate Sleep Apnoea.

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.

• Status: Unknown
• Phase: N/A
• Study type: Interventional
• Enrollment: 66 (estimated)
• Sponsor: BioAnalytics Holdings Pty Ltd · Industry
• Sex: All
• Age: 18 Years – 75 Years
• Healthy volunteers: Not accepted

Summary

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.

Detailed description

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

Conditions

• Sleep Apnea
• Snoring

Interventions

Type	Name	Description
DEVICE	iSlpr™	mandibular advancement device
DEVICE	SomnoDent® Classic	mandibular advancement device

Timeline

• Start date: 2020-03-01
• Primary completion: 2021-06-01
• Completion: 2021-06-01
• First posted: 2020-01-31
• Last updated: 2020-01-31