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

Not Applicable

• Conditions: Sleep Apnea; Snoring
• Interventions: Device: SomnoDent® Classic; Device: iSlpr™

• Registration Number: NCT04250584
• Lead Sponsor: BioAnalytics Holdings Pty Ltd

Brief 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

Study Timeline

• Status Verified: 2020-01
• Study First Submitted: 2020-01-30
• Study First Submitted QC: 2020-01-30
• Last Update Submitted: 2020-01-30
• Study First Posted: 2020-01-31
• Last Update Posted: 2020-01-31
• Study Start: 2020-03
• Primary Completion: 2021-06
• Study Completion: 2021-06

Recruitment & Eligibility

• Status: UNKNOWN
• Sex: All
• Target Recruitment: 66

Inclusion Criteria

• 18 years or older and younger than 75 years at time of screening
• Snoring and mild to moderate sleep apnoea ( AHI > 5 and < 30 per hr)
• Written informed consent
• Able to complete the study procedures within the study timeline.

Exclusion Criteria

• Women who are pregnant or breast-feeding
• Central sleep apnoea
• Severe respiratory disorders
• Loose teeth or advanced periodontal disease
• Lateral bruxers
• Full or partial dentures
• Temporomandibular Joint (TMJ) abnormalities, pain or dysfunction
• Other teeth, jaw or gum disorders would preclude use of the device
• Cardiovascular comorbidities or stroke/heart attack in past 12 months
• Drug-addiction
• Major Depressive Disorder or psychosis
• Undergoing concomitant therapy for OSA/Snoring
• current or previous therapy with SomnoDent Classic
• Professional drivers or machine operators required to be undertaking CPAP

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: PARALLEL

Arm && Interventions

Group	Intervention	Description
Predicate Device	SomnoDent® Classic	Predicate Mandibular Advancement Device
Test Device	iSlpr™	Novel Mandibular Advancement Device

Primary Outcome Measures

Name	Time	Method
AHI	24 weeks	Apnea Hypopnea Index
ODI	24 weeks	Oxygen Desaturation Index