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

Study Overview
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Brief Summary
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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
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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

Official Title
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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.

Conditions
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Sleep Apnea, Snoring

Intervention / Treatment
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* Device: iSlpr™
* Device: SomnoDent® Classic


Participation Criteria
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Eligibility Criteria
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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

Ages Eligible for Study
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Minimum Age: 18 Years
Maximum Age: 75 Years

Sexes Eligible for Study
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All

Accepts Healthy Volunteers
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No

Study Plan
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How is the study designed?
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Design Details

Primary Purpose: Treatment
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: None (Open Label)


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Experimental: Test Device<br>Novel Mandibular Advancement Device | Device: iSlpr™<br>* mandibular advancement device<br>|
| Active Comparator: Predicate Device<br>Predicate Mandibular Advancement Device | Device: SomnoDent® Classic<br>* mandibular advancement device<br>|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| AHI | Apnea Hypopnea Index | 24 weeks | 
| ODI | Oxygen Desaturation Index | 24 weeks |