Substantial Equivalence of iSlpr™ and SomnoDent® Classic in the Treatment of Snoring and Mild to Moderate Sleep Apnoea.
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|ClinicalTrials.gov Identifier: NCT04250584|
Recruitment Status : Not yet recruiting
First Posted : January 31, 2020
Last Update Posted : January 31, 2020
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.
|Condition or disease||Intervention/treatment||Phase|
|Sleep Apnea Snoring||Device: iSlpr™ Device: SomnoDent® Classic||Not Applicable|
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 Type :||Interventional (Clinical Trial)|
|Estimated Enrollment :||66 participants|
|Intervention Model:||Parallel Assignment|
|Masking:||None (Open Label)|
|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.|
|Estimated Study Start Date :||March 2020|
|Estimated Primary Completion Date :||June 2021|
|Estimated Study Completion Date :||June 2021|
Experimental: Test Device
Novel Mandibular Advancement Device
mandibular advancement device
Active Comparator: Predicate Device
Predicate Mandibular Advancement Device
Device: SomnoDent® Classic
mandibular advancement device
- AHI [ Time Frame: 24 weeks ]Apnea Hypopnea Index
- ODI [ Time Frame: 24 weeks ]Oxygen Desaturation Index
To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.
Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT04250584
|Contact: Cyril Jones||+61 419 594 firstname.lastname@example.org|