Substantial Equivalence of iSlpr™ and SomnoDent® Classic in the Treatment of Snoring and Mild to Moderate Sleep Apnoea.
NCT ID: NCT04250584
Last Updated: 2020-01-31
Study Results
The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.
Basic Information
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UNKNOWN
NA
66 participants
INTERVENTIONAL
2020-03-31
2021-06-30
Brief Summary
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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 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
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Study Design
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RANDOMIZED
PARALLEL
TREATMENT
NONE
Study Groups
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Test Device
Novel Mandibular Advancement Device
iSlpr™
mandibular advancement device
Predicate Device
Predicate Mandibular Advancement Device
SomnoDent® Classic
mandibular advancement device
Interventions
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iSlpr™
mandibular advancement device
SomnoDent® Classic
mandibular advancement device
Eligibility Criteria
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Inclusion Criteria
* 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
* 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
18 Years
75 Years
ALL
No
Sponsors
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BioAnalytics Holdings Pty Ltd
INDUSTRY
Responsible Party
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Central Contacts
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Other Identifiers
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BAH001
Identifier Type: -
Identifier Source: org_study_id