- ICH GCP
- US Clinical Trials Registry
- Clinical Trial 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.
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.
Study Overview
Status
Conditions
Intervention / Treatment
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 Type
Enrollment (Anticipated)
Phase
- Not Applicable
Contacts and Locations
Study Contact
- Name: Cyril Jones
- Phone Number: +61 419 594 572
- Email: cjones@bioanalytics.com.au
Participation Criteria
Eligibility Criteria
Ages Eligible for Study
Accepts Healthy Volunteers
Genders Eligible for Study
Description
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 Plan
How is the study designed?
Design Details
- Primary Purpose: Treatment
- Allocation: Randomized
- Interventional Model: Parallel Assignment
- Masking: None (Open Label)
Arms and Interventions
Participant Group / Arm |
Intervention / Treatment |
---|---|
Experimental: Test Device
Novel Mandibular Advancement Device
|
mandibular advancement device
|
Active Comparator: Predicate Device
Predicate Mandibular Advancement Device
|
mandibular advancement device
|
What is the study measuring?
Primary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
---|---|---|
AHI
Time Frame: 24 weeks
|
Apnea Hypopnea Index
|
24 weeks
|
ODI
Time Frame: 24 weeks
|
Oxygen Desaturation Index
|
24 weeks
|
Collaborators and Investigators
Sponsor
Study record dates
Study Major Dates
Study Start (Anticipated)
Primary Completion (Anticipated)
Study Completion (Anticipated)
Study Registration Dates
First Submitted
First Submitted That Met QC Criteria
First Posted (Actual)
Study Record Updates
Last Update Posted (Actual)
Last Update Submitted That Met QC Criteria
Last Verified
More Information
Terms related to this study
Additional Relevant MeSH Terms
Other Study ID Numbers
- BAH001
Plan for Individual participant data (IPD)
Plan to Share Individual Participant Data (IPD)?
Drug and device information, study documents
Studies a U.S. FDA-regulated drug product
Studies a U.S. FDA-regulated device product
This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.
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