Substantial Equivalence of iSlpr™ and SomnoDent® Classic in the Treatment of Snoring and Mild to Moderate Sleep Apnoea.
Primary Purpose
Sleep Apnea, Snoring
Status
Unknown status
Phase
Not Applicable
Locations
Study Type
Interventional
Intervention
iSlpr™
SomnoDent® Classic
Sponsored by
About this trial
This is an interventional treatment trial for Sleep Apnea
Eligibility Criteria
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
Sites / Locations
Arms of the Study
Arm 1
Arm 2
Arm Type
Experimental
Active Comparator
Arm Label
Test Device
Predicate Device
Arm Description
Novel Mandibular Advancement Device
Predicate Mandibular Advancement Device
Outcomes
Primary Outcome Measures
AHI
Apnea Hypopnea Index
ODI
Oxygen Desaturation Index
Secondary Outcome Measures
Full Information
NCT ID
NCT04250584
First Posted
January 30, 2020
Last Updated
January 30, 2020
Sponsor
BioAnalytics Holdings Pty Ltd
1. Study Identification
Unique Protocol Identification Number
NCT04250584
Brief Title
Substantial Equivalence of iSlpr™ and SomnoDent® Classic in the Treatment of Snoring and Mild to Moderate Sleep Apnoea.
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.
Study Type
Interventional
2. Study Status
Record Verification Date
January 2020
Overall Recruitment Status
Unknown status
Study Start Date
March 2020 (Anticipated)
Primary Completion Date
June 2021 (Anticipated)
Study Completion Date
June 2021 (Anticipated)
3. Sponsor/Collaborators
Responsible Party, by Official Title
Sponsor
Name of the Sponsor
BioAnalytics Holdings Pty Ltd
4. Oversight
Studies a U.S. FDA-regulated Drug Product
No
Studies a U.S. FDA-regulated Device Product
No
Data Monitoring Committee
No
5. Study Description
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
6. Conditions and Keywords
Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Sleep Apnea, Snoring
7. Study Design
Primary Purpose
Treatment
Study Phase
Not Applicable
Interventional Study Model
Parallel Assignment
Masking
None (Open Label)
Allocation
Randomized
Enrollment
66 (Anticipated)
8. Arms, Groups, and Interventions
Arm Title
Test Device
Arm Type
Experimental
Arm Description
Novel Mandibular Advancement Device
Arm Title
Predicate Device
Arm Type
Active Comparator
Arm Description
Predicate Mandibular Advancement Device
Intervention Type
Device
Intervention Name(s)
iSlpr™
Intervention Description
mandibular advancement device
Intervention Type
Device
Intervention Name(s)
SomnoDent® Classic
Intervention Description
mandibular advancement device
Primary Outcome Measure Information:
Title
AHI
Description
Apnea Hypopnea Index
Time Frame
24 weeks
Title
ODI
Description
Oxygen Desaturation Index
Time Frame
24 weeks
10. Eligibility
Sex
All
Minimum Age & Unit of Time
18 Years
Maximum Age & Unit of Time
75 Years
Accepts Healthy Volunteers
No
Eligibility Criteria
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
Central Contact Person:
First Name & Middle Initial & Last Name or Official Title & Degree
Cyril Jones
Phone
+61 419 594 572
Email
cjones@bioanalytics.com.au
12. IPD Sharing Statement
Plan to Share IPD
No
Learn more about this trial
Substantial Equivalence of iSlpr™ and SomnoDent® Classic in the Treatment of Snoring and Mild to Moderate Sleep Apnoea.
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