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

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Know the risks and potential benefits of clinical studies and talk to your health care provider before participating. Read our disclaimer for details.
 
ClinicalTrials.gov Identifier: NCT04250584
Recruitment Status : Not yet recruiting
First Posted : January 31, 2020
Last Update Posted : January 31, 2020
Sponsor:
Information provided by (Responsible Party):
BioAnalytics Holdings Pty Ltd

Tracking Information
First Submitted Date  ICMJE January 30, 2020
First Posted Date  ICMJE January 31, 2020
Last Update Posted Date January 31, 2020
Estimated Study Start Date  ICMJE March 2020
Estimated Primary Completion Date June 2021   (Final data collection date for primary outcome measure)
Current Primary Outcome Measures  ICMJE
 (submitted: January 30, 2020)
  • AHI [ Time Frame: 24 weeks ]
    Apnea Hypopnea Index
  • ODI [ Time Frame: 24 weeks ]
    Oxygen Desaturation Index
Original Primary Outcome Measures  ICMJE Same as current
Change History No Changes Posted
Current Secondary Outcome Measures  ICMJE Not Provided
Original Secondary Outcome Measures  ICMJE Not Provided
Current Other Pre-specified Outcome Measures Not Provided
Original Other Pre-specified Outcome Measures Not Provided
 
Descriptive Information
Brief Title  ICMJE Substantial Equivalence of iSlpr™ and SomnoDent® Classic in the Treatment of Snoring and Mild to Moderate Sleep Apnoea.
Official Title  ICMJE 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.
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
Study Type  ICMJE Interventional
Study Phase  ICMJE Not Applicable
Study Design  ICMJE Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: None (Open Label)
Primary Purpose: Treatment
Condition  ICMJE
  • Sleep Apnea
  • Snoring
Intervention  ICMJE
  • Device: iSlpr™
    mandibular advancement device
  • Device: SomnoDent® Classic
    mandibular advancement device
Study Arms  ICMJE
  • Experimental: Test Device
    Novel Mandibular Advancement Device
    Intervention: Device: iSlpr™
  • Active Comparator: Predicate Device
    Predicate Mandibular Advancement Device
    Intervention: Device: SomnoDent® Classic
Publications * Not Provided

*   Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.
 
Recruitment Information
Recruitment Status  ICMJE Not yet recruiting
Estimated Enrollment  ICMJE
 (submitted: January 30, 2020)
66
Original Estimated Enrollment  ICMJE Same as current
Estimated Study Completion Date  ICMJE June 2021
Estimated Primary Completion Date June 2021   (Final data collection date for primary outcome measure)
Eligibility Criteria  ICMJE

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
Sex/Gender  ICMJE
Sexes Eligible for Study: All
Ages  ICMJE 18 Years to 75 Years   (Adult, Older Adult)
Accepts Healthy Volunteers  ICMJE No
Contacts  ICMJE
Contact: Cyril Jones +61 419 594 572 cjones@bioanalytics.com.au
Listed Location Countries  ICMJE Not Provided
Removed Location Countries  
 
Administrative Information
NCT Number  ICMJE NCT04250584
Other Study ID Numbers  ICMJE BAH001
Has Data Monitoring Committee No
U.S. FDA-regulated Product
Studies a U.S. FDA-regulated Drug Product: No
Studies a U.S. FDA-regulated Device Product: No
IPD Sharing Statement  ICMJE
Plan to Share IPD: No
Responsible Party BioAnalytics Holdings Pty Ltd
Study Sponsor  ICMJE BioAnalytics Holdings Pty Ltd
Collaborators  ICMJE Not Provided
Investigators  ICMJE Not Provided
PRS Account BioAnalytics Holdings Pty Ltd
Verification Date January 2020

ICMJE     Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP