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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

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.


Condition or disease Intervention/treatment Phase
Sleep Apnea Snoring Device: iSlpr™ Device: SomnoDent® Classic Not Applicable

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

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Study Type : Interventional  (Clinical Trial)
Estimated Enrollment : 66 participants
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: None (Open Label)
Primary Purpose: Treatment
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

Resource links provided by the National Library of Medicine

MedlinePlus related topics: Sleep Apnea Snoring

Arm Intervention/treatment
Experimental: Test Device
Novel Mandibular Advancement Device
Device: iSlpr™
mandibular advancement device

Active Comparator: Predicate Device
Predicate Mandibular Advancement Device
Device: SomnoDent® Classic
mandibular advancement device




Primary Outcome Measures :
  1. AHI [ Time Frame: 24 weeks ]
    Apnea Hypopnea Index

  2. ODI [ Time Frame: 24 weeks ]
    Oxygen Desaturation Index



Information from the National Library of Medicine

Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the contacts provided below. For general information, Learn About Clinical Studies.


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Ages Eligible for Study:   18 Years to 75 Years   (Adult, Older Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
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

Information from the National Library of Medicine

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


Contacts
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Contact: Cyril Jones +61 419 594 572 cjones@bioanalytics.com.au

Sponsors and Collaborators
BioAnalytics Holdings Pty Ltd
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Responsible Party: BioAnalytics Holdings Pty Ltd
ClinicalTrials.gov Identifier: NCT04250584    
Other Study ID Numbers: BAH001
First Posted: January 31, 2020    Key Record Dates
Last Update Posted: January 31, 2020
Last Verified: January 2020
Individual Participant Data (IPD) Sharing Statement:
Plan to Share IPD: No

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Studies a U.S. FDA-regulated Drug Product: No
Studies a U.S. FDA-regulated Device Product: No
Additional relevant MeSH terms:
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Apnea
Sleep Apnea Syndromes
Snoring
Respiration Disorders
Respiratory Tract Diseases
Signs and Symptoms, Respiratory
Sleep Disorders, Intrinsic
Dyssomnias
Sleep Wake Disorders
Nervous System Diseases
Respiratory Sounds