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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
BioAnalytics Holdings Pty Ltd
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional treatment trial for Sleep Apnea

Eligibility Criteria

18 Years - 75 Years (Adult, Older Adult)All SexesDoes not accept healthy volunteers

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

    First Posted
    January 30, 2020
    Last Updated
    January 30, 2020
    Sponsor
    BioAnalytics Holdings Pty Ltd
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    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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