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.

Status

UNKNOWN

Phases

Study type

Interventional

Source

ClinicalTrials.gov

Registry ID

NCT04250584

Enrollment

Registered

2020-01-31

Start date

2020-03-31

Completion date

2021-06-30

Last updated

2020-01-31

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Sleep Apnea, Snoring

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

Interventions

DEVICEiSlpr™

mandibular advancement device

DEVICESomnoDent® Classic

mandibular advancement device

Study design

Allocation

RANDOMIZED

Intervention model

PARALLEL

Primary purpose

TREATMENT

Masking

NONE

Eligibility

Sex/Gender

ALL

Age

18 Years to 75 Years

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

Design outcomes

Primary

Measure	Time frame	Description
AHI	24 weeks	Apnea Hypopnea Index
ODI	24 weeks	Oxygen Desaturation Index

Contacts

Primary ContactCyril Jones

cjones@bioanalytics.com.au+61 419 594 572

Outcome results

None listed

Source: ClinicalTrials.gov · Data processed: Feb 4, 2026