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

Sleep Apnea Clinical Trial

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.

Clinical Trial Details — Status: Not yet recruiting

Administrative data

• NCT number: NCT04250584
• Other study ID #: BAH001
• Status: Not yet recruiting
• Phase: N/A
• Start date: March 2020
• Est. completion date: June 2021

Study information

• Verified date: January 2020
• Source: BioAnalytics Holdings Pty Ltd
• Contact: Cyril Jones
• Phone: +61 419 594 572
• Email: cjones[@]bioanalytics.com.au
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial 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.

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

Recruitment information / eligibility

• Status: Not yet recruiting
• Enrollment: 66
• Est. completion date: June 2021
• Est. primary completion date: June 2021
• Accepts healthy volunteers: No
• Gender: All
• Age group: 18 Years to 75 Years

Eligibility

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

Related Conditions & MeSH terms

• Apnea
• Sleep Apnea
• Sleep Apnea Syndromes
• Snoring

Intervention

Device:
• iSlpr™
mandibular advancement device
• SomnoDent® Classic
mandibular advancement device

Locations

Country	Name	City	State
n/a

Sponsors (1)

Lead Sponsor	Collaborator
BioAnalytics Holdings Pty Ltd

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	AHI	Apnea Hypopnea Index	24 weeks
Primary	ODI	Oxygen Desaturation Index	24 weeks