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.
1 other identifier
interventional
66
0 countries
N/A
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.
Trial Health
Trial Health Score
Automated assessment based on enrollment pace, timeline, and geographic reach
participants targeted
Target at P50-P75 for not_applicable
Started Mar 2020
Health score is calculated from publicly available data and should be used for screening purposes only.
Trial Relationships
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Study Timeline
Key milestones and dates
First Submitted
Initial submission to the registry
January 30, 2020
CompletedFirst Posted
Study publicly available on registry
January 31, 2020
CompletedStudy Start
First participant enrolled
March 1, 2020
CompletedPrimary Completion
Last participant's last visit for primary outcome
June 1, 2021
CompletedStudy Completion
Last participant's last visit for all outcomes
June 1, 2021
CompletedJanuary 31, 2020
January 1, 2020
1.3 years
January 30, 2020
January 30, 2020
Conditions
Outcome Measures
Primary Outcomes (2)
AHI
Apnea Hypopnea Index
24 weeks
ODI
Oxygen Desaturation Index
24 weeks
Study Arms (2)
Test Device
EXPERIMENTALNovel Mandibular Advancement Device
Predicate Device
ACTIVE COMPARATORPredicate Mandibular Advancement Device
Interventions
Eligibility Criteria
You may qualify if:
- 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.
You may not qualify if:
- 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
Contact the study team to confirm eligibility.
Sponsors & Collaborators
MeSH Terms
Conditions
Condition Hierarchy (Ancestors)
Central Study Contacts
Study Design
- Study Type
- interventional
- Phase
- not applicable
- Allocation
- RANDOMIZED
- Masking
- NONE
- Purpose
- TREATMENT
- Intervention Model
- PARALLEL
- Sponsor Type
- INDUSTRY
- Responsible Party
- SPONSOR
Study Record Dates
First Submitted
January 30, 2020
First Posted
January 31, 2020
Study Start
March 1, 2020
Primary Completion
June 1, 2021
Study Completion
June 1, 2021
Last Updated
January 31, 2020
Record last verified: 2020-01
Data Sharing
- IPD Sharing
- Will not share