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.
NCT number | NCT04250584 |
Other study ID # | BAH001 |
Secondary ID | |
Status | Not yet recruiting |
Phase | N/A |
First received | |
Last updated | |
Start date | March 2020 |
Est. completion date | June 2021 |
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.
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 |
Country | Name | City | State |
---|---|---|---|
n/a |
Lead Sponsor | Collaborator |
---|---|
BioAnalytics Holdings Pty Ltd |
Type | Measure | Description | Time frame | Safety issue |
---|---|---|---|---|
Primary | AHI | Apnea Hypopnea Index | 24 weeks | |
Primary | ODI | Oxygen Desaturation Index | 24 weeks |
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