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.
Sponsor study identifier
interventional
66
0 countries
N/A
Study Start
March 2020
Estimated (date passed)This estimate has passed. The registry has not confirmed an actual date for this milestone.
Primary Completion
June 2021
Estimated (date passed)This estimate has passed. The registry has not confirmed an actual date for this milestone.
Study Completion
June 2021
Estimated (date passed)This estimate has passed. The registry has not confirmed an actual date for this milestone.
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.
Registry-reported information. Elapsed time and enrollment totals alone do not measure study progress or recruitment pace.
June 2021
Estimated (date passed)This estimate has passed. The registry has not confirmed an actual date for this milestone.
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Dates and qualifiers reported by the registry. Estimated dates do not confirm that a milestone has occurred.
January 30, 2020
Actual (reported)January 31, 2020
Actual (reported)March 2020
Estimated (date passed)This estimate has passed. The registry has not confirmed an actual date for this milestone.
June 2021
Estimated (date passed)This estimate has passed. The registry has not confirmed an actual date for this milestone.
June 2021
Estimated (date passed)This estimate has passed. The registry has not confirmed an actual date for this milestone.
AHI
Apnea Hypopnea Index
24 weeks
ODI
Oxygen Desaturation Index
24 weeks
Novel Mandibular Advancement Device
Predicate Mandibular Advancement Device
mandibular advancement device
mandibular advancement device
Registry-reported names are shown in full. Names without a link have not yet been matched to a Syfrah profile.
First Submitted
January 30, 2020
First Posted
January 31, 2020
Study Start
March 2020
Estimated (date passed)This estimate has passed. The registry has not confirmed an actual date for this milestone.
Primary Completion
June 2021
Estimated (date passed)Nasal Appliance for the Treatment of Snoring in Adult Subjects - A Pilot Study
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This estimate has passed. The registry has not confirmed an actual date for this milestone.
Study Completion
June 2021
Estimated (date passed)This estimate has passed. The registry has not confirmed an actual date for this milestone.
Last Updated
January 31, 2020
Record last verified: 2020-01
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Source: ClinicalTrials.gov.
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