Substantial Equivalence of iSlpr™ and SomnoDent® Classic in the Treatment of Snoring and Mild to Moderate Sleep Apnoea.
Last updated on July 2021Recruitment
- Recruitment Status
- Not yet recruiting
- Estimated Enrollment
- Same as current
Summary
- Conditions
- Sleep Apnea
- Snoring
- Type
- Interventional
- Phase
- Not Applicable
- Design
- Allocation: RandomizedIntervention Model: Parallel AssignmentMasking: None (Open Label)Primary Purpose: Treatment
Participation Requirements
- Age
- Between 18 years and 75 years
- Gender
- Both males and females
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 fro...
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
Tracking Information
- NCT #
- NCT04250584
- Collaborators
- Not Provided
- Investigators
- Not Provided
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