NCT01772017

A Trial to Evaluate a Device for the Treatment of OSA and Snoring

A Multi Center, Open Label Study to Evaluate a Tongue Advancement Retainer Device in the Treatment of Subjects With Obstructive Sleep Apnea and Snoring (OPEN Trial)

• Status: Terminated
• Phase: N/A
• Study type: Interventional
• Enrollment: 15 (actual)
• Sponsor: Sleepy, Inc · Industry
• Sex: All
• Age: 18 Years – 65 Years
• Healthy volunteers: Not accepted

Summary

To evaluate the safety and efficacy of the Tongue Advancement Retainer Device in treating subjects with Obstructive Sleep Apnea (OSA) and snoring.

Detailed description

The Tongue Advancement Retainer Device is a device that was developed to treat subjects with OSA and snoring. The purpose of this study is to evaluate initial safety and effectiveness of this device in treating one or both conditions.

Conditions

• Obstructive Sleep Apnea
• Snoring

Interventions

Type	Name	Description
DEVICE	Tongue Advancement Retainer Device	Tongue Advancement Retainer Device

Timeline

• Start date: 2012-10-01
• Primary completion: 2013-08-01
• Completion: 2013-08-01
• First posted: 2013-01-21
• Last updated: 2015-11-24

Locations

3 sites across 2 countries: United States, Australia