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

Study Overview
=================
Brief 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.

Official Title
-----------------
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)

Conditions
-----------------
Obstructive Sleep Apnea, Snoring

Intervention / Treatment
-----------------
* Device: Tongue Advancement Retainer Device


Participation Criteria
=================
Eligibility Criteria
-----------------
Inclusion Criteria: • Aged 18-65 AHI greater than or equal to 10 but less than or equal to 60 (<10 AHI <60/hr) Complete set of lower anterior incisors with no evidence of periodontal disease or mobility and the ability to floss between teeth Additionally subjects will in the screening phase must: Tolerate the device when being fitted Used the device for >4 hours on at least two consecutive nights during the screening period. Be able to reliably demonstrate proper installation of the device after fitting. Be willing to trial the device for a 4 week period Exclusion Criteria: • Central sleep apnea events >10% of the total events Evidence of Cheyne stokes breathing Currently on treatment for OSA or OSA treatment discontinued less than 3 months prior. Currently on regular treatment with prescription hypnosedatives or prescription stimulants Very severe OSA, defined as AHI>60/hour and/or minimum oxygen saturation <75% Need for immediate initiation of treatment as assessed by physician (e.g. Excessive sleepiness posing driving risk) Previous surgery to treat OSA (other than nasal surgery) Evidence of periodontal disease or tooth mobility Severe nasal obstruction or enlarged tonsils based on clinical assessment Unstable cardiovascular disease (untreated hypertension acceptable). Inability to tolerate oral device due to oral condition or claustrophobia as determined by the study investigator Pregnant/Breast Feeding Any known factor or disease that might interfere with treatment compliance, study conduct or interpretation of the results such as co-existent other sleep disorder, psychiatric disease, history of non compliance to medical regimens, or unwillingness to comply with study requirements.

Ages Eligible for Study
-----------------
Minimum Age: 18 Years
Maximum Age: 65 Years

Sexes Eligible for Study
-----------------
All

Accepts Healthy Volunteers
-----------------
No

Study Plan
=================
How is the study designed?
-----------------

Design Details

Primary Purpose: Treatment
Intervention Model: Single Group Assignment
Masking: None (Open Label)


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Experimental: Device Treatment<br>Tongue Advancement Retainer Device | Device: Tongue Advancement Retainer Device<br>* Tongue Advancement Retainer Device<br>* Other names: Sleepy Tongue Advancement Retainer Device;|

What is the study measuring?
-----------------
Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Primary Safety Endpoint - The safety of the device will be measured through recorded observations of adverse events. | Safety endpoint will be measured throughout the duration of the study. | Approximately 6 weeks | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Primary Efficacy Endpoint - Change in the overall Apnea Hypopnea Index (AHI) from the PSG at baseline and end of treatment phase. | Efficacy Endpoint will be measured at baseline and at end of treatment. | Approximately 6 weeks | 

 Terms related to the study
=================
Keywords Provided by Centre Hospitalier Valida
-----------------
Obstructive Sleep Apnea, OSA, Snoring, Tongue Advancement Retainer Device