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

November 22, 2015 updated by: Sleepy, Inc

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)

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

Study Overview

Status

Terminated

Conditions

Intervention / Treatment

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.

Study Type

Interventional

Enrollment (Actual)

15

Phase

  • Not Applicable

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

  • Australia
    • New South Wales
      • St. Leonards, New South Wales, Australia, 2065
        • Royal North Shore Hospital
  • United States
    • California
      • San Diego, California, United States, 92120
        • Senta Clinic
      • Visalia, California, United States, 93291
        • Visalia Medical Clinic

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

18 years to 65 years (Adult, Older Adult)

Accepts Healthy Volunteers

No

Genders Eligible for Study

All

Description

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.

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: Treatment
  • Allocation: N/A
  • Interventional Model: Single Group Assignment
  • Masking: None (Open Label)

Arms and Interventions

Participant Group / Arm
Intervention / Treatment
Experimental: Device Treatment
Tongue Advancement Retainer Device
Device: Tongue Advancement Retainer Device
Tongue Advancement Retainer Device
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.
Time Frame: Approximately 6 weeks
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.
Time Frame: Approximately 6 weeks
Efficacy Endpoint will be measured at baseline and at end of treatment.
Approximately 6 weeks

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Sleepy, Inc

Investigators

  • Principal Investigator: Brian Weeks, MD, Senta Clinic

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start

October 1, 2012

Primary Completion (Actual)

August 1, 2013

Study Completion (Actual)

August 1, 2013

Study Registration Dates

First Submitted

October 30, 2012

First Submitted That Met QC Criteria

January 16, 2013

First Posted (Estimate)

January 21, 2013

Study Record Updates

Last Update Posted (Estimate)

November 24, 2015

Last Update Submitted That Met QC Criteria

November 22, 2015

Last Verified

November 1, 2015

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

  • OPEN-002

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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