Reiterative Development and Evaluation Study of OSA Therapy System

November 21, 2013 updated by: ApniCure, Inc.

A Multicenter, Prospective, Variable Duration, Reiterative Development and Evaluation Study of ApniCure's Therapy System(s) for the Treatment of Obstructive Sleep Apnea (OSA)

The purpose of this study is to evaluate new iterations/generations of the ApniCure sleep therapy device.

Study Overview

Status

Unknown

Conditions

Study Type

Observational

Enrollment (Anticipated)

150

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

  • United States
    • California
      • Burlingame, California, United States, 94010
        • Recruiting
        • Penninsula Sleep Center (PSC)
        • Contact:
        • Principal Investigator:
          • Mehran Farid-Moayer, MD
      • Redwood City, California, United States, 94063
        • Recruiting
        • ApniCure, Inc.
        • Contact:
        • Principal Investigator:
          • Lawrence Siegel, MD
    • Georgia
      • Atlanta, Georgia, United States, 30342
        • Recruiting
        • Sleep Disorders Center of Georgia (SDCG)
        • Contact:
        • Principal Investigator:
          • Alan Lankford, PhD
    • Kentucky
      • Louisville, Kentucky, United States, 40218
        • Recruiting
        • Kentucky Research Group
        • Principal Investigator:
          • David H Winslow, MD
        • Contact:
          • Pamela A McCullough, PhD, APRN, CCRC
          • Phone Number: 502-479-1217
    • Maryland
      • Chevy Chase, Maryland, United States, 20815
        • Recruiting
        • The Center for Sleep & Wake Disorders
        • Contact:
          • Jaime Stiles
          • Phone Number: 301-654-5665
        • Principal Investigator:
          • Helene A Emsellem, MD
    • South Carolina
      • Columbia, South Carolina, United States, 29201
        • Recruiting
        • SleepMed
        • Contact:
    • Texas
      • Dallas, Texas, United States, 75231
        • Recruiting
        • Sleep Medicine Associates of Texas (SMAT)
        • Principal Investigator:
          • Philip Becker, MD
        • Contact:

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 80 years (Adult, Older Adult)

Accepts Healthy Volunteers

No

Genders Eligible for Study

All

Sampling Method

Probability Sample

Study Population

Patients with known or suspected OSA

Description

Inclusion Criteria:

  1. Subject is between the ages of 18 and 80.
  2. Subject is fluent in English and understands the Study protocol and is willing and able to comply with Study requirements and sign the informed consent form.
  3. Subject has a least one molar in each of the four quadrants of the mouth (right upper, right lower, left upper, and left lower).

Exclusion Criteria:

  1. Poor nasal patency as evidenced by the inability to breathe through the nose with the mouth closed.
  2. Oral cavity infection or any other oral or dental condition or problem that would limit subject use of the ApniCure System (e.g. dentures, loose tooth/teeth, temporomandibular joint (TMJ) conditions, or any oral or dental condition that the Investigator believes could be exacerbated by the Attune Sleep Apnea System.
  3. History of any OSA surgical treatment including uvulopalatopharyngoplasty surgery (UPPP), maxillomandibular advancement surgery (MMA), radio frequency (RF) ablation treatment, palatal stent devices, etc.
  4. Any concomitant diagnosed or suspected sleep or chronic neurological disorders, other than OSA, including insomnia, and central sleep apnea.
  5. Currently working nights, or rotating night shifts.
  6. Current disease state, use of medication or other treatment which, in the investigator's opinion, may pose additional risk to the subject or confound the results of the study.
  7. Female subjects of child bearing age who are pregnant or intend to become pregnant during the study period.

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

Cohorts and Interventions

Group / Cohort
OSA patients
Patients with Obstructive Sleep Apnea (OSA), or suspected OSA

Collaborators and Investigators

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

Sponsor

ApniCure, Inc.

Investigators

  • Principal Investigator: Mehran Farid-Moayer, MD, Peninsula Sleep lab

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

July 1, 2012

Primary Completion (Anticipated)

July 1, 2014

Study Completion (Anticipated)

July 1, 2014

Study Registration Dates

First Submitted

July 3, 2012

First Submitted That Met QC Criteria

July 5, 2012

First Posted (Estimate)

July 6, 2012

Study Record Updates

Last Update Posted (Estimate)

November 25, 2013

Last Update Submitted That Met QC Criteria

November 21, 2013

Last Verified

November 1, 2013

More Information

Terms related to this study

Additional Relevant MeSH Terms

Other Study ID Numbers

  • 11847

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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