The ATLAST Long-Term Study

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details. Identifier: NCT01476917
Recruitment Status : Completed
First Posted : November 22, 2011
Last Update Posted : November 7, 2012
Information provided by (Responsible Party):
ApniCure, Inc.

Brief Summary:
The Study is a multi-center, prospective, open label, single-arm, three-month, long-term study of the Attune Sleep Apnea System for the treatment of obstructive sleep apnea (OSA). The objective of the study is to monitor long-term use of the Attune Sleep Apnea System.

Condition or disease Intervention/treatment Phase
Obstructive Sleep Apnea (OSA) Device: Attune Sleep Apnea System Phase 2 Phase 3

Study Type : Interventional  (Clinical Trial)
Actual Enrollment : 39 participants
Intervention Model: Single Group Assignment
Masking: None (Open Label)
Primary Purpose: Treatment
Official Title: The ATLAST Long-Term Study. A Multicenter, Prospective, Long-Term Study of the Attune Sleep Apnea System for the Treatment of Obstructive Sleep Apnea (OSA)
Study Start Date : November 2011
Primary Completion Date : June 2012
Study Completion Date : October 2012

Resource links provided by the National Library of Medicine

MedlinePlus related topics: Sleep Apnea
U.S. FDA Resources

Arm Intervention/treatment
Experimental: Treatment
Subjects that completed the ATLAST Study
Device: Attune Sleep Apnea System
Observation of Attune Sleep Apnea System for use during sleep.

Primary Outcome Measures :
  1. Mean number of hours per night of device use over a 3-month period [ Time Frame: Each night's use ]
    Nightly use will be monitored over a 3-month take-home period.

Information from the National Library of Medicine

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Ages Eligible for Study:   18 Years to 80 Years   (Adult, Senior)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No

Inclusion Criteria:

  • Subject participated in the ATLAST Study, and completed the 28-day take-home period
  • Subject understands the Study protocol and is willing and able to comply with Study requirements and sign the informed consent form.
  • The study physician and investigator believe that study participation is appropriate for the subject.
  • Subject has at least one molar in each of the four quadrants of the mouth (right upper, right lower, left upper, and left lower).

Exclusion Criteria:

  • Female subjects who are pregnant or intend to become pregnant during the study period.
  • Poor nasal patency as evidenced by the inability to breathe through the nose with the mouth closed.
  • Oral cavity infection or any other oral or dental condition or problem that would limit subject use of the Attune Sleep Apnea System
  • History of any OSA surgical treatment

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its identifier (NCT number): NCT01476917

United States, Arizona
REM Medical
Phoenix, Arizona, United States, 85037
United States, California
Penninsula Sleep Center (PSC)
Burlingame, California, United States, 94010
SRI International
Menlo Park, California, United States, 94025
United States, Georgia
Sleep Disorders Center of Georgia
Atlanta, Georgia, United States, 30342
United States, South Carolina
Columbia, South Carolina, United States, 29201
United States, Texas
Sleep Medicine Associates of Texas (SMAT)
Dallas, Texas, United States, 75231
Sponsors and Collaborators
ApniCure, Inc.
Principal Investigator: Ian Colrain, PhD Stanford Research Institute (SRI)

Responsible Party: ApniCure, Inc. Identifier: NCT01476917     History of Changes
Other Study ID Numbers: 11449
First Posted: November 22, 2011    Key Record Dates
Last Update Posted: November 7, 2012
Last Verified: November 2012

Additional relevant MeSH terms:
Sleep Apnea Syndromes
Sleep Apnea, Obstructive
Respiration Disorders
Respiratory Tract Diseases
Sleep Disorders, Intrinsic
Sleep Wake Disorders
Nervous System Diseases