The ATLAST Long-Term Study

This study has been completed.
Sponsor:
Information provided by (Responsible Party):
ApniCure, Inc.
ClinicalTrials.gov Identifier:
NCT01476917
First received: November 16, 2011
Last updated: November 5, 2012
Last verified: November 2012
  Purpose

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 Intervention Phase
Obstructive Sleep Apnea (OSA)
Device: Attune Sleep Apnea System
Phase 2
Phase 3

Study Type: Interventional
Study Design: Endpoint Classification: Safety/Efficacy Study
Intervention Model: Single Group Assignment
Masking: 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)

Resource links provided by NLM:


Further study details as provided by ApniCure, Inc.:

Primary Outcome Measures:
  • Mean number of hours per night of device use over a 3-month period [ Time Frame: Each night's use ] [ Designated as safety issue: No ]
    Nightly use will be monitored over a 3-month take-home period.


Enrollment: 39
Study Start Date: November 2011
Study Completion Date: October 2012
Primary Completion Date: June 2012 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
Experimental: Treatment
Subjects that completed the ATLAST Study
Device: Attune Sleep Apnea System
Observation of Attune Sleep Apnea System for use during sleep.

  Eligibility

Ages Eligible for Study:   18 Years to 80 Years
Genders Eligible for Study:   Both
Accepts Healthy Volunteers:   No
Criteria

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
  Contacts and Locations
Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the Contacts provided below. For general information, see Learn About Clinical Studies.

Please refer to this study by its ClinicalTrials.gov identifier: NCT01476917

Locations
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
SleepMed
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.
Investigators
Principal Investigator: Ian Colrain, PhD Stanford Research Institute (SRI)
  More Information

No publications provided

Responsible Party: ApniCure, Inc.
ClinicalTrials.gov Identifier: NCT01476917     History of Changes
Other Study ID Numbers: 11449
Study First Received: November 16, 2011
Last Updated: November 5, 2012
Health Authority: United States: Institutional Review Board

Additional relevant MeSH terms:
Apnea
Sleep Apnea Syndromes
Sleep Apnea, Obstructive
Respiration Disorders
Respiratory Tract Diseases
Signs and Symptoms, Respiratory
Signs and Symptoms
Sleep Disorders, Intrinsic
Dyssomnias
Sleep Disorders
Nervous System Diseases

ClinicalTrials.gov processed this record on July 23, 2014