Status:
COMPLETED
The ATLAST Long-Term Study
Lead Sponsor:
ApniCure, Inc.
Conditions:
Obstructive Sleep Apnea (OSA)
Eligibility:
All Genders
18-80 years
Phase:
PHASE2
PHASE3
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...
Eligibility Criteria
Inclusion
- 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
- 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
Key Trial Info
Start Date :
November 1 2011
Trial Type :
INTERVENTIONAL
Allocation :
ACTUAL
End Date :
October 1 2012
Estimated Enrollment :
39 Patients enrolled
Trial Details
Trial ID
NCT01476917
Start Date
November 1 2011
End Date
October 1 2012
Last Update
November 7 2012
Active Locations (6)
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1
REM Medical
Phoenix, Arizona, United States, 85037
2
Penninsula Sleep Center (PSC)
Burlingame, California, United States, 94010
3
SRI International
Menlo Park, California, United States, 94025
4
Sleep Disorders Center of Georgia
Atlanta, Georgia, United States, 30342