The ATLAST Long-Term Study
Completed · Phase 2/Phase 3
Conditions studied: Obstructive Sleep Apnea (OSA)
In brief
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.
Key facts
- Study ID
- NCT01476917
- Run by
- ApniCure, Inc.
- People needed
- 39
- Starts
- 2011-11-01
- Expected to finish
- 2012-10-01
- Last updated by the study team
- 2012-11-07
Who can join
Age: 18 and older, up to 80. Sex: any. Healthy volunteers: not accepted.
You may qualify if…
- 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).
You may not qualify if…
- 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
Where it is running
- REM Medical — Phoenix, Arizona, United States
- Penninsula Sleep Center (PSC) — Burlingame, California, United States
- SRI International — Menlo Park, California, United States
- Sleep Disorders Center of Georgia — Atlanta, Georgia, United States
- SleepMed — Columbia, South Carolina, United States
- Sleep Medicine Associates of Texas (SMAT) — Dallas, Texas, United States
Full record on ClinicalTrials.gov
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