Reiterative Development and Evaluation Study of OSA Therapy System
Status unconfirmed
Conditions studied: Obstructive Sleep Apnea
In brief
The purpose of this study is to evaluate new iterations/generations of the ApniCure sleep therapy device.
Key facts
- Study ID
- NCT01634074
- Run by
- ApniCure, Inc.
- People needed
- 150
- Starts
- 2012-07-01
- Expected to finish
- 2014-07-01
- Last updated by the study team
- 2013-11-25
Who can join
Age: 18 and older, up to 80. Sex: any. Healthy volunteers: not accepted.
You may qualify if…
- Subject is between the ages of 18 and 80.
- 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.
- Subject has a 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…
- 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 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.
- History of any OSA surgical treatment including uvulopalatopharyngoplasty surgery (UPPP), maxillomandibular advancement surgery (MMA), radio frequency (RF) ablation treatment, palatal stent devices, etc.
- Any concomitant diagnosed or suspected sleep or chronic neurological disorders, other than OSA, including insomnia, and central sleep apnea.
- Currently working nights, or rotating night shifts.
- 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.
- Female subjects of child bearing age who are pregnant or intend to become pregnant during the study period.
Where it is running
- ApniCure, Inc. — Redwood City, California, United States (enrolling)
- Sleep Disorders Center of Georgia (SDCG) — Atlanta, Georgia, United States (enrolling)
- Kentucky Research Group — Louisville, Kentucky, United States (enrolling)
- The Center for Sleep & Wake Disorders — Chevy Chase, Maryland, United States (enrolling)
- SleepMed — Columbia, South Carolina, United States (enrolling)
- Sleep Medicine Associates of Texas (SMAT) — Dallas, Texas, United States (enrolling)
- Penninsula Sleep Center (PSC) — Burlingame, California, United States (enrolling)
Full record on ClinicalTrials.gov
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