A Multicenter, Prospective, Variable Duration, Reiterative Development and Evaluation Study of ApniCure's Therapy System(s) for the Treatment of Obstructive Sleep Apnea (OSA)

ApniCure, Inc.7 个研究点分布在 1 个国家目标入组 150 人开始时间: 2012年7月最近更新: 2013年11月25日

适应症

试验速览

The purpose of this study is to evaluate new iterations/generations of the ApniCure sleep therapy device.

•Subject is between the ages of 18 and
•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).

•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.

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