Reiterative Development and Evaluation Study of OSA Therapy System

• Conditions: Obstructive Sleep Apnea

• Registration Number: NCT01634074
• Lead Sponsor: ApniCure, Inc.

Brief Summary

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

Detailed Description

Not available

Study Timeline

• Study Start: 2012-07
• Study First Submitted: 2012-07-03
• Study First Submitted QC: 2012-07-05
• Study First Posted: 2012-07-06
• Status Verified: 2013-11
• Last Update Submitted: 2013-11-21
• Last Update Posted: 2013-11-25
• Primary Completion: 2014-07
• Study Completion: 2014-07

Recruitment & Eligibility

• Status: UNKNOWN
• Sex: All
• Target Recruitment: 150

Inclusion Criteria

1. Subject is between the ages of 18 and 80.
2. 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.
3. Subject has a least one molar in each of the four quadrants of the mouth (right upper, right lower, left upper, and left lower).

Exclusion Criteria

1. Poor nasal patency as evidenced by the inability to breathe through the nose with the mouth closed.
2. 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.
3. History of any OSA surgical treatment including uvulopalatopharyngoplasty surgery (UPPP), maxillomandibular advancement surgery (MMA), radio frequency (RF) ablation treatment, palatal stent devices, etc.
4. Any concomitant diagnosed or suspected sleep or chronic neurological disorders, other than OSA, including insomnia, and central sleep apnea.
5. Currently working nights, or rotating night shifts.
6. 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.
7. Female subjects of child bearing age who are pregnant or intend to become pregnant during the study period.

Study & Design

• Study Type: OBSERVATIONAL
• Study Design: Not specified

Trial Locations

Locations (7)

Sleep Medicine Associates of Texas (SMAT); 🇺🇸 Dallas, Texas, United States

SleepMed; 🇺🇸 Columbia, South Carolina, United States

Kentucky Research Group; 🇺🇸 Louisville, Kentucky, United States

Penninsula Sleep Center (PSC); 🇺🇸 Burlingame, California, United States

ApniCure, Inc.; 🇺🇸 Redwood City, California, United States

The Center for Sleep & Wake Disorders; 🇺🇸 Chevy Chase, Maryland, United States

Sleep Disorders Center of Georgia (SDCG); 🇺🇸 Atlanta, Georgia, United States