Reiterative Development and Evaluation Study of OSA Therapy System
A Multicenter, Prospective, Variable Duration, Reiterative Development and Evaluation Study of ApniCure's Therapy System(s) for the Treatment of Obstructive Sleep Apnea (OSA)
1 other identifier
observational
150
1 country
7
Brief Summary
The purpose of this study is to evaluate new iterations/generations of the ApniCure sleep therapy device.
Trial Health
Trial Health Score
Automated assessment based on enrollment pace, timeline, and geographic reach
participants targeted
Target at P50-P75 for all trials
Started Jul 2012
7 active sites
Health score is calculated from publicly available data and should be used for screening purposes only.
Trial Relationships
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Study Timeline
Key milestones and dates
Study Start
First participant enrolled
July 1, 2012
CompletedFirst Submitted
Initial submission to the registry
July 3, 2012
CompletedFirst Posted
Study publicly available on registry
July 6, 2012
CompletedPrimary Completion
Last participant's last visit for primary outcome
July 1, 2014
CompletedStudy Completion
Last participant's last visit for all outcomes
July 1, 2014
CompletedNovember 25, 2013
November 1, 2013
2 years
July 3, 2012
November 21, 2013
Conditions
Study Arms (1)
OSA patients
Patients with Obstructive Sleep Apnea (OSA), or suspected OSA
Eligibility Criteria
Patients with known or suspected OSA
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.
Contact the study team to confirm eligibility.
Sponsors & Collaborators
- ApniCure, Inc.lead
Study Sites (7)
Penninsula Sleep Center (PSC)
Burlingame, California, 94010, United States
ApniCure, Inc.
Redwood City, California, 94063, United States
Sleep Disorders Center of Georgia (SDCG)
Atlanta, Georgia, 30342, United States
Kentucky Research Group
Louisville, Kentucky, 40218, United States
The Center for Sleep & Wake Disorders
Chevy Chase, Maryland, 20815, United States
SleepMed
Columbia, South Carolina, 29201, United States
Sleep Medicine Associates of Texas (SMAT)
Dallas, Texas, 75231, United States
MeSH Terms
Conditions
Condition Hierarchy (Ancestors)
Study Officials
- PRINCIPAL INVESTIGATOR
Mehran Farid-Moayer, MD
Peninsula Sleep lab
Study Design
- Study Type
- observational
- Observational Model
- COHORT
- Time Perspective
- PROSPECTIVE
- Sponsor Type
- INDUSTRY
- Responsible Party
- SPONSOR
Study Record Dates
First Submitted
July 3, 2012
First Posted
July 6, 2012
Study Start
July 1, 2012
Primary Completion
July 1, 2014
Study Completion
July 1, 2014
Last Updated
November 25, 2013
Record last verified: 2013-11