Clinical trial NCT01634074: Reiterative Development and Evaluation Study of OSA Therapy System
Official title: A Multicenter, Prospective, Variable Duration, Reiterative Development and Evaluation Study of ApniCure's Therapy System(s) for the Treatment of Obstructive Sleep Apnea (OSA)
Study type: OBSERVATIONAL
Overall status: UNKNOWN
Conditions: Obstructive Sleep Apnea
Lead sponsor: ApniCure, Inc.
Sponsor class: INDUSTRY
First posted: 2012-07-06
Enrollment: 150
Sex: ALL
Minimum age (years): 18
Maximum age (years): 80
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Observational model: COHORT
Time perspective: PROSPECTIVE
Sampling method: PROBABILITY_SAMPLE
Study population: Patients with known or suspected OSA

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


Eligibility criteria: 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.

Primary outcomes:
Secondary outcomes:
Other outcomes:
Locations:
city: Burlingame
country: United States
facility: Penninsula Sleep Center (PSC)
state: California
city: Redwood City
country: United States
facility: ApniCure, Inc.
state: California
city: Atlanta
country: United States
facility: Sleep Disorders Center of Georgia (SDCG)
state: Georgia
city: Louisville
country: United States
facility: Kentucky Research Group
state: Kentucky
city: Chevy Chase
country: United States
facility: The Center for Sleep & Wake Disorders
state: Maryland
city: Columbia
country: United States
facility: SleepMed
state: South Carolina
city: Dallas
country: United States
facility: Sleep Medicine Associates of Texas (SMAT)
state: Texas
Study officials:
affiliation: Peninsula Sleep lab
name: Mehran Farid-Moayer, MD
role: PRINCIPAL_INVESTIGATOR
References: