Recruiting

OSA Therapy

Sponsor:

ApniCure, Inc.

Code:

NCT01634074

Conditions

Obstructive Sleep Apnea

Eligibility Criteria

Sex: All

Age: 18 - 70+

Healthy Volunteers: Not accepted

Study Details

Brief summary:

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

Conditions

Obstructive Sleep Apnea

Study ID

NCT01634074

Start date

Jul, 2012

Status verified date

Nov, 2013

Completion date

Jul, 2014

Anticipated

Primary completion date

Jul, 2014

Anticipated

Eligibility Criteria

Eligibility Criteria

Sex: All

Age: 18 - 70+

Healthy Volunteers: Not accepted

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

Enrollment

150 participants

Anticipated

Interventions and Outcome Measures

Arms

OSA patients

Patients with Obstructive Sleep Apnea (OSA), or suspected OSA

Central Contacts and Locations

Locations

Penninsula Sleep Center (PSC)

Recruiting

Burlingame, California, United States, 94010

Contacts

Principal Investigator:

Mehran Farid-Moayer, MD

ApniCure, Inc.

Recruiting

Redwood City, California, United States, 94063

Contacts

Principal Investigator:

Lawrence Siegel, MD

Sleep Disorders Center of Georgia (SDCG)

Recruiting

Atlanta, Georgia, United States, 30342

Contacts

Principal Investigator:

Alan Lankford, PhD

Kentucky Research Group

Recruiting

Louisville, Kentucky, United States, 40218

Contacts

Pamela A McCullough, PhD, APRN, CCRC

502-479-1217

Principal Investigator:

David H Winslow, MD

The Center for Sleep & Wake Disorders

Recruiting

Chevy Chase, Maryland, United States, 20815

Contacts

Jaime Stiles

301-654-5665

Principal Investigator:

Helene A Emsellem, MD

SleepMed

Recruiting

Columbia, South Carolina, United States, 29201

Contacts

Principal Investigator:

Richard Bogan, MD

Sleep Medicine Associates of Texas (SMAT)

Recruiting

Dallas, Texas, United States, 75231

Contacts

Principal Investigator:

Philip Becker, MD

More Information

Sponsor

ApniCure, Inc.

Last update posted

Nov 25, 2013

Last verified

Nov, 2013

Trial information was received from ClinicalTrials.gov and was last updated on 2026-09-09. This information was provided to ClinicalTrials.gov by ApniCure, Inc. on 2013-11-25.