Reiterative Development and Evaluation Study of OSA Therapy System

Obstructive Sleep Apnea Clinical Trial

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)

Clinical Trial Details — Status: Recruiting

Administrative data

• NCT number: NCT01634074
• Other study ID #: 11847
• Status: Recruiting
• Phase: N/A
• First received: July 3, 2012
• Last updated: November 21, 2013
• Start date: July 2012
• Est. completion date: July 2014

Study information

• Verified date: November 2013
• Source: ApniCure, Inc.
• Contact: n/a
• Is FDA regulated: No
• Health authority: United States: Institutional Review Board
• Study type: Observational

Clinical Trial Summary

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

Recruitment information / eligibility

• Status: Recruiting
• Enrollment: 150
• Est. completion date: July 2014
• Est. primary completion date: July 2014
• Accepts healthy volunteers: No
• Gender: Both
• Age group: 18 Years to 80 Years

Eligibility

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

Observational Model: Cohort, Time Perspective: Prospective

Related Conditions & MeSH terms

• Obstructive Sleep Apnea
• Sleep Apnea Syndromes
• Sleep Apnea, Obstructive

Locations

Country	Name	City	State
United States	Sleep Disorders Center of Georgia (SDCG)	Atlanta	Georgia
United States	Penninsula Sleep Center (PSC)	Burlingame	California
United States	The Center for Sleep & Wake Disorders	Chevy Chase	Maryland
United States	SleepMed	Columbia	South Carolina
United States	Sleep Medicine Associates of Texas (SMAT)	Dallas	Texas
United States	Kentucky Research Group	Louisville	Kentucky
United States	ApniCure, Inc.	Redwood City	California

Sponsors (1)

Lead Sponsor	Collaborator
ApniCure, Inc.

Country where clinical trial is conducted

United States,