The ATLAST Long-Term Study
Phase 2
Completed
- Conditions
- Obstructive Sleep Apnea (OSA)
- Interventions
- Device: Attune Sleep Apnea System
- Registration Number
- NCT01476917
- Lead Sponsor
- ApniCure, Inc.
- Brief Summary
The Study is a multi-center, prospective, open label, single-arm, three-month, long-term study of the Attune Sleep Apnea System for the treatment of obstructive sleep apnea (OSA). The objective of the study is to monitor long-term use of the Attune Sleep Apnea System.
- Detailed Description
Not available
Recruitment & Eligibility
- Status
- COMPLETED
- Sex
- All
- Target Recruitment
- 39
Inclusion Criteria
- Subject participated in the ATLAST Study, and completed the 28-day take-home period
- Subject understands the Study protocol and is willing and able to comply with Study requirements and sign the informed consent form.
- The study physician and investigator believe that study participation is appropriate for the subject.
- Subject has at least one molar in each of the four quadrants of the mouth (right upper, right lower, left upper, and left lower).
Exclusion Criteria
- Female subjects who are pregnant or intend to become pregnant during the study period.
- 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 Attune Sleep Apnea System
- History of any OSA surgical treatment
Study & Design
- Study Type
- INTERVENTIONAL
- Study Design
- SINGLE_GROUP
- Arm && Interventions
Group Intervention Description Treatment Attune Sleep Apnea System Subjects that completed the ATLAST Study
- Primary Outcome Measures
Name Time Method Mean number of hours per night of device use over a 3-month period Each night's use Nightly use will be monitored over a 3-month take-home period.
- Secondary Outcome Measures
Name Time Method
Trial Locations
- Locations (6)
SleepMed
🇺🇸Columbia, South Carolina, United States
Sleep Disorders Center of Georgia
🇺🇸Atlanta, Georgia, United States
Penninsula Sleep Center (PSC)
🇺🇸Burlingame, California, United States
REM Medical
🇺🇸Phoenix, Arizona, United States
SRI International
🇺🇸Menlo Park, California, United States
Sleep Medicine Associates of Texas (SMAT)
🇺🇸Dallas, Texas, United States