NCT01476917CompletedPhase 2
The ATLAST Long-Term Study. A Multicenter, Prospective, Long-Term Study of the Attune Sleep Apnea System for the Treatment of Obstructive Sleep Apnea (OSA)
Conditions
Trial Snapshot
- Phase
- Phase 2
- Status
- Completed
- Sponsor
- ApniCure, Inc.
- Enrollment
- 39
- Locations
- 12
- Primary Endpoint
- Mean number of hours per night of device use over a 3-month period
Study Overview
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.
Study Design
- Study Type
- Interventional
- Allocation
- Na
- Intervention Model
- Single Group
- Primary Purpose
- Treatment
- Masking
- None
Eligibility Criteria
- Ages
- 18 Years to 80 Years (Adult, Older Adult)
- Sex
- All
- Accepts Healthy Volunteers
- No
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
Outcomes
Primary Outcomes
Mean number of hours per night of device use over a 3-month period
Time Frame: Each night's use
Nightly use will be monitored over a 3-month take-home period.
Secondary Outcomes
No secondary outcomes reported
Investigators
Study Sites (12)
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