Obstructive Sleep Apnea (OSA)
Conditions
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.
Interventions
Observation of Attune Sleep Apnea System for use during sleep.
Sponsors
ApniCure, Inc.
Study design
Allocation
NA
Intervention model
SINGLE_GROUP
Primary purpose
TREATMENT
Masking
NONE
Eligibility
Sex/Gender
ALL
Age
18 Years to 80 Years
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
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| 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. |
Countries
United States
Outcome results
None listed