The ATLAST Long-Term Study

ApniCure

Status and phase

Completed

Phase 3

Phase 2

Conditions

Obstructive Sleep Apnea (OSA)

Treatments

Device: Attune Sleep Apnea System

Study type

Interventional

Funder types

Industry

Identifiers

NCT01476917

11449

Details and patient eligibility

About

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.

Enrollment

39 patients

Sex

All

Ages

18 to 80 years old

Volunteers

No Healthy Volunteers

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