The ATLAST Long-Term Study

ApniCure, Inc.39 enrolled

Overview

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 Type

INTERVENTIONAL

Allocation

Purpose

TREATMENT

Masking

NONE

Enrollment

Conditions

Obstructive Sleep Apnea (OSA)

Interventions

Attune Sleep Apnea SystemDEVICE

Observation of Attune Sleep Apnea System for use during sleep.

Eligibility

Sex: ALLMin age: 18 YearsMax age: 80 Years

Medical Language ↔ Plain English

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

Locations (6)

REM Medical

Phoenix, Arizona, United States

Penninsula Sleep Center (PSC)

Burlingame, California, United States

SRI International

Menlo Park, California, United States

Sleep Disorders Center of Georgia

Atlanta, Georgia, United States

Outcomes

Primary Outcomes

Mean number of hours per night of device use over a 3-month period

Nightly use will be monitored over a 3-month take-home period.

Time frame: Each night's use

Data from ClinicalTrials.gov

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