The ATLAST Long-Term Study

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)

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 Overview

• Status: Completed
• Conditions: Obstructive Sleep Apnea (OSA)
• Intervention / Treatment: Device: Attune Sleep Apnea System

• Study Type: Interventional
• Enrollment (Actual): 39
• Phase: Phase 2; Phase 3

Contacts and Locations

Study Locations

• United States
  • Arizona
    • Phoenix, Arizona, United States, 85037
      • REM Medical
  • California
    • Burlingame, California, United States, 94010
      • Penninsula Sleep Center (PSC)
    • Menlo Park, California, United States, 94025
      • SRI International
  • Georgia
    • Atlanta, Georgia, United States, 30342
      • Sleep Disorders Center of Georgia
  • South Carolina
    • Columbia, South Carolina, United States, 29201
      • SleepMed
  • Texas
    • Dallas, Texas, United States, 75231
      • Sleep Medicine Associates of Texas (SMAT)

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 18 years to 80 years (Adult, Older Adult)
• Accepts Healthy Volunteers: No
• Genders Eligible for Study: All

Description

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 Plan

How is the study designed?

Design Details

• Primary Purpose: Treatment
• Allocation: N/A
• Interventional Model: Single Group Assignment
• Masking: None (Open Label)

Number of Arms

1

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
Experimental: Treatment; Subjects that completed the ATLAST Study	Device: Attune Sleep Apnea System; Observation of Attune Sleep Apnea System for use during sleep.

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
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.	Each night's use

Collaborators and Investigators

• Sponsor: ApniCure, Inc.
• Investigators: Principal Investigator: Ian Colrain, PhD, Stanford Research Institute (SRI)

Study record dates

Study Major Dates

• Study Start: November 1, 2011
• Primary Completion (Actual): June 1, 2012
• Study Completion (Actual): October 1, 2012

Study Registration Dates

• First Submitted: November 16, 2011
• First Submitted That Met QC Criteria: November 18, 2011
• First Posted (Estimate): November 22, 2011

Study Record Updates

• Last Update Posted (Estimate): November 7, 2012
• Last Update Submitted That Met QC Criteria: November 5, 2012
• Last Verified: November 1, 2012

More Information

Terms related to this study

• Additional Relevant MeSH Terms: Nervous System Diseases; Respiratory Tract Diseases; Apnea; Respiration Disorders; Sleep Disorders, Intrinsic; Dyssomnias; Sleep Wake Disorders; Sleep Apnea Syndromes; Sleep Apnea, Obstructive
• Other Study ID Numbers: 11449