Back to resultsThe ATLAST Long-Term Study
Primary Purpose
Obstructive Sleep Apnea (OSA)
Status
Completed
Phase
Phase 2
Locations
United States
Study Type
Interventional
Intervention
Attune Sleep Apnea System
Sponsored by
About this trial
This is an interventional treatment trial for Obstructive Sleep Apnea (OSA)
Eligibility Criteria
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
Sites / Locations
- REM Medical
- Penninsula Sleep Center (PSC)
- SRI International
- Sleep Disorders Center of Georgia
- SleepMed
- Sleep Medicine Associates of Texas (SMAT)
Arms of the Study
Arm 1
Arm Type
Experimental
Arm Label
Treatment
Arm Description
Subjects that completed the ATLAST Study
Outcomes
Primary Outcome Measures
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.
Secondary Outcome Measures
Full Information
1. Study Identification
Unique Protocol Identification Number
NCT01476917
Brief Title
The ATLAST Long-Term Study
Official Title
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)
Study Type
Interventional
2. Study Status
Record Verification Date
November 2012
Overall Recruitment Status
Completed
Study Start Date
November 2011 (undefined)
Primary Completion Date
June 2012 (Actual)
Study Completion Date
October 2012 (Actual)
3. Sponsor/Collaborators
Responsible Party, by Official Title
Sponsor
Name of the Sponsor
ApniCure, Inc.
4. Oversight
Data Monitoring Committee
No
5. Study Description
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.
6. Conditions and Keywords
Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Obstructive Sleep Apnea (OSA)
7. Study Design
Primary Purpose
Treatment
Study Phase
Phase 2, Phase 3
Interventional Study Model
Single Group Assignment
Masking
None (Open Label)
Allocation
N/A
Enrollment
39 (Actual)
8. Arms, Groups, and Interventions
Arm Title
Treatment
Arm Type
Experimental
Arm Description
Subjects that completed the ATLAST Study
Intervention Type
Device
Intervention Name(s)
Attune Sleep Apnea System
Intervention Description
Observation of Attune Sleep Apnea System for use during sleep.
Primary Outcome Measure Information:
Title
Mean number of hours per night of device use over a 3-month period
Description
Nightly use will be monitored over a 3-month take-home period.
Time Frame
Each night's use
10. Eligibility
Sex
All
Minimum Age & Unit of Time
18 Years
Maximum Age & Unit of Time
80 Years
Accepts Healthy Volunteers
No
Eligibility Criteria
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
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Ian Colrain, PhD
Organizational Affiliation
Stanford Research Institute (SRI)
Official's Role
Principal Investigator
Facility Information:
Facility Name
REM Medical
City
Phoenix
State/Province
Arizona
ZIP/Postal Code
85037
Country
United States
Facility Name
Penninsula Sleep Center (PSC)
City
Burlingame
State/Province
California
ZIP/Postal Code
94010
Country
United States
Facility Name
SRI International
City
Menlo Park
State/Province
California
ZIP/Postal Code
94025
Country
United States
Facility Name
Sleep Disorders Center of Georgia
City
Atlanta
State/Province
Georgia
ZIP/Postal Code
30342
Country
United States
Facility Name
SleepMed
City
Columbia
State/Province
South Carolina
ZIP/Postal Code
29201
Country
United States
Facility Name
Sleep Medicine Associates of Texas (SMAT)
City
Dallas
State/Province
Texas
ZIP/Postal Code
75231
Country
United States
12. IPD Sharing Statement
Learn more about this trial
The ATLAST Long-Term Study
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