The ATLAST Long-Term Study
1 other identifier
interventional
39
1 country
6
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.
Trial Health
Trial Health Score
Automated assessment based on enrollment pace, timeline, and geographic reach
participants targeted
Target at P25-P50 for phase_2
Started Nov 2011
Shorter than P25 for phase_2
6 active sites
Health score is calculated from publicly available data and should be used for screening purposes only.
Trial Relationships
Click on a node to explore related trials.
Study Timeline
Key milestones and dates
Study Start
First participant enrolled
November 1, 2011
CompletedFirst Submitted
Initial submission to the registry
November 16, 2011
CompletedFirst Posted
Study publicly available on registry
November 22, 2011
CompletedPrimary Completion
Last participant's last visit for primary outcome
June 1, 2012
CompletedStudy Completion
Last participant's last visit for all outcomes
October 1, 2012
CompletedNovember 7, 2012
November 1, 2012
7 months
November 16, 2011
November 5, 2012
Conditions
Outcome Measures
Primary Outcomes (1)
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
Study Arms (1)
Treatment
EXPERIMENTALSubjects that completed the ATLAST Study
Interventions
Observation of Attune Sleep Apnea System for use during sleep.
Eligibility Criteria
You may qualify if:
- 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).
You may not qualify if:
- 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
Contact the study team to confirm eligibility.
Sponsors & Collaborators
- ApniCure, Inc.lead
Study Sites (6)
REM Medical
Phoenix, Arizona, 85037, United States
Penninsula Sleep Center (PSC)
Burlingame, California, 94010, United States
SRI International
Menlo Park, California, 94025, United States
Sleep Disorders Center of Georgia
Atlanta, Georgia, 30342, United States
SleepMed
Columbia, South Carolina, 29201, United States
Sleep Medicine Associates of Texas (SMAT)
Dallas, Texas, 75231, United States
MeSH Terms
Conditions
Condition Hierarchy (Ancestors)
Study Officials
- PRINCIPAL INVESTIGATOR
Ian Colrain, PhD
Stanford Research Institute (SRI)
Study Design
- Study Type
- interventional
- Phase
- phase 2
- Allocation
- NA
- Masking
- NONE
- Purpose
- TREATMENT
- Intervention Model
- SINGLE GROUP
- Sponsor Type
- INDUSTRY
- Responsible Party
- SPONSOR
Study Record Dates
First Submitted
November 16, 2011
First Posted
November 22, 2011
Study Start
November 1, 2011
Primary Completion
June 1, 2012
Study Completion
October 1, 2012
Last Updated
November 7, 2012
Record last verified: 2012-11