Study of a Sleep Apnea System for the Treatment of Obstructive Sleep Apnea (ATLAST)
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|ClinicalTrials.gov Identifier: NCT01146782|
Recruitment Status : Completed
First Posted : June 22, 2010
Results First Posted : June 30, 2014
Last Update Posted : June 30, 2014
|Condition or disease||Intervention/treatment|
|Obstructive Sleep Apnea||Device: Attune Sleep Apnea System|
|Study Type :||Interventional (Clinical Trial)|
|Actual Enrollment :||367 participants|
|Intervention Model:||Single Group Assignment|
|Masking:||Single (Outcomes Assessor)|
|Official Title:||The ATLAST Trial - A Multicenter, Prospective Study of the Attune Sleep Apnea System for the Treatment of Obstructive Sleep Apnea (OSA)|
|Study Start Date :||June 2010|
|Primary Completion Date :||March 2012|
|Study Completion Date :||March 2012|
Treatment with the Attune Sleep Apnea System
Device: Attune Sleep Apnea System
Console and mouthpiece sleep apnea system
- Clinical Success Defined as Apnea-hypopnea Index (AHI) Reduction of >50% and Treated AHI<20 [ Time Frame: first treatment night ]Comparing first treatment night AHI to control/baseline night. AHI is calculated by dividing the number of apnea/hypopnea events by the number of hours of sleep. AHI values are typically characterized as 5-15/hr = mild OSA, 15-30/hr = moderate OSA, and >30/hr = severe OSA. For each subject, Clinical success was defined as apnea-hypopnea index (AHI) reduction of >50% and treated AHI<20. The number of subjects with clinical success was determined to calculate the primary endpoint as the ratio of the number of subjects with clinical success to the number of subjects.
- Adverse Event Rate [ Time Frame: 4 weeks ]Further categorized as serious and non-serious, device-related and non-device-related, unanticipated and anticipated, and based on level of severity. Adverse events will be evaluated during the trial at the following visits during 28-day take-home period: 7-day, 14-day, 21-day, 28-day follow-up, and any unscheduled visits.
- Last Treatment Night Response (AHI Reduction) [ Time Frame: At completion of 28 day home use. ]Comparing AHI at the last treatment night to the control/baseline night is reported as the percent change in AHI. AHI is calculated by dividing the number of apnea/hypopnea events by the number of hours of sleep. AHI values are typically characterized as 5-15/hr = mild OSA, 15-30/hr = moderate OSA, and >30/hr = severe OSA. Negative numbers represent a decrease/improvement in AHI, whereas positive numbers represent an increase/no improvement in AHI.
- Percent Reduction in Oxygen Desaturation Index (ODI) [ Time Frame: First treatment night ]Comparing first treatment night to control/baseline night reported as percent change. Negative numbers represent a reduction/improvement in ODI, whereas positive numbers represent increases/no improvement in ODI.
To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.
Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT01146782
|United States, Arizona|
|Phoenix, Arizona, United States, 85037|
|United States, California|
|Peninsula Sleep Center|
|Burlingame, California, United States, 94010|
|Menlo Park, California, United States, 94025|
|United States, Georgia|
|Sleep Disorders Center of Georgia (SDCG)|
|Atlanta, Georgia, United States, 30342|
|United States, South Carolina|
|Columbia, South Carolina, United States, 29201|
|United States, Texas|
|Sleep Medicine Associates of Texas (SMAT)|
|Dallas, Texas, United States, 75231|
|Principal Investigator:||Ian Colrain, PhD||Stanford Reasearch Institute (SRI)|