Condition: Obstructive Sleep Apnea · Sponsor: Slow Wave, Inc.
This is a safety and efficacy trial for a Slow Wave, Inc. UASD oral appliance for the treatment of Obstructive Sleep Apnea. This trial will recruit 60-80 participants through our IRB partner. Each participant will take pre-trial and post trail sleep studies and be measured before, throughout and after the trial for Apnea-Hypopnea Index (AHI), Oxygen Desaturation Index (ODI), pulse rate to determine level of sleep improvement while wearing the device. Safety will also be measured through survey, dental exams and adverse events monitoring. Patients will wear an O2 monitoring ring throughout the study and upload results daily. Primary Objectives will evaluate AHI and ODI between sleep studies. Secondary outcomes will compare the daily ring data to these two sleep studies to evaluate changes over time. Patients will have the opportunity to complete daily diaries on their sleep experiences.
This description comes directly from the study's public registry record.
Bill S Morris · 5124663977 · bmorris@slowwave.net
Wayne R Wagner · 2817875589 · wwagner@slowwave.net
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| Austin Heart Research | Austin, Texas, United States | Recruiting |
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Source record: clinicaltrials.gov/study/NCT06519149