Safety and Effectiveness of Slow Wave Device for the Treatment of Obstructive Sleep Apnea
Slow Wave, Inc.
Summary
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.
Description
This study is a single-center, single-arm open label study to evaluate the safety and effectiveness of the Slow Wave UASD sleep and snore device in individuals with mild-to-moderate Obstructive Sleep Apnea (OSA) and individuals with severe OSA of less than 40 AHI events per hour who are not able to tolerate CPAP treatment. All participants will be given and initial Home Sleep Apnea Test (HSAT) to establish baseline readings for: Number of OSA events during sleep, average O2 score during sleep, average pulse rate and Oxygen desaturation events of more than 4% during sleep (ODI). The initial HS…
Eligibility
- Age range
- 18+ years
- Sex
- All
- Healthy volunteers
- Yes
Inclusion Criteria: * • Provision of signed and dated informed consent form * Unable to tolerate or decline positive airway pressure therapy * Absence of markedly enlarged tonsils, defined as 3+ or 4+ according to the Brodsky classification * Able to protrude tongue ≥20mm beyond maxillary incisors * No uncontrolled nasal obstruction (must be able to breathe through nose) * Stable medication regimen for ≥1 month * Stated willingness to comply with all study procedures and availability for the duration of the study * Male or female, of any race, aged 18-70 years (inclusive) * I…
Interventions
- DeviceSlow Wave UASD
An oral appliance for the treatment of OSA and snoring
Location
- Austin Heart ResearchAustin, Texas