Safety and Effectiveness of Slow Wave Device for the Treatment of Obstructive Sleep Apnea
Eligible age
18+ yrs
Accepts
All genders
Locations
1 state
Healthy volunteers
Yes
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About this study
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.
Sponsor: Slow Wave, Inc.
You may qualify if…
- ✓ • 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)
You may not qualify if…
- ✕ • Inability to breathe through the nose comfortably
- ✕ Presence of \> 25% Central Sleep Apnea (CSA)
- ✕ Severe OSA above AHI \>40
- ✕ Uncontrolled sleep disorder such as narcolepsy, chronic insomnia, restless legs syndrome, or REM behavior disorder
- ✕ Presence of positional obstructive sleep apnea per Cartwright's definition (Ratio of respiratory events in the supine to nonsupine position greater than 2:1)
- ✕ History of surgery intended to alter anatomy for the correction of OSA, such as uvulopalatopharyngoplasty (UPPP), maxillomandibular advancement (MMA), or tongue/hyoid suspension.
- ✕ History of surgery intended to restore normal anatomy, such as tonsillectomy, adenoidectomy, septoplasty, or polypectomy within the previous 6 months
- ✕ Presence of hypoglossal nerve stimulation device
Where it's recruiting
Austin
Source: ClinicalTrials.gov · NCT06519149 · last updated 2025-04-23