Safety and Effectiveness of Slow Wave Device for the Treatment of Obstructive Sleep Apnea

Part of paid clinical trials in Austin, Texas.

Sponsor
Slow Wave, Inc.
Study ID
NCT06519149
Status
Recruiting
Apply to this trial

Conditions

  • Obstructive Sleep Apnea

Eligibility Criteria

Sex
ALL
Age
18 Years - N/A
Healthy Volunteers
Accepted

Interventions

  • Slow Wave UASD — DEVICE
    An oral appliance for the treatment of OSA and snoring

Study Details

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.

Key Dates

Start date
Oct 1, 2024
Status verified
Apr 2025
Primary completion
Aug 21, 2025
Completion
Sep 30, 2025

Study Design

Enrollment
70 participants (estimated)

Arms

  • Arm: Slow Wave UASD
    Participants who wear the Slow Wave UASD oral device fora 90 day period and a Wellue O2 ring to measure daily sleep metrics

Primary Outcome Measure

AHI Events per hour [ Time Frame: 90 days ]

Central Contacts

Locations (1)

FacilityCityStateZIPSite coordinators
Austin Heart ResearchAustinTexas78705
Hanna Mendyuk, RN
[email protected]
512-421-3896
Angela Dela Llana, RN
[email protected]
(512) 953-1511

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By research site
Austin Heart Research· Austin, TX

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