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RECRUITING
NCT06519149

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

Sponsor: Slow Wave, Inc.

View on ClinicalTrials.gov

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.

Key Details

Gender

All

Age Range

18 Years - Any

Study Type

OBSERVATIONAL

Enrollment

70

Start Date

2024-10-01

Completion Date

2025-09-30

Last Updated

2025-04-23

Healthy Volunteers

Yes

Interventions

DEVICE

Slow Wave UASD

An oral appliance for the treatment of OSA and snoring

Locations (1)

Austin Heart Research

Austin, Texas, United States