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

NCT06519149 · Status: RECRUITING · Type: OBSERVATIONAL · Enrollment: 70

Last updated 2025-04-23

No results posted yet for this study

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.

Conditions

Interventions

DEVICE

Slow Wave UASD

An oral appliance for the treatment of OSA and snoring

Sponsors & Collaborators

  • St. David's HealthCare

    collaborator OTHER

  • Slow Wave, Inc.

    lead INDUSTRY

Principal Investigators

  • Matthew Jepson, MD · St. David's HealthCare

  • Nirman Koladia, MD · Clinical Research Consultant

Eligibility

Min Age
18 Years
Sex
ALL
Healthy Volunteers
Yes

Timeline & Regulatory

Start
2024-10-01
Primary Completion
2025-08-21
Completion
2025-09-30
FDA Device
Yes

Countries

  • United States

Study Locations

More Related Trials

Entities

Diseases

Read the full study record

This page highlights key information. For complete eligibility criteria, study locations, investigator contacts, and the full protocol, visit the original record on ClinicalTrials.gov.

View NCT06519149 on ClinicalTrials.gov