Actively Recruiting

Age: 18Years +
All Genders
Healthy Volunteers
NCT06519149

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

Led by Slow Wave, Inc. · Updated on 2025-04-23

70

Participants Needed

1

Research Sites

52 weeks

Total Duration

On this page

Sponsors

S

Slow Wave, Inc.

Lead Sponsor

S

St. David's HealthCare

Collaborating Sponsor

AI-Summary

What this Trial Is About

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

Official Title

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

Who Can Participate

Age: 18Years +
All Genders
Healthy Volunteers

Eligibility Criteria

Eligible

You may qualify if you...

  • Signed and dated informed consent form provided
  • Unable to tolerate or declined positive airway pressure therapy
  • No markedly enlarged tonsils (less than 3+ by Brodsky classification)
  • Able to stick out tongue 20mm or more beyond upper front teeth
  • No uncontrolled nasal blockage; able to breathe through nose
  • Stable medication use for at least 1 month
  • Willing to follow all study procedures and available for entire study
  • Male or female, any race, aged 18 to 70 years inclusive
  • Diagnosed with uncomplicated mild to moderate OSA (AHI between 5 and 30 events/hour) without certain other sleep disorders or conditions
  • Body mass index under 35 kg/m2
  • Neck circumference less than 45 cm
  • Average oxygen saturation during sleep above 82%
  • Jaw movement forward more than 5 mm
  • Adequate teeth condition as confirmed by study dentist
  • Owns a smartphone capable of downloading the oxygen ring app
Not Eligible

You will not qualify if you...

  • Unable to breathe comfortably through the nose
  • More than 25% central sleep apnea events
  • Severe OSA with AHI greater than 40
  • Uncontrolled sleep disorders like narcolepsy, chronic insomnia, restless legs, or REM behavior disorder
  • Positional obstructive sleep apnea (more than twice as many events when lying on back)
  • History of major surgery for OSA correction (e.g., UPPP, maxillomandibular advancement, tongue/hyoid suspension)
  • Recent surgery to restore normal anatomy within past 6 months (e.g., tonsillectomy, adenoidectomy, septoplasty)
  • Presence of hypoglossal nerve stimulation device
  • Use of CPAP or oral appliance therapy within 2 weeks before screening
  • Expected changes in medical therapy affecting OSA during the study
  • Loose teeth or advanced gum disease
  • Teeth extractions or dental implants less than 12 months old
  • Removable dentures
  • History of temporomandibular joint disorder
  • Resistant high blood pressure despite treatment with 3 or more medicines
  • Congestive heart failure class IV, ongoing atrial fibrillation, or recent acute coronary syndrome
  • Neuromuscular diseases affecting breathing during sleep
  • Severe lung disease causing low oxygen levels
  • Stroke within last 12 months
  • Use of pacemaker or life-supporting devices
  • Expected body weight change over 5% during study
  • Participation in other interfering studies

AI-Screening

AI-Powered Screening

Complete this quick 3-step screening to check your eligibility

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Trial Site Locations

Total: 1 location

1

Austin Heart Research

Austin, Texas, United States, 78705

Actively Recruiting

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Research Team

B

Bill S Morris

CONTACT

W

Wayne R Wagner

CONTACT

How is the study designed?

Study Type

OBSERVATIONAL

Masking

N/A

Allocation

N/A

Model

N/A

Primary Purpose

N/A

Number of Arms

1

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