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Slow Wave Device for Obstructive Sleep Apnea

This study is testing a device called the Slow Wave UASD, an oral appliance designed to treat obstructive sleep apnea (OSA) and snoring. Researchers want to see how safe and effective this device is. You might be able to join if you are an adult who can't use or doesn't want to use CPAP therapy, and you meet certain physical requirements like being able to stick out your tongue and breathe through your nose. The study will measure how well the device reduces breathing interruptions during sleep (Apnea-Hypopnea Index or AHI) and low oxygen events (Oxygen Desaturation Index or ODI) after 90 days. They will also check the device's safety and your comfort.

Study design
This is an observational study with 70 planned participants. It is a single-center, single-arm, open-label study, meaning all participants will receive the Slow Wave UASD device.
What's involved
You will have an initial home sleep study, receive a custom-made Slow Wave UASD device, and wear it for 90 days. You will also wear an O2 monitoring ring nightly and upload the results daily.
Compensation
Not stated in the trial record.
Follow-up
Your progress will be measured at 90 days after starting to use the device.

AI-generated from the public study record. Only the study team can confirm whether you're eligible — confirm details with them before making decisions.

NCT06519149

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

Recruiting
Not specifiedAges 18+Observational
Slow Wave, Inc.
~70 participants
Updated 2025-04-23 on ClinicalTrials.gov
What's tested:Slow Wave UASD

At a glance

Recruiting sites
1 of 1 listed site is recruiting right now
RecruitingSuspended, closed, or not yet open
What they're measuring
AHI Events per hour
Measured over 90 days
+2 more outcomes measured

Conditions

Obstructive Sleep Apnea

Explore related trials

Obstructive Sleep Apnea

Where it's being run

1 sites across 1 states
Texas1

Study leadership

  • Matthew Jepson, MD · PRINCIPAL_INVESTIGATOR · St. David's HealthCare
  • Nirman Koladia, MD · STUDY_DIRECTOR · Clinical Research Consultant

Who to contact

Bill S Morris
[email protected]
5124663977
Email the study team

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Do you actually qualify for this trial?

Add a private profile and we'll compare every criterion below against your situation — and tell you which ones are met, uncertain, or excluding.

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Eligibility criteria

Inclusion

• 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)
If diagnosed with uncomplicated Mild to moderate, moderate to severe OSA (i.e., AHI \>5, \<30 h-1); where uncomplicated is defined by the absence of:
Conditions that place the patient at increased risk of non-obstructive sleep-disordered breathing (e.g., central sleep apnea, hypoventilation, and sleep-related hypoxemia). Examples of such conditions include significant cardiopulmonary disease, potential respiratory muscles weakness due to neuromuscular conditions, history of stroke, and chronic opiate medication use.
Concern for significant non-respiratory sleep disorder(s) that require evaluation (e.g., disorders of central hypersomnolence, parasomnias, sleep-related movement disorders) or interfere with accuracy of HSAT (e.g., severe insomnia).
Environmental or personal factors that preclude the adequate acquisition and interpretation of data from HSAT.
Body mass index (BMI) \< 35 kg/m2
Neck circumference \< 45 cm
Absence of severe oxyhemoglobin desaturation during sleep, indicated by mean nocturnal SpO2 \> 82%
Mandibular range of motion \> 5 mm in protrusive direction
Adequate dentition, as determined by the site dentist
Must have a smart phone able to download 02 ring app

Exclusion

• 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
Use of CPAP or OAT within the two weeks prior to the screening HSAT
Anticipated change in medical therapy during the study protocol that could alter OSA severity (e.g., weight loss surgeries; UPPP, MMA, tongue/hyoid suspension)
Loose teeth or advanced periodontal disease
Teeth extractions/Presence of a dental post implanted less than 12 months
Removable dentures
History of temporomandibular joint disorder (TMJ)
Resistant hypertension, defined as inadequately controlled blood pressure despite therapy with ≥ 3 oral hypertensive agents
Presence of congestive heart failure (NYHA Class IV), persistent/permanent atrial fibrillation, or acute coronary artery disease (STEMI/NSTEMI/USA) in the past 30 days.
Presence of neuromuscular diseases e.g. myasthenia gravis, amyotrophic lateral sclerosis, Guillain-Barré syndrome and muscular dystrophy, or hypoventilation disorders which results in shallow breathing during sleep and/or cyanosis of the fingers/toes.
Presence of pulmonary disease resulting in significant desaturation, e.g., severe chronic obstructive pulmonary disease, interstitial lung disease (SaO2 nadir of 87%), or pulmonary hypertension
History of cerebrovascular incident within the last 12 months
Use of pacemaker or other life supporting device
Anticipated change in body weight \> 5% during the study period
Participation in other studies that could interfere with the study protocol

What this trial measures

  • AHI Events per hour90 days

    A 50% or greater reduction in apnea-hypopnea index (AHI) events from the baseline reading while wearing the device

  • Oxygen Desaturation events during sleep90 days

    a 25% or greater decrease in events where oxygen desaturation is greater than or equal to 4% during sleep while wearing the device

  • Device safety and comfort90 days

    All reported adverse events and patient input of side effects, dental exams and surveys