Recruiting

Slow Wave Device

Sponsor:

Slow Wave, Inc.

Code:

NCT06519149

Conditions

Obstructive Sleep Apnea

Eligibility Criteria

Sex: All

Age: 18+

Healthy Volunteers: Accepted

Interventions

Slow Wave UASD

Study Details

Brief 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

Obstructive Sleep Apnea

Study ID

NCT06519149

Start date

Oct 1, 2024

Status verified date

Apr, 2025

Completion date

Sep 30, 2025

Anticipated

Primary completion date

Aug 21, 2025

Anticipated

Eligibility Criteria

Eligibility Criteria

Sex: All

Age: 18+

Healthy Volunteers: Accepted

Inclusion Criteria:

  • • 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 Criteria:

  • • 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

Study Design

Enrollment

70 participants

Anticipated

Interventions and Outcome Measures

Arms

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

Interventions

Slow Wave UASD

An oral appliance for the treatment of OSA and snoring

Primary outcome measure

  • AHI Events per hour [ Time Frame: 90 days ]
  • Oxygen Desaturation events during sleep [ Time Frame: 90 days ]
  • Device safety and comfort [ Time Frame: 90 days ]

Central Contacts and Locations

Central contacts

Bill S Morris

5124663977bmorris@slowwave.net

Wayne R Wagner

2817875589wwagner@slowwave.net

Locations

Austin Heart Research

Recruiting

Austin, Texas, United States, 78705

Contacts

Hanna Mendyuk, RN

512-421-3896hanna.mendyuk@HCAhealthcare.com

Angela Dela Llana, RN

(512) 953-1511Angela.DelaLlana@HCAHealthcare.com

More Information

Sponsor

Slow Wave, Inc.

Last update posted

Apr 23, 2025

Last verified

Apr, 2025

Trial information was received from ClinicalTrials.gov and was last updated on 2026-09-09. This information was provided to ClinicalTrials.gov by Slow Wave, Inc. on 2025-04-23.