Using a device to treat obstructive sleep apnea

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

This study is testing a new oral device to see if it can safely improve sleep quality for people with obstructive sleep apnea.

Quick facts

• Study type: Observational
• Enrollment: 70 (estimated)
• Ages: 18 Years and up
• Sex: All
• Sponsor: Slow Wave, Inc. (Industry-sponsored)
• Locations: 1 site (Austin, Texas)
• Trial ID: NCT06519149 on ClinicalTrials.gov

What this trial studies

This observational study evaluates the safety and effectiveness of the Slow Wave UASD oral appliance for treating obstructive sleep apnea (OSA). It will recruit 60-80 participants who will undergo pre-trial and post-trial sleep studies to measure improvements in their Apnea-Hypopnea Index (AHI) and Oxygen Desaturation Index (ODI). Participants will wear the device for 90 days and use an O2 monitoring ring to collect daily data on their sleep patterns. The study aims to compare these measurements to assess the device's impact on sleep quality and safety.

Who should consider this trial

Good fit: Ideal candidates are adults aged 18-70 with mild to moderate or uncomplicated severe obstructive sleep apnea who are unable to tolerate positive airway pressure therapy.

Not a fit: Patients with significantly enlarged tonsils or those with uncontrolled nasal obstruction may not benefit from this study.

Why it matters

Potential benefit: If successful, this device could provide a non-invasive treatment option for patients with obstructive sleep apnea who cannot tolerate CPAP therapy.

How similar studies have performed: While similar approaches have been explored, this specific device's effectiveness in this context is novel and has not been extensively tested.

Eligibility criteria

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

Where this trial is running

Austin, Texas

• Austin Heart Research — Austin, Texas, United States (Recruiting)

Study contacts

• Principal investigator: Matthew Jepson, MD — St. David's HealthCare
• Study coordinator: Bill S Morris

Conditions Obstructive Sleep Apnea