Status:
RECRUITING
Safety and Effectiveness of Slow Wave Device for the Treatment of Obstructive Sleep Apnea
Lead Sponsor:
Slow Wave, Inc.
Collaborating Sponsors:
St. David's HealthCare
Conditions:
Obstructive Sleep Apnea
Eligibility:
All Genders
18+ years
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 par...
Detailed Description
This study is a single-center, single-arm open label study to evaluate the safety and effectiveness of the Slow Wave UASD sleep and snore device in individuals with mild-to-moderate Obstructive Sleep ...
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
Key Trial Info
Start Date :
October 1 2024
Trial Type :
OBSERVATIONAL
Allocation :
ESTIMATED
End Date :
September 30 2025
Estimated Enrollment :
70 Patients enrolled
Trial Details
Trial ID
NCT06519149
Start Date
October 1 2024
End Date
September 30 2025
Last Update
April 23 2025
Active Locations (1)
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1
Austin Heart Research
Austin, Texas, United States, 78705