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

NCT06519149 | Recruiting DMC FDA Device

• 1 other identifier: 2192249-1
• Study Type: observational
• Target: 70
• Locations: 1 country
• Sites: 1

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

Outcome Measures

Primary Outcomes (3)

• AHI Events per hour

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

  90 days

• Oxygen Desaturation events during sleep

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

  90 days

• Device safety and comfort

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

  90 days

Secondary Outcomes (3)

• Efficacy Ring Comparison

  90 days

• Pulse rate

  90 days

• Device safety and comfort

  120 days

Study Arms (1)

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

Device: Slow Wave UASD

Interventions

Slow Wave UASD DEVICE

An oral appliance for the treatment of OSA and snoring

Also known as: Slow Wave Oral appliance for the treatment of OSA

Slow Wave UASD

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: Yes
• Age Groups: Adult (18-64), Older Adult (65+)
• Sampling Method: Probability Sample

Study Population

Individuals with mild-to-moderate OSA and individuals with severe OSA below and AHI of 40 who cannot tolerate CPAP treatment

You may qualify if:

• 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%

You may not qualify if:

• 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

Sponsors & Collaborators

• Slow Wave, Inc.: lead
• St. David's HealthCare: collaborator

Study Sites (1)

Austin Heart Research

Austin, Texas, 78705, United States

RECRUITING

Related Publications (3)

• Varghese L, Rebekah G, N P, Oliver A, Kurien R. Oxygen desaturation index as alternative parameter in screening patients with severe obstructive sleep apnea. Sleep Sci. 2022 Jan-Mar;15(Spec 1):224-228. doi: 10.5935/1984-0063.20200119.

  PMID: 35273770 RESULT

• Temirbekov D, Gunes S, Yazici ZM, Sayin I. The Ignored Parameter in the Diagnosis of Obstructive Sleep Apnea Syndrome: The Oxygen Desaturation Index. Turk Arch Otorhinolaryngol. 2018 Mar;56(1):1-6. doi: 10.5152/tao.2018.3025. Epub 2018 Mar 1.

  PMID: 29988275 RESULT

• Cartwright RD. Effect of sleep position on sleep apnea severity. Sleep. 1984;7(2):110-4. doi: 10.1093/sleep/7.2.110.

  PMID: 6740055 RESULT

Related Links

• Market sizing information on OSA

MeSH Terms

Conditions

Sleep Apnea, Obstructive

Condition Hierarchy (Ancestors)

Sleep Apnea Syndromes; Apnea; Respiration Disorders; Respiratory Tract Diseases; Sleep Disorders, Intrinsic; Dyssomnias; Sleep Wake Disorders; Nervous System Diseases

Study Officials

• Matthew Jepson, MD

  St. David's HealthCare

  PRINCIPAL INVESTIGATOR

• Nirman Koladia, MD

  Clinical Research Consultant

  STUDY DIRECTOR

Central Study Contacts

Bill S Morris

CONTACT

5124663977; bmorris@slowwave.net

Wayne R Wagner

CONTACT

2817875589; wwagner@slowwave.net

Study Design

• Study Type: observational
• Observational Model: COHORT
• Time Perspective: RETROSPECTIVE
• Sponsor Type: INDUSTRY
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: July 19, 2024
• First Posted: July 25, 2024
• Study Start: October 1, 2024
• Primary Completion: August 21, 2025
• Study Completion: September 30, 2025
• Last Updated: April 23, 2025

Record last verified: 2025-04

Data Sharing

• IPD Sharing: Will not share

Locations

US (1)