Clinical trial NCT06519149: Safety and Effectiveness of Slow Wave Device for the Treatment of Obstructive Sleep Apnea
Official title: Safety and Effectiveness of Slow Wave Device for the Treatment of Obstructive Sleep Apnea
Study type: OBSERVATIONAL
Overall status: RECRUITING
Conditions: Obstructive Sleep Apnea
Lead sponsor: Slow Wave, Inc.
Sponsor class: INDUSTRY
Collaborators: name: St. David's HealthCare
First posted: 2024-07-25
Enrollment: 70
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: yes
Observational model: COHORT
Time perspective: RETROSPECTIVE
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

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.

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 Apnea (OSA) and individuals with severe OSA of less than 40 AHI events per hour who are not able to tolerate CPAP treatment.

All participants will be given and initial Home Sleep Apnea Test (HSAT) to establish baseline readings for: Number of OSA events during sleep, average O2 score during sleep, average pulse rate and Oxygen desaturation events of more than 4% during sleep (ODI). The initial HSAT will also determine if the patients have OSA.

All participants will get an intraoral scan with a closed bite by a study partner. The 3D scan will be used to create a personalized Slow Wave UASD device that will be used throughout the study. Each participant will wear the device for a 90-day period. Each participant will be given a WellUE O2 ring to wear every night throughout the study. The ring connects to the WellUE application that participants will be asked to download to their phones. The O2 ring application collects much of hte same data as is collected in a home sleep study. Participants will be asked to upload the ring results to a study-managed database on a daily basis. Ring results will be presented as secondary objectives in this trial. The failure of a participant to send ring data will not disqualify them from the trial as primary objectives are the comparison of beginning and ending HSAT results. Patients will be given patient health questionnaires and physical examinations prior to participation.

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

Primary outcomes:
measure: AHI Events per hour
timeFrame: 90 days
measure: Oxygen Desaturation events during sleep
timeFrame: 90 days
measure: Device safety and comfort
timeFrame: 90 days
Secondary outcomes:
measure: Efficacy Ring Comparison
timeFrame: 90 days
measure: Pulse rate
timeFrame: 90 days
measure: Device safety and comfort
timeFrame: 120 days
Other outcomes:
Locations:
city: Austin
country: United States
facility: Austin Heart Research
state: Texas
Study officials:
affiliation: St. David's HealthCare
name: Matthew Jepson, MD
role: PRINCIPAL_INVESTIGATOR
affiliation: Clinical Research Consultant
name: Nirman Koladia, MD
role: STUDY_DIRECTOR
References:
citation: 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.
citation: 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.
citation: Cartwright RD. Effect of sleep position on sleep apnea severity. Sleep. 1984;7(2):110-4. doi: 10.1093/sleep/7.2.110.