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

Status: Recruiting
Location: See location...
Intervention Type: Device
Study Type: Observational
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.

Eligibility
Participation Requirements
Sex: All
Minimum Age: 18
Healthy Volunteers: t
View:

• • 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

Locations
United States
Texas
Austin Heart Research
RECRUITING
Austin
Contact Information
Primary
Bill S Morris
bmorris@slowwave.net
5124663977
Backup
Wayne R Wagner
wwagner@slowwave.net
2817875589
Time Frame
Start Date: 2024-10-01
Estimated Completion Date: 2025-09-30
Participants
Target number of participants: 70
Treatments
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
Related Therapeutic Areas
Sponsors
Leads: Slow Wave, Inc.
Collaborators: St. David's HealthCare

This content was sourced from clinicaltrials.gov