Obstructive Sleep Apnea
Conditions
Keywords
Otolaryngology, Mandibular advancement device, Hypoglossal nerve stimulation
Brief summary
The purpose of this study is to evaluate the effectiveness, feasibility, and safety of mandibular advancement devices (MAD) for treating severe obstructive sleep apnea (OSA) in patients who are CPAP intolerant and have failed hypoglossal nerve stimulation (HGNS).
Detailed description
ROHMA is a pilot/single intervention study aiming to evaluate effectiveness of a mandibular advancement device (MAD) for treating moderate to severe obstructive sleep apnea (OSA) in patients who have failed hypoglossal nerve stimulation therapy (HGNS). Individuals who received a HGNS therapy at Washington University from April 4 2019 to October 20 2024, or were enrolled in a prior study (HRPO #: 202309014) will be recruited for the study.
Interventions
The intervention in this study involves fitting and using a mandibular advancement device (MAD), specifically the ProSomnus Sleep Device, to treat moderate to severe obstructive sleep apnea (OSA) in patients who are intolerant to CPAP and have failed hypoglossal nerve stimulation (HGNS) therapy.
Sponsors
Washington University School of Medicine
Study design
Allocation
NA
Intervention model
SINGLE_GROUP
Primary purpose
OTHER
Masking
NONE
Masking description
no masking required
Intervention model description
Pilot, single-intervention study
Eligibility
Sex/Gender
ALL
Age
18 Years to 70 Years
Healthy volunteers
No
Inclusion criteria
* Age ≥ 18 years. * Ability to read, write, speak, and understand English. * Failure of hypoglossal nerve stimulation (HGNS) therapy, defined as intolerance to HGNS or insufficient AHI reduction based on modified Sher criteria while using HGNS. * Ability to insert and remove the mandibular advancement device (MAD) independently. * Ability to complete all study assessments and evaluations, including home sleep apnea tests (HSAT). * Ability to abstain from any other treatment for obstructive sleep apnea (OSA) during the entire study duration. * Access to an internet-connected device (phone, tablet, or laptop) with a camera.
Exclusion criteria
* Age over 70 years. * Inability to use a mandibular advancement device (MAD), defined as having fewer than 9 healthy teeth per dental arch. * Prior intolerance to MAD therapy. * Previous participation in a trial involving the use of oral appliances. * Chronic nasal obstruction. * Dependence on or frequent use of medications that alter consciousness, respiration, or alertness. * Insomnia and/or use of medications to treat insomnia. * Sleep disorders such as narcolepsy, insomnia, restless leg syndrome, or other disorders affecting sleep, and/or use of medications to treat such disorders. * Substance abuse. * Unstable psychiatric disorders. * Current use of a GLP-1 receptor agonist (e.g., Zepbound, Wegovy, Ozempic, Mounjaro) with ongoing, active weight loss at the time of enrollment, or recent dose escalation within the prior 8 weeks.
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| Proportion of responders | through study completion on average 8 weeks | The proportion of responders will be defined as number of participants with more than a 50% reduction in apnea-hypopnea index (AHI) and a final AHI less than 15 (modified Sher criteria) after treatment compared to baseline, divided by the total number of participants treated with mandibular advancement device. The AHI is a standardized index used to diagnose and determine the severity of sleep apnea. AHI will be obtained from a home sleep apnea test completed by the participants and reviewed by a trained sleep neurologist. |
Secondary
| Measure | Time frame | Description |
|---|---|---|
| Magnitude of change in apnea-hypopnea index (AHI). | through study completion on average 8 weeks | The magnitude of change in apnea-hypopnea index (AHI) refers to the difference in AHI values measured before and after using the mandibular advancement device (MAD). |
| Change in Oxygen desaturation index (ODI) | through study completion on average 8 weeks | The ODI is an index used to measure the degree of oxygen desaturation during sleep. The ODI will be obtained from the sleep study results by a trained sleep neurologist. Change in ODI will be calculated as the difference ODI pre and post treatment sleep studies. |
| Change in the time spent below oxygen saturation 90% | through study completion on average 8 weeks | The time spent below oxygen saturation 90% difference will be defined as the difference of the length of time where participants have an arterial saturation of oxygen below 90% during pre- and post- treatment sleep study. |
| Changes in the mean arterial oxygen saturation (SaO2) | through study completion on average 8 weeks | The changes in arterial oxygen saturation (SaO2) will be defined as the difference in the mean arterial oxygen saturation recorded during pre- and post- treatment sleep studies. |
| Adherence to MAD use | through study completion on average 8 weeks | Adherence is defined as using the MAD for at least 4 hours per night on at least 5 out of 7 nights during the entire intervention period. The proportion of participants meeting this adherence criterion is calculated and reported to assess feasibility and compliance with the treatment. |
| Change in Epworth Sleepiness Scale (ESS) | through study completion on average 8 weeks | The Epworth Sleepiness Scale (ESS) is measured by asking participants to rate their likelihood of falling asleep in eight different everyday situations on a scale from 1 (least likely) to 7 (most likely). The total ESS score reflects the level of daytime sleepiness, with higher scores indicating greater sleepiness. Change in the Epworth Sleepiness Scale (ESS) is assessed by comparing participants' ESS scores before starting mandibular advancement device (MAD) therapy (baseline) with their scores after the intervention period. |
| Epworth Sleepiness Scale (ESS) improvement | through study completion on average 8 weeks | The Epworth Sleepiness Scale (ESS) is measured by asking participants to rate their likelihood of falling asleep in eight different everyday situations on a scale from 1 (least likely) to 7 (most likely). The total ESS score reflects the level of daytime sleepiness, with higher scores indicating greater sleepiness. Change in the Epworth Sleepiness Scale (ESS) is assessed by comparing participants' ESS scores before starting mandibular advancement device (MAD) therapy (baseline) with their scores after the intervention period. The proportion of participants with improved ESS will be calculated as number of participants whose ESS score changes exceed the minimal clinically important difference (MCID) of 2.4 points divided by the total number of participants. |
| Symptoms of Nocturnal Obstruction and Related Events (SNORE-25) | through study completion on average 8 weeks | The Symptoms of Nocturnal Obstruction and Related Events (SNORE-25) is a validated 25-item questionnaire used to assess sleep-disorder related morbidity by capturing the frequency and severity of symptoms associated with obstructive sleep apnea. The total score ranges from 0 to 5, with higher scores indicating a greater health burden related to sleep-disordered breathing. Change in the Symptoms of Nocturnal Obstruction and Related Events (SNORE-25) scale is assessed by comparing participants' SNORE-25 scores before starting mandibular advancement device (MAD) therapy with their scores after completing the intervention period. |
| Clinical Global Impression of Improvement (CGI-I) Scale | through study completion on average 8 weeks | The Clinical Global Impression of Improvement (CGI-I) scale is a validated, widely used tool that asks participants to rate their overall response to a treatment-in this case, mandibular advancement device (MAD) therapy for obstructive sleep apnea. Participants select one of seven response options: Very Much Improved, Much Improved, Minimally Improved, No Change, Minimally Worse, Much Worse, or Very Much Worse. The proportion of participants reporting improvement is defined as those who choose "Much Improved" or "Very Much Improved" divided by the total number of participants completing the study. |
Countries
United States
Contacts
CONTACTJay F Piccirillo, MD
CONTACTSara Kukuljan
PRINCIPAL_INVESTIGATORJay Piccirillo, MD
Washington University School of Medicine
Outcome results
None listed