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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).
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.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Mandibular Advancement Device (MAD) | Experimental | This study is experimental. It involves a single-intervention design where participants who have failed hypoglossal nerve stimulation (HGNS) therapy for moderate to severe obstructive sleep apnea (OSA) will be treated with a mandibular advancement device (MAD). |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Mandibular advancement device (MAD) | Device | 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. |
| Measure | Description | Time Frame |
|---|---|---|
| Proportion of responders | 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. | through study completion on average 8 weeks |
| Measure | Description | Time Frame |
|---|---|---|
| Magnitude of change in apnea-hypopnea index (AHI). | 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). | through study completion on average 8 weeks |
| Change in Oxygen desaturation index (ODI) |
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Inclusion Criteria:
Exclusion Criteria:
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| Name | Role | Phone | Extension | |
|---|---|---|---|---|
| Jay F Piccirillo, MD | Contact | 314-362-8641 | piccirj@wustl.edu | |
| Sara Kukuljan | Contact | 314-362-7653 | kukuljas@wustl.edu |
| Name | Affiliation | Role |
|---|---|---|
| Jay Piccirillo, MD | Washington University School of Medicine | Principal Investigator |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Washington University School of Medicine | Recruiting | St Louis | Missouri | 63110 | United States |
| PubMed Identifier | Type | Citation | Retractions |
|---|---|---|---|
| 31999308 | Background | Skirko JR, James KT, Garrison LP, Weaver EM. Development of a Sleep Apnea-Specific Health State Utility Algorithm. JAMA Otolaryngol Head Neck Surg. 2020 Mar 1;146(3):270-277. doi: 10.1001/jamaoto.2019.4469. | |
| 30255301 | Background | Wojda M, Kostrzewa-Janicka J, Sliwinski P, Bielen P, Jurkowski P, Wojda R, Mierzwinska-Nastalska E. Mandibular Advancement Devices in Obstructive Sleep Apnea Patients Intolerant to Continuous Positive Airway Pressure Treatment. Adv Exp Med Biol. 2019;1150:35-42. doi: 10.1007/5584_2018_275. |
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| ID | Term |
|---|---|
| D020181 | Sleep Apnea, Obstructive |
| ID | Term |
|---|---|
| D012891 | Sleep Apnea Syndromes |
| D001049 | Apnea |
| D012120 | Respiration Disorders |
| D012140 | Respiratory Tract Diseases |
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| ID | Term |
|---|---|
| D017090 | Occlusal Splints |
| ID | Term |
|---|---|
| D009989 | Orthotic Devices |
| D009983 | Orthopedic Equipment |
| D013523 | Surgical Equipment |
| D004864 | Equipment and Supplies |
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Pilot, single-intervention study
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no masking required
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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. |
| through study completion on average 8 weeks |
| Change in the time spent below oxygen saturation 90% | 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. | through study completion on average 8 weeks |
| Changes in the mean arterial oxygen saturation (SaO2) | 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. | through study completion on average 8 weeks |
| Adherence to MAD use | 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. | through study completion on average 8 weeks |
| Change in Epworth Sleepiness Scale (ESS) | 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. | through study completion on average 8 weeks |
| Epworth Sleepiness Scale (ESS) improvement | 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. | through study completion on average 8 weeks |
| Symptoms of Nocturnal Obstruction and Related Events (SNORE-25) | 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. | through study completion on average 8 weeks |
| Clinical Global Impression of Improvement (CGI-I) Scale | 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. | through study completion on average 8 weeks |
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| D020919 |
| Sleep Disorders, Intrinsic |
| D020920 | Dyssomnias |
| D012893 | Sleep Wake Disorders |
| D009422 | Nervous System Diseases |