Obstructive Sleep ApneaROHMANCT07132307
Reducing Obstructive Sleep Apnea After Hypoglossal Nerve Stimulation Through Mandibular Advancement
A study testing Mandibular advancement device (MAD) in people with Obstructive Sleep Apnea, run by Washington University School of Medicine at 1 site in United States.
Trial 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). Read more about this study
- Who is it for?
- Ages 18 to 70 years
- Conditions the study is for
- Obstructive Sleep Apnea
- What is being tested?
- Mandibular advancement device (MAD)
- Type of treatment
- Medical device
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 30 participants
- Where
- 1 siteUnited States
- Study dates
- 29 Jul 2025to 1 Feb 2027
- Phase
- Interventional
- Are there results?
- Not yet: the study is under way
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 to 70 years
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- 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.
Who cannot join
- 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.
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- 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.
Trial locations and contacts
1 site in 1 country. Contact the study team or a site near you to ask about taking part.
United States1 site, 1 recruiting
- Recruiting
Washington University School of Medicine
St Louis, Missouri, 63110
Sara Kukuljan, BS, RN, 314-362-7563, kukuljans@ent.wustl.edu
About this study
Official title: Reducing Obstructive Sleep Apnea After Hypoglossal Nerve Stimulation Through
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).
Read the 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.
- Conditions
- Obstructive Sleep Apnea
- Being tested
- Mandibular advancement device (MAD)
- Keywords
- Otolaryngology, Mandibular advancement device, Hypoglossal nerve stimulation
- Medical subject headings
- Sleep Apnea, Obstructive
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Mandibular advancement device (MAD)Device
Also called ProSomnus Sleep 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.
| Study group | Role | What they receive |
|---|---|---|
| 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). Receives: Device: Mandibular advancement device (MAD) |
What is being measured
The primary outcome is the main question the study is designed to answer.
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.
Measured: through study completion on average 8 weeks
Secondary outcomes (9)
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).
Measured: through study completion on average 8 weeks
Change in Oxygen desaturation index (ODI)
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.
Measured: 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.
Measured: 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.
Measured: 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.
Measured: 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.
Measured: 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.
Measured: 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.
Measured: 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.
Measured: through study completion on average 8 weeks
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted20 Aug 2025
- Study start29 Jul 2025
- Primary completion1 Feb 2027 (estimated)
- Study completion1 Feb 2027 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (32)Papers the sponsor has linked to this study.
- Other trials for Obstructive Sleep ApneaStudies of the same condition, open and under way.
- More trials run by Washington University School of MedicineThe sponsor's other registered studies.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Other
- Allocation
- Not applicable
- Intervention model
- Single group
- Model description
- Pilot, single-intervention study
- Masking
- None (open label)
- Enrolment
- 30 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Washington University School of Medicine
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Jay F. Piccirillo, MD, Washington University School of Medicine
- Investigators
- Jay Piccirillo, MD, Principal investigator, Washington University School of Medicine
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT07132307
- Sponsor's protocol ID
- 202504015
- Acronym
- ROHMA
- Status last verified
- Mar 2026
- First submitted
- 22 Jul 2025
- Last updated
- 19 Mar 2026
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- Yes
- Individual data sharing
- No
Publications
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.
PubMed 31999308Wojda 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.
PubMed 30255301Abbasi A, Gupta SS, Sabharwal N, Meghrajani V, Sharma S, Kamholz S, Kupfer Y. A comprehensive review of obstructive sleep apnea. Sleep Sci. 2021 Apr-Jun;14(2):142-154. doi: 10.5935/1984-0063.20200056.
PubMed 34381578Franklin KA, Lindberg E. Obstructive sleep apnea is a common disorder in the population-a review on the epidemiology of sleep apnea. J Thorac Dis. 2015 Aug;7(8):1311-22. doi: 10.3978/j.issn.2072-1439.2015.06.11.
PubMed 26380759Woo HJ, Lim JH, Ahn JC, Lee YJ, Kim DY, Kim HJ, Rhee CS, Won TB. Characteristics of Obstructive Sleep Apnea Patients With a Low Body Mass Index: Emphasis on the Obstruction Site Determined by Drug-Induced Sleep Endoscopy. Clin Exp Otorhinolaryngol. 2020 Nov;13(4):415-421. doi: 10.21053/ceo.2019.00794. Epub 2020 Apr 29.
PubMed 32344992Wong SJ, Luitje ME, Karelsky S. Patterns of Obstruction on DISE in Adults With Obstructive Sleep Apnea Change With BMI. Laryngoscope. 2021 Jan;131(1):224-229. doi: 10.1002/lary.28777. Epub 2020 Jun 8.
PubMed 32511760Lv R, Liu X, Zhang Y, Dong N, Wang X, He Y, Yue H, Yin Q. Pathophysiological mechanisms and therapeutic approaches in obstructive sleep apnea syndrome. Signal Transduct Target Ther. 2023 May 25;8(1):218. doi: 10.1038/s41392-023-01496-3.
PubMed 37230968Kazemeini E, Van de Perck E, Dieltjens M, Willemen M, Verbraecken J, Op de Beeck S, Vanderveken OM. Critical to Know Pcrit: A Review on Pharyngeal Critical Closing Pressure in Obstructive Sleep Apnea. Front Neurol. 2022 Feb 22;13:775709. doi: 10.3389/fneur.2022.775709. eCollection 2022.
PubMed 35273554Rotenberg BW, Murariu D, Pang KP. Trends in CPAP adherence over twenty years of data collection: a flattened curve. J Otolaryngol Head Neck Surg. 2016 Aug 19;45(1):43. doi: 10.1186/s40463-016-0156-0.
PubMed 27542595Aurora RN, Casey KR, Kristo D, Auerbach S, Bista SR, Chowdhuri S, Karippot A, Lamm C, Ramar K, Zak R, Morgenthaler TI; American Academy of Sleep Medicine. Practice parameters for the surgical modifications of the upper airway for obstructive sleep apnea in adults. Sleep. 2010 Oct;33(10):1408-13. doi: 10.1093/sleep/33.10.1408.
PubMed 21061864Thaler E, Schwab R, Maurer J, Soose R, Larsen C, Stevens S, Stevens D, Boon M, Huntley C, Doghramji K, Waters T, Kominsky A, Steffen A, Kezirian E, Hofauer B, Sommer U, Withrow K, Strohl K, Heiser C. Results of the ADHERE upper airway stimulation registry and predictors of therapy efficacy. Laryngoscope. 2020 May;130(5):1333-1338. doi: 10.1002/lary.28286. Epub 2019 Sep 14.
PubMed 31520484Mashaqi S, Patel SI, Combs D, Estep L, Helmick S, Machamer J, Parthasarathy S. The Hypoglossal Nerve Stimulation as a Novel Therapy for Treating Obstructive Sleep Apnea-A Literature Review. Int J Environ Res Public Health. 2021 Feb 9;18(4):1642. doi: 10.3390/ijerph18041642.
PubMed 33572156Kezirian EJ, Goding GS Jr, Malhotra A, O'Donoghue FJ, Zammit G, Wheatley JR, Catcheside PG, Smith PL, Schwartz AR, Walsh JH, Maddison KJ, Claman DM, Huntley T, Park SY, Campbell MC, Palme CE, Iber C, Eastwood PR, Hillman DR, Barnes M. Hypoglossal nerve stimulation improves obstructive sleep apnea: 12-month outcomes. J Sleep Res. 2014 Feb;23(1):77-83. doi: 10.1111/jsr.12079. Epub 2013 Sep 4.
PubMed 24033656Vanderveken OM, Maurer JT, Hohenhorst W, Hamans E, Lin HS, Vroegop AV, Anders C, de Vries N, Van de Heyning PH. Evaluation of drug-induced sleep endoscopy as a patient selection tool for implanted upper airway stimulation for obstructive sleep apnea. J Clin Sleep Med. 2013 May 15;9(5):433-8. doi: 10.5664/jcsm.2658.
PubMed 23674933Manetta IP, Ettlin D, Sanz PM, Rocha I, Meira E Cruz M. Mandibular advancement devices in obstructive sleep apnea: an updated review. Sleep Sci. 2022 Apr-Jun;15(Spec 2):398-405. doi: 10.5935/1984-0063.20210032.
PubMed 35371398
Study at a glance
From the registry record, last updated by the sponsor on 19 Mar 2026. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Reducing Obstructive Sleep Apnea After Hypoglossal Nerve Stimulation Through
- ClinicalTrials.gov ID
- NCT07132307
- Acronym / sponsor ID
- ROHMA / 202504015
- Conditions
- Obstructive Sleep Apnea
- Keywords
- Otolaryngology, Mandibular advancement device, Hypoglossal nerve stimulation
- Study type
- Interventional
- Recruitment status
- Recruiting
- Enrolment
- 30 participants (estimated)
- Lead sponsor
- Washington University School of MedicineUniversity, hospital or other
- Study start
- 29 Jul 2025 (actual)
- Primary completion
- 1 Feb 2027 (estimated)
- Study completion
- 1 Feb 2027 (estimated)
- First posted
- 20 Aug 2025 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
Study design
- Primary purpose
- Other
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Number of arms
- 1
- Model description
- Pilot, single-intervention study
| Arm | Type | Receives |
|---|---|---|
| Mandibular Advancement Device (MAD) | Experimental | Device: Mandibular advancement device (MAD)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). |
Who may qualify
- Ages
- 18 to 70 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (7 listed)
- 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).
Key exclusion criteria (11 listed)
- 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.
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Mandibular advancement device (MAD)Also: ProSomnus Sleep 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. | Device | Mandibular Advancement Device (MAD) |
Primary outcome
Proportion of responders
Time frame: 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.
9 secondary outcomes
Magnitude of change in apnea-hypopnea index (AHI).
Time frame: through study completion on average 8 weeks
Change in Oxygen desaturation index (ODI)
Time frame: through study completion on average 8 weeks
Change in the time spent below oxygen saturation 90%
Time frame: through study completion on average 8 weeks
Changes in the mean arterial oxygen saturation (SaO2)
Time frame: through study completion on average 8 weeks
Adherence to MAD use
Time frame: through study completion on average 8 weeks
Change in Epworth Sleepiness Scale (ESS)
Time frame: through study completion on average 8 weeks
Epworth Sleepiness Scale (ESS) improvement
Time frame: through study completion on average 8 weeks
Symptoms of Nocturnal Obstruction and Related Events (SNORE-25)
Time frame: through study completion on average 8 weeks
Clinical Global Impression of Improvement (CGI-I) Scale
Time frame: through study completion on average 8 weeks
Results and safety
This study is still under way. Results are not available in the source record yet.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 19 Mar 2026.
- Background: PubMed 31999308Skirko 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.
- Background: PubMed 30255301Wojda 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.
- Background: PubMed 34381578Abbasi A, Gupta SS, Sabharwal N, Meghrajani V, Sharma S, Kamholz S, Kupfer Y. A comprehensive review of obstructive sleep apnea. Sleep Sci. 2021 Apr-Jun;14(2):142-154. doi: 10.5935/1984-0063.20200056.
- Background: PubMed 26380759Franklin KA, Lindberg E. Obstructive sleep apnea is a common disorder in the population-a review on the epidemiology of sleep apnea. J Thorac Dis. 2015 Aug;7(8):1311-22. doi: 10.3978/j.issn.2072-1439.2015.06.11.
- Background: PubMed 32344992Woo HJ, Lim JH, Ahn JC, Lee YJ, Kim DY, Kim HJ, Rhee CS, Won TB. Characteristics of Obstructive Sleep Apnea Patients With a Low Body Mass Index: Emphasis on the Obstruction Site Determined by Drug-Induced Sleep Endoscopy. Clin Exp Otorhinolaryngol. 2020 Nov;13(4):415-421. doi: 10.21053/ceo.2019.00794. Epub 2020 Apr 29.
- Background: PubMed 32511760Wong SJ, Luitje ME, Karelsky S. Patterns of Obstruction on DISE in Adults With Obstructive Sleep Apnea Change With BMI. Laryngoscope. 2021 Jan;131(1):224-229. doi: 10.1002/lary.28777. Epub 2020 Jun 8.
- Background: PubMed 37230968Lv R, Liu X, Zhang Y, Dong N, Wang X, He Y, Yue H, Yin Q. Pathophysiological mechanisms and therapeutic approaches in obstructive sleep apnea syndrome. Signal Transduct Target Ther. 2023 May 25;8(1):218. doi: 10.1038/s41392-023-01496-3.
- Background: PubMed 35273554Kazemeini E, Van de Perck E, Dieltjens M, Willemen M, Verbraecken J, Op de Beeck S, Vanderveken OM. Critical to Know Pcrit: A Review on Pharyngeal Critical Closing Pressure in Obstructive Sleep Apnea. Front Neurol. 2022 Feb 22;13:775709. doi: 10.3389/fneur.2022.775709. eCollection 2022.
- Background: PubMed 27542595Rotenberg BW, Murariu D, Pang KP. Trends in CPAP adherence over twenty years of data collection: a flattened curve. J Otolaryngol Head Neck Surg. 2016 Aug 19;45(1):43. doi: 10.1186/s40463-016-0156-0.
- Background: PubMed 21061864Aurora RN, Casey KR, Kristo D, Auerbach S, Bista SR, Chowdhuri S, Karippot A, Lamm C, Ramar K, Zak R, Morgenthaler TI; American Academy of Sleep Medicine. Practice parameters for the surgical modifications of the upper airway for obstructive sleep apnea in adults. Sleep. 2010 Oct;33(10):1408-13. doi: 10.1093/sleep/33.10.1408.
- Background: PubMed 31520484Thaler E, Schwab R, Maurer J, Soose R, Larsen C, Stevens S, Stevens D, Boon M, Huntley C, Doghramji K, Waters T, Kominsky A, Steffen A, Kezirian E, Hofauer B, Sommer U, Withrow K, Strohl K, Heiser C. Results of the ADHERE upper airway stimulation registry and predictors of therapy efficacy. Laryngoscope. 2020 May;130(5):1333-1338. doi: 10.1002/lary.28286. Epub 2019 Sep 14.
- Background: PubMed 33572156Mashaqi S, Patel SI, Combs D, Estep L, Helmick S, Machamer J, Parthasarathy S. The Hypoglossal Nerve Stimulation as a Novel Therapy for Treating Obstructive Sleep Apnea-A Literature Review. Int J Environ Res Public Health. 2021 Feb 9;18(4):1642. doi: 10.3390/ijerph18041642.
- Individual participant dataSharing planned: No
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part.
Jay Piccirillo, MD principal investigator
Washington University School of Medicine
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Mandibular advancement device (MAD) in people with Obstructive Sleep Apnea, run by Washington University School of Medicine at 1 site in United States.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 7 inclusion and 11 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: looking for participants now, as of the sponsor's last update on 19 Mar 2026. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in United States. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
This study is still under way. Results are not available in the source record yet.
How can a doctor refer a patient or contact the research team?
Contact Jay F Piccirillo, MD (314-362-8641, piccirj@wustl.edu), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Proportion of responders (time frame: through study completion on average 8 weeks). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT07132307, which also lists 32 linked publications.
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 19 Mar 2026; AzTrials last refreshed its copy on 31 Oct 2026.