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Obstructive Sleep ApneaOSANOVANCT07074288

Obstructive Sleep Apnea Non-PAP Outcomes and Viable Alternatives

A study testing MAD and HGNS in people with Obstructive Sleep Apnea, run by Washington University School of Medicine at 1 site in United States.

Recruiting

Looking for participants now. Contact the study team or a site below to ask about taking part.

Sites and contacts
Official record
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Trial summary

OSANOVA is a non-randomized clinical trial which aims to compare outcomes of mandibular advancement device (MAD) and hypoglossal nerve stimulation (HGNS) therapies in moderate-to-severe OSA patients who fail, decline, or are intolerant to positive airway pressure (PAP) therapy (referred to as PAP-failing patients). Read more about this study

Who is it for?
Ages 18 years and older
Conditions the study is for
Obstructive Sleep Apnea
What is being tested?
MAD and HGNS
Type of treatment
Medical device
Could I receive a placebo?
No, everyone receives an active treatment
How many people
60 participants
Where
1 siteUnited States
Study dates
30 Jun 2025to May 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 years and older
  • All sexes
  • No healthy volunteers
  • Adult, Older adult

Who may be able to join

  • Must consent to being a part of the study
  • Must be willing and able to physically present to the our office site on the Hospital campus whenever necessary over the course of the study
  • Able to read, write, speak, and understand English
  • Willing to complete study surveys over the course of the study.
  • Must have a diagnosis for moderate to severe OSA (AHI ≥15) with indications for PAP therapy OSA is stratified into mild (5 ≤ AHI ≤ 15), moderate (15 < AHI ≤ 30), and severe (AHI>30)
  • Must have declined PAP therapy (unwillingness to use), failed PAP therapy (AHI > 15 on PAP), or are inadherent to PAP therapy (not using PAP ≥4 hours/night for ≥5 nights per week, also defined as intolerance to PAP)
Show all 11Show fewer
  • Age ≥ 18 years
  • BMI ≤ 40 kg/m²
  • Central/Mixed apneas contribute < 25% of AHI (Predominantly Obstructive Sleep Apnea)
  • Willing to complete pre-intervention and post-intervention sleep studies
  • Planning to obtain MAD or HGNS as part of clinical care

Who cannot join

  • AHI > 65
  • o The guidelines for HGNS usage were originally approved for an AHI upper limit of 65. We will not enroll anyone in the study with an AHI greater than 65.
  • Dental conditions such as temporomandibular joint disease, periodontal disease, dental disease, insufficient dentition (edentulism) to support appliance retention, and inadequate range of motion of the jaw. Similarly, patients undergoing dental realignment (e.g., braces or retaining device) are not suitable candidates.
  • Chronic nasal obstruction
  • Individuals without manual dexterity to place and remove the device such as those afflicted with severe arthritis, or neuromuscular disease that affects dexterity.
  • Prior intolerance to MAD
Show all 11Show fewer
  • Rapid therapy required: patients in whom rapid initiation of treatment is desirable (e.g., patients with severe symptomatic OSA, sleepiness while driving) and they declined PAP without PAP failure. PAP therapy can be initiated quickly while MAD initiation requires incremental titration of the device over weeks to months to attain optimal efficacy.
  • Severe or prolonged Oxygen desaturation: patients with severe oxyhemoglobin desaturation during sleep (e.g., nadir peripheral oxygen saturation [SpO2] <70 percent), caution is warranted as oral appliance therapy may not provide optimal improvement in oxygenation.
  • Alcohol or illicit substance use at least daily
  • Unstable psychiatric condition
  • 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.

Sara Kukuljan contact

314-362-7563

kukuljas@wustl.edu

Mohamed Jama contact

314-362-9475

mjama@wustl.edu

United States1 site, 1 recruiting

  • Washington University

    St Louis, Missouri, 63110

    Sara Kukuljan, 314-362-7563, kukuljas@wustl.edu

    Recruiting

Other trials in United States

About this study

Official title: Obstructive Sleep Apnea Non-PAP Outcomes and Viable Alternatives (OSANOVA): Comparison of Mandibular Advancement Device and Hypoglossal Nerve Stimulation Outcomes

OSANOVA is a non-randomized clinical trial which aims to compare outcomes of mandibular advancement device (MAD) and hypoglossal nerve stimulation (HGNS) therapies in moderate-to-severe OSA patients who fail, decline, or are intolerant to positive airway pressure (PAP) therapy (referred to as PAP-failing patients).

The primary aim of the study is to compare the outcomes between PAP-failing moderate-to-severe OSA patients receiving MAD and those receiving HGNS therapy. Primary Outcome measures include changes in Pittsburgh Sleep Quality Index (PSQI) scores.

Read more

Secondary aims will help us describe the outcomes between PAP-failing moderate-to-severe OSA patients receiving MAD and those receiving HGNS therapy. Secondary outcome measures include:

  • adverse events,
  • Epworth Sleepiness Scale (ESS),
  • Symptoms of Nocturnal Obstruction and Related Events (SNORE-25),
  • patient-reported satisfaction,
  • CGI-Improvement,
  • the rate of subjects re-selecting the treatment, and
  • the rate of subjects recommending the treatment. and
  • changes in sleep study metrics (i.e., AHI, ODI, mean arterial saturation, and Time<90%),
Read the detailed description

The study will enroll and follow a cohort of PAP-failing patients receiving MAD therapy and a second cohort receiving HGNS therapy. Baseline and post-intervention patient-reported outcome measures (PROMs) and standard sleep study parameters to evaluate and compare treatment efficacy will be captured.

Both MAD and HGNS are accepted treatments for moderate OSA patients following PAP intolerance, refusal, or failure. Current decision-making is based heavily on patient preference rather than well-defined evidence-based recommendations. Choosing the right therapy is a crucial aspect of treatment for OSA, a chronic and lifelong condition.

Being tested
MAD, HGNS
Keywords
Otolaryngology, Mandibular Advancement Device therapy, Hypoglossal Nerve Stimulation therapy
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.

  • MADDevice

    MAD intervention involves the use of a mandibular advancement device, which is designed to reposition the lower jaw and tongue to keep the airway open during sleep.

  • HGNSDevice

    HGNS intervention involves a surgical procedure to implant a device that stimulates the hypoglossal nerve to prevent airway collapse during sleep.

Study groups in NCT07074288
Study groupRoleWhat they receive
Mandibular Advancement Device (MAD) therapyExperimentalThis arm includes patients who will receive treatment with a mandibular advancement device, which is an accepted therapy for moderate obstructive sleep apnea (OSA) patients following intolerance, refusal, or failure of positive airway pressure (PAP) therapy.
Receives: Device: MAD
Hypoglossal Nerve Stimulation (HGNS) therapyActive comparatorThis arm consists of patients who will receive hypoglossal nerve stimulation therapy, another accepted treatment option for moderate obstructive sleep apnea (OSA) patients following intolerance, refusal, or failure of positive airway pressure (PAP) therapy.
Receives: Device: HGNS

What is being measured

The primary outcome is the main question the study is designed to answer.

  1. Pittsburgh Sleep Quality Index (PSQI)

    Pittsburgh Sleep Quality Index (PSQI) asks patients to reflect on their sleep experiences over the last month prior to assessment. The global PSQI score is calculated by summing all seven components scores (i.e., subjective sleep quality,sleep latency, sleep duration, habitual sleep efficiency,sleep disturbances, use of sleeping medication and daytime dysfunction). Each component is scored between 0 and 3, resulting in a total PSQI score ranging from 0 to 21. A higher score indicates poorer sleep quality, with a global sum greater than 5 signifying poor sleep quality.

    The change in PSQI is calculated as the difference in PSQI score post-treatment minus PSQI score pre-treatment.

    Measured: baseline(pre-treatment) and through study completion on average 8 weeks

Secondary outcomes (11)

  1. Clinical Global Impressions-Improvement (CGI-I)

    CGI-I scale is a tool used to assess the change in a patient's condition following treatment. It is adapted from the Clinical Global Impression of Improvement scale and specifically measures improvement in obstructive sleep apnea (OSA). Patients are asked to evaluate their current condition compared to their status prior to receiving therapy. The response options for the CGI-I include categories such as:

    • Very much improved,
    • Somewhat improved,
    • Minimally improved,
    • No change,
    • Minimally worse,
    • Somewhat worse,
    • Very much worse.

    This scale helps quantify the perceived effectiveness of the treatment from the patient's perspective during follow-up assessments.

    Patients responding at least "minimally improved improvement" will be defined as responders to treatment.

    Measured: through study completion on average 8 weeks

  2. Epworth Sleepiness Scale (ESS) scores.

    The Epworth Sleepiness Scale (ESS) is a self-reported questionnaire that measures daytime sleepiness. It consists of eight scenarios in which respondents rate their likelihood of dozing off or falling asleep on a scale from 0 to 3, with higher scores indicating greater levels of daytime sleepiness. The total score can range from 0 to 24, with scores above 10 typically suggesting excessive daytime sleepiness.

    ESS score is calculated as the difference in ESS score post-treatment minus ESS score pre-treatment.

    Measured: baseline (pre-treatment) and through study completion on average 8 weeks

  3. Symptoms of Nocturnal Obstruction and Related Events (SNORE-25) scores.

    The SNORE-25 is a measure of sleep-disordered breathing-related health burden over the past two weeks. It is derived from a 7-item reduction of the OSA Patient-Oriented Severity Index (OSAPOSI). The SNORE-25 uses a magnitude scale ranging from 0 to 5 for each of its twenty-five items, resulting in a final score range of 0 to 125.

    A clinically meaningful difference is a 50% change (decrease) from pretreatment.

    The change in SNORE-25 is calculated as the difference in SNORE-25 score post-treatment minus SNORE-25 pre-treatment.

    Measured: baseline (pre-treatment) and through study completion on average 8 weeks

  4. Measure of satisfaction with treatment

    Measure of satisfaction with treatment will capture global indication of satisfaction with the treatment.

    Response options are:

    • Very dissatisfied,
    • Mildly satisfied,
    • Neither satisfied or dissatisfied,
    • Mildly satisfied, , and
    • Very satisfied

    Measured: and through study completion on average 8 weeks

  5. The rate of subject re-selecting the treatment

    Response options are:

    • I would definitely select this treatment again,
    • I would likely select this treatment again,
    • I would likely not select this treatment again,
    • I would never select this treatment again.

    The rate of subjects responding "…definitely select this treatment again" and"…likely select this treatment again" will be compared between the two study group.

    Measured: and through study completion on average 8 weeks

  6. The rate of subjects recommending the treatment

    Response options are:

    • I would definitely recommend this treatment,
    • I would likely recommend this treatment,
    • I would likely not recommend this treatment,
    • I would never recommend this treatment,

    The rate of subjects responding "…definitely recommend this treatment" and "…likely recommend this treatment" will be compared between the two study groups.

    Measured: and through study completion on average 8 weeks

  7. Apnea-Hypopnea Index (AHI)

    AHI is a measure of breathing interruptions during sleep. A higher AHI indicates more frequent breathing disruptions and more severe sleep apnea. A reduction in AHI indicates improved sleep apnea

    Measured: baseline (pre-treatment) and through study completion on average 8 weeks

  8. Oxygen Desaturation Index (ODI)

    ODI is a measure of oxygen desaturations during sleep. A reduction in ODI indicates improved sleep apnea.

    Measured: baseline (pre-treatment) and through study completion on average 8 weeks

  9. Mean arterial saturation

    Mean arterial saturation, which is a measure of peripheral artery oxygenation during sleep. An increase of mean arterial saturation indicates improved sleep apnea

    Measured: baseline (pre-treatment) and through study completion on average 8 weeks

  10. Time <90%

    This is a measure of the time spent below an oxygen saturation of 90% during sleep. A reduction in time < 90% indicates improved sleep apnea

    Measured: baseline (pre-treatment) and through study completion on average 8 weeks

  11. Adverse events

    Any undesirable experiences associated with the use of the intervention, which can include but are not limited to discomfort, pain, device-related issues, or other health problems.

    Measured: throughout the entire study period on average 10 weeks

Timeline

From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.

  1. First posted20 Jul 2025
  2. Study start30 Jun 2025
  3. Primary completionMar 2027 (estimated)
  4. Study completionMay 2027 (estimated)

Resources

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
Treatment
Allocation
Non-randomised
Intervention model
Parallel groups
Masking
None (open label)
Enrolment
60 participants (estimated)
IDs, dates and publications
ClinicalTrials.gov ID
NCT07074288
Sponsor's protocol ID
202502149
Acronym
OSANOVA
Status last verified
Apr 2026
First submitted
25 Jun 2025
Last updated
14 Apr 2026
Results posted
No
Data monitoring committee
No
FDA-regulated drug
No
FDA-regulated device
Yes
Individual data sharing
No

Publications

  • Basyuni S, Barabas M, Quinnell T. An update on mandibular advancement devices for the treatment of obstructive sleep apnoea hypopnoea syndrome. J Thorac Dis. 2018 Jan;10(Suppl 1):S48-S56. doi: 10.21037/jtd.2017.12.18.

    PubMed 29445528

  • Bentan MA, Nord R. Comprehensive Analysis of Adverse Events Associated With Hypoglossal Nerve Stimulators: Insights From the MAUDE Database. Otolaryngol Head Neck Surg. 2024 Nov;171(5):1580-1590. doi: 10.1002/ohn.883. Epub 2024 Jun 29.

    PubMed 38943447

  • Buysse DJ, Reynolds CF 3rd, Monk TH, Berman SR, Kupfer DJ. The Pittsburgh Sleep Quality Index: a new instrument for psychiatric practice and research. Psychiatry Res. 1989 May;28(2):193-213. doi: 10.1016/0165-1781(89)90047-4.

    PubMed 2748771

  • Cistulli PA. Oral appliances in the treatment of obstructive sleep apnea in adults. In: Collop N, Finlay G, eds. UpToDate. Waltham, MA: UpToDate Inc. https://www.uptodate.com/contents/oral-appliances-in-the-treatment-of-obstructive-sleep-apnea-in-adults. Topic 7678, Version 38.0. Accessed October 30, 2024.

  • de Vries GE, Hoekema A, Vermeulen KM, Claessen JQPJ, Jacobs W, van der Maten J, van der Hoeven JH, Stegenga B, Kerstjens HAM, Wijkstra PJ. Clinical- and Cost-Effectiveness of a Mandibular Advancement Device Versus Continuous Positive Airway Pressure in Moderate Obstructive Sleep Apnea. J Clin Sleep Med. 2019 Oct 15;15(10):1477-1485. doi: 10.5664/jcsm.7980.

    PubMed 31596213

  • El-Solh AA, Moitheennazima B, Akinnusi ME, Churder PM, Lafornara AM. Combined oral appliance and positive airway pressure therapy for obstructive sleep apnea: a pilot study. Sleep Breath. 2011 May;15(2):203-8. doi: 10.1007/s11325-010-0437-1. Epub 2010 Nov 10.

    PubMed 21063793

  • Epstein LJ, Kristo D, Strollo PJ Jr, Friedman N, Malhotra A, Patil SP, Ramar K, Rogers R, Schwab RJ, Weaver EM, Weinstein MD; Adult Obstructive Sleep Apnea Task Force of the American Academy of Sleep Medicine. Clinical guideline for the evaluation, management and long-term care of obstructive sleep apnea in adults. J Clin Sleep Med. 2009 Jun 15;5(3):263-76.

    PubMed 19960649

  • Francis CE, Quinnell T. Mandibular Advancement Devices for OSA: An Alternative to CPAP? Pulm Ther. 2021 Jun;7(1):25-36. doi: 10.1007/s41030-020-00137-2. Epub 2020 Nov 10.

    PubMed 33170490

  • Glos M, Penzel T, Schoebel C, Nitzsche GR, Zimmermann S, Rudolph C, Blau A, Baumann G, Jost-Brinkmann PG, Rautengarten S, Meier JC, Peroz I, Fietze I. Comparison of effects of OSA treatment by MAD and by CPAP on cardiac autonomic function during daytime. Sleep Breath. 2016 May;20(2):635-46. doi: 10.1007/s11325-015-1265-0. Epub 2015 Oct 13.

    PubMed 26463420

  • Gonzalez Castro S, Pozuelo Sánchez L, Jara Alonso I, Pérez Figuera A, Muriel García A, Carreño Alejandre A, Parra Jarque M, Delgado Vera-Pinto L, García Sánchez A,Cano Pumarega I, Mañas Baena E. [Title of the article]. Eur Respir J. 2023;62(suppl 67). doi:10.1183/13993003.congress-2023.PA3012.

  • Gotsopoulos H, Chen C, Qian J, Cistulli PA. Oral appliance therapy improves symptoms in obstructive sleep apnea: a randomized, controlled trial. Am J Respir Crit Care Med. 2002 Sep 1;166(5):743-8. doi: 10.1164/rccm.200203-208OC.

    PubMed 12204875

  • Guimaraes MLR, Hermont AP, Guimaraes TM, Dal-Fabbro C, Bittencourt L, Chaves Junior CM. Severe obstructive sleep apnea treatment with mandibular advancement device: A case report. Sleep Sci. 2018 Mar-Apr;11(2):118-122. doi: 10.5935/1984-0063.20180022.

    PubMed 30083300

  • Johns MW. A new method for measuring daytime sleepiness: the Epworth sleepiness scale. Sleep. 1991 Dec;14(6):540-5. doi: 10.1093/sleep/14.6.540.

    PubMed 1798888

  • Kent D, Stanley J, Aurora RN, Levine C, Gottlieb DJ, Spann MD, Torre CA, Green K, Harrod CG. Referral of adults with obstructive sleep apnea for surgical consultation: an American Academy of Sleep Medicine clinical practice guideline. J Clin Sleep Med. 2021 Dec 1;17(12):2499-2505. doi: 10.5664/jcsm.9592.

    PubMed 34351848

  • Kline LR. Clinical presentation and diagnosis of obstructive sleep apnea in adults. In: Collop N, Finlay G, eds. UpToDate. Waltham, MA: UpToDate Inc. https://www.uptodate.com/contents/clinical-presentation-and-diagnosis-of-obstructive-sleep-apnea-in-adults. Topic 7706, Version 66.0. Accessed October 30, 2024.

Questions about this trial

What is this clinical trial studying?

A study testing MAD and HGNS 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 11 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 14 Apr 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 Sara Kukuljan (314-362-7563, kukuljas@wustl.edu), or a site near the patient. AzTrials does not enrol participants or take referrals.

What does the primary outcome measure?

Pittsburgh Sleep Quality Index (PSQI) (time frame: baseline(pre-treatment) and 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 NCT07074288, which also lists 35 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 14 Apr 2026.

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