St Louis, MONCT07074288Now EnrollingIRB Ready

Obstructive Sleep Apnea Clinical Trial in St Louis, MO

Access cutting-edge obstructive sleep apnea treatment through this clinical trial at a research site in St Louis. Study-provided care at no cost to qualified participants.

Sponsored by Washington University School of Medicine

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Expert Care in St Louis

Access obstructive sleep apnea specialists at no cost

IRB Approved

This study follows strict safety protocols and ethical guidelines

No-Cost Care

All study-related obstructive sleep apnea treatment provided free

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Check if you qualify for this obstructive sleep apnea clinical trial in St Louis, MO

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Why Participate?

  • No-Cost Study Care

  • Local to St Louis

    Convenient for MO residents

  • Cutting-Edge Treatment

    Access to innovative therapies

  • Expert Medical Care

    Close monitoring by specialists

  • Possible Compensation*

    For time and travel

*Compensation varies by study. Confirm details with coordinator.

Simple Process

  1. 1Submit this form
  2. 2Phone screening
  3. 3Visit St Louis site if eligible
  4. 4Begin participation

About This Obstructive Sleep Apnea Study in St Louis

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. 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%),

Sponsor: Washington University School of Medicine

Who Can Participate

Inclusion Criteria

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)
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

Exclusion Criteria

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
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.

Not sure if you qualify? Submit your interest and a study coordinator will help determine your eligibility.

Frequently Asked Questions

Q:Is this study available in St Louis?

Yes, this clinical trial (NCT07074288) has an active research site in St Louis, MO that is currently enrolling participants.

Q:Is it safe to participate?

Clinical trials follow strict safety guidelines and ethical standards. This study has been reviewed and approved, and participants are closely monitored by medical professionals. You can withdraw at any time.

Q:Will I be compensated?

Many clinical trials offer compensation for your time and travel expenses. Specific compensation details will be discussed during the screening process. All study-related medical care is provided at no cost.

Q:Can I leave the trial if I change my mind?

Absolutely. Participation is completely voluntary. You have the right to withdraw from the study at any time, for any reason, without penalty.

Still have questions? Our study coordinators are here to help.

Obstructive Sleep Apnea Treatment Options in St Louis, MO

If you're searching for obstructive sleep apnea treatment options in St Louis, MO, this clinical trial (NCT07074288) may be an excellent opportunity. Clinical trials provide access to cutting-edge treatments that aren't yet available to the general public, often at no cost to participants.

Our St Louis research site is actively enrolling participants for this clinical trial. You'll receive care from experienced obstructive sleep apnea specialists who are at the forefront of medical research. All study-related care, including examinations, treatments, and monitoring, is provided at no cost to qualified participants.

Looking for more options? Browse all obstructive sleep apnea clinical trials near you to find additional studies recruiting in your area.

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