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New treatment option for Obstructive Sleep Apnea
Official title Obstructive Sleep Apnea Non-PAP Outcomes and Viable Alternatives
ClinicalTrials.gov ID: NCT07074288
What this study is testing
- What it's testing
- 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.
- Which group you join is decided by chance.
A plain-language read of the study's public ClinicalTrials.gov listing. The study team confirms the details.
Who can take part
Ages 18 and older
You may be able to join if
- 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...
You likely can't join if
- 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...
- Dental conditions such as temporomandibular joint disease, periodontal disease, dental disease, insufficient dentition (edentulism) to support...
- Chronic nasal obstruction
- Individuals without manual dexterity to place and remove the device such as those afflicted with severe arthritis, or neuromuscular disease that...
- 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...
See the full eligibility 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 \ 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
- 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...
- 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...
- 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...
- 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.
The study team makes the final eligibility decision.
Where it's taking place
- St Louis, Missouri, United States
Questions & answers
Do participants get paid in this trial?
This listing doesn't specify compensation. Many trials still reimburse travel or offer a stipend, so it's worth asking the study team when you connect.
Is it free to join, and do I need insurance?
Searching and applying through BridgeMD is free. In clinical trials the study-related treatment and visits are generally provided at no cost to you. You usually don't need insurance to take part - confirm specifics with the study team.
How long does this study last?
The listing doesn't state an exact length. The study team walks you through the schedule and number of visits before you decide to enroll.
Who can join this trial?
This study is enrolling all sexes, 18 years and older. The study team makes the final eligibility decision.
Where is this trial taking place?
Study sites include St Louis, Missouri, United States. Enter your location above to see the nearest site and check your eligibility.
Explore other conditions
BridgeMD is an information and trial-matching tool - not medical advice, and not the study sponsor. Details come from ClinicalTrials.gov; the study team decides eligibility.