Which mouthpiece best keeps airways open during sleep? a Head-to-Head test
NCT ID NCT06810479
First seen Aug 11, 2026 · Last updated Aug 12, 2026 · Updated 1 time
Summary
This study compares two different mandibular advancement devices—oral appliances that hold the jaw forward during sleep—to see which works better for people with mild-to-moderate obstructive sleep apnea. Participants will wear each device for three months, with a two-week break in between, and the order is randomly assigned. The main goal is to see how much each device reduces breathing pauses (apneas and hypopneas) per hour, measured by an overnight home sleep test. The trial also tracks oxygen levels and patient-reported sleepiness and comfort.
What this could mean
Our plain-language read of the trial. This is informational only, not medical advice or a prediction.
- Active substance
- Two mandibular advancement devices (oral appliances that reposition the jaw during sleep)
- What this could lead to
- If one device proves more effective, it could point to a better non-invasive option for managing mild-to-moderate sleep apnea.
- What could go wrong
- The trial is small (16 participants) and early, so results may not apply broadly. Devices may cause discomfort or not improve breathing enough.
This is an AI summary of the original study and may miss details. Read our disclaimer.
Study facts
What this study's own registry entry says, in plain language.
- Phase
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Not a phased trial
Phase numbers describe drug development. The registry uses this when they do not apply, as it does for trials of devices, procedures or behaviour changes, and for observational studies.
- Participants
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16 people
The number who actually took part.
- Started
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Mar 2025
- Finished
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Mar 2026
- Lead sponsor
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Other sponsor
The registry's catch-all category, for sponsors it does not file as a company, a government agency, or a research network.
Who can take part
This study's own entry requirements. Only the study team can say for certain whether you qualify.
- Ages
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18 years and older
- Sex
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Anyone
- Healthy volunteers
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Not accepted
This study is not open to healthy volunteers. The entry requirements below say who it is open to.
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Copied word for word from the study's registry entry, so the wording is the study team's rather than ours.
In order to be eligible to participate in this study, a subject must meet all of the following criteria: * Provide signed and dated informed consent * Males or females aged 18 and above * Apnea-Hypopnea Index (AHI) between 5 and 30 events per hour diagnosed by a polysomnography A potential subject who meets any of the following criteria will be excluded from participation in this study: * Previous surgery on the upper airways * Prior treatment of OSA (CPAP or MRA) * Presence of unstable cardiovascular conditions, neurological, mental, or psychiatric disorders * Insufficient dental or periodontal condition for a mandibular repositioning appliance (MRA) * Presence of temporomandibular joint dysfunction
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Conditions
The condition(s) this trial relates to.
As listed by the trial registrant
The condition terms exactly as the trial's registrant entered them.
Contacts and locations
Locations
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Ziekenhuis Oost-Limburg
Genk, 3600, Belgium
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Other studies related to the condition(s) this trial covers.