Sleep apnea mouthpiece showdown: which device wins on comfort?
NCT ID NCT06970171
First seen Jun 25, 2026 · Last updated Jun 27, 2026 · Updated 1 time
Summary
This study tests two different mouthpieces (mandibular advancement devices) for people with obstructive sleep apnea who cannot use a CPAP machine. Twenty-eight participants will wear one of the two devices for a year, and researchers will track comfort, side effects like jaw pain, and how well they stick with treatment. The goal is to find out which device is easier to tolerate, helping doctors make better treatment choices.
What this could mean
Our plain-language read of the trial. This is informational only, not medical advice or a prediction.
- Active substance
- mandibular advancement device (MAD)
- What this could lead to
- If successful, this study could help doctors choose the most comfortable and tolerable mouthpiece for sleep apnea patients who cannot use CPAP.
- What could go wrong
- This is a small, early-phase trial with only 28 participants, so results may not apply to everyone. Side effects like jaw pain or bite changes are possible.
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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About 28 people
The number the study aims to enrol. It can still change while the study runs.
- Started
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May 2025
- Expected to finish
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May 2028
An estimate. End dates often move.
- 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 to 75 years
- 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.
Inclusion Criteria: * Medical indication for MAD therapy due to OSAS * Mandibular advancement of at least 5 mm possible * Fixed prosthetics or stable removable partial dentures * Bilateral support extending to at least the second premolars * Legal capacity and signed informed consent Exclusion Criteria: * Polyarthritis * Mouth opening \< 30 mm * More than two prior therapy attempts * Fibromyalgia, neuralgia * Central sleep apnea syndrome * Pulmonary diseases * Untreated generalized periodontitis * Chronic dysfunctional pain (GCPS Grade 3-4) * Long-term use of psychotropic or analgesic medications
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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.
How to take part
Only the study team decides who joins. These are the ways to reach them.
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The places running it
1 site. The list below names each one and where it is.
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The official record
The full official record for this study. This one lists no contact details, but it is the first place any would appear.
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A doctor treating you
A doctor who knows your case can contact a study site on your behalf, and can tell you whether this study is worth pursuing at all.
Contacts and locations
Locations
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University Medicine Greifswald, Department of Restorative Dentistry, Periodontology and Endodontology
Greifswald, Mecklenburg-Vorpommern, 17475, Germany
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