Can a simple mouthpiece outperform CPAP for brain fog in sleep apnea?
NCT ID NCT06983769
First seen Jun 27, 2026 · Last updated Jun 27, 2026
Summary
This study tests whether a dental mouthpiece (MAD) works as well as a CPAP machine to improve thinking and memory in people with sleep apnea who also have mild memory problems. About 260 adults aged 45 and older will be randomly assigned to use either device for one year. Researchers will track changes in cognitive tests, blood pressure, and brain scans to see which treatment helps more.
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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 260 people
The number the study aims to enrol. It can still change while the study runs.
- Started
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Jan 2026
- Expected to finish
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Dec 2030
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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45 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.
Inclusion Criteria: Age of at least 45 Chinese, Malay, Indian Referred to the sleep clinics of the CRESCENDO participating centers for suspected OSA, underwent a clinically indicated level 1 polysomnography, and diagnosed to have moderate-to-severe OSA (AHI ≥ 15 events/hour) Mild cognitive impairment: MoCA score \<27 (for those with \>10 years of education) and \<26 (for those with ≤10 years of education) Agree to follow the study protocol Exclusion Criteria: Known OSA and already on regular treatment Severe cognitive impairment (MoCA \<10) Severe hypoxemia on polysomnography ODI \>60 or min SpO2 \<60% Known schizophrenia, bipolar disorder, severe depression, drug abuse or alcohol abuse Contraindications to MAD: less than six teeth in each arch; inability to advance the mandible and open the jaw widely. Pre-existing temporomandibular joint problems, severe bruxism, and advanced periodontal disease Limited life expectancy (\< one year) Cardiac or cerebrovascular events leading to hospitalization in the past three months Complex cardiovascular diseases: cyanotic congenital heart disease, moderate to severe pulmonary hypertension On regular medications that could affect the neurocognitive function and/or alertness
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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
ClinicalTrials.gov lists the study team's own contact details, including names and phone numbers. We don't republish those.
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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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National University Hospital
RECRUITINGKent Ridge, Please Select, 267383, Singapore
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