Could a nasal device boost brain health in sleep apnea patients?
NCT ID NCT07353359
First seen Jun 27, 2026 · Last updated Jun 27, 2026
Summary
This study tests a nasal device (iNAP) that uses gentle suction to keep the airway open during sleep. It includes 65 adults aged 50-75 with mild cognitive impairment and moderate-to-severe sleep apnea. Half will use the device nightly for 24 weeks, while the other half receive sleep tips. Researchers will measure changes in memory tests, sleep quality, and brain health markers.
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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 65 people
The number the study aims to enrol. It can still change while the study runs.
- Expected to start
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Jan 2026
An estimate. Start dates often move.
- Expected to finish
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Dec 2026
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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50 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.
Show the full entry requirements Hide the full entry requirements
Copied word for word from the study's registry entry, so the wording is the study team's rather than ours.
Inclusion Criteria: 1. Aged between 50 and 75 years, regardless of gender. 2. Diagnosed with moderate-to-severe obstructive sleep apnea (OSA) via polysomnography (PSG), with an Apnea-Hypopnea Index (AHI) ≥ 15 events/hour. 3. Neuropsychological assessment consistent with mild cognitive impairment (MCI), defined as a Clinical Dementia Rating (CDR) of 0.5 and a Montreal Cognitive Assessment (MoCA) score between 20 and 26. 4. Successful completion of the iNAP device adaptation test (no significant oral discomfort, nausea, or other adverse reactions after 30 minutes of wear). 5. If using cognitive-enhancing medications (e.g., cholinesterase inhibitors, memantine), stable doses must be maintained for at least 12 weeks prior to baseline. 6. Voluntary signing of the informed consent form and willingness to comply with follow-up procedures. Exclusion Criteria: 1. History of allergy to silicone components of the iNAP device. Severe nasal obstructive diseases (e.g., nasal polyps, moderate-to-severe chronic rhinitis) that impair nasal breathing function. 2. Acute cardio-cerebrovascular events (e.g., myocardial infarction, cerebral infarction) or acute exacerbation of moderate-to-severe lung diseases (e.g., COPD exacerbation) within the past 6 months. 3. Comorbidities with other sleep disorders (e.g., primary insomnia, narcolepsy, restless legs syndrome) that may interfere with OSA assessment. 4. Diagnosis of central nervous system diseases (e.g., epilepsy, sequelae of encephalitis) or severe mental illness (e.g., schizophrenia, major depression with SDS ≥ 63 points). 5. Severe aphasia or physical disability precluding completion of neuropsychological assessments. 6. Presence of consciousness disturbance from any cause. 7. Current diagnosis of depression or psychiatric disorders. 8. History of alcoholism, drug addiction, or neurological diseases known to cause cognitive impairment (e.g., traumatic brain injury, epilepsy, encephalitis, normal pressure hydrocephalus). 9. Concurrent participation in other clinical trials.
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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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Xuanwu Hospital, Capital Medical University
Beijing, 100053, China
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