NCT07353359 · NOT YET RECRUITING
Effect of Intranasal Negative Pressure Therapy on Cognitive Function in Patients With Mild Cognitive Impairment and Obstructive Sleep Apnea
This trial is testing whether a device called iNAP, which uses gentle intranasal negative pressure to keep the airway open during sleep, can improve cognitive scores in people who already have both mild cognitive impairment and moderate-to-severe sleep apnea. Researchers will measure thinking ability using the MoCA test after 24 weeks of nightly use. This is a Phase NA, meaning it is a straightforward randomized controlled trial focused on feasibility and effect, not a drug approval track.
You may qualify if
- Aged between 50 and 75 years, regardless of gender.
- Diagnosed with moderate-to-severe obstructive sleep apnea (OSA) via polysomnography (PSG), with an Apnea-Hypopnea Index (AHI) ≥ 15 events/hour.
- 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.
- Successful completion of the iNAP device adaptation test (no significant oral discomfort, nausea, or other adverse reactions after 30 minutes of wear).
- If using cognitive-enhancing medications (e.g., cholinesterase inhibitors, memantine), stable doses must be maintained for at least 12 weeks prior to baseline.
- Voluntary signing of the informed consent form and willingness to comply with follow-up procedures.
You're excluded if
- 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.
- 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.
- Comorbidities with other sleep disorders (e.g., primary insomnia, narcolepsy, restless legs syndrome) that may interfere with OSA assessment.
- 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).
- Severe aphasia or physical disability precluding completion of neuropsychological assessments.
- Presence of consciousness disturbance from any cause.
- Current diagnosis of depression or psychiatric disorders.
- History of alcoholism, drug addiction, or neurological diseases known to cause cognitive impairment (e.g., traumatic brain injury, epilepsy, encephalitis, normal pressure hydrocephalus).
- Concurrent participation in other clinical trials.
The sponsor's own eligibility wording, lightly reformatted. The study team makes the final eligibility decision — worth discussing with your doctor.
Eligibility criteria as of 2026-01-20