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Not yet recruiting NCT07353359

Effect of Intranasal Negative Pressure Therapy on Cognitive Function in Patients With Mild Cognitive Impairment and Obstructive Sleep Apnea

No phase Interventional Mild Cognitive Impairment (MCI)

For patients and families

In plain language

An automatic summary of structured registry data. It is an orientation aid, not a substitute for the official protocol or a physician assessment.

What is being studied
The protocol lists: Intranasal Negative Pressure.
Who it may be relevant to
Registry conditions: Mild Cognitive Impairment (MCI). Basic parameters: 50 years — 75 years · All.
What needs checking
Age, condition and sex are only basic indicators. Prior treatment, laboratory values and other mandatory requirements appear in the eligibility criteria below.
Where it takes place
China
Next step
Save the trial, show it to the treating physician, and confirm current recruitment with the study center. Costs, documents and travel →

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Official title

The Efficacy and Safety of Intranasal Negative Pressure Therapy (iNAP) in Patients With Mild Cognitive Impairment Complicated With Obstructive Sleep Apnea: A Randomized Controlled Trial

Overview

This study is a randomized controlled trial with two phases: pre-trial and formal trial. The pre-trial will include 5 participants to observe the 4-week adherence (≥4 hours/night) and safety (adverse event rate) of the iNAP device. For the formal trial, 60 patients with MCI and moderate-to-severe OSA will be stratified and block randomized (by baseline AHI levels: 15-30 events/h vs \>30 events/h) into either the iNAP intervention group (using the device nightly for 24 weeks) or the control group (receiving only sleep hygiene guidance). The primary outcome is the change in MoCA scores from baseline at week 24. Secondary outcomes include AHI reduction rate, sleep efficiency, plasma Aβ42/Aβ40 ratio, cognitive assessments, and brain imaging indicators. Follow-up visits will occur at baseline, week 12, and week 24 to monitor cognitive function, sleep parameters, and safety.

Interventions

  • Device Intranasal Negative Pressure
    No interventions have been assigned to arm 'iNAP group' Intervention 'Intranasal Negative Pressure' has not been assigned to an arm/group.

Primary outcome measures

  • Change in MoCA Score from Baseline to Week 24 [Time frame: Baseline (Day7～0 days) and Week 24 (Day 168±7 days)]
Secondary outcome measures (12)
  • AHI Reduction Rate at Week 12 and Week 24 [Time frame: Baseline, Week 12 (Day 84±7 days), and Week 24]
  • Change in Plasma Aβ42/Aβ40 Ratio [Time frame: Baseline, Week 12, and Week 24]
  • Change in Minimum Oxygen Saturation (LSaO₂) [Time frame: Baseline, Week 12, and Week 24]
  • Change in Sleep Efficiency [Time frame: Baseline, Week 12, and Week 24]
  • Change in Auditory Verbal Learning Test Scores [Time frame: Baseline, Week 12, and Week 24]
  • Changes in Plasma P-tau217 Concentrations [Time frame: Baseline, Week 12, Week 24]
  • Changes in Structural MRI (sMRI) Metrics [Time frame: Baseline, Week 12, Week 24]
  • Changes in Diffusion Tensor Imaging (DTI) Metrics [Time frame: Baseline, Week 12, Week 24]
  • Change in Resting-State fMRI (rs-fMRI) Brain Network Connectivity [Time frame: Baseline, Week 12, Week 24]
  • Changes in EEG Metrics [Time frame: Baseline, Week 12, Week 24]
  • Changes in HAMA Score [Time frame: Baseline, Week 12, Week 24]
  • Changes in HAMD Score [Time frame: Baseline, Week 12, Week 24]

Eligibility criteria

Inclusion criteria

  • 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.

Exclusion criteria

  • 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.

Criteria are shown verbatim from the registry (in English). Final eligibility is always assessed by the study center.

Healthy volunteers: No

Study design

Allocation
Randomized
Model
Parallel assignment
Masking
Open label
Primary purpose
Treatment

Study locations

China · 1 center
  • Xuanwu Hospital, Capital Medical University — Beijing

Identifiers

NCT: NCT07353359 · 2025433 · LinYanShen [2025] No.433-002

Primary sources (government registries)

View this study on ClinicalTrials.gov ↗