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

N/ANot Yet RecruitingNCT07353359

Xuanwu Hospital, Beijing65 enrolled

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.

Study Type

INTERVENTIONAL

Allocation

RANDOMIZED

Purpose

TREATMENT

Masking

NONE

Enrollment

Conditions

Mild Cognitive Impairment (MCI)

Interventions

Eligibility

Sex: ALLMin age: 50 YearsMax age: 75 Years

Medical Language ↔ Plain English

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.

Outcomes

Primary Outcomes

Change in MoCA Score from Baseline to Week 24

Montreal Cognitive Assessment (MoCA) scale ranges from 0 to 30, and higher value represents a better outcome. This study will use MoCA to assess changes in the global cognitive function after intervention.

Time frame: Baseline (Day7～0 days) and Week 24 (Day 168±7 days)

Secondary Outcomes

AHI Reduction Rate at Week 12 and Week 24

Percentage reduction in Apnea-Hypopnea Index (AHI) calculated as \[(Baseline AHI - Follow-up AHI)/Baseline AHI\] × 100%.

Time frame: Baseline, Week 12 (Day 84±7 days), and Week 24

Change in Plasma Aβ42/Aβ40 Ratio

Alteration in the ratio of plasma amyloid-beta 42 to 42/40

Time frame: Baseline, Week 12, and Week 24

Change in Minimum Oxygen Saturation (LSaO₂)

Increase in LSaO₂ from baseline, monitored via polysomnography (PSG)

Time frame: Baseline, Week 12, and Week 24

Change in Sleep Efficiency

Improvement in sleep efficiency \[(Total Sleep Time/Time in Bed) × 100%\] assessed by PSG.

Time frame: Baseline, Week 12, and Week 24

Change in Auditory Verbal Learning Test Scores

Auditory Verbal Learning Test (AVLT) scale ranges from 0 to 75 (sum of immediate recall and delayed recall), and higher value represents a better verbal memory. This study will use AVLT to assess changes in the episodic memory after intervention.

Time frame: Baseline, Week 12, and Week 24

Changes in Plasma P-tau217 Concentrations

Reductions in plasma phosphorylated tau 217 (P-tau217) concentrations.