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

NCT07353359 | Not Yet Recruiting

• 2 other identifiers: 2025433LinYanShen [2025] No.433-002
• Study Type: interventional
• Target: 65
• Locations: 1 country
• Sites: 1

Brief Summary

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.

Conditions

Mild Cognitive Impairment (MCI)

Outcome Measures

Primary Outcomes (1)

• 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.

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

Secondary Outcomes (17)

• AHI Reduction Rate at Week 12 and Week 24

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

• Change in Plasma Aβ42/Aβ40 Ratio

  Baseline, Week 12, and Week 24

• Change in Minimum Oxygen Saturation (LSaO₂)

  Baseline, Week 12, and Week 24

• Change in Sleep Efficiency

  Baseline, Week 12, and Week 24

• Change in Auditory Verbal Learning Test Scores

  Baseline, Week 12, and Week 24

Study Arms (2)

iNAP group

EXPERIMENTAL

Participants use the iNAP device nightly for 24 weeks, combined with best support care.

Device: Intranasal Negative Pressure

Control Group

NO INTERVENTION

Participants receive only sleep hygiene guidance without using the iNAP device.

Interventions

Intranasal Negative Pressure DEVICE

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

iNAP group

Eligibility Criteria

• Age: 50 Years - 75 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

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 may not qualify 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.

Sponsors & Collaborators

• Xuanwu Hospital, Beijing: lead

Study Sites (1)

Xuanwu Hospital, Capital Medical University

Beijing, 100053, China

Location

MeSH Terms

Conditions

Cognitive Dysfunction

Condition Hierarchy (Ancestors)

Cognition Disorders; Neurocognitive Disorders; Mental Disorders

Central Study Contacts

Yi Tang

CONTACT

00861083199456; tangyi@xwhosp.org

Liyang Liu

CONTACT

00861083192332; liuliyang@xwhosp.org

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: NONE
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: January 9, 2026
• First Posted: January 20, 2026
• Study Start: January 15, 2026
• Primary Completion (Estimated): December 31, 2026
• Study Completion (Estimated): December 31, 2026
• Last Updated: January 20, 2026

Record last verified: 2026-01

Data Sharing

• IPD Sharing: Will not share

Locations

CN (1)