NCT07353359

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

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

• Status: Not Yet Recruiting
• Phase: N/A
• Study type: Interventional
• Enrollment: 65 (estimated)
• Sponsor: Xuanwu Hospital, Beijing · Academic / Other
• Sex: All
• Age: 50 Years – 75 Years
• Healthy volunteers: Not accepted

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)

Interventions

Type	Name	Description
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.

Timeline

• Start date: 2026-01-15
• Primary completion: 2026-12-31
• Completion: 2026-12-31
• First posted: 2026-01-20
• Last updated: 2026-01-20

Locations

1 site across 1 country: China