Not provided
| ID | Type | Description | Link |
|---|---|---|---|
| LinYanShen [2025] No.433-002 | Other Identifier | Xuanwu Hospital Capital Medical University |
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
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.
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
| Label | Type | Description | Intervention Names |
|---|---|---|---|
| iNAP group | Experimental | Participants use the iNAP device nightly for 24 weeks, combined with best support care. |
|
| Control Group | No Intervention | Participants receive only sleep hygiene guidance without using the iNAP device. |
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| 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. |
|
| Measure | Description | Time Frame |
|---|---|---|
| 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) |
| Measure | Description | Time Frame |
|---|---|---|
| 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%. | Baseline, Week 12 (Day 84±7 days), and Week 24 |
| Change in Plasma Aβ42/Aβ40 Ratio |
Not provided
Inclusion Criteria:
Exclusion Criteria:
Not provided
Not provided
Not provided
Not provided
| Name | Role | Phone | Extension | |
|---|---|---|---|---|
| Yi Tang | Contact | 00861083199456 | tangyi@xwhosp.org | |
| Liyang Liu | Contact | 00861083192332 | liuliyang@xwhosp.org |
Not provided
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Xuanwu Hospital, Capital Medical University | Beijing | 100053 | China |
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Alteration in the ratio of plasma amyloid-beta 42 to 42/40
| Baseline, Week 12, and Week 24 |
| Change in Minimum Oxygen Saturation (LSaO₂) | Increase in LSaO₂ from baseline, monitored via polysomnography (PSG) | Baseline, Week 12, and Week 24 |
| Change in Sleep Efficiency | Improvement in sleep efficiency [(Total Sleep Time/Time in Bed) × 100%] assessed by PSG. | 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. | Baseline, Week 12, and Week 24 |
| Changes in Plasma P-tau217 Concentrations | Reductions in plasma phosphorylated tau 217 (P-tau217) concentrations. | Baseline, Week 12, Week 24 |
| Changes in Structural MRI (sMRI) Metrics | Alterations in brain structure measured by T1-weighted sMRI. | Baseline, Week 12, Week 24 |
| Changes in Diffusion Tensor Imaging (DTI) Metrics | Improvements in white matter microstructural integrity and perivascular space (PVS) status. | Baseline, Week 12, Week 24 |
| Change in Resting-State fMRI (rs-fMRI) Brain Network Connectivity | Modifications in functional brain network connectivity compared to baseline. | Baseline, Week 12, Week 24 |
| Changes in EEG Metrics | Alterations in electroencephalogram (EEG) parameters (e.g., spectral power, coherence). | Baseline, Week 12, Week 24 |
| Changes in HAMA Score | Hamilton Anxiety Scale (HAMA) scale ranges from 0 to 56, and higher value represents more severe anxiety symptoms. This study will use HAMA to assess changes in the anxiety status after intervention. | Baseline, Week 12, Week 24 |
| Changes in HAMD Score | Hamilton Depression Scale (HAMD) scale ranges from 0 to 52, and higher value represents more severe depressive symptoms. This study will use HAMD to assess changes in the depressive status after intervention. | Baseline, Week 12, Week 24 |
| Incidence of Adverse Events (AEs) and Serious Adverse Events (SAEs) | Rate of treatment-related AEs (e.g., tongue soreness, increased salivation, dry mouth) and SAEs throughout the intervention period | Baseline, Week 12, Week 24 |
| change in Trail Making Test | Trail Making Test (TMT) scale is quantified by completion time, and shorter time represents better executive function. This study will use TMT to assess changes in the cognitive flexibility and processing speed after intervention. | Baseline, week 12, and week 24 |
| change in Stroop Color-Word Test | Stroop Color-Word Test (SCWT) scale is quantified by interference score (reaction time of conflict trials minus reaction time of non-conflict trials), and smaller value represents better inhibitory control. This study will use SCWT to assess changes in the executive function after intervention. | Baseline, week 12, and week 24 |
| Change in plasma Neurofilament Light Chain | alterations in plasma Neurofilament Light Chain concentrations | baseline, week 12, and week 24 |
| changes in plasma Glial Fibrillary Acidic Protein concentrations | changes in plasma Glial Fibrillary Acidic Protein concentrations | baseline, week 12, and week 24 |
| ID | Term |
|---|---|
| D060825 | Cognitive Dysfunction |
| ID | Term |
|---|---|
| D003072 | Cognition Disorders |
| D019965 | Neurocognitive Disorders |
| D001523 | Mental Disorders |
Not provided
Not provided