Mild Cognitive Impairment (MCI)
Conditions
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.
Interventions
DEVICEIntranasal Negative Pressure
No interventions have been assigned to arm 'iNAP group' Intervention 'Intranasal Negative Pressure' has not been assigned to an arm/group.
Sponsors
Xuanwu Hospital, Beijing
Study design
Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
TREATMENT
Masking
NONE
Eligibility
Sex/Gender
ALL
Age
50 Years to 75 Years
Healthy volunteers
No
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.
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| Change in MoCA Score from Baseline to Week 24 | Baseline (Day7～0 days) and Week 24 (Day 168±7 days) | 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. |
Secondary
| Measure | Time frame | Description |
|---|---|---|
| AHI Reduction Rate at Week 12 and Week 24 | Baseline, Week 12 (Day 84±7 days), and Week 24 | Percentage reduction in Apnea-Hypopnea Index (AHI) calculated as \[(Baseline AHI - Follow-up AHI)/Baseline AHI\] × 100%. |
| Change in Plasma Aβ42/Aβ40 Ratio | Baseline, Week 12, and Week 24 | Alteration in the ratio of plasma amyloid-beta 42 to 42/40 |
| Change in Minimum Oxygen Saturation (LSaO₂) | Baseline, Week 12, and Week 24 | Increase in LSaO₂ from baseline, monitored via polysomnography (PSG) |
| Change in Sleep Efficiency | Baseline, Week 12, and Week 24 | Improvement in sleep efficiency \[(Total Sleep Time/Time in Bed) × 100%\] assessed by PSG. |
| Change in Auditory Verbal Learning Test Scores | Baseline, Week 12, and Week 24 | 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. |
| Changes in Plasma P-tau217 Concentrations | Baseline, Week 12, Week 24 | Reductions in plasma phosphorylated tau 217 (P-tau217) concentrations. |
| Changes in Structural MRI (sMRI) Metrics | Baseline, Week 12, Week 24 | Alterations in brain structure measured by T1-weighted sMRI. |
| Changes in Diffusion Tensor Imaging (DTI) Metrics | Baseline, Week 12, Week 24 | Improvements in white matter microstructural integrity and perivascular space (PVS) status. |
| Change in Resting-State fMRI (rs-fMRI) Brain Network Connectivity | Baseline, Week 12, Week 24 | Modifications in functional brain network connectivity compared to baseline. |
| Changes in EEG Metrics | Baseline, Week 12, Week 24 | Alterations in electroencephalogram (EEG) parameters (e.g., spectral power, coherence). |
| Changes in HAMA Score | Baseline, Week 12, Week 24 | 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. |
| Changes in HAMD Score | Baseline, Week 12, Week 24 | 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. |
| Incidence of Adverse Events (AEs) and Serious Adverse Events (SAEs) | Baseline, Week 12, Week 24 | Rate of treatment-related AEs (e.g., tongue soreness, increased salivation, dry mouth) and SAEs throughout the intervention period |
| change in Trail Making Test | Baseline, week 12, and week 24 | 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. |
| change in Stroop Color-Word Test | Baseline, week 12, and week 24 | 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. |
| Change in plasma Neurofilament Light Chain | baseline, week 12, and week 24 | alterations in plasma Neurofilament Light Chain concentrations |
| changes in plasma Glial Fibrillary Acidic Protein concentrations | baseline, week 12, and week 24 | changes in plasma Glial Fibrillary Acidic Protein concentrations |
Countries
China
Contacts
CONTACTYi Tang
CONTACTLiyang Liu
Outcome results
None listed