Effect of Intranasal Negative Pressure Therapy on Cognitive Function in Patients With Mild Cognitive Impairment and Obstructive Sleep Apnea
NCT07353359, Not applicable, Not yet recruiting, Xuanwu Hospital, Beijing
Trial 10
As registered on ClinicalTrials.gov, in the graph's capture of the registry.
| Field | Value | Source |
|---|---|---|
| Title | Effect of Intranasal Negative Pressure Therapy on Cognitive Function in Patients With Mild Cognitive Impairment and Obstructive Sleep Apnea | ClinicalTrials.gov |
| NCT number | NCT07353359 | ClinicalTrials.gov |
| Status | Not yet recruiting | ClinicalTrials.gov |
| Phases | Not applicable | ClinicalTrials.gov |
| Enrollment | 65 participants, estimated | ClinicalTrials.gov |
| Lead sponsor | Xuanwu Hospital, Beijing | ClinicalTrials.gov |
| Conditions | Mild Cognitive Impairment (MCI) | ClinicalTrials.gov |
| Interventions | Intranasal Negative Pressure | ClinicalTrials.gov |
| First posted | 2026-01-20 | ClinicalTrials.gov |
| Last updated | 2026-01-20 | ClinicalTrials.gov |
Registered outcomes 18
Each outcome the trial registered, primary first, in ClinicalTrials.gov's words.
| List | Outcome | Time frame | Description | Source |
|---|---|---|---|---|
| Primary | 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. | ClinicalTrials.gov |
| Secondary | 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%. | ClinicalTrials.gov |
| Secondary | Change in Plasma Aβ42/Aβ40 Ratio | Baseline, Week 12, and Week 24 | Alteration in the ratio of plasma amyloid-beta 42 to 42/40 | ClinicalTrials.gov |
| Secondary | Change in Minimum Oxygen Saturation (LSaO₂) | Baseline, Week 12, and Week 24 | Increase in LSaO₂ from baseline, monitored via polysomnography (PSG) | ClinicalTrials.gov |
| Secondary | Change in Sleep Efficiency | Baseline, Week 12, and Week 24 | Improvement in sleep efficiency \[(Total Sleep Time/Time in Bed) × 100%\] assessed by PSG. | ClinicalTrials.gov |
| Secondary | 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. | ClinicalTrials.gov |
| Secondary | Changes in Plasma P-tau217 Concentrations | Baseline, Week 12, Week 24 | Reductions in plasma phosphorylated tau 217 (P-tau217) concentrations. | ClinicalTrials.gov |
| Secondary | Changes in Structural MRI (sMRI) Metrics | Baseline, Week 12, Week 24 | Alterations in brain structure measured by T1-weighted sMRI. | ClinicalTrials.gov |
| Secondary | Changes in Diffusion Tensor Imaging (DTI) Metrics | Baseline, Week 12, Week 24 | Improvements in white matter microstructural integrity and perivascular space (PVS) status. | ClinicalTrials.gov |
| Secondary | Change in Resting-State fMRI (rs-fMRI) Brain Network Connectivity | Baseline, Week 12, Week 24 | Modifications in functional brain network connectivity compared to baseline. | ClinicalTrials.gov |
| Secondary | Changes in EEG Metrics | Baseline, Week 12, Week 24 | Alterations in electroencephalogram (EEG) parameters (e.g., spectral power, coherence). | ClinicalTrials.gov |
| Secondary | 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. | ClinicalTrials.gov |
| Secondary | 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. | ClinicalTrials.gov |
| Secondary | 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 | ClinicalTrials.gov |
| Secondary | 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. | ClinicalTrials.gov |
| Secondary | 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. | ClinicalTrials.gov |
| Secondary | Change in plasma Neurofilament Light Chain | baseline, week 12, and week 24 | alterations in plasma Neurofilament Light Chain concentrations | ClinicalTrials.gov |
| Secondary | changes in plasma Glial Fibrillary Acidic Protein concentrations | baseline, week 12, and week 24 | changes in plasma Glial Fibrillary Acidic Protein concentrations | ClinicalTrials.gov |
Outcomes 0
Each outcome the trial posted results for, in ClinicalTrials.gov's words.
| Type | Outcome | Time frame | Population | Units | Measured as | Source |
|---|
Results by group 0
Each measurement the trial posted, group by group, in the words and numbers it posted.
| Outcome | Group | Category | Value | Spread | Units | Source |
|---|
Participant flow 0
How many started, completed or left each group, period by period.
| Period | Milestone | Group | Participants | Units counted | Source |
|---|
Adverse events 0
Each adverse event the trial posted, group by group: the participants affected out of those at risk.
| Type | Event | Organ system | Group | Affected | At risk | Events | Source |
|---|
Adverse event totals 0
The totals the trial posted for each group.
| Total | Group | Affected | At risk | Source |
|---|
Papers 0
The papers the trial lists on ClinicalTrials.gov.
| PMID | Listed as | Source |
|---|
Grants 0
The grants NIH RePORTER links to the trial, newest funded first: NIH's, and some of AHRQ's, CDC's, FDA's and VA's. Each shows its title, principal investigators, organization and funder in its newest year.
| Project | Title | Principal investigators | Organization | Funder | Fiscal years | Source |
|---|
Trial comparisons 0
Comparisons of the trial's two groups, calculated by ConductScience from the counts it posted.
| Comparison | Source |
|---|
Tests 4
The ConductCognition tests this trial's registered outcomes name, as ScienceGraph matched them in trial-tests-2026-11-12-0.2.1.
| Test | Named as | Source |
|---|---|---|
| Stroop Color-Word Test | Secondary outcome | ConductCognition |
| Trail Making Test A | Secondary outcome | ConductCognition |
| Trail Making Test B | Secondary outcome | ConductCognition |
| Verbal Learning | Secondary outcome | ConductCognition |
Source 5
| Field | Value | Source |
|---|---|---|
| Release | trials-2026-11-12-0.4.0 | ClinicalTrials.gov |
| Release manifest SHA-256 | 0f4a8d8c48aee2a7573ae0fa94ecbeab70c1adbe449bbc95c424bc7d3e97b9d4 | ClinicalTrials.gov |
| Registry capture | 2026-11-12 | ClinicalTrials.gov |
| Results copy, AACT | 2026-03-23 | ClinicalTrials.gov |
| NIH clinical studies file | 2026-11-13 | ClinicalTrials.gov |
Release trials-2026-11-12-0.4.0
ClinicalTrials.gov's posted results, through CTTI's AACT: ClinicalTrials.gov data via Aggregate Analysis of ClinicalTrials.gov (AACT), CTTI. CTTI makes its materials freely available and requests acknowledgement. https://aact.ctti-clinicaltrials.org/documentation/299 ClinicalTrials.gov's data carry an international copyright outside the United States: https://clinicaltrials.gov/about-site/terms-conditions.
ClinicalTrials.gov: none stated ClinicalTrials.gov's data carry an international copyright outside the United States: https://clinicaltrials.gov/about-site/terms-conditions.
NIH RePORTER's clinical studies and project files: Public domain (NIH RePORTER)