Mild Cognitive Impairment (MCI)NCT07353359
Effect of Intranasal Negative Pressure Therapy on Cognitive Function in Patients With Mild Cognitive Impairment and Obstructive Sleep Apnea
A study testing Intranasal Negative Pressure in people with Mild Cognitive Impairment (MCI), run by Xuanwu Hospital, Beijing at 1 site in China.
Trial 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. Read more about this study
- Who is it for?
- Ages 50 to 75 years
- Conditions the study is for
- Mild Cognitive Impairment (MCI)
- What is being tested?
- Intranasal Negative Pressure
- Type of treatment
- Medical device
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 65 participants
- Where
- 1 siteChina
- Study dates
- 15 Jan 2026to 31 Dec 2026
- Phase
- Interventional
- Are there results?
- Not yet: the study is under way
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 50 to 75 years
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- 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.
Who cannot join
- 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.
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- 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.
Trial locations and contacts
1 site in 1 country. Contact the study team or a site near you to ask about taking part.
China1 site
Xuanwu Hospital, Capital Medical University
Beijing, 100053
Liyang liu, 00861083192332, liuliyang@xwhosp.org
About this study
Official title: 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
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)
- Being tested
- Intranasal Negative Pressure
- Medical subject headings
- Cognitive Dysfunction
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Intranasal Negative PressureDevice
No interventions have been assigned to arm 'iNAP group' Intervention 'Intranasal Negative Pressure' has not been assigned to an arm/group.
| Study group | Role | What they receive |
|---|---|---|
| iNAP group | Experimental | Participants use the iNAP device nightly for 24 weeks, combined with best support care. Receives: Device: Intranasal Negative Pressure |
| Control Group | No intervention | Participants receive only sleep hygiene guidance without using the iNAP device. |
What is being measured
The primary outcome is the main question the study is designed to answer.
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.
Measured: Baseline (Day7～0 days) and Week 24 (Day 168±7 days)
Secondary outcomes (17)
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%.
Measured: Baseline, Week 12 (Day 84±7 days), and Week 24
Change in Plasma Aβ42/Aβ40 Ratio
Alteration in the ratio of plasma amyloid-beta 42 to 42/40
Measured: Baseline, Week 12, and Week 24
Change in Minimum Oxygen Saturation (LSaO₂)
Increase in LSaO₂ from baseline, monitored via polysomnography (PSG)
Measured: Baseline, Week 12, and Week 24
Change in Sleep Efficiency
Improvement in sleep efficiency [(Total Sleep Time/Time in Bed) × 100%] assessed by PSG.
Measured: 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.
Measured: Baseline, Week 12, and Week 24
Changes in Plasma P-tau217 Concentrations
Reductions in plasma phosphorylated tau 217 (P-tau217) concentrations.
Measured: Baseline, Week 12, Week 24
Changes in Structural MRI (sMRI) Metrics
Alterations in brain structure measured by T1-weighted sMRI.
Measured: Baseline, Week 12, Week 24
Changes in Diffusion Tensor Imaging (DTI) Metrics
Improvements in white matter microstructural integrity and perivascular space (PVS) status.
Measured: Baseline, Week 12, Week 24
Change in Resting-State fMRI (rs-fMRI) Brain Network Connectivity
Modifications in functional brain network connectivity compared to baseline.
Measured: Baseline, Week 12, Week 24
Changes in EEG Metrics
Alterations in electroencephalogram (EEG) parameters (e.g., spectral power, coherence).
Measured: 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.
Measured: 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.
Measured: 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
Measured: 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.
Measured: 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.
Measured: Baseline, week 12, and week 24
Change in plasma Neurofilament Light Chain
alterations in plasma Neurofilament Light Chain concentrations
Measured: baseline, week 12, and week 24
changes in plasma Glial Fibrillary Acidic Protein concentrations
changes in plasma Glial Fibrillary Acidic Protein concentrations
Measured: baseline, week 12, and week 24
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted20 Jan 2026
- Study start15 Jan 2026 (estimated)
- Primary completion31 Dec 2026 (estimated)
- Study completion31 Dec 2026 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Mild Cognitive Impairment (MCI)Studies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Enrolment
- 65 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Xuanwu Hospital, Beijing
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT07353359
- Sponsor's protocol ID
- 2025433
- Other IDs
- LinYanShen [2025] No.433-002
- Status last verified
- Jan 2026
- First submitted
- 9 Jan 2026
- Last updated
- 20 Jan 2026
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Study at a glance
From the registry record, last updated by the sponsor on 20 Jan 2026. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- 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
- ClinicalTrials.gov ID
- NCT07353359
- Acronym / sponsor ID
- 2025433
- Conditions
- Mild Cognitive Impairment (MCI)
- Study type
- Interventional
- Recruitment status
- Not yet recruiting
- Enrolment
- 65 participants (estimated)
- Lead sponsor
- Xuanwu Hospital, BeijingUniversity, hospital or other
- Study start
- 15 Jan 2026 (estimated)
- Primary completion
- 31 Dec 2026 (estimated)
- Study completion
- 31 Dec 2026 (estimated)
- First posted
- 20 Jan 2026 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| iNAP group | Experimental | Device: Intranasal Negative PressureParticipants 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. |
Who may qualify
- Ages
- 50 to 75 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (6 listed)
- 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.
Key exclusion criteria (9 listed)
- 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.
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Intranasal Negative PressureNo interventions have been assigned to arm 'iNAP group' Intervention 'Intranasal Negative Pressure' has not been assigned to an arm/group. | Device | iNAP group |
Primary outcome
Change in MoCA Score from Baseline to Week 24
Time frame: 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.
17 secondary outcomes
AHI Reduction Rate at Week 12 and Week 24
Time frame: Baseline, Week 12 (Day 84±7 days), and Week 24
Change in Plasma Aβ42/Aβ40 Ratio
Time frame: Baseline, Week 12, and Week 24
Change in Minimum Oxygen Saturation (LSaO₂)
Time frame: Baseline, Week 12, and Week 24
Change in Sleep Efficiency
Time frame: Baseline, Week 12, and Week 24
Change in Auditory Verbal Learning Test Scores
Time frame: Baseline, Week 12, and Week 24
Changes in Plasma P-tau217 Concentrations
Time frame: Baseline, Week 12, Week 24
Changes in Structural MRI (sMRI) Metrics
Time frame: Baseline, Week 12, Week 24
Changes in Diffusion Tensor Imaging (DTI) Metrics
Time frame: Baseline, Week 12, Week 24
Change in Resting-State fMRI (rs-fMRI) Brain Network Connectivity
Time frame: Baseline, Week 12, Week 24
Changes in EEG Metrics
Time frame: Baseline, Week 12, Week 24
Changes in HAMA Score
Time frame: Baseline, Week 12, Week 24
Changes in HAMD Score
Time frame: Baseline, Week 12, Week 24
Incidence of Adverse Events (AEs) and Serious Adverse Events (SAEs)
Time frame: Baseline, Week 12, Week 24
change in Trail Making Test
Time frame: Baseline, week 12, and week 24
change in Stroop Color-Word Test
Time frame: Baseline, week 12, and week 24
Change in plasma Neurofilament Light Chain
Time frame: baseline, week 12, and week 24
changes in plasma Glial Fibrillary Acidic Protein concentrations
Time frame: baseline, week 12, and week 24
Results and safety
This study is still under way. Results are not available in the source record yet.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 20 Jan 2026.
- Individual participant dataSharing planned: No
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part.
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Intranasal Negative Pressure in people with Mild Cognitive Impairment (MCI), run by Xuanwu Hospital, Beijing at 1 site in China.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 6 inclusion and 9 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: opening soon, as of the sponsor's last update on 20 Jan 2026. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in China. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
This study is still under way. Results are not available in the source record yet.
How can a doctor refer a patient or contact the research team?
Contact Yi Tang (00861083199456, tangyi@xwhosp.org), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Change in MoCA Score from Baseline to Week 24 (time frame: Baseline (Day7～0 days) and Week 24 (Day 168±7 days)). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 20 Jan 2026; AzTrials last refreshed its copy on 1 Nov 2026.