Study on Cognitive Impairment of Insomnia Based on MRI

NCT ID: NCT05659511

Last Updated: 2023-01-04

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

UNKNOWN

Total Enrollment

684 participants

Study Classification

OBSERVATIONAL

Study Start Date

2022-07-01

Study Completion Date

2024-06-30

Brief Summary

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Insomnia is a common sleep disorder. In recent years, the incidence of insomnia is increasing worldwide. Studies point out that insomnia plays an important role in the pathogenesis of cognitive impairment. Although sleep and cognitive scales are the main methods to detect sleep quality and cognitive changes, there are problems such as strong subjectivity and poor repetition. There is an urgent need to use non-invasive and objective detection methods to assess the potential mechanisms of cognitive impairment caused by sleep disorders. Previous studies have shown that different brain states may show different neurovascular coupling (NVC) characteristics. However, after prolonged sleep deprivation, the evoked hemodynamics response was attenuated despite an increased electroencephalogram (EEG) signal response, suggesting that sustained neural activity may reduce vascular compliance. It is suggested that sleep disorder may lead to NVC disorder. However, whether sleep disorders regulate the mechanism of cognitive impairment in the brain through NVC disorders has not been demonstrated in vivo. Currently, functional magnetic resonance imaging (fMRI) can be used to study brain function and blood flow changes non-invasively. In our previous research, we combined cerebral blood flow (CBF) with mean amplitude of low-frequency fluctuation (mALFF), mean regional homogeneity (mReHo) and degree-centrality (DC), the early warning effect of fMRI features based on neurovascular uncoupling on early cognitive impairment was confirmed, providing a basis for further selection of functional imaging indicators. In conclusion, the present study proposes the scientific hypothesis that neurovascular decoupling-based MRI features are more appropriate for exploring the neural mechanisms underlying sleep disorders-induced brain cognitive impairment. The aim of this study is to establish an early warning and monitoring system for early non-invasive diagnosis and intervention of sleep-related cognitive impairment.

Detailed Description

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Conditions

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Insomnia Cognitive Disorder MRI

Study Design

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Observational Model Type

CASE_CONTROL

Study Time Perspective

CROSS_SECTIONAL

Study Groups

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healthy control group

Healthy people neither in insomnia group nor in MCI group.

MRI

Intervention Type DIAGNOSTIC_TEST

MRI data was acquired with a GE discovery MR750 3.0 T scanner using an eight-channel phased- array head coil. Foam padding was used to restrict head movement and ear plugs were used to eliminate scanner noise. During the acquisition period, all participants were asked to keep their eyes closed and not to think anything.

insomnia

Pittsburgh sleep quality index (PSQI)\>5, Epworth Sleepiness Scale (ESS)\>9 ,Insomnia Severity Index (ISI)\>8.

MRI

Intervention Type DIAGNOSTIC_TEST

MRI data was acquired with a GE discovery MR750 3.0 T scanner using an eight-channel phased- array head coil. Foam padding was used to restrict head movement and ear plugs were used to eliminate scanner noise. During the acquisition period, all participants were asked to keep their eyes closed and not to think anything.

insomnia-MCI

Pittsburgh sleep quality index(PSQI)\>5 ,Epworth Sleepiness Scale(ESS)\>9 ,Insomnia Severity Indeex(ISI)\>8; 20\< MoCA\<26.

MRI

Intervention Type DIAGNOSTIC_TEST

MRI data was acquired with a GE discovery MR750 3.0 T scanner using an eight-channel phased- array head coil. Foam padding was used to restrict head movement and ear plugs were used to eliminate scanner noise. During the acquisition period, all participants were asked to keep their eyes closed and not to think anything.

Interventions

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MRI

MRI data was acquired with a GE discovery MR750 3.0 T scanner using an eight-channel phased- array head coil. Foam padding was used to restrict head movement and ear plugs were used to eliminate scanner noise. During the acquisition period, all participants were asked to keep their eyes closed and not to think anything.

Intervention Type DIAGNOSTIC_TEST

Eligibility Criteria

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Inclusion Criteria

* Sleep score meets the group standard
* Education time more than 8 years
* Without dementia
* Inform Consent Form

Exclusion Criteria

* Pregnant woman
* Suffer from serious brain disease
* Magnetic resonance contraindications
* Image quality is too poor to deal with
* Lack of compliance
Minimum Eligible Age

18 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

Yes

Sponsors

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Tang-Du Hospital

OTHER

Sponsor Role lead

Responsible Party

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Responsibility Role SPONSOR

Locations

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Tangdu Hospital

Xi'an, Shaanxi, China

Site Status RECRUITING

Countries

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China

Central Contacts

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Lin-Feng Yan

Role: CONTACT

029-18691899018

Ying Yu

Role: CONTACT

029-18191260958

Facility Contacts

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Lin-Feng Yan

Role: primary

029-18691899018

Other Identifiers

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202211-16

Identifier Type: -

Identifier Source: org_study_id

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