Clinical trial NCT05659511: Study on Cognitive Impairment of Insomnia Based on MRI
Official title: Research on Early Warning Technology to Explore Insomnia-related Cognitive Impairment Based on MRI Neurovascular Uncoupling
Study type: OBSERVATIONAL
Overall status: UNKNOWN
Conditions: Insomnia
Cognitive Disorder
MRI
Lead sponsor: Tang-Du Hospital
Sponsor class: OTHER
First posted: 2022-12-21
Enrollment: 684
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: yes
Observational model: CASE_CONTROL
Time perspective: CROSS_SECTIONAL
Sampling method: PROBABILITY_SAMPLE
Study population: insomnia

Brief summary: 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.


Eligibility criteria: 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

Primary outcomes:
measure: Screening out early warning indicators of MCI in patients with insomnia
timeFrame: baseline
Secondary outcomes:
measure: Construct an automatic and individualized accurate diagnosis model for insomnia with MCI
timeFrame: through study completion, an average of 2 year
Other outcomes:
Locations:
city: Xi'an
country: China
facility: Tangdu Hospital
state: Shaanxi
Study officials:
References: