Study on Cognitive Impairment of Insomnia Based on MRI

Recruiting

• Conditions: Insomnia; Cognitive Disorder; MRI
• Interventions: Diagnostic Test: MRI

• Registration Number: NCT05659511
• Lead Sponsor: Tang-Du Hospital

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.

Detailed Description

Not available

Study Timeline

• Study Start: 2022-07-01
• Study First Submitted: 2022-12-13
• Study First Submitted QC: 2022-12-13
• Study First Posted: 2022-12-21
• Status Verified: 2023-01
• Last Update Submitted: 2023-01-02
• Last Update Posted: 2023-01-04
• Primary Completion: 2023-06-30
• Study Completion: 2024-06-30

Recruitment & Eligibility

• Status: RECRUITING
• Sex: All
• Target Recruitment: 684

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

Study & Design

• Study Type: OBSERVATIONAL
• Study Design: Not specified

Arm && Interventions

Group	Intervention	Description
insomnia-MCI	MRI	Pittsburgh sleep quality index(PSQI)\>5 ,Epworth Sleepiness Scale(ESS)\>9 ，Insomnia Severity Indeex(ISI)\>8; 20\< MoCA\<26.
insomnia	MRI	Pittsburgh sleep quality index (PSQI)\>5, Epworth Sleepiness Scale (ESS)\>9 ，Insomnia Severity Index (ISI)\>8.
healthy control group	MRI	Healthy people neither in insomnia group nor in MCI group.

Primary Outcome Measures

Name	Time	Method
Screening out early warning indicators of MCI in patients with insomnia	baseline	Based on the neurovascular uncoupled MRI features and imaging omics features of ID patients with MCI, the early warning indicators of MCI in ID patients were screened by machine learning algorithm.

Secondary Outcome Measures

Name	Time	Method
Construct an automatic and individualized accurate diagnosis model for insomnia with MCI	through study completion, an average of 2 year	The structural MRI and functional MRI were used to analyze the biological changes or other mechanisms related to sleep disorders, and the clinical information and neuroimaging characteristics were combined to initially build an automatic and individualized accurate diagnostic model for insomnia and MCI with sensitivity, specificity and accuracy\>80%.

Trial Locations

Locations (1)

Tangdu Hospital; 🇨🇳 Xi'an, Shaanxi, China