An observational study in Insomnia, Cognitive Disorder and MRI, sponsored by Tang-Du Hospital. Status unknown at 1 site in China. Open to participants aged 18 Years and older, including healthy volunteers. Per ClinicalTrials.gov, last updated 2023-01-04.
Sponsored by Tang-Du Hospital · Observational
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.
1,856 studies on the registry are indexed under Sleep Initiation and Maintenance Disorders; 594 are open to participants now.
This study's planned enrollment of 684 is above the median of 128 across 191 observational studies indexed under Sleep Initiation and Maintenance Disorders.
Browse Sleep Initiation and Maintenance Disorders studies →Tang-Du Hospital is the lead sponsor of 164 studies on the registry; 77 are open to participants now.
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insomnia
Exclusion Criteria:
Healthy people neither in insomnia group nor in MCI group.
Diagnostic Test: MRI
Pittsburgh sleep quality index (PSQI)\>5, Epworth Sleepiness Scale (ESS)\>9 ，Insomnia Severity Index (ISI)\>8.
Diagnostic Test: MRI
Pittsburgh sleep quality index(PSQI)\>5 ,Epworth Sleepiness Scale(ESS)\>9 ，Insomnia Severity Indeex(ISI)\>8; 20\< MoCA\<26.
Diagnostic Test: 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.
Screening out early warning indicators of MCI in patients with insomnia
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.
Time frame: baseline
Construct an automatic and individualized accurate diagnosis model for insomnia with MCI
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%.
Time frame: through study completion, an average of 2 year
This study is status unknown, as verified in Jan 2023. You cannot join it, but the record below documents what was studied.
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Sleep Initiation and Maintenance Disorders→
Tang-Du Hospital