NCT05659511

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.

Trial Health

43
At Risk

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Trial has exceeded expected completion date
Enrollment
684

participants targeted

Target at P75+ for all trials

Timeline
Completed

Started Jul 2022

Geographic Reach
1 country

1 active site

Status
unknown

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

Study Start

First participant enrolled

July 1, 2022

Completed
6 months until next milestone

First Submitted

Initial submission to the registry

December 13, 2022

Completed
8 days until next milestone

First Posted

Study publicly available on registry

December 21, 2022

Completed
6 months until next milestone

Primary Completion

Last participant's last visit for primary outcome

June 30, 2023

Completed
1 year until next milestone

Study Completion

Last participant's last visit for all outcomes

June 30, 2024

Completed
Last Updated

January 4, 2023

Status Verified

January 1, 2023

Enrollment Period

12 months

First QC Date

December 13, 2022

Last Update Submit

January 2, 2023

Conditions

InsomniaCognitive DisorderMRI

Outcome Measures

Primary Outcomes (1)

  • 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.

    baseline

Secondary Outcomes (1)

  • Construct an automatic and individualized accurate diagnosis model for insomnia with MCI

    through study completion, an average of 2 year

Study Arms (3)

healthy control group

Healthy people neither in insomnia group nor in MCI group.

Diagnostic Test: MRI

insomnia

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

Diagnostic Test: MRI

insomnia-MCI

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

Diagnostic Test: MRI

Interventions

MRIDIAGNOSTIC_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.

healthy control groupinsomniainsomnia-MCI

Eligibility Criteria

Age18 Years+
Sexall
Healthy VolunteersYes
Age GroupsAdult (18-64), Older Adult (65+)
Sampling MethodProbability Sample
Study Population

insomnia

You may qualify if:

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

You may not qualify if:

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

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Tangdu Hospital

Xi'an, Shaanxi, 710032, China

RECRUITING

MeSH Terms

Conditions

Sleep Initiation and Maintenance DisordersCognitive Dysfunction

Condition Hierarchy (Ancestors)

Sleep Disorders, IntrinsicDyssomniasSleep Wake DisordersNervous System DiseasesMental DisordersCognition DisordersNeurocognitive Disorders

Central Study Contacts

Lin-Feng Yan

CONTACT

029-18691899018ylf8342@163.com

Ying Yu

CONTACT

029-18191260958yqlmn@126.com

Study Design

Study Type
observational
Observational Model
CASE CONTROL
Time Perspective
CROSS SECTIONAL
Sponsor Type
OTHER
Responsible Party
SPONSOR

Study Record Dates

First Submitted

December 13, 2022

First Posted

December 21, 2022

Study Start

July 1, 2022

Primary Completion

June 30, 2023

Study Completion

June 30, 2024

Last Updated

January 4, 2023

Record last verified: 2023-01

Locations

CN(1)