A Registered Cohort Study on Neurodegenerative Associated With Sleep Disorder.

NCT ID: NCT05524922

Last Updated: 2025-01-22

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

RECRUITING

Total Enrollment

500 participants

Study Classification

OBSERVATIONAL

Study Start Date

2021-09-01

Study Completion Date

2030-06-01

Brief Summary

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Cognitive impairment often appears in neurodegenerative diseases, and it is expected to further study the mechanism of sleep disorders associated with the progression of neurodegenerative diseases by exploring the clinical manifestations, imaging, and biological marker changes of sleep disorders in neurodegenerative diseases.

Detailed Description

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Conditions

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Neurodegenerative Disorder

Study Design

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Observational Model Type

COHORT

Study Time Perspective

PROSPECTIVE

Study Groups

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Neurodegenerative disorders associated with sleep disorders

Data collection

Intervention Type OTHER

Neuropsychological assessment, brain MRI, electroencephalogram and biomarker datas will be collected

Interventions

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Data collection

Neuropsychological assessment, brain MRI, electroencephalogram and biomarker datas will be collected

Intervention Type OTHER

Eligibility Criteria

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Inclusion Criteria

1. clinical diagnosis of neurodegenerative disease.
2. patients experience insomnia, excessive drowsiness, or confusion at night.
3. Patients experience frequent awakenings, daily sleep episodes, or nocturnal confusion.
4. The presence of one or more of the following characteristics: a. wandering at night with inappropriate activity; b. agitation, combativeness; c. confusion, disorientation, or marked delirium.
5. Polysomnographic monitoring showed the following two conditions: a. poor sleep efficiency, increased number and duration of awakenings; b. multiple sleep latency tests showed increased daytime sleepiness.
6. Presence of other medical symptoms that do not indicate the primary disease.
7. Other sleep disorders (e.g., periodic limb movement disorders, obstructive sleep apnea syndrome) may be present, but do not explain the patient 's main symptoms.
8. any of the above can be diagnosed

Exclusion Criteria

1. Patients with other neurological disorders.
2. Pregnant or lactating women.
Minimum Eligible Age

30 Years

Maximum Eligible Age

80 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

No

Sponsors

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Fujian Medical University Union Hospital

OTHER

Sponsor Role lead

Responsible Party

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Responsibility Role SPONSOR

Locations

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Fujian Medical University Union Hospital

Fuzhou, Fujian, China

Site Status RECRUITING

Countries

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China

Central Contacts

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Xiaodong Pan, Doctor

Role: CONTACT

0591-86218341

Facility Contacts

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Xiaodong Pan

Role: primary

0591-86218341

Other Identifiers

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Cohort-Sleep Disorder

Identifier Type: -

Identifier Source: org_study_id

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