A Registered Cohort Study on Neurodegenerative Associated With Sleep Disorder.

NCT05524922 | Recruiting

• 1 other identifier: Cohort-Sleep Disorder
• Study Type: observational
• Target: 500
• Locations: 1 country
• Sites: 1

Brief Summary

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.

Conditions

Neurodegenerative Disorder

Outcome Measures

Primary Outcomes (1)

• PSQI Scores

  Pittsburgh Sleep Quality Index (PSQI),

  Baseline

Secondary Outcomes (7)

• MoCA scores

  Baseline

• ACE-III scores

  Baseline

• HRV (ms)

  Baseline

• Plasma Aβ-42 levels (ng/ml)

  Baseline

• Vic

  Baseline

Study Arms (1)

Neurodegenerative disorders associated with sleep disorders

Other: Data collection

Interventions

Data collection OTHER

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

Neurodegenerative disorders associated with sleep disorders

Eligibility Criteria

• Age: 30 Years - 80 Years
• Sex: all
• Age Groups: Adult (18-64), Older Adult (65+)
• Sampling Method: Non-Probability Sample

Study Population

Neurodegenerative disorders are a cluster of chronic progressive diseases characterized by specific pathological manifestations. Common neurodegenerative disorders include Alzheimer's disease, Parkinson's disease and so on. We studied people with sleep disorders associated with neurodegenerative disorders.

You may qualify if:

• clinical diagnosis of neurodegenerative disease.
• patients experience insomnia, excessive drowsiness, or confusion at night.
• Patients experience frequent awakenings, daily sleep episodes, or nocturnal confusion.
• 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.
• 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.
• Presence of other medical symptoms that do not indicate the primary disease.
• 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.
• any of the above can be diagnosed

You may not qualify if:

• Patients with other neurological disorders.
• Pregnant or lactating women.

Sponsors & Collaborators

• Fujian Medical University Union Hospital: lead

Study Sites (1)

Fujian Medical University Union Hospital

Fuzhou, Fujian, 350000, China

RECRUITING

MeSH Terms

Conditions

Neurodegenerative Diseases

Interventions

Data Collection

Condition Hierarchy (Ancestors)

Nervous System Diseases

Intervention Hierarchy (Ancestors)

Epidemiologic Methods; Investigative Techniques; Health Care Evaluation Mechanisms; Quality of Health Care; Health Care Quality, Access, and Evaluation; Public Health; Environment and Public Health

Central Study Contacts

Xiaodong Pan, Doctor

CONTACT

0591-86218341; pxd77316@163.com

Study Design

• Study Type: observational
• Observational Model: COHORT
• Time Perspective: PROSPECTIVE
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: August 28, 2022
• First Posted: September 1, 2022
• Study Start: September 1, 2021
• Primary Completion (Estimated): June 1, 2030
• Study Completion (Estimated): June 1, 2030
• Last Updated: January 22, 2025

Record last verified: 2024-09

Data Sharing

• IPD Sharing: Will not share

Locations

CN (1)