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Recruiting NCT05524922

A Registered Cohort Study on Neurodegenerative Associated With Sleep Disorder.

— Observational Neurodegenerative Disorder

For patients and families

In plain language

An automatic summary of structured registry data. It is an orientation aid, not a substitute for the official protocol or a physician assessment.

What is being studied
The protocol lists: Data collection.
Who it may be relevant to
Registry conditions: Neurodegenerative Disorder. Basic parameters: 30 years — 80 years · All.
What needs checking
Age, condition and sex are only basic indicators. Prior treatment, laboratory values and other mandatory requirements appear in the eligibility criteria below.
Where it takes place
China
Next step
Save the trial, show it to the treating physician, and confirm current recruitment with the study center. Costs, documents and travel →

Unsure about the terms? Read our patient guide →

Official title

A Registered Observational Cohort Study on Neurodegenerative Associated With Sleep Disorder.

Overview

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.

Interventions

  • Other Data collection
    Neuropsychological assessment, brain MRI, electroencephalogram and biomarker datas will be collected

Primary outcome measures

  • PSQI Scores [Time frame: Baseline]
Secondary outcome measures (7)
  • MoCA scores [Time frame: Baseline]
  • ACE-III scores [Time frame: Baseline]
  • HRV (ms) [Time frame: Baseline]
  • Plasma Aβ-42 levels (ng/ml) [Time frame: Baseline]
  • Vic [Time frame: Baseline]
  • PAF (Hz) [Time frame: Baseline]
  • Vic [Time frame: 1 year after baseline]

Eligibility criteria

Inclusion criteria

  • 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

Exclusion criteria

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

Criteria are shown verbatim from the registry (in English). Final eligibility is always assessed by the study center.

Study design

Observational model
Cohort

Study locations

China · 1 center
  • Fujian Medical University Union Hospital — Fuzhou

Identifiers

NCT: NCT05524922 · Cohort-Sleep Disorder

Primary sources (government registries)

View this study on ClinicalTrials.gov ↗