A Registered Cohort Study on Neurodegenerative Associated With Sleep Disorder.

January 19, 2025 updated by: Fujian Medical University Union Hospital

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

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.

Study Overview

Status

Recruiting

Conditions

Intervention / Treatment

Study Type

Observational

Enrollment (Estimated)

500

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Contact

  • Name: Xiaodong Pan, Doctor
  • Phone Number: 0591-86218341
  • Email: pxd77316@163.com

Study Locations

  • China
    • Fujian
      • Fuzhou, Fujian, China, 350000
        • Recruiting
        • Fujian Medical University Union Hospital
        • Contact:

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

26 years to 76 years (Adult, Older Adult)

Accepts Healthy Volunteers

N/A

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.

Description

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.

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Observational Models: Cohort
  • Time Perspectives: Prospective

Cohorts and Interventions

Group / Cohort
Intervention / Treatment
Neurodegenerative disorders associated with sleep disorders
Other: Data collection
Neuropsychological assessment, brain MRI, electroencephalogram and biomarker datas will be collected

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
PSQI Scores
Time Frame: Baseline
Pittsburgh Sleep Quality Index (PSQI),
Baseline

Secondary Outcome Measures

Outcome Measure
Measure Description
Time Frame
MoCA scores
Time Frame: Baseline
The Montreal Cognitive Assessment (MoCA)
Baseline
ACE-III scores
Time Frame: Baseline
Addenbrooke's Cognitive Examination (ACE) score
Baseline
HRV (ms)
Time Frame: Baseline
Heart rate variability (HRV) was calculated as the maximum bpm - minimum bpm.
Baseline
Plasma Aβ-42 levels (ng/ml)
Time Frame: Baseline
Baseline
Vic
Time Frame: Baseline
The intra-cellular compartment (Vic) of the Neurite Orientation Dispersion and Density Imaging (NODDI) model represents diffusion within the axons and cells.
Baseline
PAF (Hz)
Time Frame: Baseline
The alpha-peak frequency (PAF) is the frequency with the highest power within the alpha-band.
Baseline
Vic
Time Frame: 1 year after baseline
The intra-cellular compartment (Vic) of the Neurite Orientation Dispersion and Density Imaging (NODDI) model represents diffusion within the axons and cells.
1 year after baseline

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Fujian Medical University Union Hospital

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start (Actual)

September 1, 2021

Primary Completion (Estimated)

June 1, 2030

Study Completion (Estimated)

June 1, 2030

Study Registration Dates

First Submitted

August 28, 2022

First Submitted That Met QC Criteria

August 30, 2022

First Posted (Actual)

September 1, 2022

Study Record Updates

Last Update Posted (Actual)

March 25, 2025

Last Update Submitted That Met QC Criteria

January 19, 2025

Last Verified

September 1, 2024

More Information

Terms related to this study

Additional Relevant MeSH Terms

Other Study ID Numbers

  • Cohort-Sleep Disorder

Plan for Individual participant data (IPD)

Plan to Share Individual Participant Data (IPD)?

NO

Drug and device information, study documents

Studies a U.S. FDA-regulated drug product

No

Studies a U.S. FDA-regulated device product

No

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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