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NCT Number: NCT05524922

A Registered 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.

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Key information

Age range

30 year–80 year

Sex eligibility

All sexes

Study type

Observational

Primary location

Fujian Medical University Union Hospital

Fuzhou, Fujian, 350000, China

Location status: Recruiting

Location contact

Xiaodong Pan

CONTACT

[email protected]

0591-86218341

Who can participate

Only the study team can determine whether someone qualifies for participation.

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.

Treatment and study plan

Data Collection

Other

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

Primary outcomes

  1. PSQI Scores

    Time frame: Baseline

    Pittsburgh Sleep Quality Index (PSQI),

Secondary outcomes

  1. MoCA scores

    Time frame: Baseline

    The Montreal Cognitive Assessment (MoCA)

  2. ACE-III scores

    Time frame: Baseline

    Addenbrooke's Cognitive Examination (ACE) score

  3. HRV (ms)

    Time frame: Baseline

    Heart rate variability (HRV) was calculated as the maximum bpm - minimum bpm.

  4. Plasma Aβ-42 levels (ng/ml)

    Time frame: Baseline

  5. 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.

  6. PAF (Hz)

    Time frame: Baseline

    The alpha-peak frequency (PAF) is the frequency with the highest power within the alpha-band.

  7. 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.

Study contacts

Contact information is provided by the study sponsor or research team.

Xiaodong Pan, Doctor

CONTACT

[email protected]

0591-86218341

Sponsors and collaborators

Lead sponsor

Fujian Medical University Union Hospital

Other

Registry information

Official study title

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

Important dates

Study start
2021
Primary completion
2030
Study completion
2030
First posted
Sep 1, 2022
Registry last updated
Jan 22, 2025

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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