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A Registered Cohort Study on Neurodegenerative Associated With Sleep Disorder.

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

Status
Recruiting
Phases
Unknown
Study type
Observational
Source
ClinicalTrials.gov
Registry ID
NCT05524922
Enrollment
500
Registered
2022-09-01
Start date
2021-09-01
Completion date
2030-06-01
Last updated
2025-01-22

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Neurodegenerative Disorder

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.

Interventions

OTHERData collection

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

Sponsors

Fujian Medical University Union Hospital
Lead SponsorOTHER

Study design

Observational model
COHORT
Time perspective
PROSPECTIVE

Eligibility

Sex/Gender
ALL
Age
30 Years to 80 Years

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.

Design outcomes

Primary

MeasureTime frameDescription
PSQI ScoresBaselinePittsburgh Sleep Quality Index (PSQI),

Secondary

MeasureTime frameDescription
Plasma Aβ-42 levels (ng/ml)Baseline
MoCA scoresBaselineThe Montreal Cognitive Assessment (MoCA)
HRV (ms)BaselineHeart rate variability (HRV) was calculated as the maximum bpm - minimum bpm.
VicBaselineThe intra-cellular compartment (Vic) of the Neurite Orientation Dispersion and Density Imaging (NODDI) model represents diffusion within the axons and cells.
PAF (Hz)BaselineThe alpha-peak frequency (PAF) is the frequency with the highest power within the alpha-band.
ACE-III scoresBaselineAddenbrooke's Cognitive Examination (ACE) score

Countries

China

Contacts

Primary ContactXiaodong Pan, Doctor
pxd77316@163.com0591-86218341

Outcome results

None listed

Source: ClinicalTrials.gov · Data processed: Feb 4, 2026