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Enrolling by invitation NCT07374393

Establishment of a Sleep and Sleep-disorder Research Cohort in Patients With Neurological Disorders

— Observational Sleep Neurology

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: Symptomatic and Etiological Treatment.
Who it may be relevant to
Registry conditions: Sleep, Neurology. Basic parameters: 14 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 →

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Official title

Establishment of a Research Cohort on Sleep and Sleep Disorders in Patients With Neurological Diseases

Overview

This study aims to establish a research cohort on sleep and sleep disorders in patients with neurological diseases to systematically evaluate the relationship between various neurological conditions and sleep characteristics or disturbances.

Detailed description

The cohort will include patients with confirmed diagnoses such as stroke, Parkinson's disease, epilepsy, cognitive disorders, neuroinfections, and immune-mediated neurological diseases, with collection of demographic data, medical history, and lifestyle factors. All participants will undergo standardized polysomnography (PSG), sleep questionnaires, assessments of cognition, mood, daytime function, as well as relevant imaging and laboratory tests. Designed as a prospective observational study, the cohort will focus on sleep architecture alterations, periodic limb movements, sleep-disordered breathing, REM sleep behavior disorder, nocturnal awakenings, heart rate, and oxygen saturation, and their associations with disease severity and progression. The data will provide a basis for exploring the mechanisms, early indicators, and potential interventions for sleep disturbances in neurological patients.

Interventions

  • Other Symptomatic and Etiological Treatment
    sleep-related

Primary outcome measures

  • Total sleep time measured by polysomnography [Time frame: baseline, 3 months and one year]
  • Wake after sleep onset measured by polysomnography [Time frame: baseline, 3 months and one year]
  • Sleep onset latency measured by polysomnography [Time frame: baseline, 3 months and one year]
  • Number of arousal events measured by polysomnography [Time frame: baseline, 3 months and one year]
  • Rapid eye movement sleep onset latency measured by polysomnography [Time frame: baseline, 3 months and one year]
  • Non rapid eye movement sleep stage 1, 2, 3, and rapid eye movement sleep time measured by polysomnography [Time frame: baseline, 3 months and one year]
  • Number of awakenings related to the event measured by polysomnography [Time frame: baseline, 3 months and one year]
  • Number of respiratory events measured by polysomnography [Time frame: baseline, 3 months and one year]
  • Number of decreases in oxygen saturation measured by polysomnography [Time frame: baseline, 3 months and one year]
  • Sleep period heart rate measured by polysomnography [Time frame: baseline, 3 months and one year]
Secondary outcome measures (4)
  • The score of Insomnia Severity Index scale [Time frame: baseline, 3 months and one year]
  • The score of 14-item Hamilton anxiety rating scale [Time frame: baseline, 3 months and one year]
  • The score of 17-item Hamilton depression rating scale [Time frame: baseline, 3 months and one year]
  • The score of montreal cognitive assessment scale [Time frame: baseline, 3 months and one year]

Eligibility criteria

Inclusion criteria

  • Confirmed diagnosis of neurological diseases, including but not limited to: Stroke (ischemic or hemorrhagic)，Parkinson's disease and other movement disorders，Epilepsy，Cognitive disorders (mild cognitive impairment or dementia)，Neuroinfections or immune-mediated neurological disorders
  • Ability to complete standardized polysomnography, sleep questionnaires, and assessments of cognition, mood, and daytime function
  • Voluntary participation and provision of written informed consent

Exclusion criteria

  • Severe psychiatric disorders or unstable mental status precluding study assessments，Recent (within 3 months) serious infection, surgery, or major medical event
  • Previously diagnosed severe primary sleep disorders (e.g., sleep apnea) under active treatment， -Pregnancy or lactation (if the study involves medication or interventions)

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

Healthy volunteers: Yes

Study design

Observational model
Cohort

Study locations

China · 1 center
  • The first hospital of Jilin University — Changchun

Identifiers

NCT: NCT07374393 · SD-V01

Primary sources (government registries)

View this study on ClinicalTrials.gov ↗