Ireland
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Enrolling by invitation Observational

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

NCT07374393 · tracked via the Priya Life Science China tracker
Phase
Observational
Started
2026-07-04
Last updated
2026-08-04

Condition(s) studied

SleepNeurology

Investigational drug(s) / intervention(s)

Symptomatic and Etiological Treatment

Symptomatic and Etiological Treatment: sleep-related

Study summary

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.

Eligibility

Sex
ALL
Min age
14 Years
Max age
80 Years
Healthy volunteers
Accepted
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)

Primary outcome measure(s)

  • Total sleep time measured by polysomnography — baseline, 3 months and one year
    Total sleep time is defined as the total amount of time spent asleep during the overnight polysomnography recording, expressed in minutes.
  • Wake after sleep onset measured by polysomnography — baseline, 3 months and one year
    Wake after sleep onset is defined as the total duration of wakefulness after sleep onset and before final awakening during the overnight polysomnography recording, expressed in minutes.
  • Sleep onset latency measured by polysomnography — baseline, 3 months and one year
    Sleep onset latency is defined as the time from lights off to the first epoch of sleep during overnight polysomnography.
  • Number of arousal events measured by polysomnography — baseline, 3 months and one year
    The number of arousal events is defined as the total number of arousals occurring during the overnight polysomnography recording.
  • Rapid eye movement sleep onset latency measured by polysomnography — baseline, 3 months and one year
    Rapid eye movement sleep onset latency is defined as the interval between sleep onset and the first occurrence of rapid eye movement sleep during the overnight polysomnography recording, expressed in minutes.
  • Non rapid eye movement sleep stage 1, 2, 3, and rapid eye movement sleep time measured by polysomnography — baseline, 3 months and one year
    Non-rapid eye movement (NREM) sleep stages 1, 2, and 3, and rapid eye movement (REM) sleep time are defined as the total duration spent in each sleep stage during overnight polysomnography, expressed in minutes.
  • Number of awakenings related to the event measured by polysomnography — baseline, 3 months and one year
    The number of awakenings related to respiratory events is defined as the total count of awakenings temporally associated with respiratory events during overnight polysomnography.
  • Number of respiratory events measured by polysomnography — baseline, 3 months and one year
    The number of respiratory events is defined as the total count of apnea and hypopnea events identified during overnight polysomnography.
  • Number of decreases in oxygen saturation measured by polysomnography — baseline, 3 months and one year
    The number of respiratory events is defined as the total count of respiratory events identified during overnight polysomnography.
  • Sleep period heart rate measured by polysomnography — baseline, 3 months and one year
    Sleep period heart rate is defined as the average heart rate measured during the sleep period as recorded by overnight polysomnography.
  • Number of rapid eye movement sleep without atonia measured by polysomnography — baseline, 3 months and one year
    The number of rapid eye movement sleep without atonia events is defined as the total count of rapid eye movement sleep epochs exhibiting increased muscle activity during overnight polysomnography.
  • Hypoxic burden measured by polysomnography — baseline, 3 months and one year
    Hypoxic burden is a quantitative measure of the cumulative severity of nocturnal hypoxemia, calculated from overnight polysomnography. It represents the total area under the curve of oxygen desaturation events, integrating both the depth and duration of oxygen desaturation across the entire sleep period.

Trial sites (1)

FacilityCityRegionStatus
The first hospital of Jilin University Changchun Jilin
Official registry record

This page summarises publicly available registry data for informational purposes — not medical advice. Eligibility is determined by each study team; patients should discuss participation with their clinician.

View NCT07374393 on ClinicalTrials.gov ↗ ← All trials in China