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

NCT07374393 | Enrolling By Invitation DMC

• 1 other identifier: SD-V01
• Study Type: observational
• Target: 100
• Locations: 1 country
• Sites: 1

Brief 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.

Conditions

Sleep; Neurology

Outcome Measures

Primary Outcomes (12)

• Total sleep time measured by polysomnography

  Total sleep time is defined as the total amount of time spent asleep during the overnight polysomnography recording, expressed in minutes.

  baseline, 3 months and one year

• Wake after sleep onset measured by polysomnography

  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.

  baseline, 3 months and one year

• Sleep onset latency measured by polysomnography

  Sleep onset latency is defined as the time from lights off to the first epoch of sleep during overnight polysomnography.

  baseline, 3 months and one year

• Number of arousal events measured by polysomnography

  The number of arousal events is defined as the total number of arousals occurring during the overnight polysomnography recording.

  baseline, 3 months and one year

• Rapid eye movement sleep onset latency measured by polysomnography

  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.

  baseline, 3 months and one year

• Non rapid eye movement sleep stage 1, 2, 3, and rapid eye movement sleep time measured by polysomnography

  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.

  baseline, 3 months and one year

• Number of awakenings related to the event measured by polysomnography

  The number of awakenings related to respiratory events is defined as the total count of awakenings temporally associated with respiratory events during overnight polysomnography.

  baseline, 3 months and one year

• Number of respiratory events measured by polysomnography

  The number of respiratory events is defined as the total count of apnea and hypopnea events identified during overnight polysomnography.

  baseline, 3 months and one year

• Number of decreases in oxygen saturation measured by polysomnography

  The number of respiratory events is defined as the total count of respiratory events identified during overnight polysomnography.

  baseline, 3 months and one year

• Sleep period heart rate measured by polysomnography

  Sleep period heart rate is defined as the average heart rate measured during the sleep period as recorded by overnight polysomnography.

  baseline, 3 months and one year

• Number of rapid eye movement sleep without atonia measured by polysomnography

  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.

  baseline, 3 months and one year

• Hypoxic burden measured by polysomnography

  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.

  baseline, 3 months and one year

Secondary Outcomes (4)

• The score of Insomnia Severity Index scale

  baseline, 3 months and one year

• The score of 14-item Hamilton anxiety rating scale

  baseline, 3 months and one year

• The score of 17-item Hamilton depression rating scale

  baseline, 3 months and one year

• The score of montreal cognitive assessment scale

  baseline, 3 months and one year

Other Outcomes (16)

• Plasma corticotropin-releasing factor level

  baseline, 3 months and one year

• Plasma cortisol level

  baseline, 3 months and one year

• Serum interleukin-6 level

  baseline, 3 months and one year

Study Arms (1)

patients with neurological diseases

patients with confirmed diagnoses such as stroke, Parkinson's disease, epilepsy, cognitive disorders, neuroinfections, and immune-mediated neurological diseases

Other: Symptomatic and Etiological Treatment

Interventions

Symptomatic and Etiological Treatment OTHER

sleep-related

patients with neurological diseases

Eligibility Criteria

• Age: 14 Years - 80 Years
• Sex: all
• Healthy Volunteers: Yes
• Age Groups: Child (0-17), Adult (18-64), Older Adult (65+)
• Sampling Method: Non-Probability Sample

Study Population

Neurology patients able to undergo polysomnography examination

You may qualify if:

• 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

You may not qualify if:

• 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)

Sponsors & Collaborators

• The First Hospital of Jilin University: lead

Study Sites (1)

The first hospital of Jilin University

Changchun, Jilin, 130000, China

Location

Study Design

• Study Type: observational
• Observational Model: COHORT
• Time Perspective: PROSPECTIVE
• Target Duration: 3 Months
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Professor，Chief Physician

Study Record Dates

• First Submitted: January 14, 2026
• First Posted: January 28, 2026
• Study Start: January 4, 2026
• Primary Completion (Estimated): December 31, 2028
• Study Completion (Estimated): December 31, 2030
• Last Updated: January 28, 2026

Record last verified: 2026-01

Data Sharing

• IPD Sharing: Will not share

Locations

CN (1)