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

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

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.

Study Overview

• Status: Enrolling by invitation
• Conditions: Sleep; Neurology
• Intervention / Treatment: Other: Symptomatic and Etiological Treatment

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.

• Study Type: Observational
• Enrollment (Estimated): 100

Contacts and Locations

Study Locations

• China
  • Jilin
    • Changchun, Jilin, China, 130000
      • The First Hospital of Jilin University

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: Child; Adult; Older Adult
• Accepts Healthy Volunteers: Yes

• Sampling Method: Non-Probability Sample

Study Population

Neurology patients able to undergo polysomnography examination

Description

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)

Study Plan

How is the study designed?

Number of groups / cohorts

1

Cohorts and Interventions

Group / Cohort	Intervention / Treatment
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; sleep-related

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
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 Outcome Measures

Outcome Measure	Measure Description	Time Frame
The score of Insomnia Severity Index scale	The total score ranges from 0 to 28, and a higher score indicates higher levels of insomnia severity. A score of 8 or greater is the cut point for clinically possible insomnia.	baseline, 3 months and one year
The score of 14-item Hamilton anxiety rating scale	The total score ranges from 0 to 56, and a higher score indicates higher levels of anxiety symptoms. A score of 7 or greater is the cut point for clinically possible anxiety.	baseline, 3 months and one year
The score of 17-item Hamilton depression rating scale	The total score ranges from 0 to 52, and a higher score indicates higher levels of depression symptoms. A score of 7 or greater is the cut point for clinically possible depression symptom	baseline, 3 months and one year
The score of montreal cognitive assessment scale	The total score ranges from 0 to 30, with higher scores indicating better global cognitive function. A score below 26 is commonly used as the cut-off for cognitive impairment.	baseline, 3 months and one year

Other Outcome Measures

Outcome Measure	Measure Description	Time Frame
Plasma corticotropin-releasing factor level	Plasma corticotropin-releasing factor concentration was measured as a biomarker of hypothalamic-pituitary adrenal axis activity. Higher levels indicate increased neuroendocrine stress response. Unit of Measure: pg/mL.	baseline, 3 months and one year
Plasma cortisol level	Plasma cortisol concentration was assessed as an indicator of hypothalamic-pituitary-adrenal axis function. Higher levels reflect increased physiological stress response. Unit of Measure: μg/dL.	baseline, 3 months and one year
Serum interleukin-6 level	Serum interleukin-6 concentration was measured as a marker of systemic inflammation. Higher levels indicate greater inflammatory activity. Unit of Measure: pg/mL.	baseline, 3 months and one year
Serum brain-derived neurotrophic factor level	Serum brain-derived neurotrophic factor concentration was measured as a biomarker associated with neuroplasticity and neuronal function. Higher levels indicate enhanced neurotrophic activity. Unit of Measure: pg/mL.	baseline, 3 months and one year
Gray matter volume measured by structural magnetic resonance Imaging	Gray matter volume was derived from T1-weighted structural MRI using voxel-based morphometry, reflecting regional brain tissue volume.	baseline, 3 months and one year
Cortical thickness measured by structural magnetic resonance Imaging	Cortical thickness was quantified from T1-weighted MRI as the distance between the white matter and pial surfaces, reflecting cortical integrity.	baseline, 3 months and one year
Hippocampal volume measured by structural magnetic resonance Imaging	Hippocampal volume was extracted from T1-weighted MRI using automated segmentation and normalized for intracranial volume.	baseline, 3 months and one year
Resting-state functional connectivity measured by resting-state functional magnetic resonance imaging	Functional connectivity was assessed by calculating temporal correlations of blood-oxygen-level-dependent signals between predefined brain regions during rest.	baseline, 3 months and one year
Amplitude of low-frequency fluctuation measured by resting-state functional magnetic resonance	Amplitude of low-frequency fluctuation reflects the amplitude of spontaneous low-frequency BOLD signal oscillations, indicating regional intrinsic neural activity.	baseline, 3 months and one year
Regional homogeneity measured by resting-state functional magnetic resonance	Regional homogeneity was calculated to assess the similarity of the time series of a given voxel with its neighboring voxels, reflecting local synchronization of brain activity.	baseline, 3 months and one year
Global blood-oxygen-level-dependent signal measured by resting-state functional magnetic resonance	The global blood-oxygen-level-dependent signal represents the average blood-oxygen-level-dependent signal across the whole brain, reflecting the overall amplitude and synchronization of brain activity.	baseline, 3 months and one year
Fractional anisotropy measured by diffusion tensor imaging	Fractional anisotropy reflects the degree of directional water diffusion and was used to assess white matter microstructural integrity.	baseline, 3 months and one year
Mean diffusivity measured by diffusion tensor imaging	Mean diffusivity quantifies the overall magnitude of water diffusion and reflects microstructural tissue changes.	baseline, 3 months and one year
Cerebrospinal fluid flow dynamics measured by resting-state functional magnetic resonance	Cerebrospinal fluid flow dynamics were assessed using MRI-based methods to characterize CSF motion and pulsatility.	baseline, 3 months and one year
Phase difference of dynamic cerebral autoregulation	Dynamic cerebral autoregulation was assessed using the phase difference between cerebral blood flow velocity and arterial blood pressure fluctuations. Larger phase differences indicate better autoregulatory function.	baseline, 3 months and one year
Gain of dynamic cerebral autoregulation	Gain represents the magnitude of cerebral blood flow velocity changes in response to blood pressure fluctuations, with lower gain values indicating more effective autoregulation.	baseline, 3 months and one year

Collaborators and Investigators

• Sponsor: The First Hospital of Jilin University

Study record dates

Study Major Dates

• Study Start (Estimated): January 4, 2026
• Primary Completion (Estimated): December 31, 2028
• Study Completion (Estimated): December 31, 2030

Study Registration Dates

• First Submitted: January 14, 2026
• First Submitted That Met QC Criteria: January 25, 2026
• First Posted (Actual): January 28, 2026

Study Record Updates

• Last Update Posted (Actual): January 28, 2026
• Last Update Submitted That Met QC Criteria: January 25, 2026
• Last Verified: January 1, 2026

More Information

Terms related to this study

• Other Study ID Numbers: SD-V01

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: NO

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: No