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

August 1, 2026 updated by: Zan Wang, The First Hospital of Jilin University

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

Status

Indicates the current recruitment status or the expanded access status.
Enrolling by invitation

Conditions

Conditions

The disease, disorder, syndrome, illness, or injury that is being studied. On ClinicalTrials.gov, conditions may also include other health-related issues, such as lifespan, quality of life, and health risks.

Intervention / Treatment

Intervention / Treatment

A process or action that is the focus of a clinical study. Interventions include drugs, medical devices, procedures, vaccines, and other products that are either investigational or already available. Interventions can also include noninvasive approaches, such as education or modifying diet and exercise.

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

Study Type

Describes the nature of a clinical study. Study types include interventional studies (also called clinical trials), observational studies (including patient registries), and expanded access.
Observational

Enrollment (Estimated)

Enrollment

The number of participants in a clinical study. The "anticipated" enrollment is the target number of participants that the researchers need for the study.
100

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

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

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Eligibility Criteria

The key requirements that people who want to participate in a clinical study must meet or the characteristics they must have. Eligibility criteria consist of both inclusion criteria (which are required for a person to participate in the study) and exclusion criteria (which prevent a person from participating). Types of eligibility criteria include whether a study accepts healthy volunteers, has age or age group requirements, or is limited by sex.

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

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

Cohorts and Interventions

Group / Cohort

Group / Cohort

A group or subgroup of participants in an observational study that is assessed for biomedical or health outcomes.
Intervention / Treatment

Intervention / Treatment

A process or action that is the focus of a clinical study. Interventions include drugs, medical devices, procedures, vaccines, and other products that are either investigational or already available. Interventions can also include noninvasive approaches, such as education or modifying diet and exercise.
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

Primary Outcome Measures

In a clinical study's protocol, the planned outcome measure that is the most important for evaluating the effect of an intervention/treatment. Most clinical studies have one primary outcome measure, but some have more than one.
Outcome Measure
Measure Description
Time Frame
Total sleep time measured by polysomnography
Time Frame: 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.
baseline, 3 months and one year
Wake after sleep onset measured by polysomnography
Time Frame: 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.
baseline, 3 months and one year
Sleep onset latency measured by polysomnography
Time Frame: 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.
baseline, 3 months and one year
Number of arousal events measured by polysomnography
Time Frame: 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.
baseline, 3 months and one year
Rapid eye movement sleep onset latency measured by polysomnography
Time Frame: 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.
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
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
Time Frame: 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.
baseline, 3 months and one year
Number of respiratory events measured by polysomnography
Time Frame: 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.
baseline, 3 months and one year
Number of decreases in oxygen saturation measured by polysomnography
Time Frame: baseline, 3 months and one year
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
Time Frame: 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.
baseline, 3 months and one year
Number of rapid eye movement sleep without atonia measured by polysomnography
Time Frame: 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.
baseline, 3 months and one year
Hypoxic burden measured by polysomnography
Time Frame: 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.
baseline, 3 months and one year

Secondary Outcome Measures

Secondary Outcome Measures

In a clinical study's protocol, a planned outcome measure that is not as important as the primary outcome measure for evaluating the effect of an intervention but is still of interest. Most clinical studies have more than one secondary outcome measure.
Outcome Measure
Measure Description
Time Frame
The score of Insomnia Severity Index scale
Time Frame: baseline, 3 months and one year
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
Time Frame: baseline, 3 months and one year
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
Time Frame: baseline, 3 months and one year
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
Time Frame: baseline, 3 months and one year
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

Other Outcome Measures

For clinical trials, a planned measurement described in the protocol that is used to determine the effect of an intervention/treatment on participants. For observational studies, a measurement or observation that is used to describe patterns of diseases or traits, or associations with exposures, risk factors, or treatment. Types of outcome measures include primary outcome measure and secondary outcome measure.
Outcome Measure
Measure Description
Time Frame
Plasma corticotropin-releasing factor level
Time Frame: baseline, 3 months and one year
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
Time Frame: baseline, 3 months and one year
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
Time Frame: baseline, 3 months and one year
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
Time Frame: baseline, 3 months and one year
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
Time Frame: baseline, 3 months and one year
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
Time Frame: baseline, 3 months and one year
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
Time Frame: baseline, 3 months and one year
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
Time Frame: baseline, 3 months and one year
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
Time Frame: baseline, 3 months and one year
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
Time Frame: baseline, 3 months and one year
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
Time Frame: baseline, 3 months and one year
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
Time Frame: baseline, 3 months and one year
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
Time Frame: baseline, 3 months and one year
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
Time Frame: baseline, 3 months and one year
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
Time Frame: baseline, 3 months and one year
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
Time Frame: baseline, 3 months and one year
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

This is where you will find people and organizations involved with this study.

Sponsor

Sponsor

The organization or person who initiates the study and who has authority and control over the study.
The First Hospital of Jilin University

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start (Estimated)

Study Start

The actual date on which the first participant was enrolled in a clinical study. The "anticipated" study start date is the date that the researchers think will be the study start date.
July 4, 2026

Primary Completion (Estimated)

Primary Completion

The date on which the last participant in a clinical study was examined or received an intervention to collect final data for the primary outcome measure. Whether the clinical study ended according to the protocol or was terminated does not affect this date. For clinical studies with more than one primary outcome measure with different completion dates, this term refers to the date on which data collection is completed for all the primary outcome measures. The "anticipated" primary completion date is the date that the researchers think will be the primary completion date for the study.
December 31, 2028

Study Completion (Estimated)

Study Completion

The date on which the last participant in a clinical study was examined or received an intervention/treatment to collect final data for the primary outcome measures, secondary outcome measures, and adverse events (that is, the last participant's last visit). The "anticipated" study completion date is the date that the researchers think will be the study completion date.
December 31, 2030

Study Registration Dates

First Submitted

First Submitted

The date on which the study sponsor or investigator first submitted a study record to ClinicalTrials.gov. There is typically a delay of a few days between the first submitted date and the record's availability on ClinicalTrials.gov (the first posted date).
January 14, 2026

First Submitted That Met QC Criteria

First Submitted That Met QC Criteria

The date on which the study sponsor or investigator first submits a study record that is consistent with National Library of Medicine (NLM) quality control (QC) review criteria. The sponsor or investigator may need to revise and submit a study record one or more times before NLM's QC review criteria are met. It is the responsibility of the sponsor or investigator to ensure that the study record is consistent with the NLM QC review criteria.
January 25, 2026

First Posted (Actual)

First Posted

The date on which the study record was first available on ClinicalTrials.gov after National Library of Medicine (NLM) quality control (QC) review has concluded. There is typically a delay of a few days between the date the study sponsor or investigator submitted the study record and the first posted date.
January 28, 2026

Study Record Updates

Last Update Posted (Actual)

Last Update Posted

The most recent date on which changes to a study record were made available on ClinicalTrials.gov. There may be a delay between when the changes were submitted to ClinicalTrials.gov by the study's sponsor or investigator (the last update submitted date) and the last update posted date.
August 4, 2026

Last Update Submitted That Met QC Criteria

Last Update Submitted That Met QC Criteria

The most recent date on which the study sponsor or investigator submitted changes to a study record that are consistent with National Library of Medicine (NLM) quality control (QC) review criteria. It is the responsibility of the sponsor or investigator to ensure that the study record is consistent with the NLM QC review criteria.
August 1, 2026

Last Verified

Last Verified

The most recent date on which the study sponsor or investigator confirmed the information about a clinical study on ClinicalTrials.gov as accurate and current. If a study with a recruitment status of recruiting; not yet recruiting; or active, not recruiting has not been confirmed within the past 2 years, the study's recruitment status is shown as unknown.
August 1, 2026

More Information

Terms related to this study

Other Study ID Numbers

Other Study ID Numbers

Identifiers or ID numbers other than the NCT number that are assigned to a clinical study by the study's sponsor, funders, or others. These numbers may include unique identifiers from other trial registries and National Institutes of Health grant 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

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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