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NCT Number: NCT07374393

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

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.

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Key information

Conditions

Age range

14 year–80 year

Sex eligibility

All sexes

Study type

Observational

Primary location

The first hospital of Jilin University

Changchun, Jilin, 130000, China

About this study

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.

Who can participate

Healthy volunteers accepted: Yes

Only the study team can determine whether someone qualifies for participation.

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)

Treatment and study plan

Symptomatic and Etiological Treatment

Other

sleep-related

Primary outcomes

  1. 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.

  2. 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.

  3. 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.

  4. 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.

  5. 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.

  6. 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.

  7. 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.

  8. 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.

  9. 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.

  10. 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.

  11. 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.

  12. 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.

Secondary outcomes

  1. 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.

  2. 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.

  3. 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

  4. 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.

Other outcomes

  1. 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.

  2. 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.

  3. 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.

  4. 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.

  5. 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.

  6. 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.

  7. 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.

  8. 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.

  9. 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.

  10. 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.

  11. 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.

  12. 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.

  13. 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.

  14. 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.

  15. 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.

  16. 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.

Sponsors and collaborators

Lead sponsor

The First Hospital of Jilin University

Other

Registry information

Official study title

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

Important dates

Study start
2026
Primary completion
2028
Study completion
2030
First posted
Jan 28, 2026
Registry last updated
Jan 28, 2026

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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