The first hospital of Jilin University
Changchun, Jilin, 130000, China
NCT Number: NCT07374393
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.
Interested in participating?
Request InfoThe 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.
Healthy volunteers accepted: Yes
Only the study team can determine whether someone qualifies for participation.
Inclusion criteria
Exclusion criteria
sleep-related
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.
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.
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.
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.
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.
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.
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.
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.
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.
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.
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.
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.
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.
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.
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
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.
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.
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.
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.
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.
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.
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.
Time frame: baseline, 3 months and one year
Hippocampal volume was extracted from T1-weighted MRI using automated segmentation and normalized for intracranial volume.
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.
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.
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.
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.
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.
Time frame: baseline, 3 months and one year
Mean diffusivity quantifies the overall magnitude of water diffusion and reflects microstructural tissue changes.
Time frame: baseline, 3 months and one year
Cerebrospinal fluid flow dynamics were assessed using MRI-based methods to characterize CSF motion and pulsatility.
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.
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.
The First Hospital of Jilin University
Other
Establishment of a Research Cohort on Sleep and Sleep Disorders in Patients With Neurological Diseases
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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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