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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

Status
Enrolling by invitation
Phases
Unknown
Study type
Observational
Source
ClinicalTrials.gov
Registry ID
NCT07374393
Enrollment
100
Registered
2026-01-28
Start date
2026-07-04
Completion date
2030-12-31
Last updated
2026-08-04

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Neurology, Sleep

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.

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.

Interventions

OTHERSymptomatic and Etiological Treatment

sleep-related

Sponsors

The First Hospital of Jilin University
Lead SponsorOTHER

Study design

Observational model
COHORT
Time perspective
PROSPECTIVE

Eligibility

Sex/Gender
ALL
Age
14 Years to 80 Years
Healthy volunteers
Yes

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)

Design outcomes

Primary

MeasureTime frameDescription
Total sleep time measured by polysomnographybaseline, 3 months and one yearTotal sleep time is defined as the total amount of time spent asleep during the overnight polysomnography recording, expressed in minutes.
Wake after sleep onset measured by polysomnographybaseline, 3 months and one yearWake 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.
Sleep onset latency measured by polysomnographybaseline, 3 months and one yearSleep onset latency is defined as the time from lights off to the first epoch of sleep during overnight polysomnography.
Number of arousal events measured by polysomnographybaseline, 3 months and one yearThe number of arousal events is defined as the total number of arousals occurring during the overnight polysomnography recording.
Rapid eye movement sleep onset latency measured by polysomnographybaseline, 3 months and one yearRapid 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.
Non rapid eye movement sleep stage 1, 2, 3, and rapid eye movement sleep time measured by polysomnographybaseline, 3 months and one yearNon-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.
Number of awakenings related to the event measured by polysomnographybaseline, 3 months and one yearThe number of awakenings related to respiratory events is defined as the total count of awakenings temporally associated with respiratory events during overnight polysomnography.
Number of respiratory events measured by polysomnographybaseline, 3 months and one yearThe number of respiratory events is defined as the total count of apnea and hypopnea events identified during overnight polysomnography.
Number of decreases in oxygen saturation measured by polysomnographybaseline, 3 months and one yearThe number of respiratory events is defined as the total count of respiratory events identified during overnight polysomnography.
Sleep period heart rate measured by polysomnographybaseline, 3 months and one yearSleep period heart rate is defined as the average heart rate measured during the sleep period as recorded by overnight polysomnography.
Number of rapid eye movement sleep without atonia measured by polysomnographybaseline, 3 months and one yearThe 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.
Hypoxic burden measured by polysomnographybaseline, 3 months and one yearHypoxic 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

MeasureTime frameDescription
The score of Insomnia Severity Index scalebaseline, 3 months and one yearThe 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.
The score of 14-item Hamilton anxiety rating scalebaseline, 3 months and one yearThe 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.
The score of 17-item Hamilton depression rating scalebaseline, 3 months and one yearThe 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
The score of montreal cognitive assessment scalebaseline, 3 months and one yearThe 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.

Countries

China

Outcome results

None listed

Source: ClinicalTrials.gov · Data processed: Aug 5, 2026