SleepNCT07374393
Establishment of a Sleep and Sleep-disorder Research Cohort in Patients With Neurological Disorders
An observational study of Sleep and Neurology, run by The First Hospital of Jilin University at 1 site in China.
Trial 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. Read more about this study
- Who is it for?
- Ages 14 to 80 yearsHealthy volunteers can take part
- What is being tested?
- Symptomatic and Etiological Treatment
- How many people
- 100 participants
- Where
- 1 siteChina
- Study dates
- 4 Jul 2026to 31 Dec 2030
- How long will I take part?
- 3 Months
- Phase
- Observational
- Are there results?
- Not yet: the study is under way
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 14 to 80 years
- All sexes
- Healthy volunteers accepted
- Child, Adult, Older adult
Study population: Neurology patients able to undergo polysomnography examination
Who may be able to join
- 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
Who cannot join
- 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)
Trial locations and contacts
1 site in 1 country. Contact the study team or a site near you to ask about taking part.
About this study
Official title: 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.
Read the 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.
- Being tested
- Symptomatic and Etiological Treatment
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Symptomatic and Etiological TreatmentOther
sleep-related
| Study group | Role | What they receive |
|---|---|---|
| patients with neurological diseases | patients with confirmed diagnoses such as stroke, Parkinson's disease, epilepsy, cognitive disorders, neuroinfections, and immune-mediated neurological diseases Receives: Other: Symptomatic and Etiological Treatment |
What is being measured
The primary outcome is the main question the study is designed to answer.
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.
Measured: 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.
Measured: 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.
Measured: 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.
Measured: 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.
Measured: 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.
Measured: 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.
Measured: 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.
Measured: 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.
Measured: 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.
Measured: 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.
Measured: 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.
Measured: baseline, 3 months and one year
Secondary outcomes (4)
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.
Measured: 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.
Measured: 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
Measured: 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.
Measured: baseline, 3 months and one year
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted28 Jan 2026
- Study start4 Jul 2026 (estimated)
- Primary completion31 Dec 2028 (estimated)
- Study completion31 Dec 2030 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for SleepStudies of the same condition, open and under way.
- More trials run by The First Hospital of Jilin UniversityThe sponsor's other registered studies.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Observational
- Observational model
- Cohort
- Time perspective
- Prospective
- Enrolment
- 100 participants (estimated)
- Target duration
- 3 Months
Sponsor and investigators
- Lead sponsor
- The First Hospital of Jilin University
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Zan Wang, The First Hospital of Jilin University
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT07374393
- Sponsor's protocol ID
- SD-V01
- Status last verified
- Aug 2026
- First submitted
- 14 Jan 2026
- Last updated
- 4 Aug 2026
- Results posted
- No
- Data monitoring committee
- Yes
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Study at a glance
From the registry record, last updated by the sponsor on 4 Aug 2026. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Establishment of a Research Cohort on Sleep and Sleep Disorders in Patients With Neurological Diseases
- ClinicalTrials.gov ID
- NCT07374393
- Acronym / sponsor ID
- SD-V01
- Study type
- Observational
- Recruitment status
- Enrolling by invitation
- Enrolment
- 100 participants (estimated)
- Lead sponsor
- The First Hospital of Jilin UniversityUniversity, hospital or other
- Study start
- 4 Jul 2026 (estimated)
- Primary completion
- 31 Dec 2028 (estimated)
- Study completion
- 31 Dec 2030 (estimated)
- First posted
- 28 Jan 2026 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
Study design
- Observational model
- Cohort
- Time perspective
- Prospective
- Target follow-up
- 3 Months
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| patients with neurological diseases | – | Other: Symptomatic and Etiological Treatmentpatients with confirmed diagnoses such as stroke, Parkinson's disease, epilepsy, cognitive disorders, neuroinfections, and immune-mediated neurological diseases |
Who may qualify
- Ages
- 14 to 80 years
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Child, Adult, Older adult
- Study population
- Neurology patients able to undergo polysomnography examination
Key inclusion criteria (3 listed)
- 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
Key exclusion criteria (2 listed)
- 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)
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Symptomatic and Etiological Treatmentsleep-related | Other | patients with neurological diseases |
Primary outcome
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.
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.
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.
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.
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.
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.
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.
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.
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.
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.
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.
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.
4 secondary outcomes
The score of Insomnia Severity Index scale
Time frame: baseline, 3 months and one year
The score of 14-item Hamilton anxiety rating scale
Time frame: baseline, 3 months and one year
The score of 17-item Hamilton depression rating scale
Time frame: baseline, 3 months and one year
The score of montreal cognitive assessment scale
Time frame: baseline, 3 months and one year
Results and safety
This study is still under way. Results are not available in the source record yet.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 4 Aug 2026.
- Individual participant dataSharing planned: No
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part.
The record lists no contact. Use the official record to reach the sponsor.
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
An observational study of Sleep and Neurology, run by The First Hospital of Jilin University at 1 site in China.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 3 inclusion and 2 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: enrolling by invitation, as of the sponsor's last update on 4 Aug 2026. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in China. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
This study is still under way. Results are not available in the source record yet.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Total sleep time measured by polysomnography (time frame: baseline, 3 months and one year). The study lists 12 primary outcomes in all. It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 4 Aug 2026.