Cerebral ApoplexyNCT07401784
Efficacy and Safety Evaluation of Remote Ischemic Adaptation ( Intermittent Pressure Stimulation ) in the Treatment of Insomnia After Stroke
A study testing Automatic ischemic preconditioning therapeutic apparatus in people with Cerebral Apoplexy and Depression Anxiety Disorder, run by Second Affiliated Hospital of Nanchang University.
Trial summary
The incidence of post-stroke depression is high, which will affect the rehabilitation of neurological function, damage cognitive function, and increase the risk of subsequent stroke recurrence. Read more about this study
- Who is it for?
- Ages 18 to 80 years
- Conditions the study is for
- Cerebral Apoplexy, Depression Anxiety Disorder, Cerebrovascular Disease
- What is being tested?
- Automatic ischemic preconditioning therapeutic apparatus
- Type of treatment
- Medical device
- Could I receive a placebo?
- Yes, some participants may receive a placebo
- How many people
- 40 participants
- Where
- No sites listed yet
- Study dates
- 27 Jan 2026to 30 Dec 2027
- Phase
- Interventional
- 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 18 to 80 years
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- Age 18-80 years old ;
- In line with the diagnostic criteria of ischemic stroke, with reference to the ' Chinese guidelines for the diagnosis and treatment of acute ischemic stroke ' diagnosed ischemic stroke ;
- Despite adequate sleep opportunities, patients still have difficulty in falling asleep or maintaining sleep, staying asleep at least 3 times a week for at least 3 months, which leads to pain or impaired daytime function.
- PSQI score ≥ 6 and ISI score ≥ 8 ;
- All research contents have been understood and informed consent has been signed.
Who cannot join
- Insomnia before stroke ;
- Patients with mental disorders, bipolar disorder or depression, generalized anxiety disorder and other mental disorders ;
- Patients were pregnant or lactating women ;
- Other reasons identified by the researchers are not suitable for patients ;
Trial locations and contacts
No sites are listed yet. Contact the study team or a site near you to ask about taking part.
About this study
The incidence of post-stroke depression is high, which will affect the rehabilitation of neurological function, damage cognitive function, and increase the risk of subsequent stroke recurrence. The guidelines recommend that in addition to antiplatelet, blood pressure control, lipid-lowering and other treatments, secondary prevention of post-stroke depression should also be strengthened. Moreover, after the occurrence of post-stroke depression, methods such as medication and psychotherapy have their own limitations, such as potential adverse drug reactions and limited psychotherapy. Therefore, it is necessary to pay attention to the prevention of post-stroke depression.
The remote ischemic adaptation therapy applied in our study is a safe, non-invasive and convenient physical therapy. By transiently and repeatedly applying ischemia-reperfusion stimulation to both upper arms, it induces a systemic protective response, improves the brain 's tolerance to ischemia and hypoxia, and exerts a protective effect on multiple organs such as the brain and heart. The RIC therapeutic instrument has been national patented and has been maturely applied to the prevention and treatment of acute cerebral infarction, which can promote the rehabilitation of neurological function. In addition, it also has certain curative effect in the treatment of cerebrovascular stenosis, refractory hypertension, depression, insomnia, anxiety and so on.
Read the detailed description
Stroke is the second leading cause of death and one of the main causes of disability. The incidence of stroke is increasing worldwide. In 2010, the number of patients with first stroke increased by 68 % compared with 1990. The long-term effects of stroke sequelae include mobility, cognitive ability, language and communication disorders, as well as emotional problems, difficulties in daily life activities and social barriers. Sleep often changes after stroke. Insomnia disorder is a risk factor for stroke and an independent predictor of life satisfaction 6 months after stroke. Insomnia disorder is a sleep disorder characterized by frequent and persistent difficulty in falling asleep and / or difficulty in maintaining sleep and leading to poor sleep quality. Insomnia disorder can exist in isolation or co-exist with mental disorders, physical diseases or substance abuse, which can be accompanied by a variety of functional impairments during awakening. It is reported that in the general population, the prevalence of insomnia is 6 % to 48 % according to different definitions of insomnia. The prevalence of insomnia is higher in stroke patients. Insomnia after stroke has a high correlation with depression, disability and fatigue, and has a greater impact on returning to work one year after stroke. Therefore, actively dealing with the insomnia symptoms of stroke patients is conducive to improving the prognosis of stroke patients and improving the quality of life of stroke patients. The current treatment methods are divided into drug therapy and non-drug therapy. Drug therapy mainly includes benzodiazepines and barbiturates, but its clinical application and long-term use are limited due to many adverse reactions, contraindications, and strong dependence. In addition to drug therapy, other treatments for post-stroke depression and insomnia include psychotherapy, strong light therapy, transcranial magnetic stimulation and acupuncture. Some evidence shows that these methods are beneficial to the improvement of insomnia, fatigue, mood and quality of life, but the conclusions are different and the quality of evidence is low.
Remote ischemic condition ( RIC ), also known as intermittent pressure stimulation, is a non-invasive and easy-to-use physical therapy that has been used in clinical trials to protect the brain ( including ischemic and hemorrhagic stroke ), heart and many other organs. Studies have shown that RIC also has the effect of treating depression, insomnia and anxiety, but the research reports on the treatment of insomnia after stroke are still limited. At present, the mechanism of insomnia after stroke is unknown, and there may be many factors involved, such as inflammatory stress, stroke location, environmental factors, etc. The potential mechanisms of RIC include anti-inflammatory, anti-oxidative stress, immune system regulation and other potential pathways. Therefore, RIC can be used as a promising non-invasive physical therapy for post-stroke insomnia.
Therefore, this study takes patients with post-stroke insomnia as the research object, uses RIC technology to treat patients with post-stroke insomnia, and observes its therapeutic effect and adverse reactions.
- Being tested
- Automatic ischemic preconditioning therapeutic apparatus, Sham Ischemic Preconditioning Device
- Keywords
- Remote ischemic adaptation technology, cerebral apoplexy, Depression Anxiety Disorder, Cerebrovascular Disease
- Medical subject headings
- Stroke, Cerebrovascular Disorders
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Automatic ischemic preconditioning therapeutic apparatusDevice
The patient 's upper arms were pressurized for 5 minutes( Test group pressure = 200 mmHg ), and then breathed for 5 minutes. It was an ischemia-reperfusion cycle. Each training was performed for 5 consecutive cycles, 1 in the morning and 1 in the afternoon, 2 times / day, at least 5 days a week, for a total of 4 weeks.
Sham Ischemic Preconditioning DeviceDevice
A sham training device that is identical in appearance, sound, and wear sensation to the experimental device. During the "pressure" phase, the cuff is inflated to a non-ischemic low pressure (60 mmHg) to mimic device operation. The treatment schedule (cycles, frequency, duration) is identical to the experimental arm.
| Study group | Role | What they receive |
|---|---|---|
| treatment group | Experimental | The full-automatic ischemic preconditioning therapeutic instrument was used to pressurize the patients ' upper arms ( experimental group pressure = 200 mmHg ) for 5 minutes, and then breathe out for 5 minutes, which was an ischemia-reperfusion cycle. Each training was performed for 5 consecutive cycles, once in the morning and once in the afternoon, twice a day, at least 5 days a week, for a total of 4 weeks. Receives: Device: Automatic ischemic preconditioning therapeutic apparatus |
| control group | Sham comparator | Participants in this group will use a sham training device that is identical in appearance, sound, and sense of wear to the experimental device. The treatment plan was consistent with the experimental group in time and process : wearing a cuff for 5 minutes, rest for 5 minutes, a total of 5 cycles. The key difference is that during the so-called ' pressure ', the cuff is inflated to a pressure of only 60 mmHg to simulate the sense of operation of the device and a slight sense of skin contact. The treatment frequency, cycle and execution personnel were the same as those of the experimental group. Receives: Device: Sham Ischemic Preconditioning Device |
What is being measured
The primary outcome is the main question the study is designed to answer.
Sleep efficiency as measured by polysomnography
Sleep efficiency is calculated as (total sleep time / total time in bed) × 100%, assessed by overnight polysomnography. Higher percentage indicates better sleep efficiency.
Measured: 4 weeks
Insomnia Severity Index (ISI) total score
The Insomnia Severity Index is a 7-item self-report questionnaire assessing perceived insomnia severity. Each item is rated on a 0-4 scale, yielding a total score ranging from 0 to 28. Higher scores indicate more severe insomnia.
Measured: 4 weeks
Secondary outcomes (12)
Pittsburgh Sleep Quality Index (PSQI) global score
he PSQI is a self-rated questionnaire assessing sleep quality over the past month. It contains 19 items generating 7 component scores, which are summed to yield a global score ranging from 0 to 21. Higher scores indicate worse sleep quality.
Measured: 4 weeks, 3 months, 6 months
Change from baseline in sleep onset latency (SOL) as measured by polysomnography
Sleep onset latency is defined as the time from lights out to the first epoch of any stage of sustained sleep (in minutes), measured by overnight polysomnography. The change from baseline to post-intervention will be calculated. Lower values indicate faster sleep onset.
Measured: 4 weeks
Change from baseline in total sleep time (TST) as measured by polysomnography
Total sleep time is the total duration of all sleep stages (N1, N2, N3, REM) during the recording night (in minutes), measured by overnight polysomnography. The change from baseline to post-intervention will be calculated. Higher values indicate longer sleep duration.
Measured: 4 weeks
Change from baseline in percentage of stage N1 sleep (N1%) as measured by polysomnography
Stage N1 sleep is the transitional, lightest stage of non-rapid eye movement (NREM) sleep. N1% is calculated as (total time in N1 sleep / total sleep time) × 100%, derived from overnight polysomnography. The change from baseline to post-intervention will be calculated.
Measured: 4 weeks
Change from baseline in percentage of stage N2 sleep (N2%) as measured by polysomnography
Stage N2 sleep is a stable stage of NREM sleep characterized by sleep spindles and K-complexes. N2% is calculated as (total time in N2 sleep / total sleep time) × 100%, derived from overnight polysomnography. The change from baseline to post-intervention will be calculated.
Measured: 4 weeks
Change from baseline in percentage of stage N3 sleep (N3%) as measured by polysomnography
Stage N3 sleep is deep sleep or slow-wave sleep. N3% is calculated as (total time in N3 sleep / total sleep time) × 100%, derived from overnight polysomnography. The change from baseline to post-intervention will be calculated. Higher values typically indicate more deep sleep.
Measured: 4 weeks
National Institutes of Health Stroke Scale (NIHSS) total score
The NIHSS is a systematic assessment tool that provides a quantitative measure of stroke-related neurologic deficit. It assesses level of consciousness, gaze, visual fields, facial palsy, motor strength, ataxia, sensation, language, dysarthria, and extinction/inattention. The total score ranges from 0 (no deficit) to 42 (severe deficit). A lower score indicates less severe neurological impairment.
Measured: 4 weeks, 3 months, 6 months
modified Rankin Scale (mRS) score
The mRS is a clinician-reported measure of global disability in patients with stroke. It is a single-item scale ranging from 0 to 6: 0 (No symptoms), 1 (No significant disability), 2 (Slight disability), 3 (Moderate disability), 4 (Moderately severe disability), 5 (Severe disability), 6 (Death). A lower score indicates better functional outcome.
Measured: 4 weeks, 3 months, 6 months
Barthel Index (BI) score
The Barthel Index is an ordinal scale used to measure performance in basic activities of daily living (ADL), including feeding, bathing, grooming, dressing, bowel and bladder control, toileting, chair transfer, ambulation, and stair climbing. The total score ranges from 0 (fully dependent) to 100 (fully independent) . A higher score indicates greater independence in ADL.
Measured: 4 weeks,3 months,6 months
Functional Independence Measure (FIM) total score
The Functional Independence Measure is a standardized assessment of functional independence used in rehabilitation settings. It measures the level of assistance a person requires to perform basic life activities. The scale comprises 18 items covering two domains: Motor (13 items) and Cognitive (5 items). Each item is scored from 1 (total assistance) to 7 (complete independence). The total score ranges from 18 (totally dependent) to 126 (completely independent). A higher score indicates a greater level of functional independence.
Measured: 4 weeks,3months,6months
Mini-Mental State Examination (MMSE) total score
The MMSE is a brief 30-point questionnaire used to screen for cognitive impairment. It assesses orientation, registration, attention and calculation, recall, language, and visual construction. The total score ranges from 0 to 30, with a higher score indicating better cognitive function. A score below 24 is typically indicative of cognitive impairment.
Measured: 4 weeks,3months,6months
Montreal Cognitive Assessment (MoCA) total score
The MoCA is a cognitive screening tool designed to detect mild cognitive impairment. It assesses multiple domains: visuospatial/executive function, naming, memory, attention, language, abstraction, delayed recall, and orientation. The total score ranges from 0 to 30, with a higher score indicating better cognitive function. A score of 26 or above is generally considered normal.
Measured: 4 weeks,3 months,6 months
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted10 Feb 2026
- Study start27 Jan 2026 (estimated)
- Primary completion30 Dec 2027 (estimated)
- Study completion30 Dec 2027 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Cerebral ApoplexyStudies of the same condition, open and under way.
- More trials run by Second Affiliated Hospital of Nanchang 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
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Quadruple blind
- Who is masked
- Participant, Care provider, Investigator, Outcomes assessor
- Enrolment
- 40 participants (estimated)
Sponsor and investigators
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT07401784
- Sponsor's protocol ID
- IIT-I-2025-045
- Status last verified
- Jan 2026
- First submitted
- 25 Jan 2026
- Last updated
- 10 Feb 2026
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- Yes
- Individual data sharing
- No
Study at a glance
From the registry record, last updated by the sponsor on 10 Feb 2026. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Efficacy and Safety Evaluation of Remote Ischemic Adaptation ( Intermittent Pressure Stimulation ) in the Treatment of Insomnia After Stroke
- ClinicalTrials.gov ID
- NCT07401784
- Acronym / sponsor ID
- IIT-I-2025-045
- Keywords
- Remote ischemic adaptation technology, cerebral apoplexy, Depression Anxiety Disorder, Cerebrovascular Disease
- Study type
- Interventional
- Recruitment status
- Not yet recruiting
- Enrolment
- 40 participants (estimated)
- Lead sponsor
- Second Affiliated Hospital of Nanchang UniversityUniversity, hospital or other
- Study start
- 27 Jan 2026 (estimated)
- Primary completion
- 30 Dec 2027 (estimated)
- Study completion
- 30 Dec 2027 (estimated)
- First posted
- 10 Feb 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.
The incidence of post-stroke depression is high, which will affect the rehabilitation of neurological function, damage cognitive function, and increase the risk of subsequent stroke recurrence. The guidelines recommend that in addition to antiplatelet, blood pressure control, lipid-lowering and other treatments, secondary prevention of post-stroke depression should also be strengthened. Moreover, after the occurrence of post-stroke depression, methods such as medication and psychotherapy have their own limitations, such as potential adverse drug reactions and limited psychotherapy. Therefore, it is necessary to pay attention to the prevention of post-stroke depression.
The remote ischemic adaptation therapy applied in our study is a safe, non-invasive and convenient physical therapy. By transiently and repeatedly applying ischemia-reperfusion stimulation to both upper arms, it induces a systemic protective response, improves the brain 's tolerance to ischemia and hypoxia, and exerts a protective effect on multiple organs such as the brain and heart. The RIC therapeutic instrument has been national patented and has been maturely applied to the prevention and treatment of acute cerebral infarction, which can promote the rehabilitation of neurological function. In addition, it also has certain curative effect in the treatment of cerebrovascular stenosis, refractory hypertension, depression, insomnia, anxiety and so on.
Detailed description
Stroke is the second leading cause of death and one of the main causes of disability. The incidence of stroke is increasing worldwide. In 2010, the number of patients with first stroke increased by 68 % compared with 1990. The long-term effects of stroke sequelae include mobility, cognitive ability, language and communication disorders, as well as emotional problems, difficulties in daily life activities and social barriers. Sleep often changes after stroke. Insomnia disorder is a risk factor for stroke and an independent predictor of life satisfaction 6 months after stroke. Insomnia disorder is a sleep disorder characterized by frequent and persistent difficulty in falling asleep and / or difficulty in maintaining sleep and leading to poor sleep quality. Insomnia disorder can exist in isolation or co-exist with mental disorders, physical diseases or substance abuse, which can be accompanied by a variety of functional impairments during awakening. It is reported that in the general population, the prevalence of insomnia is 6 % to 48 % according to different definitions of insomnia. The prevalence of insomnia is higher in stroke patients. Insomnia after stroke has a high correlation with depression, disability and fatigue, and has a greater impact on returning to work one year after stroke. Therefore, actively dealing with the insomnia symptoms of stroke patients is conducive to improving the prognosis of stroke patients and improving the quality of life of stroke patients. The current treatment methods are divided into drug therapy and non-drug therapy. Drug therapy mainly includes benzodiazepines and barbiturates, but its clinical application and long-term use are limited due to many adverse reactions, contraindications, and strong dependence. In addition to drug therapy, other treatments for post-stroke depression and insomnia include psychotherapy, strong light therapy, transcranial magnetic stimulation and acupuncture. Some evidence shows that these methods are beneficial to the improvement of insomnia, fatigue, mood and quality of life, but the conclusions are different and the quality of evidence is low.
Remote ischemic condition ( RIC ), also known as intermittent pressure stimulation, is a non-invasive and easy-to-use physical therapy that has been used in clinical trials to protect the brain ( including ischemic and hemorrhagic stroke ), heart and many other organs. Studies have shown that RIC also has the effect of treating depression, insomnia and anxiety, but the research reports on the treatment of insomnia after stroke are still limited. At present, the mechanism of insomnia after stroke is unknown, and there may be many factors involved, such as inflammatory stress, stroke location, environmental factors, etc. The potential mechanisms of RIC include anti-inflammatory, anti-oxidative stress, immune system regulation and other potential pathways. Therefore, RIC can be used as a promising non-invasive physical therapy for post-stroke insomnia.
Therefore, this study takes patients with post-stroke insomnia as the research object, uses RIC technology to treat patients with post-stroke insomnia, and observes its therapeutic effect and adverse reactions.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Quadruple blind (participant, care provider, investigator, outcomes assessor)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| treatment group | Experimental | Device: Automatic ischemic preconditioning therapeutic apparatusThe full-automatic ischemic preconditioning therapeutic instrument was used to pressurize the patients ' upper arms ( experimental group pressure = 200 mmHg ) for 5 minutes, and then breathe out for 5 minutes, which was an ischemia-reperfusion cycle. Each training was performed for 5 consecutive cycles, once in the morning and once in the afternoon, twice a day, at least 5 days a week, for a total of 4 weeks. |
| control group | Sham comparator | Device: Sham Ischemic Preconditioning DeviceParticipants in this group will use a sham training device that is identical in appearance, sound, and sense of wear to the experimental device. The treatment plan was consistent with the experimental group in time and process : wearing a cuff for 5 minutes, rest for 5 minutes, a total of 5 cycles. The key difference is that during the so-called ' pressure ', the cuff is inflated to a pressure of only 60 mmHg to simulate the sense of operation of the device and a slight sense of skin contact. The treatment frequency, cycle and execution personnel were the same as those of the experimental group. |
Who may qualify
- Ages
- 18 to 80 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (5 listed)
- Age 18-80 years old ;
- In line with the diagnostic criteria of ischemic stroke, with reference to the ' Chinese guidelines for the diagnosis and treatment of acute ischemic stroke ' diagnosed ischemic stroke ;
- Despite adequate sleep opportunities, patients still have difficulty in falling asleep or maintaining sleep, staying asleep at least 3 times a week for at least 3 months, which leads to pain or impaired daytime function.
- PSQI score ≥ 6 and ISI score ≥ 8 ;
- All research contents have been understood and informed consent has been signed.
Key exclusion criteria (4 listed)
- Insomnia before stroke ;
- Patients with mental disorders, bipolar disorder or depression, generalized anxiety disorder and other mental disorders ;
- Patients were pregnant or lactating women ;
- Other reasons identified by the researchers are not suitable for patients ;
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 |
|---|---|---|
| Automatic ischemic preconditioning therapeutic apparatusThe patient 's upper arms were pressurized for 5 minutes( Test group pressure = 200 mmHg ), and then breathed for 5 minutes. It was an ischemia-reperfusion cycle. Each training was performed for 5 consecutive cycles, 1 in the morning and 1 in the afternoon, 2 times / day, at least 5 days a week, for a total of 4 weeks. | Device | treatment group |
| Sham Ischemic Preconditioning DeviceA sham training device that is identical in appearance, sound, and wear sensation to the experimental device. During the "pressure" phase, the cuff is inflated to a non-ischemic low pressure (60 mmHg) to mimic device operation. The treatment schedule (cycles, frequency, duration) is identical to the experimental arm. | Device | control group |
Primary outcome
Sleep efficiency as measured by polysomnography
Time frame: 4 weeks
Sleep efficiency is calculated as (total sleep time / total time in bed) × 100%, assessed by overnight polysomnography. Higher percentage indicates better sleep efficiency.
Insomnia Severity Index (ISI) total score
Time frame: 4 weeks
The Insomnia Severity Index is a 7-item self-report questionnaire assessing perceived insomnia severity. Each item is rated on a 0-4 scale, yielding a total score ranging from 0 to 28. Higher scores indicate more severe insomnia.
12 secondary outcomes
Pittsburgh Sleep Quality Index (PSQI) global score
Time frame: 4 weeks, 3 months, 6 months
Change from baseline in sleep onset latency (SOL) as measured by polysomnography
Time frame: 4 weeks
Change from baseline in total sleep time (TST) as measured by polysomnography
Time frame: 4 weeks
Change from baseline in percentage of stage N1 sleep (N1%) as measured by polysomnography
Time frame: 4 weeks
Change from baseline in percentage of stage N2 sleep (N2%) as measured by polysomnography
Time frame: 4 weeks
Change from baseline in percentage of stage N3 sleep (N3%) as measured by polysomnography
Time frame: 4 weeks
National Institutes of Health Stroke Scale (NIHSS) total score
Time frame: 4 weeks, 3 months, 6 months
modified Rankin Scale (mRS) score
Time frame: 4 weeks, 3 months, 6 months
Barthel Index (BI) score
Time frame: 4 weeks,3 months,6 months
Functional Independence Measure (FIM) total score
Time frame: 4 weeks,3months,6months
Mini-Mental State Examination (MMSE) total score
Time frame: 4 weeks,3months,6months
Montreal Cognitive Assessment (MoCA) total score
Time frame: 4 weeks,3 months,6 months
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 10 Feb 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.
Questions about this trial
What is this clinical trial studying?
A study testing Automatic ischemic preconditioning therapeutic apparatus in people with Cerebral Apoplexy and Depression Anxiety Disorder, run by Second Affiliated Hospital of Nanchang University.
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 5 inclusion and 4 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: opening soon, as of the sponsor's last update on 10 Feb 2026. Status can change between updates, so confirm with the study contact before making plans.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. Some participants in this study may receive a placebo. 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?
Contact Liang Xie (+86 18679162717, Ndefy14067@ncu.edu.cn), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Sleep efficiency as measured by polysomnography (time frame: 4 weeks). The study lists 2 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 10 Feb 2026.