Atrial Fibrillation (AF)US-RESTNCT07595068
Low-Intensity Focused Ultrasound Targeting the Stellate Ganglion for Regulating Autonomic Nerve Function and Sleep Quality in Perioperative Patients With Cardiovascular Diseases
A study testing Low-intensity focused ultrasound (LIFU) targeting the left stellate ganglion in people with Atrial Fibrillation (AF) and Cardiovascular Diseases, run by Renmin Hospital of Wuhan University at 7 sites in China.
Trial summary
The goal of this multicenter, double-blind, randomized controlled trial is to evaluate the efficacy and safety of low-intensity focused ultrasound (LIFU) stellate ganglion modulation for improving autonomic function and sleep quality in perioperative cardiovascular disease patients. Read more about this study
- Who is it for?
- Ages 18 to 79 years
- Conditions the study is for
- Atrial Fibrillation (AF), Cardiovascular Diseases
- What is being tested?
- Low-intensity focused ultrasound (LIFU) targeting the left stellate ganglion
- Type of treatment
- Medical device
- Could I receive a placebo?
- Yes, some participants may receive a placebo
- How many people
- 200 participants
- Where
- 7 sitesChina
- Study dates
- 20 May 2026to 1 Apr 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 79 years
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- Diagnosed with cardiovascular disease (CVD) and scheduled to undergo cardiology-related surgical treatment
- Able to receive and tolerate the aforementioned cardiology-related surgical treatment
- Aged between 18 and 79 years (inclusive), with no restriction on gender
- Agree to accept random allocation of the treatment strategies
- With clear consciousness, no severe mental disorders or cognitive impairment; voluntarily sign the written informed consent form (ICF) and are willing to actively cooperate with the study treatment
Who cannot join
- Have used sedative-hypnotic drugs, antipsychotic drugs, opioid analgesics, antihistamines, non-steroidal anti-inflammatory drugs (NSAIDs), central nervous system (CNS) stimulant drugs, or any other medications that alter sleep architecture within the past 30 days
- Have a history of cervical infection, trauma, severe cervical deformity, or prior cervical surgery
- Unable to complete the daily study intervention as required by the trial protocol
- Are participating in another clinical trial, or have participated in other clinical trials with interventions that may interfere with the results of this study
- Have undergone major surgery or general anesthesia within the past 30 days
- Have a history of alcohol abuse
Show all 12Show fewer
- Are female subjects who are pregnant or lactating, or plan to become pregnant during the study period
- Have severe cognitive impairment, severe psychiatric disorders, epilepsy, or other related neurological disorders
- Have concomitant malignant tumor or severe dysfunction of vital organs
- Have active systemic infection
- Have significant bleeding tendency, or renal failure undergoing regular hemodialysis
- Are deemed unsuitable for the trial by the investigator for any other reason -
Trial locations and contacts
7 sites in 1 country. Contact the study team or a site near you to ask about taking part.
7 sites in 1 country
China7 sites, 7 recruiting
- Not yet recruiting
Huangshi Central Hospital
Huangshi, Hubei, 430060
Kai Zhang, MD, +86 13907230225, zk9620@163.com
- Not yet recruiting
Jingzhou Central Hospital
Jingzhou, Hubei, 430060
Keping Yang, MD, +86 18107168679, 30461400@qq.com
- Recruiting
Renmin Hospital of Wuhan University
Wuhan, Hubei, 430060
Songyun Wang, MD, +86 13871262107, wsy7982@126.com
- Not yet recruiting
Wuhan Central Hospital
Wuhan, Hubei, 430060
Long Wang, MD, +86 15761600527, 319921605@qq.com
- Not yet recruiting
Wuhan Third Hospital
Wuhan, Hubei, 430060
Dongsheng Li, MD, +86 18872288277, lidongsheng693@sina.com
- Not yet recruiting
Xiangyang Central Hospital
Xiangyang, Hubei, 430060
Tongjian Zhu, MD, +86 15971160197, whuzhutongjian@126.com
- Not yet recruiting
Yichang Central People's Hospital
Yichang, Hubei, 430060
Zhuli Guo, MD, +86 15271455251, guozhuli@yczxyy.com
About this study
Official title: Low-Intensity Focused Ultrasound Targeting the Stellate Ganglion for Regulating Autonomic Nerve Function and Sleep Quality in Perioperative Patients With Cardiovascular Diseases: A Multicenter, Double-Blind, Randomized Controlled Trial
The goal of this multicenter, double-blind, randomized controlled trial is to evaluate the efficacy and safety of low-intensity focused ultrasound (LIFU) stellate ganglion modulation for improving autonomic function and sleep quality in perioperative cardiovascular disease patients.
The main questions it aims to answer are:
Read more
- Does LIFU improve heart rate variability and sleep characteristics from baseline at 3-7 days post-surgery compared to sham ultrasound?
- Does LIFU improve serological markers, vital signs, Pittsburgh Sleep Quality Index (PSQI), and reduce >30-second perioperative arrhythmias?
- What is the safety profile of LIFU in this population? 200 eligible patients will be randomized 1:1 to receive either active LIFU (2.0W, 1MHz, 50% duty cycle, 30min daily for 3-7 days) plus standard care, or identical sham ultrasound plus standard care. A four-party double-blind design (subjects, operators, assessors, analysts) will be implemented. The study will run from May 1, 2026 to April 1, 2027 at 6 centers in China.
Participants will:
- Complete pre-surgery screening and baseline assessments (PSQI, 12h ECG/sleep monitoring, residual blood sample collection)
- Receive daily assigned ultrasound intervention for 3-7 consecutive days post-surgery
- Undergo 72h continuous ECG monitoring post-surgery, and repeat assessments at 3-7 days
- Have all adverse events and arrhythmias recorded throughout the study
- May withdraw voluntarily at any time without affecting routine medical care
- Conditions
- Atrial Fibrillation (AF), Cardiovascular Diseases
- Being tested
- Low-intensity focused ultrasound (LIFU) targeting the left stellate ganglion, Sham low-intensity focused ultrasound targeting the left stellate ganglion
- Keywords
- Low-Intensity Focused Ultrasound, Cardiovascular Diseases, Stellate Ganglion, Autonomic Nervous Function, Sleep Quality
- Medical subject headings
- Atrial Fibrillation, Cardiovascular Diseases, Sleep Initiation and Maintenance Disorders
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Low-intensity focused ultrasound (LIFU) targeting the left stellate ganglionDevice
The experimental group receives active low-intensity focused ultrasound (LIFU) treatment: the ultrasound probe is placed on the skin surface corresponding to the left stellate ganglion and fixed with a mechanical arm, with parameters set as power 2.0W, frequency 1MHz, duty cycle 50%, 30 minutes per session, once daily for 3-7 consecutive days. All enrolled subjects receive standard perioperative cardiovascular care simultaneously throughout the study period.
Sham low-intensity focused ultrasound targeting the left stellate ganglionDevice
The control group receives sham low-intensity focused ultrasound intervention: the ultrasound probe is placed on the skin surface corresponding to the left stellate ganglion and fixed with a mechanical arm, with the same instrument appearance, operation process, parameter setting display (power 2.0W, frequency 1MHz, duty cycle 50%), duration (30 minutes per session, once daily for 3-7 consecutive days) and subject experience as the experimental group, but no actual ultrasound energy is output. All enrolled subjects receive standard perioperative cardiovascular care simultaneously throughout the study period.
| Study group | Role | What they receive |
|---|---|---|
| Low-Intensity Focused Ultrasound (LIFU) Intervention Arm | Experimental | Subjects in this arm will receive low-intensity focused ultrasound (LIFU) intervention on the left stellate ganglion. Ultrasound parameters: power 2.0 W, frequency 1 MHz, 50% duty cycle, 30 minutes per session, once daily for 3-7 consecutive days. All subjects will receive guideline-concordant standard perioperative cardiovascular care, including surgery and indicated medications. Receives: Device: Low-intensity focused ultrasound (LIFU) targeting the left stellate ganglion |
| Sham Ultrasound Control Arm (Placebo) | Placebo comparator | Subjects in this arm will receive sham ultrasound intervention with identical operational procedures, device appearance, and parameter settings (no actual energy output) as the intervention arm. Sessions are once daily for 3-7 consecutive days. All subjects will receive the same guideline-concordant standard perioperative cardiovascular care as the intervention arm. Receives: Device: Sham low-intensity focused ultrasound targeting the left stellate ganglion |
What is being measured
The primary outcome is the main question the study is designed to answer.
SDNN
Standard deviation of all normal-to-normal intervals measured by wearable Holter monitor; Unit: ms; Measurement device: wearable Holter monitors.
Measured: Pre-operative 24 hours and Post-operative 72 hours
Total sleep duration
Total sleep time measured by wearable sleep monitor; Unit: hours; Measurement device: Wearable sleep monitor.
Measured: Pre-operative 24 hours and Post-operative 72 hours
SDANN
Standard deviation of the averages of NN intervals in all 5-minute segments; Unit: ms; Measurement device: wearable Holter monitors.
Measured: Pre-operative 24 hours and Post-operative 72 hours
SDNN Index
Mean of the standard deviations of all NN intervals for all 5-minute segments; Unit: ms; Measurement device: wearable Holter monitors.
Measured: Pre-operative 24 hours and Post-operative 72 hours
RMSSD
Root mean square of successive differences between normal heartbeats; Unit: ms; Measurement device: wearable Holter monitors.
Measured: Pre-operative 24 hours and Post-operative 72 hours
pNN50
Percentage of successive NN intervals that differ by more than 50 ms; Unit: %; Measurement device: wearable Holter monitors.
Measured: Pre-operative 24 hours and Post-operative 72 hours
LF power
Low frequency power of heart rate variability; Unit: ms²; Measurement device: wearable Holter monitors.
Measured: Pre-operative 24 hours and Post-operative 72 hours
HF power
High frequency power of heart rate variability; Unit: ms²; Measurement device: wearable Holter monitors.
Measured: Pre-operative 24 hours and Post-operative 72 hours
TP
Total power of heart rate variability; Unit: ms²; Measurement device: wearable Holter monitors.
Measured: Pre-operative 24 hours and Post-operative 72 hours
LF/HF ratio
Ratio of low frequency to high frequency power; Unit: ratio; Measurement device: wearable Holter monitors.
Measured: Pre-operative 24 hours and Post-operative 72 hours
Wakefulness percentage
Percentage of time awake during sleep period; Unit: %; Measurement device: Wearable sleep monitor.
Measured: Pre-operative 24 hours and Post-operative 72 hours
Insomnia percentage
Percentage of time with insomnia symptoms during sleep period; Unit: %; Measurement device: Wearable sleep monitor.
Measured: Pre-operative 24 hours and Post-operative 72 hours
REM sleep percentage
Percentage of rapid eye movement sleep during total sleep time; Unit: %; Measurement device: Wearable sleep monitor.
Measured: Pre-operative 24 hours and Post-operative 72 hours
N1 sleep stage percentage
Percentage of N1 sleep stage during total sleep time; Unit: %; Measurement device: Wearable sleep monitor.
Measured: Pre-operative 24 hours and Post-operative 72 hours
N2 and N3 sleep stages percentage
Combined percentage of N2 and N3 sleep stages during total sleep time; Unit: %; Measurement device: Wearable sleep monitor.
Measured: Pre-operative 24 hours and Post-operative 72 hours
Sleep efficiency
Ratio of total sleep time to time in bed; Unit: %; Measurement device: Wearable sleep monitor.
Measured: Pre-operative 24 hours and Post-operative 72 hours
Secondary outcomes (9)
IL-1β level
Serum IL-1β concentration; Unit: pg/mL.
Measured: Pre-operative 24 hours and Post-operative 72 hours
Norepinephrine (NE) level
Serum norepinephrine concentration; Unit: pg/mL.
Measured: Pre-operative 24 hours and Post-operative 72 hours
Brain-derived neurotrophic factor (BDNF) level
Serum brain-derived neurotrophic factor concentration; Unit: pg/mL.
Measured: Pre-operative 24 hours and Post-operative 72 hours
Pittsburgh Sleep Quality Index (PSQI) score
Subjective sleep quality assessed using the Pittsburgh Sleep Quality Index questionnaire; Unit: Score on a 0-21 scale, where higher scores indicate worse sleep quality; Method of Measurement: Self-administered questionnaire.
Measured: Pre-operative 24 hours and Post-operative 72 hours
Number of atrial arrhythmias
Measurement: count of atrial arrhythmia episodes. Measurement device: wearable Holter monitors.
Measured: Pre-operative 24 hours and Post-operative 72 hours
Duration of atrial arrhythmias
Measurement: Duration of atrial arrhythmia episodes. Measurement device: wearable Holter monitors.
Measured: Pre-operative 24 hours and Post-operative 72 hours
TNF-α level
Serum TNF-α concentration; Unit: pg/mL.
Measured: Pre-operative 24 hours and Post-operative 72 hours
Neuropeptide Y (NPY) level
Serum neuropeptide Y concentration; Unit: pg/mL.
Measured: Pre-operative 24 hours and Post-operative 72 hours
Melatonin level
Serum melatonin concentration; Unit: pg/mL.
Measured: Pre-operative 24 hours and Post-operative 72 hours
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted19 May 2026
- Study start20 May 2026
- Primary completion1 Apr 2027 (estimated)
- Study completion1 Apr 2027 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Atrial Fibrillation (AF)Studies of the same condition, open and under way.
- 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
- 200 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Renmin Hospital of Wuhan University
- Sponsor type
- University, hospital or other
- Collaborators
- Yichang Central People's Hospital, Wuhan Central Hospital, Huangshi Central Hospital, Wuhan Third Hospital, Xiangyang Central Hospital, Jingzhou Central Hospital
- Responsible party
- Principal investigator, Songyun Wang, Renmin Hospital of Wuhan University
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT07595068
- Sponsor's protocol ID
- WDRY2026-K085
- Other IDs
- 82570593
- Acronym
- US-REST
- Status last verified
- Apr 2026
- First submitted
- 28 Apr 2026
- Last updated
- 21 Aug 2026
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- Undecided: Due to considerations for protecting participant privacy, undetermined data ownership, or the absence of a detailed data-sharing policy.
Study at a glance
From the registry record, last updated by the sponsor on 21 Aug 2026. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Low-Intensity Focused Ultrasound Targeting the Stellate Ganglion for Regulating Autonomic Nerve Function and Sleep Quality in Perioperative Patients With Cardiovascular Diseases: A Multicenter, Double-Blind, Randomized Controlled Trial
- ClinicalTrials.gov ID
- NCT07595068
- Acronym / sponsor ID
- US-REST / WDRY2026-K085
- Conditions
- Atrial Fibrillation (AF), Cardiovascular Diseases
- Keywords
- Low-Intensity Focused Ultrasound, Cardiovascular Diseases, Stellate Ganglion, Autonomic Nervous Function, Sleep Quality
- Study type
- Interventional
- Recruitment status
- Recruiting
- Enrolment
- 200 participants (estimated)
- Lead sponsor
- Renmin Hospital of Wuhan UniversityUniversity, hospital or other
- Collaborators
- Yichang Central People's Hospital, Wuhan Central Hospital, Huangshi Central Hospital, Wuhan Third Hospital, Xiangyang Central Hospital, Jingzhou Central Hospital
- Study start
- 20 May 2026 (actual)
- Primary completion
- 1 Apr 2027 (estimated)
- Study completion
- 1 Apr 2027 (estimated)
- First posted
- 19 May 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 goal of this multicenter, double-blind, randomized controlled trial is to evaluate the efficacy and safety of low-intensity focused ultrasound (LIFU) stellate ganglion modulation for improving autonomic function and sleep quality in perioperative cardiovascular disease patients.
The main questions it aims to answer are:
- Does LIFU improve heart rate variability and sleep characteristics from baseline at 3-7 days post-surgery compared to sham ultrasound?
- Does LIFU improve serological markers, vital signs, Pittsburgh Sleep Quality Index (PSQI), and reduce >30-second perioperative arrhythmias?
- What is the safety profile of LIFU in this population? 200 eligible patients will be randomized 1:1 to receive either active LIFU (2.0W, 1MHz, 50% duty cycle, 30min daily for 3-7 days) plus standard care, or identical sham ultrasound plus standard care. A four-party double-blind design (subjects, operators, assessors, analysts) will be implemented. The study will run from May 1, 2026 to April 1, 2027 at 6 centers in China.
Participants will:
- Complete pre-surgery screening and baseline assessments (PSQI, 12h ECG/sleep monitoring, residual blood sample collection)
- Receive daily assigned ultrasound intervention for 3-7 consecutive days post-surgery
- Undergo 72h continuous ECG monitoring post-surgery, and repeat assessments at 3-7 days
- Have all adverse events and arrhythmias recorded throughout the study
- May withdraw voluntarily at any time without affecting routine medical care
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 |
|---|---|---|
| Low-Intensity Focused Ultrasound (LIFU) Intervention Arm | Experimental | Device: Low-intensity focused ultrasound (LIFU) targeting the left stellate ganglionSubjects in this arm will receive low-intensity focused ultrasound (LIFU) intervention on the left stellate ganglion. Ultrasound parameters: power 2.0 W, frequency 1 MHz, 50% duty cycle, 30 minutes per session, once daily for 3-7 consecutive days. All subjects will receive guideline-concordant standard perioperative cardiovascular care, including surgery and indicated medications. |
| Sham Ultrasound Control Arm (Placebo) | Placebo comparator | Device: Sham low-intensity focused ultrasound targeting the left stellate ganglionSubjects in this arm will receive sham ultrasound intervention with identical operational procedures, device appearance, and parameter settings (no actual energy output) as the intervention arm. Sessions are once daily for 3-7 consecutive days. All subjects will receive the same guideline-concordant standard perioperative cardiovascular care as the intervention arm. |
Who may qualify
- Ages
- 18 to 79 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (5 listed)
- Diagnosed with cardiovascular disease (CVD) and scheduled to undergo cardiology-related surgical treatment
- Able to receive and tolerate the aforementioned cardiology-related surgical treatment
- Aged between 18 and 79 years (inclusive), with no restriction on gender
- Agree to accept random allocation of the treatment strategies
- With clear consciousness, no severe mental disorders or cognitive impairment; voluntarily sign the written informed consent form (ICF) and are willing to actively cooperate with the study treatment
Key exclusion criteria (12 listed)
- Have used sedative-hypnotic drugs, antipsychotic drugs, opioid analgesics, antihistamines, non-steroidal anti-inflammatory drugs (NSAIDs), central nervous system (CNS) stimulant drugs, or any other medications that alter sleep architecture within the past 30 days
- Have a history of cervical infection, trauma, severe cervical deformity, or prior cervical surgery
- Unable to complete the daily study intervention as required by the trial protocol
- Are participating in another clinical trial, or have participated in other clinical trials with interventions that may interfere with the results of this study
- Have undergone major surgery or general anesthesia within the past 30 days
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 |
|---|---|---|
| Low-intensity focused ultrasound (LIFU) targeting the left stellate ganglionThe experimental group receives active low-intensity focused ultrasound (LIFU) treatment: the ultrasound probe is placed on the skin surface corresponding to the left stellate ganglion and fixed with a mechanical arm, with parameters set as power 2.0W, frequency 1MHz, duty cycle 50%, 30 minutes per session, once daily for 3-7 consecutive days. All enrolled subjects receive standard perioperative cardiovascular care simultaneously throughout the study period. | Device | Low-Intensity Focused Ultrasound (LIFU) Intervention Arm |
| Sham low-intensity focused ultrasound targeting the left stellate ganglionThe control group receives sham low-intensity focused ultrasound intervention: the ultrasound probe is placed on the skin surface corresponding to the left stellate ganglion and fixed with a mechanical arm, with the same instrument appearance, operation process, parameter setting display (power 2.0W, frequency 1MHz, duty cycle 50%), duration (30 minutes per session, once daily for 3-7 consecutive days) and subject experience as the experimental group, but no actual ultrasound energy is output. All enrolled subjects receive standard perioperative cardiovascular care simultaneously throughout the study period. | Device | Sham Ultrasound Control Arm (Placebo) |
Primary outcome
SDNN
Time frame: Pre-operative 24 hours and Post-operative 72 hours
Standard deviation of all normal-to-normal intervals measured by wearable Holter monitor; Unit: ms; Measurement device: wearable Holter monitors.
Total sleep duration
Time frame: Pre-operative 24 hours and Post-operative 72 hours
Total sleep time measured by wearable sleep monitor; Unit: hours; Measurement device: Wearable sleep monitor.
SDANN
Time frame: Pre-operative 24 hours and Post-operative 72 hours
Standard deviation of the averages of NN intervals in all 5-minute segments; Unit: ms; Measurement device: wearable Holter monitors.
SDNN Index
Time frame: Pre-operative 24 hours and Post-operative 72 hours
Mean of the standard deviations of all NN intervals for all 5-minute segments; Unit: ms; Measurement device: wearable Holter monitors.
RMSSD
Time frame: Pre-operative 24 hours and Post-operative 72 hours
Root mean square of successive differences between normal heartbeats; Unit: ms; Measurement device: wearable Holter monitors.
pNN50
Time frame: Pre-operative 24 hours and Post-operative 72 hours
Percentage of successive NN intervals that differ by more than 50 ms; Unit: %; Measurement device: wearable Holter monitors.
LF power
Time frame: Pre-operative 24 hours and Post-operative 72 hours
Low frequency power of heart rate variability; Unit: ms²; Measurement device: wearable Holter monitors.
HF power
Time frame: Pre-operative 24 hours and Post-operative 72 hours
High frequency power of heart rate variability; Unit: ms²; Measurement device: wearable Holter monitors.
TP
Time frame: Pre-operative 24 hours and Post-operative 72 hours
Total power of heart rate variability; Unit: ms²; Measurement device: wearable Holter monitors.
LF/HF ratio
Time frame: Pre-operative 24 hours and Post-operative 72 hours
Ratio of low frequency to high frequency power; Unit: ratio; Measurement device: wearable Holter monitors.
Wakefulness percentage
Time frame: Pre-operative 24 hours and Post-operative 72 hours
Percentage of time awake during sleep period; Unit: %; Measurement device: Wearable sleep monitor.
Insomnia percentage
Time frame: Pre-operative 24 hours and Post-operative 72 hours
Percentage of time with insomnia symptoms during sleep period; Unit: %; Measurement device: Wearable sleep monitor.
REM sleep percentage
Time frame: Pre-operative 24 hours and Post-operative 72 hours
Percentage of rapid eye movement sleep during total sleep time; Unit: %; Measurement device: Wearable sleep monitor.
N1 sleep stage percentage
Time frame: Pre-operative 24 hours and Post-operative 72 hours
Percentage of N1 sleep stage during total sleep time; Unit: %; Measurement device: Wearable sleep monitor.
N2 and N3 sleep stages percentage
Time frame: Pre-operative 24 hours and Post-operative 72 hours
Combined percentage of N2 and N3 sleep stages during total sleep time; Unit: %; Measurement device: Wearable sleep monitor.
Sleep efficiency
Time frame: Pre-operative 24 hours and Post-operative 72 hours
Ratio of total sleep time to time in bed; Unit: %; Measurement device: Wearable sleep monitor.
9 secondary outcomes
IL-1β level
Time frame: Pre-operative 24 hours and Post-operative 72 hours
Norepinephrine (NE) level
Time frame: Pre-operative 24 hours and Post-operative 72 hours
Brain-derived neurotrophic factor (BDNF) level
Time frame: Pre-operative 24 hours and Post-operative 72 hours
Pittsburgh Sleep Quality Index (PSQI) score
Time frame: Pre-operative 24 hours and Post-operative 72 hours
Number of atrial arrhythmias
Time frame: Pre-operative 24 hours and Post-operative 72 hours
Duration of atrial arrhythmias
Time frame: Pre-operative 24 hours and Post-operative 72 hours
TNF-α level
Time frame: Pre-operative 24 hours and Post-operative 72 hours
Neuropeptide Y (NPY) level
Time frame: Pre-operative 24 hours and Post-operative 72 hours
Melatonin level
Time frame: Pre-operative 24 hours and Post-operative 72 hours
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 21 Aug 2026.
- Individual participant dataSharing planned: Undecided. Due to considerations for protecting participant privacy, undetermined data ownership, or the absence of a detailed data-sharing policy.
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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.
7 sites in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Low-intensity focused ultrasound (LIFU) targeting the left stellate ganglion in people with Atrial Fibrillation (AF) and Cardiovascular Diseases, run by Renmin Hospital of Wuhan University at 7 sites 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 5 inclusion and 12 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: looking for participants now, as of the sponsor's last update on 21 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 7 sites 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. 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 Songyun Wang, MD (+86 13871262107, wsy7982@126.com), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
SDNN (time frame: Pre-operative 24 hours and Post-operative 72 hours). The study lists 16 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 21 Aug 2026.