Transcutaneous Electrical Acupoint StimulationNCT04850196
TEAS on Sleep Quality and POCD in Elderly Patients
A study testing TEAS in people with Transcutaneous Electrical Acupoint Stimulation and Postoperative Sleep Disturbances, run by Shengjing Hospital.
Trial summary
Elderly patients are often considered as a high-risk population for major abdominal surgery due to reduced functional reserve and increased comorbidities. Previous study reported that about 40 and 10% of elderly (60 yr and older) patients suffered from postoperative cognitive dysfunction (POCD) 7 days and 3 months… Read more about this study
- Who is it for?
- Ages 65 years and older
- Conditions the study is for
- Transcutaneous Electrical Acupoint Stimulation, Postoperative Sleep Disturbances, Postoperative Cognitive Dysfunction
- What is being tested?
- TEAS
- Type of treatment
- Medical device
- Could I receive a placebo?
- Yes, some participants may receive a placebo
- How many people
- 100 participants
- Where
- No sites listed yet
- Study dates
- 1 Dec 2022to 10 Apr 2024
- Phase
- Interventional
- Are there results?
- None posted in the registry
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 65 years and older
- All sexes
- No healthy volunteers
- Older adult
Who may be able to join
- patient's age was 65 yr or older
- patient was scheduled to undergo elective major laparoscopic abdominal surgery (e.g., gastrointestinal and gynecologic surgery).
- the surgery was expected to last 2h or longer.
Who cannot join
- severe diseases in cardiovascular, respiratory, liver, kidney, or central nervous systems and having a life span of less than 3 months;
- a mini-mental status examination score (MMSE) of less than 23;
- a history of dementia or psychiatric illness;
- current use of sedatives, antidepressants or corticosteroids;
- alcoholism and drug dependence;
- difficulty with follow-up or poor compliance;
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- patients with preoperative sleep disturbances;
- patients with sleep apnea or moderate and severe obstructive sleep apnea-hypopnea syndrome (OSAHS);
- patients with severe visual or hearing impairment or who were unable to communicate.
Trial locations and contacts
No sites are listed yet.
About this study
Official title: Effects of Transcutaneous Electrical Acupoint Stimulation on the Postoperative Sleep Quality and Postoperative Cognition in Elderly Patients Undergoing Laparoscopic Abdominal Surgery
Elderly patients are often considered as a high-risk population for major abdominal surgery due to reduced functional reserve and increased comorbidities. Previous study reported that about 40 and 10% of elderly (60 yr and older) patients suffered from postoperative cognitive dysfunction (POCD) 7 days and 3 months, respectively, after noncardiac surgery. POCD is a central nervous system complication after anesthesia and an operation, whose risk factors include age, education level, the operation (time, type, and mode), anesthesia (methods, drugs, and time) and postoperative analgesia. In the study of Su X et al, elderly patients are also more prone to develop postoperative sleep disturbances after surgery with prolonged sleep latencies, fragmented sleep, decreased sleep efficiency and abnormally sleep stages. Increasing evidence showed that sleep and circadian rhythm disturbances after surgery could promote β-amyloid peptide (Aβ) accumulation by simultaneously upregulating Aβ synthesis and interfering with Aβ clearance. This insoluble Aβ aggregates to form brain extracellular senile plaques, which are one of the neuropathological hallmarks of numerous postoperative cognitive disorders such as Alzheimer's disease(AD), and can be measured by amyloid positron emission tomography (PET) imaging through injecting 18F-florbetapir, a novel imaging agent that binds with high affinity (Kd 3.1 nM+0.7) to β-amyloid peptide fibrils in brain amyloid plaques, to the patients.Transcutaneous electrical acupoint stimulation (TEAS) is a new acupuncture therapy developed by combining transcutaneous electrical nerve stimulation (TENS) in European and American countries and traditional Chinese acupuncture. TEAS treat disease through inputting a pulse current of different frequencies, intensities, and waveforms via electrode paste adhering to the skin. Previous studies proved that TEAS has been successfully applied in many different procedures through stimulating different acupoints such as reducing postoperative pain, postoperative nausea and vomiting (PONV), and improving postoperative sleep quality. However, whether TEAS could affect Aβ deposition by improving postoperative sleep quality and thus affect the development of long-term cognitive impairment is still unclear. The aim of our study is to conduct the TEAS intervention to elderly patients who received laparoscopic abdominal surgery, and then to examine its effect on postoperative sleep quality, postoperative cognition and complications. In this study, we utilized 18F-florbetapir imaging to assess the relationships between postoperative sleep disturbances and POCD and brain Aβ burden through measuring by PET imaging.
- Conditions
- Transcutaneous Electrical Acupoint Stimulation, Postoperative Sleep Disturbances, Postoperative Cognitive Dysfunction, Elderly Patients
- Being tested
- TEAS, control group
- Medical subject headings
- Postoperative Cognitive Complications
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
TEASDevice
TEAS treatment was performed for 30 mins before anesthesia on bilateral side by an experienced acupuncturist at the Neiguan (PC6), HT7 (Shenmen), ST36 (Zusanli) and LI4 (Hegu) acupoints . And TEAS treatment for 30 mins was also performed on bilateral side by an experienced acupuncturist at the Neiguan (PC6), HT7 (Shenmen), ST36 (Zusanli) and LI4 (Hegu) acupoints at the end of surgery as well as on the each night before sleeping after surgery until discharged from the hospital
control groupOther
Patients in the Control group received electrical stimulation at a non-acupoint which was located 2 cm interior to the bilateral Neiguan (PC6), HT7 (Shenmen), ST36 (Zusanli) and LI4 (Hegu) acupoints similar to patients in group TEAS
| Study group | Role | What they receive |
|---|---|---|
| TEAS group | Experimental | TEAS treatment was performed for 30 mins before anesthesia on bilateral side by an experienced acupuncturist at the Neiguan (PC6), HT7 (Shenmen), ST36 (Zusanli) and LI4 (Hegu) acupoints And TEAS treatment for 30 mins was also performed on bilateral side by an experienced acupuncturist at the Neiguan (PC6), HT7 (Shenmen), ST36 (Zusanli) and LI4 (Hegu) acupoints at the end of surgery as well as on the each night before sleeping after surgery until discharged from the hospital Receives: Device: TEAS |
| Control group | Sham comparator | Patients in the Control group received electrical stimulation at a non-acupoint which was located 2 cm interior to the bilateral Neiguan (PC6), HT7 (Shenmen), ST36 (Zusanli) and LI4 (Hegu) acupoints similar to patients in group TEAS. Receives: Other: control group |
What is being measured
The primary outcome is the main question the study is designed to answer.
Sleep Quality Assessment
use the Athens Insomnia Scale (AIS): the total AIS scores range from 0 to 24 points with ≤ 4 indicating no combined with insomnia at night; 4-6 indicating suspicious insomnia at night; ≥ 6 points indicating a diagnosis of insomnia at night
Measured: on the first night before surgery (Preop 1)
Sleep Quality Assessment
use the Athens Insomnia Scale (AIS): the total AIS scores range from 0 to 24 points with ≤ 4 indicating no combined with insomnia at night; 4-6 indicating suspicious insomnia at night; ≥ 6 points indicating a diagnosis of insomnia at night
Measured: the third night after surgery (POD 3).
Sleep Quality Assessment
use the Athens Insomnia Scale (AIS): the total AIS scores range from 0 to 24 points with ≤ 4 indicating no combined with insomnia at night; 4-6 indicating suspicious insomnia at night; ≥ 6 points indicating a diagnosis of insomnia at night
Measured: the first week after surgery (POD 1W).
Sleep Quality Assessment
use the Athens Insomnia Scale (AIS): the total AIS scores range from 0 to 24 points with ≤ 4 indicating no combined with insomnia at night; 4-6 indicating suspicious insomnia at night; ≥ 6 points indicating a diagnosis of insomnia at night
Measured: the sixth months after surgery (POD 6M).
Cognitive Assessment
MMSE is a 30-point questionnaire that is widely used to evaluate the severity of cognitive impairment in individuals with cognitive disorders. Score cutoffs for the MMSE are as follows: greater than or equal to 24 for normal cognition, between 19 and 23 for MCI, between 10 and 18 for moderate cognitive impairment, and less than or equal to 9 for severe cognitive impairment.
Measured: on the first night before surgery (Preop 1)
Cognitive Assessment
MMSE is a 30-point questionnaire that is widely used to evaluate the severity of cognitive impairment in individuals with cognitive disorders. Score cutoffs for the MMSE are as follows: greater than or equal to 24 for normal cognition, between 19 and 23 for MCI, between 10 and 18 for moderate cognitive impairment, and less than or equal to 9 for severe cognitive impairment.
Measured: the third night after surgery (POD 3).
Cognitive Assessment
MMSE is a 30-point questionnaire that is widely used to evaluate the severity of cognitive impairment in individuals with cognitive disorders. Score cutoffs for the MMSE are as follows: greater than or equal to 24 for normal cognition, between 19 and 23 for MCI, between 10 and 18 for moderate cognitive impairment, and less than or equal to 9 for severe cognitive impairment.
Measured: the first week after surgery ( POD 1W)
Cognitive Assessment
MMSE is a 30-point questionnaire that is widely used to evaluate the severity of cognitive impairment in individuals with cognitive disorders. Score cutoffs for the MMSE are as follows: greater than or equal to 24 for normal cognition, between 19 and 23 for MCI, between 10 and 18 for moderate cognitive impairment, and less than or equal to 9 for severe cognitive impairment.
Measured: the sixth month after surgery (POD 6M).
Aβburden PET imaging
participants were injected intravenously with fluorine 18-labeled florbetaben tracer (Neuraceq; Piramel Imaging), and imaging was performed approximately 60 minutes later as per a standard protocol using PET-computed tomography.
Measured: Aβ PET imaging was performed on the first week after surgery ( POD 1W)
Aβburden PET imaging
participants were injected intravenously with fluorine 18-labeled florbetaben tracer (Neuraceq; Piramel Imaging), and imaging was performed approximately 60 minutes later as per a standard protocol using PET-computed tomography.
Measured: Aβ PET imaging was performed on the sixth month after surgery (POD 6M).
Secondary outcomes (2)
Postoperative pain assessment
pain scores were assessed on the visual analogue scale (VAS), where 0 indicates painlessness, and 10 indicates severe pain. The VAS score was measured at 2, 4, 6, and 24 hours postoperatively.
Measured: 24 hours after surgery
Postoperative adverse effects assessment
adverse effects during 24 hours after surgery such as respiratory depression, bradycardia, nausea and vomiting, and dizzy were recorded and treated accordingly.
Measured: 24 hours after surgery
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted20 Apr 2021
- Study start1 Dec 2022 (estimated)
- Primary completion30 Mar 2024 (estimated)
- Study completion10 Apr 2024 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Transcutaneous Electrical Acupoint StimulationStudies of the same condition, open and under way.
- More trials run by Shengjing HospitalThe 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
- 100 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Shengjing Hospital
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Yanchao Yang, Shengjing Hospital
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT04850196
- Sponsor's protocol ID
- TEAS and POCD
- Status last verified
- Apr 2022
- First submitted
- 27 Mar 2021
- Last updated
- 28 Apr 2022
- Results posted
- No
- Data monitoring committee
- No
- 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 28 Apr 2022. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Effects of Transcutaneous Electrical Acupoint Stimulation on the Postoperative Sleep Quality and Postoperative Cognition in Elderly Patients Undergoing Laparoscopic Abdominal Surgery
- ClinicalTrials.gov ID
- NCT04850196
- Acronym / sponsor ID
- TEAS and POCD
- Conditions
- Transcutaneous Electrical Acupoint Stimulation, Postoperative Sleep Disturbances, Postoperative Cognitive Dysfunction, Elderly Patients
- Study type
- Interventional
- Recruitment status
- Unknown status
- Enrolment
- 100 participants (estimated)
- Lead sponsor
- Shengjing HospitalUniversity, hospital or other
- Study start
- 1 Dec 2022 (estimated)
- Primary completion
- 30 Mar 2024 (estimated)
- Study completion
- 10 Apr 2024 (estimated)
- First posted
- 20 Apr 2021 (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.
Elderly patients are often considered as a high-risk population for major abdominal surgery due to reduced functional reserve and increased comorbidities. Previous study reported that about 40 and 10% of elderly (60 yr and older) patients suffered from postoperative cognitive dysfunction (POCD) 7 days and 3 months, respectively, after noncardiac surgery. POCD is a central nervous system complication after anesthesia and an operation, whose risk factors include age, education level, the operation (time, type, and mode), anesthesia (methods, drugs, and time) and postoperative analgesia. In the study of Su X et al, elderly patients are also more prone to develop postoperative sleep disturbances after surgery with prolonged sleep latencies, fragmented sleep, decreased sleep efficiency and abnormally sleep stages. Increasing evidence showed that sleep and circadian rhythm disturbances after surgery could promote β-amyloid peptide (Aβ) accumulation by simultaneously upregulating Aβ synthesis and interfering with Aβ clearance. This insoluble Aβ aggregates to form brain extracellular senile plaques, which are one of the neuropathological hallmarks of numerous postoperative cognitive disorders such as Alzheimer's disease(AD), and can be measured by amyloid positron emission tomography (PET) imaging through injecting 18F-florbetapir, a novel imaging agent that binds with high affinity (Kd 3.1 nM+0.7) to β-amyloid peptide fibrils in brain amyloid plaques, to the patients.Transcutaneous electrical acupoint stimulation (TEAS) is a new acupuncture therapy developed by combining transcutaneous electrical nerve stimulation (TENS) in European and American countries and traditional Chinese acupuncture. TEAS treat disease through inputting a pulse current of different frequencies, intensities, and waveforms via electrode paste adhering to the skin. Previous studies proved that TEAS has been successfully applied in many different procedures through stimulating different acupoints such as reducing postoperative pain, postoperative nausea and vomiting (PONV), and improving postoperative sleep quality. However, whether TEAS could affect Aβ deposition by improving postoperative sleep quality and thus affect the development of long-term cognitive impairment is still unclear. The aim of our study is to conduct the TEAS intervention to elderly patients who received laparoscopic abdominal surgery, and then to examine its effect on postoperative sleep quality, postoperative cognition and complications. In this study, we utilized 18F-florbetapir imaging to assess the relationships between postoperative sleep disturbances and POCD and brain Aβ burden through measuring by PET imaging.
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 |
|---|---|---|
| TEAS group | Experimental | Device: TEASTEAS treatment was performed for 30 mins before anesthesia on bilateral side by an experienced acupuncturist at the Neiguan (PC6), HT7 (Shenmen), ST36 (Zusanli) and LI4 (Hegu) acupoints And TEAS treatment for 30 mins was also performed on bilateral side by an experienced acupuncturist at the Neiguan (PC6), HT7 (Shenmen), ST36 (Zusanli) and LI4 (Hegu) acupoints at the end of surgery as well as on the each night before sleeping after surgery until discharged from the hospital |
| Control group | Sham comparator | Other: control groupPatients in the Control group received electrical stimulation at a non-acupoint which was located 2 cm interior to the bilateral Neiguan (PC6), HT7 (Shenmen), ST36 (Zusanli) and LI4 (Hegu) acupoints similar to patients in group TEAS. |
Who may qualify
- Ages
- 65 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Older adult
Key inclusion criteria (3 listed)
- patient's age was 65 yr or older
- patient was scheduled to undergo elective major laparoscopic abdominal surgery (e.g., gastrointestinal and gynecologic surgery).
- the surgery was expected to last 2h or longer.
Key exclusion criteria (9 listed)
- severe diseases in cardiovascular, respiratory, liver, kidney, or central nervous systems and having a life span of less than 3 months;
- a mini-mental status examination score (MMSE) of less than 23;
- a history of dementia or psychiatric illness;
- current use of sedatives, antidepressants or corticosteroids;
- alcoholism and drug dependence;
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 |
|---|---|---|
| TEASTEAS treatment was performed for 30 mins before anesthesia on bilateral side by an experienced acupuncturist at the Neiguan (PC6), HT7 (Shenmen), ST36 (Zusanli) and LI4 (Hegu) acupoints . And TEAS treatment for 30 mins was also performed on bilateral side by an experienced acupuncturist at the Neiguan (PC6), HT7 (Shenmen), ST36 (Zusanli) and LI4 (Hegu) acupoints at the end of surgery as well as on the each night before sleeping after surgery until discharged from the hospital | Device | TEAS group |
| control groupPatients in the Control group received electrical stimulation at a non-acupoint which was located 2 cm interior to the bilateral Neiguan (PC6), HT7 (Shenmen), ST36 (Zusanli) and LI4 (Hegu) acupoints similar to patients in group TEAS | Other | Control group |
Primary outcome
Sleep Quality Assessment
Time frame: on the first night before surgery (Preop 1)
use the Athens Insomnia Scale (AIS): the total AIS scores range from 0 to 24 points with ≤ 4 indicating no combined with insomnia at night; 4-6 indicating suspicious insomnia at night; ≥ 6 points indicating a diagnosis of insomnia at night
Sleep Quality Assessment
Time frame: the third night after surgery (POD 3).
use the Athens Insomnia Scale (AIS): the total AIS scores range from 0 to 24 points with ≤ 4 indicating no combined with insomnia at night; 4-6 indicating suspicious insomnia at night; ≥ 6 points indicating a diagnosis of insomnia at night
Sleep Quality Assessment
Time frame: the first week after surgery (POD 1W).
use the Athens Insomnia Scale (AIS): the total AIS scores range from 0 to 24 points with ≤ 4 indicating no combined with insomnia at night; 4-6 indicating suspicious insomnia at night; ≥ 6 points indicating a diagnosis of insomnia at night
Sleep Quality Assessment
Time frame: the sixth months after surgery (POD 6M).
use the Athens Insomnia Scale (AIS): the total AIS scores range from 0 to 24 points with ≤ 4 indicating no combined with insomnia at night; 4-6 indicating suspicious insomnia at night; ≥ 6 points indicating a diagnosis of insomnia at night
Cognitive Assessment
Time frame: on the first night before surgery (Preop 1)
MMSE is a 30-point questionnaire that is widely used to evaluate the severity of cognitive impairment in individuals with cognitive disorders. Score cutoffs for the MMSE are as follows: greater than or equal to 24 for normal cognition, between 19 and 23 for MCI, between 10 and 18 for moderate cognitive impairment, and less than or equal to 9 for severe cognitive impairment.
Cognitive Assessment
Time frame: the third night after surgery (POD 3).
MMSE is a 30-point questionnaire that is widely used to evaluate the severity of cognitive impairment in individuals with cognitive disorders. Score cutoffs for the MMSE are as follows: greater than or equal to 24 for normal cognition, between 19 and 23 for MCI, between 10 and 18 for moderate cognitive impairment, and less than or equal to 9 for severe cognitive impairment.
Cognitive Assessment
Time frame: the first week after surgery ( POD 1W)
MMSE is a 30-point questionnaire that is widely used to evaluate the severity of cognitive impairment in individuals with cognitive disorders. Score cutoffs for the MMSE are as follows: greater than or equal to 24 for normal cognition, between 19 and 23 for MCI, between 10 and 18 for moderate cognitive impairment, and less than or equal to 9 for severe cognitive impairment.
Cognitive Assessment
Time frame: the sixth month after surgery (POD 6M).
MMSE is a 30-point questionnaire that is widely used to evaluate the severity of cognitive impairment in individuals with cognitive disorders. Score cutoffs for the MMSE are as follows: greater than or equal to 24 for normal cognition, between 19 and 23 for MCI, between 10 and 18 for moderate cognitive impairment, and less than or equal to 9 for severe cognitive impairment.
Aβburden PET imaging
Time frame: Aβ PET imaging was performed on the first week after surgery ( POD 1W)
participants were injected intravenously with fluorine 18-labeled florbetaben tracer (Neuraceq; Piramel Imaging), and imaging was performed approximately 60 minutes later as per a standard protocol using PET-computed tomography.
Aβburden PET imaging
Time frame: Aβ PET imaging was performed on the sixth month after surgery (POD 6M).
participants were injected intravenously with fluorine 18-labeled florbetaben tracer (Neuraceq; Piramel Imaging), and imaging was performed approximately 60 minutes later as per a standard protocol using PET-computed tomography.
2 secondary outcomes
Postoperative pain assessment
Time frame: 24 hours after surgery
Postoperative adverse effects assessment
Time frame: 24 hours after surgery
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 28 Apr 2022.
- 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. This study is not recruiting at the moment.
Questions about this trial
What is this clinical trial studying?
A study testing TEAS in people with Transcutaneous Electrical Acupoint Stimulation and Postoperative Sleep Disturbances, run by Shengjing Hospital.
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 9 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: status not confirmed, as of the sponsor's last update on 28 Apr 2022. 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?
Results are not available in the source record.
How can a doctor refer a patient or contact the research team?
Contact Junchao Zhu (+8618940257257, zhujunchao1@hotmail.com), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Sleep Quality Assessment (time frame: on the first night before surgery (Preop 1)). The study lists 10 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 28 Apr 2022.