- ICH GCP
- US Clinical Trials Registry
- Clinical Trial NCT04850196
TEAS on Sleep Quality and POCD in Elderly Patients
April 27, 2022 updated by: Yanchao Yang, Shengjing Hospital
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.
Study Overview
Status
Not yet recruiting
Conditions
Intervention / Treatment
Study Type
Interventional
Enrollment (Anticipated)
100
Phase
- Not Applicable
Participation Criteria
Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.
Eligibility Criteria
Ages Eligible for Study
65 years and older (Older Adult)
Accepts Healthy Volunteers
No
Genders Eligible for Study
All
Description
Inclusion Criteria:
- 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.
Exclusion Criteria:
- 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;
- 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.
Study Plan
This section provides details of the study plan, including how the study is designed and what the study is measuring.
How is the study designed?
Design Details
- Primary Purpose: Treatment
- Allocation: Randomized
- Interventional Model: Parallel Assignment
- Masking: Quadruple
Arms and Interventions
Participant Group / Arm |
Intervention / Treatment |
---|---|
Experimental: TEAS group
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
|
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
|
Sham Comparator: Control group
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.
|
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
|
What is the study measuring?
Primary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
---|---|---|
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
|
on the first night before surgery (Preop 1)
|
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
|
the third night after surgery (POD 3).
|
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
|
the first week after surgery (POD 1W).
|
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
|
the sixth months after surgery (POD 6M).
|
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.
|
on the first night before surgery (Preop 1)
|
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.
|
the third night after surgery (POD 3).
|
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.
|
the first week after surgery ( POD 1W)
|
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.
|
the sixth month after surgery (POD 6M).
|
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.
|
Aβ PET imaging was performed on the first week after surgery ( POD 1W)
|
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.
|
Aβ PET imaging was performed on the sixth month after surgery (POD 6M).
|
Secondary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
---|---|---|
Postoperative pain assessment
Time Frame: 24 hours after surgery
|
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.
|
24 hours after surgery
|
Postoperative adverse effects assessment
Time Frame: 24 hours after surgery
|
adverse effects during 24 hours after surgery such as respiratory depression, bradycardia, nausea and vomiting, and dizzy were recorded and treated accordingly.
|
24 hours after surgery
|
Collaborators and Investigators
This is where you will find people and organizations involved with this study.
Sponsor
Study record dates
These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.
Study Major Dates
Study Start (Anticipated)
December 1, 2022
Primary Completion (Anticipated)
March 30, 2024
Study Completion (Anticipated)
April 10, 2024
Study Registration Dates
First Submitted
March 27, 2021
First Submitted That Met QC Criteria
April 18, 2021
First Posted (Actual)
April 20, 2021
Study Record Updates
Last Update Posted (Actual)
April 28, 2022
Last Update Submitted That Met QC Criteria
April 27, 2022
Last Verified
April 1, 2022
More Information
Terms related to this study
Additional Relevant MeSH Terms
Other Study ID Numbers
- TEAS and POCD
Plan for Individual participant data (IPD)
Plan to Share Individual Participant Data (IPD)?
NO
Drug and device information, study documents
Studies a U.S. FDA-regulated drug product
No
Studies a U.S. FDA-regulated device product
No
This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.
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