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TEAS on Sleep Quality and POCD in Elderly Patients

Primary Purpose

Transcutaneous Electrical Acupoint Stimulation, Postoperative Sleep Disturbances, Postoperative Cognitive Dysfunction

Status
Not yet recruiting
Phase
Not Applicable
Locations
Study Type
Interventional
Intervention
TEAS
control group
Sponsored by
Shengjing Hospital
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional treatment trial for Transcutaneous Electrical Acupoint Stimulation

Eligibility Criteria

65 Years - undefined (Older Adult)All SexesDoes not accept healthy volunteers

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.

Sites / Locations

    Arms of the Study

    Arm 1

    Arm 2

    Arm Type

    Experimental

    Sham Comparator

    Arm Label

    TEAS group

    Control group

    Arm Description

    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

    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.

    Outcomes

    Primary Outcome Measures

    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
    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
    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
    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
    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.
    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.
    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.
    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.
    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.
    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.

    Secondary Outcome Measures

    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.
    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.

    Full Information

    First Posted
    March 27, 2021
    Last Updated
    April 27, 2022
    Sponsor
    Shengjing Hospital
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    1. Study Identification

    Unique Protocol Identification Number
    NCT04850196
    Brief Title
    TEAS on Sleep Quality and POCD in Elderly Patients
    Official Title
    Effects of Transcutaneous Electrical Acupoint Stimulation on the Postoperative Sleep Quality and Postoperative Cognition in Elderly Patients Undergoing Laparoscopic Abdominal Surgery
    Study Type
    Interventional

    2. Study Status

    Record Verification Date
    April 2022
    Overall Recruitment Status
    Not yet recruiting
    Study Start Date
    December 1, 2022 (Anticipated)
    Primary Completion Date
    March 30, 2024 (Anticipated)
    Study Completion Date
    April 10, 2024 (Anticipated)

    3. Sponsor/Collaborators

    Responsible Party, by Official Title
    Principal Investigator
    Name of the Sponsor
    Shengjing Hospital

    4. Oversight

    Studies a U.S. FDA-regulated Drug Product
    No
    Studies a U.S. FDA-regulated Device Product
    No
    Data Monitoring Committee
    No

    5. Study Description

    Brief 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, 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.

    6. Conditions and Keywords

    Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
    Transcutaneous Electrical Acupoint Stimulation, Postoperative Sleep Disturbances, Postoperative Cognitive Dysfunction, Elderly Patients

    7. Study Design

    Primary Purpose
    Treatment
    Study Phase
    Not Applicable
    Interventional Study Model
    Parallel Assignment
    Masking
    ParticipantCare ProviderInvestigatorOutcomes Assessor
    Allocation
    Randomized
    Enrollment
    100 (Anticipated)

    8. Arms, Groups, and Interventions

    Arm Title
    TEAS group
    Arm Type
    Experimental
    Arm Description
    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
    Arm Title
    Control group
    Arm Type
    Sham Comparator
    Arm Description
    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.
    Intervention Type
    Device
    Intervention Name(s)
    TEAS
    Intervention Description
    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
    Intervention Type
    Other
    Intervention Name(s)
    control group
    Intervention Description
    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
    Primary Outcome Measure Information:
    Title
    Sleep Quality Assessment
    Description
    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
    Time Frame
    on the first night before surgery (Preop 1)
    Title
    Sleep Quality Assessment
    Description
    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
    Time Frame
    the third night after surgery (POD 3).
    Title
    Sleep Quality Assessment
    Description
    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
    Time Frame
    the first week after surgery (POD 1W).
    Title
    Sleep Quality Assessment
    Description
    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
    Time Frame
    the sixth months after surgery (POD 6M).
    Title
    Cognitive Assessment
    Description
    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.
    Time Frame
    on the first night before surgery (Preop 1)
    Title
    Cognitive Assessment
    Description
    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.
    Time Frame
    the third night after surgery (POD 3).
    Title
    Cognitive Assessment
    Description
    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.
    Time Frame
    the first week after surgery ( POD 1W)
    Title
    Cognitive Assessment
    Description
    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.
    Time Frame
    the sixth month after surgery (POD 6M).
    Title
    Aβburden PET imaging
    Description
    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.
    Time Frame
    Aβ PET imaging was performed on the first week after surgery ( POD 1W)
    Title
    Aβburden PET imaging
    Description
    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.
    Time Frame
    Aβ PET imaging was performed on the sixth month after surgery (POD 6M).
    Secondary Outcome Measure Information:
    Title
    Postoperative pain assessment
    Description
    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.
    Time Frame
    24 hours after surgery
    Title
    Postoperative adverse effects assessment
    Description
    adverse effects during 24 hours after surgery such as respiratory depression, bradycardia, nausea and vomiting, and dizzy were recorded and treated accordingly.
    Time Frame
    24 hours after surgery

    10. Eligibility

    Sex
    All
    Minimum Age & Unit of Time
    65 Years
    Accepts Healthy Volunteers
    No
    Eligibility Criteria
    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.
    Central Contact Person:
    First Name & Middle Initial & Last Name or Official Title & Degree
    Junchao Zhu
    Phone
    +8618940257257
    Email
    zhujunchao1@hotmail.com

    12. IPD Sharing Statement

    Plan to Share IPD
    No

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    TEAS on Sleep Quality and POCD in Elderly Patients

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