Postoperative SleepASIS-ONCT06684236
Acupoint Stimulation and Postoperative Sleep in Elderly Patients
A study testing transcutaneous electrical stimulation and electrodes attachment in people with Postoperative Sleep, run by Air Force Military Medical University, China at 1 site in China.
Trial summary
Sleeping model can be affected after surgery. Anesthetics may be involved in the change. The changing of sleeping mode may exert adverse effect on postoperative recovery. Acupuncture and related techniques has been used for treating sleeping disorder. Read more about this study
- Who is it for?
- Ages 65 years and older
- Conditions the study is for
- Postoperative Sleep
- What is being tested?
- transcutaneous electrical stimulation and electrodes attachment
- Could I receive a placebo?
- Yes, some participants may receive a placebo
- How many people
- 104 participants
- Where
- 1 siteChina
- Study dates
- 23 Oct 2024to 10 Mar 2025
- 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
- Age≥65 years old
- scheduled for abdominal surgery under general anesthesia
Who cannot join
- anticipated duration of surgery longer than 5 hours or shorter than 1 hour
- American society of anesthesiologists status over stage 3
- Participants with sleep apnea or moderate and severe obstructive sleep apnea syndrome (defined by Apnea Hypopnea Index (AHI))
- Participants with preoperative sleep disturbances (diagnostic criteria of sleep disturbances according to the International Classification of Sleep Disorders, Third Edition (ICSD-3))
- Participants with a history of alcohol or drug abuse
- Participants with severe hepatic or renal insufficiency kidney disease
- Participants with contraindications to the use of acupoint stimulation (including those with infection or injury of the skin to attach electrodes, and those with implanted electronic devices)
Trial locations and contacts
1 site in 1 country.
China1 site
Xijing Hospital, Air Force Medical University
Xi'an, Shaanxi, 710032
About this study
Official title: Effect of Transcutaneous Electrical Acupoint Stimulation on Sleeping After General Anesthesia in Elderly Patients Undergoing Abdominal Surgery
Sleeping model can be affected after surgery. Anesthetics may be involved in the change. The changing of sleeping mode may exert adverse effect on postoperative recovery. Acupuncture and related techniques has been used for treating sleeping disorder. In this study, the effect of transcutaneous electrical acupoint stimulation on sleeping model after general anesthesia will be observed.
- Conditions
- Postoperative Sleep
- Being tested
- transcutaneous electrical stimulation, electrodes attachment
- Keywords
- acupoint stimulation, general anesthesia, sleep, elderly patients
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
transcutaneous electrical stimulationOther
electrical stimulation is given through electrodes attached to the skin
electrodes attachmentOther
electrodes are attached to the skin area of Neiguan acupoint, which is located on 3cm above the transverse crease of the wrist
| Study group | Role | What they receive |
|---|---|---|
| Acupoint stimulation | Experimental | transcutaneous electrical acupoint stimulation is one of the many forms of acupuncture, and is a distinctive part of Chinese medicine that has been practiced in China for thousands of years. It is employed by placing electrodes on acupoint and electrical stimulation is given after anesthetic induction to the end of the surgery Receives: Other: transcutaneous electrical stimulation; Other: electrodes attachment |
| Control | Sham comparator | Electrodes are placed on same acupoints as the experimental group, and will receive the "optimal intensity test" before the anesthesia induction, but no electrical stimulation is given during the operation Receives: Other: electrodes attachment |
What is being measured
The primary outcome is the main question the study is designed to answer.
total sleeping time during the first postoperative night
Measured: the first postoperative night, on an average of 12 hours
Secondary outcomes (15)
Total sleep time during the first 24 hours after surgery
Measured: from discharge from post-anesthesia care unit to 24 hours later, totally 24 hours
The Epworth Sleepiness Scale (ESS) score at 24 hours after surgery
Measured: 24 hours after surgery
The Athens Insomnia Scale (AIS) score at 24 hours after surgery
Measured: 24 hours after surgery
The Athens Insomnia Scale (AIS) score at 48 hours after surgery
Measured: 48 hours after surgery
The Epworth Sleepiness Scale (ESS) score at 48 hours after surgery
Measured: 48 hours after surgery
The Athens Insomnia Scale (AIS) score at discharge from hospital
Measured: the last day before discharge from hospital, at an average of 12 hours
The Epworth Sleepiness Scale (ESS) score at discharge from hospital
Measured: the last day before discharge from hospital, at an average of 12 hours
sleep efficiency(%) during the first postoperative night
sleep efficiency is defined as the ratio of total sleep time to time in bed
Measured: the first postoperative night, at an average of 12 hours
duration of rapid eye movement sleep during the first postoperative night
The unit of duration of rapid eye movement sleep is by minutes
Measured: the first postoperative night, at an average of 12 hours
number of wake during the first postoperative night
Measured: the first postoperative night, at an average of 12 hours
incidence of delirium during hospitalization
Measured: From end of surgery to discharge from hospital, assessed up to 7 days
length of postoperative hospital stay
Measured: From end of surgery to discharge from hospital, at an average of 5 days
number of needs for rescue analgesia by 24 hours after surgery
Measured: from discharge from operation room to 24 hours later, totally 24 hours
Number of participants with major complications during hospitalization, including cardiac failure, cardiac infarction, respiratory failure
Measured: From end of surgery to discharge from hospital, assessed up to 7 days
Scale of quality of recovery at discharge from hospital
Scale of quality of recovery is measured by the Quality-of-recovery 15 item scale (QoR-15)
Measured: the last day before discharge from hospital, at an average of 12 hours
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted12 Nov 2024
- Study start23 Oct 2024
- Primary completion3 Mar 2025
- Study completion10 Mar 2025
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (2)Papers the sponsor has linked to this study.
- Other trials for Postoperative SleepStudies 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
- Prevention
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Quadruple blind
- Who is masked
- Participant, Care provider, Investigator, Outcomes assessor
- Enrolment
- 104 participants (actual)
Sponsor and investigators
- Lead sponsor
- Air Force Military Medical University, China
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Zhihong LU, Air Force Military Medical University, China
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT06684236
- Sponsor's protocol ID
- XJH-A-20240627
- Acronym
- ASIS-O
- Status last verified
- Jan 2026
- First submitted
- 5 Jul 2024
- Last updated
- 6 Jan 2026
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Publications
Hsu WT, Hsu CM, Hung SC, Hung SY. Acupuncture Improves Sleep Disorders and Depression among Patients with Parkinson's Disease: A Meta-Analysis. Healthcare (Basel). 2023 Jul 17;11(14):2042. doi: 10.3390/healthcare11142042.
PubMed 37510483El Iskandarani S, Sun L, Li SQ, Pereira G, Giralt S, Deng G. Acupuncture improves certain aspects of sleep in hematopoietic stem cell transplantation patients: a secondary analysis of a randomized controlled trial. Acupunct Med. 2023 Dec;41(6):319-326. doi: 10.1177/09645284231181403. Epub 2023 Jul 6.
PubMed 37409464
Study at a glance
From the registry record, last updated by the sponsor on 6 Jan 2026. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Effect of Transcutaneous Electrical Acupoint Stimulation on Sleeping After General Anesthesia in Elderly Patients Undergoing Abdominal Surgery
- ClinicalTrials.gov ID
- NCT06684236
- Acronym / sponsor ID
- ASIS-O / XJH-A-20240627
- Conditions
- Postoperative Sleep
- Keywords
- acupoint stimulation, general anesthesia, sleep, elderly patients
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 104 participants (actual)
- Lead sponsor
- Air Force Military Medical University, ChinaUniversity, hospital or other
- Study start
- 23 Oct 2024 (actual)
- Primary completion
- 3 Mar 2025 (actual)
- Study completion
- 10 Mar 2025 (actual)
- First posted
- 12 Nov 2024 (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.
Sleeping model can be affected after surgery. Anesthetics may be involved in the change. The changing of sleeping mode may exert adverse effect on postoperative recovery. Acupuncture and related techniques has been used for treating sleeping disorder. In this study, the effect of transcutaneous electrical acupoint stimulation on sleeping model after general anesthesia will be observed.
Study design
- Primary purpose
- Prevention
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Quadruple blind (participant, care provider, investigator, outcomes assessor)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Acupoint stimulation | Experimental | Other: transcutaneous electrical stimulation, Other: electrodes attachmenttranscutaneous electrical acupoint stimulation is one of the many forms of acupuncture, and is a distinctive part of Chinese medicine that has been practiced in China for thousands of years. It is employed by placing electrodes on acupoint and electrical stimulation is given after anesthetic induction to the end of the surgery |
| Control | Sham comparator | Other: electrodes attachmentElectrodes are placed on same acupoints as the experimental group, and will receive the "optimal intensity test" before the anesthesia induction, but no electrical stimulation is given during the operation |
Who may qualify
- Ages
- 65 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Older adult
Key inclusion criteria (2 listed)
- Age≥65 years old
- scheduled for abdominal surgery under general anesthesia
Key exclusion criteria (7 listed)
- anticipated duration of surgery longer than 5 hours or shorter than 1 hour
- American society of anesthesiologists status over stage 3
- Participants with sleep apnea or moderate and severe obstructive sleep apnea syndrome (defined by Apnea Hypopnea Index (AHI))
- Participants with preoperative sleep disturbances (diagnostic criteria of sleep disturbances according to the International Classification of Sleep Disorders, Third Edition (ICSD-3))
- Participants with a history of alcohol or drug abuse
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 |
|---|---|---|
| transcutaneous electrical stimulationelectrical stimulation is given through electrodes attached to the skin | Other | Acupoint stimulation |
| electrodes attachmentelectrodes are attached to the skin area of Neiguan acupoint, which is located on 3cm above the transverse crease of the wrist | Other | Acupoint stimulation, Control |
Primary outcome
total sleeping time during the first postoperative night
Time frame: the first postoperative night, on an average of 12 hours
15 secondary outcomes
Total sleep time during the first 24 hours after surgery
Time frame: from discharge from post-anesthesia care unit to 24 hours later, totally 24 hours
The Epworth Sleepiness Scale (ESS) score at 24 hours after surgery
Time frame: 24 hours after surgery
The Athens Insomnia Scale (AIS) score at 24 hours after surgery
Time frame: 24 hours after surgery
The Athens Insomnia Scale (AIS) score at 48 hours after surgery
Time frame: 48 hours after surgery
The Epworth Sleepiness Scale (ESS) score at 48 hours after surgery
Time frame: 48 hours after surgery
The Athens Insomnia Scale (AIS) score at discharge from hospital
Time frame: the last day before discharge from hospital, at an average of 12 hours
The Epworth Sleepiness Scale (ESS) score at discharge from hospital
Time frame: the last day before discharge from hospital, at an average of 12 hours
sleep efficiency(%) during the first postoperative night
Time frame: the first postoperative night, at an average of 12 hours
duration of rapid eye movement sleep during the first postoperative night
Time frame: the first postoperative night, at an average of 12 hours
number of wake during the first postoperative night
Time frame: the first postoperative night, at an average of 12 hours
incidence of delirium during hospitalization
Time frame: From end of surgery to discharge from hospital, assessed up to 7 days
length of postoperative hospital stay
Time frame: From end of surgery to discharge from hospital, at an average of 5 days
number of needs for rescue analgesia by 24 hours after surgery
Time frame: from discharge from operation room to 24 hours later, totally 24 hours
Number of participants with major complications during hospitalization, including cardiac failure, cardiac infarction, respiratory failure
Time frame: From end of surgery to discharge from hospital, assessed up to 7 days
Scale of quality of recovery at discharge from hospital
Time frame: the last day before discharge from hospital, at an average of 12 hours
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 6 Jan 2026.
- Background: PubMed 37510483Hsu WT, Hsu CM, Hung SC, Hung SY. Acupuncture Improves Sleep Disorders and Depression among Patients with Parkinson's Disease: A Meta-Analysis. Healthcare (Basel). 2023 Jul 17;11(14):2042. doi: 10.3390/healthcare11142042.
- Background: PubMed 37409464El Iskandarani S, Sun L, Li SQ, Pereira G, Giralt S, Deng G. Acupuncture improves certain aspects of sleep in hematopoietic stem cell transplantation patients: a secondary analysis of a randomized controlled trial. Acupunct Med. 2023 Dec;41(6):319-326. doi: 10.1177/09645284231181403. Epub 2023 Jul 6.
- 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.
The record lists no contact. Use the official record to reach the sponsor.
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing transcutaneous electrical stimulation and electrodes attachment in people with Postoperative Sleep, run by Air Force Military Medical University, China at 1 site 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 2 inclusion and 7 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: finished, as of the sponsor's last update on 6 Jan 2026. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site 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?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
total sleeping time during the first postoperative night (time frame: the first postoperative night, on an average of 12 hours). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT06684236, which also lists 2 linked publications.
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 6 Jan 2026.