CognitionTREACLENCT06521632
Acupoint Stimulation Improves Cognition Under Hypoxia
A study testing transcutaneous electrical acupoint stimulation in people with Cognition, run by Zhihong LU at 1 site in China.
Trial summary
Cognitive impairment is common in people who suffer from hypoxia. Acupuncture and related techniques can be used to improve hypoxia and treat cognitive impairment. In this trial the effect of transcutaneous electrical acupoint stimulation on cognitive impairment in people under hypoxia will be investigated. Read more about this study
- Who is it for?
- Ages 18 to 50 years, men onlyHealthy volunteers can take part
- Conditions the study is for
- Cognition
- What is being tested?
- transcutaneous electrical acupoint stimulation
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 50 participants
- Where
- 1 siteChina
- Study dates
- 30 Jul 2024to 7 May 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 18 to 50 years
- Men only
- Healthy volunteers accepted
- Adult
Who may be able to join
- Male, age from 18 to 50 years
Who cannot join
- cardiopulmonary dysfunction;
- History of severe respiratory, circulatory, digestive, blood, ear-nose-throat system diseases;
- A history of fever or respiratory infection within the last two weeks;
- Drinking alcohol or poor sleep within the last 24 hours
Trial locations and contacts
1 site in 1 country.
China1 site
Xijing Hospital
Xi'an, Shaanxi, 710032
Zhihong Lu, +8613891975018, deerlu23@163.com
Yongzhou Jiang
About this study
Official title: Effect of Transcutaneous Electrical Acupoint Stimulation on Cognitive Function Under Exposure to Hypoxia
Cognitive impairment is common in people who suffer from hypoxia. Acupuncture and related techniques can be used to improve hypoxia and treat cognitive impairment. In this trial the effect of transcutaneous electrical acupoint stimulation on cognitive impairment in people under hypoxia will be investigated.
- Conditions
- Cognition
- Being tested
- transcutaneous electrical acupoint stimulation
- Keywords
- transcutaneous electrical acupoint stimulation, cognition, hypoxia
- Medical subject headings
- Hypoxia
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
transcutaneous electrical acupoint stimulationOther
Electrodes are placed at acupoints and connected to the stimulator. Electrical stimulation is given for 2 hours.
| Study group | Role | What they receive |
|---|---|---|
| transcutaneous electrical acupoint stimulation | Experimental | Electrodes are placed at acupoints and connected to the stimulators. Electrical stimulation is given for 2 hours Receives: Other: transcutaneous electrical acupoint stimulation |
| Control | No intervention | Electrodes are placed at acupoints but no electrical stimulation is given |
What is being measured
The primary outcome is the main question the study is designed to answer.
cognitive function measured by eye-tracking at 1 hour after hypoxia
Measured: 1 hour after hypoxia
cognitive function measured by eye-tracking at 2 hours after hypoxia
Measured: 2 hours after hypoxia
Secondary outcomes (8)
mean arterial blood pressure
Measured: starting from 10 minutes before hypoxia to 2 hours after hypoxia, every 5 minutes for 2 hours and 10 minutes
heart rate
Measured: starting from 10 minutes before hypoxia to 2 hours after hypoxia, every 5 minutes for 2 hours and 10 minutes
saturation of pulse oximetry
Measured: starting from 10 minutes before hypoxia to 2 hours after hypoxia, every 5 minutes for 2 hours and 10 minutes
Cerebral oxygen saturation
Measured: starting from 10 minutes before hypoxia to 2 hours after hypoxia, every 5 minutes for 2 hours and 10 minutes
total sleep time on the first day after hypoxia
Measured: the first day after hypoxia, in a total of 24 hours
sleep efficiency(%) on the first day after hypoxia
sleep efficiency=total sleep time/total recording time
Measured: the first day after hypoxia, in a total of 24 hours
number of awake on the first day after hypoxia
Measured: the first day after hypoxia, in a total of 24 hours
time of awake on the first day after hypoxia
Measured: the first day after hypoxia, in a total of 24 hours
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted26 Jul 2024
- Study start30 Jul 2024 (estimated)
- Primary completion30 Apr 2025 (estimated)
- Study completion7 May 2025 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for CognitionStudies 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
- Crossover
- Masking
- Double blind
- Who is masked
- Investigator, Outcomes assessor
- Enrolment
- 50 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Zhihong LU
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor-investigator, Zhihong LU, Air Force Military Medical University, China
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT06521632
- Sponsor's protocol ID
- XJH-A-20240319
- Acronym
- TREACLE
- Status last verified
- Jul 2024
- First submitted
- 4 Jul 2024
- Last updated
- 26 Jul 2024
- 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 26 Jul 2024. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Effect of Transcutaneous Electrical Acupoint Stimulation on Cognitive Function Under Exposure to Hypoxia
- ClinicalTrials.gov ID
- NCT06521632
- Acronym / sponsor ID
- TREACLE / XJH-A-20240319
- Conditions
- Cognition
- Keywords
- transcutaneous electrical acupoint stimulation, cognition, hypoxia
- Study type
- Interventional
- Recruitment status
- Unknown status
- Enrolment
- 50 participants (estimated)
- Lead sponsor
- Zhihong LUUniversity, hospital or other
- Study start
- 30 Jul 2024 (estimated)
- Primary completion
- 30 Apr 2025 (estimated)
- Study completion
- 7 May 2025 (estimated)
- First posted
- 26 Jul 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.
Cognitive impairment is common in people who suffer from hypoxia. Acupuncture and related techniques can be used to improve hypoxia and treat cognitive impairment. In this trial the effect of transcutaneous electrical acupoint stimulation on cognitive impairment in people under hypoxia will be investigated.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Crossover
- Masking
- Double blind (investigator, outcomes assessor)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| transcutaneous electrical acupoint stimulation | Experimental | Other: transcutaneous electrical acupoint stimulationElectrodes are placed at acupoints and connected to the stimulators. Electrical stimulation is given for 2 hours |
| Control | No intervention | –Electrodes are placed at acupoints but no electrical stimulation is given |
Who may qualify
- Ages
- 18 to 50 years
- Sex
- Male only
- Healthy volunteers
- Accepted
- Age groups
- Adult
Key inclusion criteria (1 listed)
- Male, age from 18 to 50 years
Key exclusion criteria (4 listed)
- cardiopulmonary dysfunction;
- History of severe respiratory, circulatory, digestive, blood, ear-nose-throat system diseases;
- A history of fever or respiratory infection within the last two weeks;
- Drinking alcohol or poor sleep within the last 24 hours
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 acupoint stimulationElectrodes are placed at acupoints and connected to the stimulator. Electrical stimulation is given for 2 hours. | Other | transcutaneous electrical acupoint stimulation |
Primary outcome
cognitive function measured by eye-tracking at 1 hour after hypoxia
Time frame: 1 hour after hypoxia
cognitive function measured by eye-tracking at 2 hours after hypoxia
Time frame: 2 hours after hypoxia
8 secondary outcomes
mean arterial blood pressure
Time frame: starting from 10 minutes before hypoxia to 2 hours after hypoxia, every 5 minutes for 2 hours and 10 minutes
heart rate
Time frame: starting from 10 minutes before hypoxia to 2 hours after hypoxia, every 5 minutes for 2 hours and 10 minutes
saturation of pulse oximetry
Time frame: starting from 10 minutes before hypoxia to 2 hours after hypoxia, every 5 minutes for 2 hours and 10 minutes
Cerebral oxygen saturation
Time frame: starting from 10 minutes before hypoxia to 2 hours after hypoxia, every 5 minutes for 2 hours and 10 minutes
total sleep time on the first day after hypoxia
Time frame: the first day after hypoxia, in a total of 24 hours
sleep efficiency(%) on the first day after hypoxia
Time frame: the first day after hypoxia, in a total of 24 hours
number of awake on the first day after hypoxia
Time frame: the first day after hypoxia, in a total of 24 hours
time of awake on the first day after hypoxia
Time frame: the first day after hypoxia, in a total of 24 hours
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 26 Jul 2024.
- 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.
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 acupoint stimulation in people with Cognition, run by Zhihong LU 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 1 inclusion and 4 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 26 Jul 2024. 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. 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 Zhihong Lu (+8613891975018, deerlu23@163.com), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
cognitive function measured by eye-tracking at 1 hour after hypoxia (time frame: 1 hour after hypoxia). The study lists 2 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 26 Jul 2024.