Acupoint Stimulation Improves Cognition Under Hypoxia (TREACLE)

July 25, 2024 updated by: Zhihong LU

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.

Study Overview

Status

Not yet recruiting

Conditions

Intervention / Treatment

Study Type

Interventional

Enrollment (Estimated)

50

Phase

  • Not Applicable

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Contact

Study Locations

  • China
    • Shaanxi
      • Xi'an, Shaanxi, China, 710032
        • Xijing Hospital
        • Contact:
        • Sub-Investigator:
          • Yongzhou Jiang

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

  • Adult

Accepts Healthy Volunteers

Yes

Description

Inclusion Criteria:

  • Male, age from 18 to 50 years

Exclusion Criteria:

  • 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

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: Crossover Assignment
  • Masking: Double

Arms and Interventions

Participant Group / Arm
Intervention / Treatment
Experimental: transcutaneous electrical acupoint stimulation
Electrodes are placed at acupoints and connected to the stimulators. Electrical stimulation is given for 2 hours
Other: transcutaneous electrical acupoint stimulation
Electrodes are placed at acupoints and connected to the stimulator. Electrical stimulation is given for 2 hours.
No Intervention: Control
Electrodes are placed at acupoints but no electrical stimulation is given

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Time Frame
cognitive function measured by eye-tracking at 1 hour after hypoxia
Time Frame: 1 hour after hypoxia
1 hour after hypoxia
cognitive function measured by eye-tracking at 2 hours after hypoxia
Time Frame: 2 hours after hypoxia
2 hours after hypoxia

Secondary Outcome Measures

Outcome Measure
Measure Description
Time Frame
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
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
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
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
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
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
sleep efficiency=total sleep time/total recording time
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
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
the first day after hypoxia, in a total of 24 hours

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Zhihong LU

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 (Estimated)

July 30, 2024

Primary Completion (Estimated)

April 30, 2025

Study Completion (Estimated)

May 7, 2025

Study Registration Dates

First Submitted

July 4, 2024

First Submitted That Met QC Criteria

July 25, 2024

First Posted (Actual)

July 26, 2024

Study Record Updates

Last Update Posted (Actual)

July 26, 2024

Last Update Submitted That Met QC Criteria

July 25, 2024

Last Verified

July 1, 2024

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

  • XJH-A-20240319

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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