Acupoint Stimulation Improves Cognition Under Hypoxia
TREACLE
Effect of Transcutaneous Electrical Acupoint Stimulation on Cognitive Function Under Exposure to Hypoxia
1 other identifier
interventional
50
1 country
1
Brief 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.
Trial Health
Trial Health Score
Automated assessment based on enrollment pace, timeline, and geographic reach
participants targeted
Target at P25-P50 for not_applicable
Started Jul 2024
Shorter than P25 for not_applicable
1 active site
Health score is calculated from publicly available data and should be used for screening purposes only.
Trial Relationships
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Study Timeline
Key milestones and dates
First Submitted
Initial submission to the registry
July 4, 2024
CompletedFirst Posted
Study publicly available on registry
July 26, 2024
CompletedStudy Start
First participant enrolled
July 30, 2024
CompletedPrimary Completion
Last participant's last visit for primary outcome
April 30, 2025
CompletedStudy Completion
Last participant's last visit for all outcomes
May 7, 2025
CompletedJuly 26, 2024
July 1, 2024
9 months
July 4, 2024
July 25, 2024
Conditions
Keywords
Outcome Measures
Primary Outcomes (2)
cognitive function measured by eye-tracking at 1 hour after hypoxia
1 hour after hypoxia
cognitive function measured by eye-tracking at 2 hours after hypoxia
2 hours after hypoxia
Secondary Outcomes (8)
mean arterial blood pressure
starting from 10 minutes before hypoxia to 2 hours after hypoxia, every 5 minutes for 2 hours and 10 minutes
heart rate
starting from 10 minutes before hypoxia to 2 hours after hypoxia, every 5 minutes for 2 hours and 10 minutes
saturation of pulse oximetry
starting from 10 minutes before hypoxia to 2 hours after hypoxia, every 5 minutes for 2 hours and 10 minutes
Cerebral oxygen saturation
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
the first day after hypoxia, in a total of 24 hours
- +3 more secondary outcomes
Study Arms (2)
transcutaneous electrical acupoint stimulation
EXPERIMENTALElectrodes are placed at acupoints and connected to the stimulators. Electrical stimulation is given for 2 hours
Control
NO INTERVENTIONElectrodes are placed at acupoints but no electrical stimulation is given
Interventions
Electrodes are placed at acupoints and connected to the stimulator. Electrical stimulation is given for 2 hours.
Eligibility Criteria
You may qualify if:
- Male, age from 18 to 50 years
You may not qualify if:
- 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
Contact the study team to confirm eligibility.
Sponsors & Collaborators
- Zhihong LUlead
Study Sites (1)
Xijing Hospital
Xi'an, Shaanxi, 710032, China
MeSH Terms
Conditions
Condition Hierarchy (Ancestors)
Central Study Contacts
Study Design
- Study Type
- interventional
- Phase
- not applicable
- Allocation
- RANDOMIZED
- Masking
- DOUBLE
- Who Masked
- INVESTIGATOR, OUTCOMES ASSESSOR
- Masking Details
- The stimulator is put in an opaque box
- Purpose
- TREATMENT
- Intervention Model
- CROSSOVER
- Sponsor Type
- OTHER
- Responsible Party
- SPONSOR INVESTIGATOR
- PI Title
- Associate professor
Study Record Dates
First Submitted
July 4, 2024
First Posted
July 26, 2024
Study Start
July 30, 2024
Primary Completion
April 30, 2025
Study Completion
May 7, 2025
Last Updated
July 26, 2024
Record last verified: 2024-07
Data Sharing
- IPD Sharing
- Will not share