NCT06521632

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

43
At Risk

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Trial has exceeded expected completion date
Enrollment
50

participants targeted

Target at P25-P50 for not_applicable

Timeline
Completed

Started Jul 2024

Shorter than P25 for not_applicable

Geographic Reach
1 country

1 active site

Status
not yet recruiting

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

Completed
22 days until next milestone

First Posted

Study publicly available on registry

July 26, 2024

Completed
4 days until next milestone

Study Start

First participant enrolled

July 30, 2024

Completed
9 months until next milestone

Primary Completion

Last participant's last visit for primary outcome

April 30, 2025

Completed
7 days until next milestone

Study Completion

Last participant's last visit for all outcomes

May 7, 2025

Completed
Last Updated

July 26, 2024

Status Verified

July 1, 2024

Enrollment Period

9 months

First QC Date

July 4, 2024

Last Update Submit

July 25, 2024

Conditions

Keywords

transcutaneous electrical acupoint stimulationcognitionhypoxia

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

EXPERIMENTAL

Electrodes are placed at acupoints and connected to the stimulators. Electrical stimulation is given for 2 hours

Other: transcutaneous electrical acupoint stimulation

Control

NO INTERVENTION

Electrodes 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.

transcutaneous electrical acupoint stimulation

Eligibility Criteria

Age18 Years - 50 Years
Sexmale
Healthy VolunteersYes
Age GroupsAdult (18-64)

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

Study Sites (1)

Xijing Hospital

Xi'an, Shaanxi, 710032, China

Location

MeSH Terms

Conditions

Hypoxia

Condition Hierarchy (Ancestors)

Signs and Symptoms, RespiratorySigns and SymptomsPathological Conditions, Signs and Symptoms

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

Locations