Effect of Transcutaneous Electrical Acupoint Stimulation on Sleep Quality in Healthy Volunteers on the Plateau

Air Force Military Medical University, China1 site in 1 country20 target enrollmentJuly 30, 2022

ConditionsSleep Disorder

Overview

Phase: Not Applicable
Intervention: Not specified
Conditions: Sleep Disorder
Sponsor: Air Force Military Medical University, China
Enrollment: 20
Locations: 1
Primary Endpoint: total sleep time in 5 days
Status: Recruiting
Last Updated: 3 years ago

Overview Investigators Eligibility Criteria Outcomes Sites Similar Trials

Overview

Brief Summary

Sleep disorder is common in people going to plateau. Acupuncture and related techniques could be used for treatment of sleep disorder. In this trial the effect of transcutaneous electrical acupoint stimulation on sleep disorder in people going to plateau will be investigated.

Registry

clinicaltrials.gov

Start Date

July 30, 2022

End Date

April 2023

Last Updated

3 years ago

Study Type

Interventional

Study Design

Crossover

Sex

All

Investigators

Sponsor

Air Force Military Medical University, China

Responsible Party

Principal Investigator

Zhihong LU

Associate professor

Air Force Military Medical University, China

Eligibility Criteria

Inclusion Criteria

•Age from 18 to 40 years
•first time to the plateau (altitude ≥3000 meters)

Exclusion Criteria

•those who live in area with altitude ≥2000 meters, or travel to plateau in the last half year
•history of insomnia
•patients with contraindication to transcutaneous electrical stimulation, including skin damage, infection or implantable electrical device
•difficulty in verbal communication
•history of taking medicine to improve sleep during the last 3 months
•regular daily intake of large dose of tea or coffee (\>400 mg of caffeine)
•suspected or existed abuse of drug or alcohol
•disease that influence sleep such as chronic pain

Outcomes

Primary Outcomes

total sleep time in 5 days

Time Frame: from arrived at plateau to 5 days after arrival, in a total of 5 days

Secondary Outcomes

sleep latency on the fifth day(from arrived at plateau to 5 days after arrival, in a total of 5 days)
sleep efficiency on the fifth day(from arrived at plateau to 5 days after arrival, in a total of 5 days)
number of awake on the fifth day(from arrived at plateau to 5 days after arrival, in a total of 5 days)
Pittsburgh sleep quality index on the fifth day(from arrived at plateau to 5 days after arrival, in a total of 5 days)
Score of Cognition Assessment on the third day(from arrived at plateau to 5 days after arrival, in a total of 5 days)
lowest saturation of pulse oxygenation on the fifth day(from arrived at plateau to 5 days after arrival, in a total of 5 days)
highest systolic blood pressure on the fifth day(from arrived at plateau to 5 days after arrival, in a total of 5 days)
highest heart rate on the fifth day(from arrived at plateau to 5 days after arrival, in a total of 5 days)