Acupoint Stimulation Improves Sleep on the Plateau (ASSOP)

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

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.

Study Overview

• Status: Recruiting
• Conditions: Sleep Disorder
• Intervention / Treatment: Device: transcutaneous electrical acupoint stimulation

• Study Type: Interventional
• Enrollment (Anticipated): 20
• Phase: Not Applicable

Contacts and Locations

Study Locations

• China
  • Shaanxi
    • Xi'an, Shaanxi, China, 710032
      • Recruiting
      • Xijing Hospital
      • Sub-Investigator: Xiaoyu Liu

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 18 years to 40 years (ADULT)
• Accepts Healthy Volunteers: Yes
• Genders Eligible for Study: All

Description

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

Study Plan

How is the study designed?

Design Details

• Primary Purpose: TREATMENT
• Allocation: RANDOMIZED
• Interventional Model: CROSSOVER
• Masking: DOUBLE

Number of Arms

2

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
EXPERIMENTAL: transcutaneous electrical acupoint stimulation; Electrodes are placed at acupoints and connected to the stimulator. Electrical stimulation is given for 30 minutes	Device: transcutaneous electrical acupoint stimulation; Electrodes are placed at acupoints and connected to the stimulator. Electrical stimulation is given for 30 minutes, twice a day for 3 days.; Other Names: TEAS
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
total sleep time in 5 days	from arrived at plateau to 5 days after arrival, in a total of 5 days

Secondary Outcome Measures

Outcome Measure	Measure Description	Time Frame
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	sleep efficiency=total sleep time/total recording time	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	cognition assessment is done using Rey Auditory Verbal Learning Test	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

Collaborators and Investigators

• Sponsor: Air Force Military Medical University, China

Study record dates

Study Major Dates

• Study Start (ACTUAL): July 30, 2022
• Primary Completion (ANTICIPATED): April 1, 2023
• Study Completion (ANTICIPATED): April 1, 2023

Study Registration Dates

• First Submitted: May 25, 2022
• First Submitted That Met QC Criteria: May 25, 2022
• First Posted (ACTUAL): May 31, 2022

Study Record Updates

• Last Update Posted (ACTUAL): November 14, 2022
• Last Update Submitted That Met QC Criteria: November 8, 2022
• Last Verified: November 1, 2022

More Information

Terms related to this study

• Keywords: healthy volunteer; sleep disorder; transcutaneous electrical acupoint stimulation; plateau
• Additional Relevant MeSH Terms: Mental Disorders; Nervous System Diseases; Neurologic Manifestations; Sleep Wake Disorders; Parasomnias
• Other Study ID Numbers: XJH-A-20220525

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