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ASSOP: Acupoint Stimulation Improves Sleep on the Plateau

Sponsor
Air Force Military Medical University, China (Other)
Overall Status
Not yet recruiting
CT.gov ID
NCT05396729
Collaborator
(none)
20
Enrollment
1
Location
2
Arms
8
Anticipated Duration (Months)
2.5
Patients Per Site Per Month

Study Details

Study Description

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.

Condition or Disease Intervention/Treatment Phase
  • Device: transcutaneous electrical acupoint stimulation
 N/A

Study Design

Study Type:
Interventional
Anticipated Enrollment :
20 participants
Allocation:
Randomized
Intervention Model:
Crossover Assignment
Masking:
Double (Investigator, Outcomes Assessor)
Masking Description:
The stimulator is put in an opaque box
Primary Purpose:
Treatment
Official Title:
Effect of Transcutaneous Electrical Acupoint Stimulation on Sleep Quality in Healthy Volunteers on the Plateau
Anticipated Study Start Date :
Aug 1, 2022
Anticipated Primary Completion Date :
Apr 1, 2023
Anticipated Study Completion Date :
Apr 1, 2023

Arms and Interventions

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

    Outcome Measures

    Primary Outcome Measures

    1. total sleep time in 3 days [from arrived at plateau to 3 days after arrival, in a total of 3 days]

    Secondary Outcome Measures

    1. sleep latency on the third day [from arrived at plateau to 3 days after arrival, in a total of 3 days]

    2. sleep efficiency on the third day [from arrived at plateau to 3 days after arrival, in a total of 3 days]

      sleep efficiency=total sleep time/total recording time

    3. number of awake on the third day [from arrived at plateau to 3 days after arrival, in a total of 3 days]

    4. Pittsburgh sleep quality index on the third day [from arrived at plateau to 3 days after arrival, in a total of 3 days]

    5. Score of Montreal Cognition Assessment on the third day [from arrived at plateau to 3 days after arrival, in a total of 3 days]

    6. lowest saturation of pulse oxygenation on the third day [from arrived at plateau to 3 days after arrival, in a total of 3 days]

    Eligibility Criteria

    Criteria

    Ages Eligible for Study:
    18 Years to 40 Years
    Sexes Eligible for Study:
    All
    Accepts Healthy Volunteers:
    Yes
    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

    Contacts and Locations

    Locations

    Site City State Country Postal Code
    1 Xijing hospital Xi'an Shaanxi China 710032

    Sponsors and Collaborators

    • Air Force Military Medical University, China

    Investigators

    None specified.

    Study Documents (Full-Text)

    None provided.

    More Information

    Publications

    None provided.
    Responsible Party:
    Zhihong LU, Associate professor, Air Force Military Medical University, China
    ClinicalTrials.gov Identifier:
    NCT05396729
    Other Study ID Numbers:
    • XJH-A-20220525
    First Posted:
    May 31, 2022
    Last Update Posted:
    May 31, 2022
    Last Verified:
    May 1, 2022
    Individual Participant Data (IPD) Sharing Statement:
    No
    Plan to Share IPD:
    No
    Studies a U.S. FDA-regulated Drug Product:
    No
    Studies a U.S. FDA-regulated Device Product:
    No
    Keywords provided by Zhihong LU, Associate professor, Air Force Military Medical University, China
    transcutaneous electrical acupoint stimulation
    plateau
    sleep disorder
    healthy volunteer
    Additional relevant MeSH terms:
    Sleep Wake Disorders
    Parasomnias

    Study Results

    No Results Posted as of May 31, 2022