Acupoint Stimulation Improves Sleep on the Plateau
ASSOP
Effect of Transcutaneous Electrical Acupoint Stimulation on Sleep Quality in Healthy Volunteers on the Plateau
1 other identifier
interventional
20
1 country
1
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.
Trial Health
Trial Health Score
Automated assessment based on enrollment pace, timeline, and geographic reach
participants targeted
Target at below P25 for not_applicable
Started Jul 2022
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
May 25, 2022
CompletedFirst Posted
Study publicly available on registry
May 31, 2022
CompletedStudy Start
First participant enrolled
July 30, 2022
CompletedPrimary Completion
Last participant's last visit for primary outcome
April 1, 2023
CompletedStudy Completion
Last participant's last visit for all outcomes
April 1, 2023
CompletedNovember 14, 2022
November 1, 2022
8 months
May 25, 2022
November 8, 2022
Conditions
Keywords
Outcome Measures
Primary Outcomes (1)
total sleep time in 5 days
from arrived at plateau to 5 days after arrival, in a total of 5 days
Secondary Outcomes (8)
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
- +3 more secondary outcomes
Study Arms (2)
transcutaneous electrical acupoint stimulation
EXPERIMENTALElectrodes are placed at acupoints and connected to the stimulator. Electrical stimulation is given for 30 minutes
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 30 minutes, twice a day for 3 days.
Eligibility Criteria
You may qualify if:
- Age from 18 to 40 years
- first time to the plateau (altitude ≥3000 meters)
You may not qualify if:
- 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
Contact the study team to confirm eligibility.
Sponsors & Collaborators
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
- PRINCIPAL INVESTIGATOR
- PI Title
- Associate professor
Study Record Dates
First Submitted
May 25, 2022
First Posted
May 31, 2022
Study Start
July 30, 2022
Primary Completion
April 1, 2023
Study Completion
April 1, 2023
Last Updated
November 14, 2022
Record last verified: 2022-11
Data Sharing
- IPD Sharing
- Will not share