Acupoint Stimulation Improves Sleep on the Plateau

Study Overview
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Brief Summary
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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.

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

Conditions
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Sleep Disorder

Intervention / Treatment
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* Device: transcutaneous electrical acupoint stimulation


Participation Criteria
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Eligibility Criteria
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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

Ages Eligible for Study
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Minimum Age: 18 Years
Maximum Age: 40 Years

Sexes Eligible for Study
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All

Accepts Healthy Volunteers
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Accepts Healthy Volunteers

Study Plan
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How is the study designed?
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Design Details

Primary Purpose: Treatment
Allocation: Randomized
Intervention Model: Crossover Assignment
Masking: Double


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Experimental: transcutaneous electrical acupoint stimulation<br>Electrodes are placed at acupoints and connected to the stimulator. Electrical stimulation is given for 30 minutes | Device: transcutaneous electrical acupoint stimulation<br>* Electrodes are placed at acupoints and connected to the stimulator. Electrical stimulation is given for 30 minutes, twice a day for 3 days.<br>* Other names: TEAS;|
| No Intervention: Control<br>Electrodes are placed at acupoints but no electrical stimulation is given | |

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | 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 | 

 Terms related to the study
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Keywords Provided by Centre Hospitalier Valida
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transcutaneous electrical acupoint stimulation, plateau, sleep disorder, healthy volunteer