Sleep Disorder
Conditions
Keywords
transcutaneous electrical acupoint stimulation, plateau, sleep disorder, healthy volunteer
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.
Interventions
DEVICEtranscutaneous 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.
Sponsors
Air Force Military Medical University, China
Study design
Allocation
RANDOMIZED
Intervention model
CROSSOVER
Primary purpose
TREATMENT
Masking
DOUBLE (Investigator, Outcomes Assessor)
Masking description
The stimulator is put in an opaque box
Eligibility
Sex/Gender
ALL
Age
18 Years to 40 Years
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
Design outcomes
Primary
| 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
| Measure | Time frame | Description |
|---|---|---|
| sleep efficiency on the fifth day | from arrived at plateau to 5 days after arrival, in a total of 5 days | sleep efficiency=total sleep time/total recording time |
| 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 | — |
| sleep latency on the fifth 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 | — |
| Score of Cognition Assessment on the third day | from arrived at plateau to 5 days after arrival, in a total of 5 days | cognition assessment is done using Rey Auditory Verbal Learning Test |
Countries
China
Contacts
Primary ContactZhihong Lu
Outcome results
None listed