Acupoint Stimulation Improves Sleep on the Plateau

NCT ID: NCT05396729

Last Updated: 2022-11-14

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

UNKNOWN

Clinical Phase

NA

Total Enrollment

20 participants

Study Classification

INTERVENTIONAL

Study Start Date

2022-07-30

Study Completion Date

2023-04-30

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.

Detailed Description

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Conditions

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Sleep Disorder

Study Design

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Allocation Method

RANDOMIZED

Intervention Model

CROSSOVER

Primary Study Purpose

TREATMENT

Blinding Strategy

DOUBLE

Investigators Outcome Assessors
The stimulator is put in an opaque box

Study Groups

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transcutaneous electrical acupoint stimulation

Electrodes are placed at acupoints and connected to the stimulator. Electrical stimulation is given for 30 minutes

Group Type EXPERIMENTAL

transcutaneous electrical acupoint stimulation

Intervention Type DEVICE

Electrodes are placed at acupoints and connected to the stimulator. Electrical stimulation is given for 30 minutes, twice a day for 3 days.

Control

Electrodes are placed at acupoints but no electrical stimulation is given

Group Type NO_INTERVENTION

No interventions assigned to this group

Interventions

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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.

Intervention Type DEVICE

Other Intervention Names

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TEAS

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
Minimum Eligible Age

18 Years

Maximum Eligible Age

40 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

Yes

Sponsors

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Air Force Military Medical University, China

OTHER

Sponsor Role lead

Responsible Party

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Zhihong LU

Associate professor

Responsibility Role PRINCIPAL_INVESTIGATOR

Locations

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Xijing hospital

Xi'an, Shaanxi, China

Site Status RECRUITING

Countries

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China

Central Contacts

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Zhihong Lu

Role: CONTACT

+8613891975018

Facility Contacts

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Zhihong Lu

Role: primary

+8613891975018

Other Identifiers

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XJH-A-20220525

Identifier Type: -

Identifier Source: org_study_id

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