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Acupoint Stimulation Improves Sleep on the Plateau (ASSOP)

Primary Purpose

Sleep Disorder

Status
Recruiting
Phase
Not Applicable
Locations
China
Study Type
Interventional
Intervention
transcutaneous electrical acupoint stimulation
Sponsored by
Air Force Military Medical University, China
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional treatment trial for Sleep Disorder focused on measuring transcutaneous electrical acupoint stimulation, plateau, sleep disorder, healthy volunteer

Eligibility Criteria

18 Years - 40 Years (Adult)All SexesAccepts Healthy Volunteers

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

Sites / Locations

  • Xijing hospitalRecruiting

Arms of the Study

Arm 1

Arm 2

Arm Type

Experimental

No Intervention

Arm Label

transcutaneous electrical acupoint stimulation

Control

Arm Description

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

Electrodes are placed at acupoints but no electrical stimulation is given

Outcomes

Primary Outcome Measures

total sleep time in 5 days

Secondary Outcome Measures

sleep latency on the fifth day
sleep efficiency on the fifth day
sleep efficiency=total sleep time/total recording time
number of awake on the fifth day
Pittsburgh sleep quality index on the fifth day
Score of Cognition Assessment on the third day
cognition assessment is done using Rey Auditory Verbal Learning Test
lowest saturation of pulse oxygenation on the fifth day
highest systolic blood pressure on the fifth day
highest heart rate on the fifth day

Full Information

First Posted
May 25, 2022
Last Updated
November 8, 2022
Sponsor
Air Force Military Medical University, China
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1. Study Identification

Unique Protocol Identification Number
NCT05396729
Brief Title
Acupoint Stimulation Improves Sleep on the Plateau
Acronym
ASSOP
Official Title
Effect of Transcutaneous Electrical Acupoint Stimulation on Sleep Quality in Healthy Volunteers on the Plateau
Study Type
Interventional

2. Study Status

Record Verification Date
November 2022
Overall Recruitment Status
Recruiting
Study Start Date
July 30, 2022 (Actual)
Primary Completion Date
April 2023 (Anticipated)
Study Completion Date
April 2023 (Anticipated)

3. Sponsor/Collaborators

Responsible Party, by Official Title
Principal Investigator
Name of the Sponsor
Air Force Military Medical University, China

4. Oversight

Studies a U.S. FDA-regulated Drug Product
No
Studies a U.S. FDA-regulated Device Product
No
Data Monitoring Committee
No

5. 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.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Sleep Disorder
Keywords
transcutaneous electrical acupoint stimulation, plateau, sleep disorder, healthy volunteer

7. Study Design

Primary Purpose
Treatment
Study Phase
Not Applicable
Interventional Study Model
Crossover Assignment
Masking
InvestigatorOutcomes Assessor
Masking Description
The stimulator is put in an opaque box
Allocation
Randomized
Enrollment
20 (Anticipated)

8. Arms, Groups, and Interventions

Arm Title
transcutaneous electrical acupoint stimulation
Arm Type
Experimental
Arm Description
Electrodes are placed at acupoints and connected to the stimulator. Electrical stimulation is given for 30 minutes
Arm Title
Control
Arm Type
No Intervention
Arm Description
Electrodes are placed at acupoints but no electrical stimulation is given
Intervention Type
Device
Intervention Name(s)
transcutaneous electrical acupoint stimulation
Other Intervention Name(s)
TEAS
Intervention Description
Electrodes are placed at acupoints and connected to the stimulator. Electrical stimulation is given for 30 minutes, twice a day for 3 days.
Primary Outcome Measure Information:
Title
total sleep time in 5 days
Time Frame
from arrived at plateau to 5 days after arrival, in a total of 5 days
Secondary Outcome Measure Information:
Title
sleep latency on the fifth day
Time Frame
from arrived at plateau to 5 days after arrival, in a total of 5 days
Title
sleep efficiency on the fifth day
Description
sleep efficiency=total sleep time/total recording time
Time Frame
from arrived at plateau to 5 days after arrival, in a total of 5 days
Title
number of awake on the fifth day
Time Frame
from arrived at plateau to 5 days after arrival, in a total of 5 days
Title
Pittsburgh sleep quality index on the fifth day
Time Frame
from arrived at plateau to 5 days after arrival, in a total of 5 days
Title
Score of Cognition Assessment on the third day
Description
cognition assessment is done using Rey Auditory Verbal Learning Test
Time Frame
from arrived at plateau to 5 days after arrival, in a total of 5 days
Title
lowest saturation of pulse oxygenation on the fifth day
Time Frame
from arrived at plateau to 5 days after arrival, in a total of 5 days
Title
highest systolic blood pressure on the fifth day
Time Frame
from arrived at plateau to 5 days after arrival, in a total of 5 days
Title
highest heart rate on the fifth day
Time Frame
from arrived at plateau to 5 days after arrival, in a total of 5 days

10. Eligibility

Sex
All
Minimum Age & Unit of Time
18 Years
Maximum Age & Unit of Time
40 Years
Accepts Healthy Volunteers
Accepts Healthy Volunteers
Eligibility Criteria
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
Central Contact Person:
First Name & Middle Initial & Last Name or Official Title & Degree
Zhihong Lu
Phone
+8613891975018
Email
deerlu23@163.com
Facility Information:
Facility Name
Xijing hospital
City
Xi'an
State/Province
Shaanxi
ZIP/Postal Code
710032
Country
China
Individual Site Status
Recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Zhihong Lu
Phone
+8613891975018
Email
deerlu23@163.com
First Name & Middle Initial & Last Name & Degree
Xiaoyu Liu

12. IPD Sharing Statement

Plan to Share IPD
No

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Acupoint Stimulation Improves Sleep on the Plateau

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