Acupoint Stimulation Improves Sleep on the Plateau

Sleep Disorder Clinical Trial

— ASSOP  

Official title:

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

Clinical Trial Details — Status: Recruiting

Administrative data

• NCT number: NCT05396729
• Other study ID #: XJH-A-20220525
• Status: Recruiting
• Phase: N/A
• Start date: July 30, 2022
• Est. completion date: April 2023

Study information

• Verified date: November 2022
• Source: Air Force Military Medical University, China
• Contact: Zhihong Lu
• Phone: +8613891975018
• Email: deerlu23[@]163.com
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial 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.

Recruitment information / eligibility

• Status: Recruiting
• Enrollment: 20
• Est. completion date: April 2023
• Est. primary completion date: April 2023
• Accepts healthy volunteers: Accepts Healthy Volunteers
• Gender: All
• Age group: 18 Years to 40 Years

Eligibility

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

Related Conditions & MeSH terms

• Parasomnias
• Sleep Disorder
• Sleep Wake Disorders

Intervention

Device:
• 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.

Locations

Country	Name	City	State
China	Xijing hospital	Xi'an	Shaanxi

Sponsors (1)

Lead Sponsor	Collaborator
Air Force Military Medical University, China

Country where clinical trial is conducted

China, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	total sleep time in 5 days		from arrived at plateau to 5 days after arrival, in a total of 5 days
Secondary	sleep latency on the fifth day		from arrived at plateau to 5 days after arrival, in a total of 5 days
Secondary	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
Secondary	number of awake on the fifth day		from arrived at plateau to 5 days after arrival, in a total of 5 days
Secondary	Pittsburgh sleep quality index on the fifth day		from arrived at plateau to 5 days after arrival, in a total of 5 days
Secondary	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
Secondary	lowest saturation of pulse oxygenation on the fifth day		from arrived at plateau to 5 days after arrival, in a total of 5 days
Secondary	highest systolic blood pressure on the fifth day		from arrived at plateau to 5 days after arrival, in a total of 5 days
Secondary	highest heart rate on the fifth day		from arrived at plateau to 5 days after arrival, in a total of 5 days