Sleep DisorderASSOPNCT05396729
Acupoint Stimulation Improves Sleep on the Plateau
A study testing transcutaneous electrical acupoint stimulation in people with Sleep Disorder, run by Air Force Military Medical University, China at 1 site in China.
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. Read more about this study
- Who is it for?
- Ages 18 to 40 yearsHealthy volunteers can take part
- Conditions the study is for
- Sleep Disorder
- What is being tested?
- transcutaneous electrical acupoint stimulation
- Type of treatment
- Medical device
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 20 participants
- Where
- 1 siteChina
- Study dates
- 30 Jul 2022to Apr 2023
- Phase
- Interventional
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 to 40 years
- All sexes
- Healthy volunteers accepted
- Adult
Who may be able to join
- Age from 18 to 40 years
- first time to the plateau (altitude ≥3000 meters)
Who cannot join
- 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
Trial locations and contacts
1 site in 1 country.
China1 site, 1 recruiting
- Recruiting
Xijing hospital
Xi'an, Shaanxi, 710032
Zhihong Lu, +8613891975018, deerlu23@163.com
Xiaoyu Liu
About this study
Official title: Effect of Transcutaneous Electrical Acupoint Stimulation on Sleep Quality in Healthy Volunteers on the Plateau
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.
- Conditions
- Sleep Disorder
- Being tested
- transcutaneous electrical acupoint stimulation
- Keywords
- transcutaneous electrical acupoint stimulation, plateau, sleep disorder, healthy volunteer
- Medical subject headings
- Sleep Wake Disorders
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
transcutaneous electrical acupoint stimulationDevice
Also called TEAS
Electrodes are placed at acupoints and connected to the stimulator. Electrical stimulation is given for 30 minutes, twice a day for 3 days.
| Study group | Role | What they receive |
|---|---|---|
| transcutaneous electrical acupoint stimulation | Experimental | Electrodes are placed at acupoints and connected to the stimulator. Electrical stimulation is given for 30 minutes Receives: Device: transcutaneous electrical acupoint stimulation |
| Control | No intervention | Electrodes are placed at acupoints but no electrical stimulation is given |
What is being measured
The primary outcome is the main question the study is designed to answer.
total sleep time in 5 days
Measured: from arrived at plateau to 5 days after arrival, in a total of 5 days
Secondary outcomes (8)
sleep latency on the fifth day
Measured: 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
Measured: from arrived at plateau to 5 days after arrival, in a total of 5 days
number of awake on the fifth day
Measured: from arrived at plateau to 5 days after arrival, in a total of 5 days
Pittsburgh sleep quality index on the fifth day
Measured: 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
Measured: from arrived at plateau to 5 days after arrival, in a total of 5 days
lowest saturation of pulse oxygenation on the fifth day
Measured: from arrived at plateau to 5 days after arrival, in a total of 5 days
highest systolic blood pressure on the fifth day
Measured: from arrived at plateau to 5 days after arrival, in a total of 5 days
highest heart rate on the fifth day
Measured: from arrived at plateau to 5 days after arrival, in a total of 5 days
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted31 May 2022
- Study start30 Jul 2022
- Primary completionApr 2023 (estimated)
- Study completionApr 2023 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Sleep DisorderStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Crossover
- Masking
- Double blind
- Who is masked
- Investigator, Outcomes assessor
- Enrolment
- 20 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Air Force Military Medical University, China
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Zhihong LU, Air Force Military Medical University, China
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT05396729
- Sponsor's protocol ID
- XJH-A-20220525
- Acronym
- ASSOP
- Status last verified
- Nov 2022
- First submitted
- 25 May 2022
- Last updated
- 14 Nov 2022
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Study at a glance
From the registry record, last updated by the sponsor on 14 Nov 2022. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Effect of Transcutaneous Electrical Acupoint Stimulation on Sleep Quality in Healthy Volunteers on the Plateau
- ClinicalTrials.gov ID
- NCT05396729
- Acronym / sponsor ID
- ASSOP / XJH-A-20220525
- Conditions
- Sleep Disorder
- Keywords
- transcutaneous electrical acupoint stimulation, plateau, sleep disorder, healthy volunteer
- Study type
- Interventional
- Recruitment status
- Unknown status
- Enrolment
- 20 participants (estimated)
- Lead sponsor
- Air Force Military Medical University, ChinaUniversity, hospital or other
- Study start
- 30 Jul 2022 (actual)
- Primary completion
- Apr 2023 (estimated)
- Study completion
- Apr 2023 (estimated)
- First posted
- 31 May 2022 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Crossover
- Masking
- Double blind (investigator, outcomes assessor)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| transcutaneous electrical acupoint stimulation | Experimental | Device: transcutaneous electrical acupoint stimulationElectrodes are placed at acupoints and connected to the stimulator. Electrical stimulation is given for 30 minutes |
| Control | No intervention | –Electrodes are placed at acupoints but no electrical stimulation is given |
Who may qualify
- Ages
- 18 to 40 years
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Adult
Key inclusion criteria (2 listed)
- Age from 18 to 40 years
- first time to the plateau (altitude ≥3000 meters)
Key exclusion criteria (8 listed)
- 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
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| transcutaneous electrical acupoint stimulationAlso: TEASElectrodes are placed at acupoints and connected to the stimulator. Electrical stimulation is given for 30 minutes, twice a day for 3 days. | Device | transcutaneous electrical acupoint stimulation |
Primary outcome
total sleep time in 5 days
Time frame: from arrived at plateau to 5 days after arrival, in a total of 5 days
8 secondary outcomes
sleep latency on the fifth day
Time frame: from arrived at plateau to 5 days after arrival, in a total of 5 days
sleep efficiency on the fifth day
Time frame: from arrived at plateau to 5 days after arrival, in a total of 5 days
number of awake on the fifth day
Time frame: from arrived at plateau to 5 days after arrival, in a total of 5 days
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
Score of Cognition Assessment on the third day
Time frame: from arrived at plateau to 5 days after arrival, in a total of 5 days
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
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
highest heart rate on the fifth day
Time frame: from arrived at plateau to 5 days after arrival, in a total of 5 days
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 14 Nov 2022.
- Individual participant dataSharing planned: No
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing transcutaneous electrical acupoint stimulation in people with Sleep Disorder, run by Air Force Military Medical University, China at 1 site in China.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 2 inclusion and 8 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: status not confirmed, as of the sponsor's last update on 14 Nov 2022. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in China. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
Results are not available in the source record.
How can a doctor refer a patient or contact the research team?
Contact Zhihong Lu (+8613891975018, deerlu23@163.com), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
total sleep time in 5 days (time frame: from arrived at plateau to 5 days after arrival, in a total of 5 days). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 14 Nov 2022.