Negative Air Ions2022JWNCT07056751
The Effects of Artificial Air Negative Ions on High-Altitude Acclimatization, Serum HIF1, and PWC170 Index
A study testing Air negative ion intervention study and No air negative ion intervention in people with Negative Air Ions and Altitude Sickness, run by The First Hospital of Putian City, Putian, Fujian at 1 site in China.
Trial summary
To explore the effects of negative ions generated by an ion converter on the high-altitude acclimatization of healthy populations and their impact on serum HIF1 (hypoxia-inducible factor 1) and PWC170 index after entering high-altitude areas. Read more about this study
- Who is it for?
- Ages 18 to 30 years, men onlyHealthy volunteers can take part
- Conditions the study is for
- Negative Air Ions, Altitude Sickness, High-altitude Adaptation
- What is being tested?
- Air negative ion intervention study and No air negative ion intervention
- Type of treatment
- Medical device
- Could I receive a placebo?
- Yes, some participants may receive a placebo
- How many people
- 60 participants
- Where
- 1 siteChina
- Study dates
- 1 May 2022to 11 Nov 2024
- 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 30 years
- Men only
- Healthy volunteers accepted
- Adult
Who may be able to join
- healthy non-smoking men aged 18 or above and long-term residents of the plains no history of high-altitude exposure in the past 6 months no cardiovascular or pulmonary diseases not currently taking any medications.
Who cannot join
- Tibetan ethnicity long-term residents of high altitudes history of high-altitude exposure in the past 6 months currently taking cold medicine, vitamins, corticosteroids, or other drugs presence of acute or chronic illnesses
Trial locations and contacts
1 site in 1 country.
About this study
Official title: The Effects of Artificial Air Negative Ions on High-Altitude Acclimatization
To explore the effects of negative ions generated by an ion converter on the high-altitude acclimatization of healthy populations and their impact on serum HIF1 (hypoxia-inducible factor 1) and PWC170 index after entering high-altitude areas.
Read the detailed description
Objective: To explore the effects of negative ions generated by an ion converter on the high-altitude acclimatization of healthy populations and their impact on serum HIF1 and PWC170 index after entering high-altitude areas.
Methods: Sixty healthy adults were randomly divided into two groups: an air negative ion intervention group (observation group) of 30 participants and a non-air negative ion intervention group (control group) of 30 participants. Air negative ion intervention was conducted one week before entering high-altitude areas, lasting for 8 hours each day. Before entering high-altitude areas, measurements were taken for height, weight, blood pressure, heart rate, routine blood tests, routine urine tests, biochemical profiles, blood oxygen saturation, and HIF1 (hypoxia-inducible factor 1). One week after entering high-altitude areas, the above indicators were retested, and the PWC170 index was calculated to evaluate changes in endurance during high-altitude activities.
- Being tested
- Air negative ion intervention study, No air negative ion intervention
- Keywords
- Air negative ions, High-Altitude Adaptation, high-altitude reactions, PWC170
- Medical subject headings
- Altitude Sickness
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Air negative ion intervention studyDevice
The observation group received air negative ion intervention every night for one week before entering the plateau (from 22:00 to 06:00). Before entering the plateau, they were in Putian City, China, where the temperature was about 28°C, humidity was about 68%, and the concentration of negative ions was approximately 800/cm³. The air negative ion converter used was the Mi Energy ET-21 model from RELTEC Medical Devices Corporation. Air negative and positive ion concentrations were measured using an ion detector (NKMH-103, HOKUTO, Japan) to ensure that each participant's room had a negative ion concentration of around 100,000/cm³.
No air negative ion interventionDevice
No air negative ion intervention
| Study group | Role | What they receive |
|---|---|---|
| Air negative ion intervention study | Experimental | Arm 1: observation group (air negative ion intervention group) consisting of 30 individuals Receives: Device: Air negative ion intervention study |
| No air negative ion intervention | Placebo comparator | Arm 2: control group (no air negative ion intervention group) consisting of 30 individuals Receives: Device: No air negative ion intervention |
What is being measured
The primary outcome is the main question the study is designed to answer.
High-Altitude Acclimatization
Following their ascent to high altitudes, all participants completed the Acute Mountain Sickness (AMS) questionnaire daily, with AMS diagnosis based on the Lake Louise Criteria.
Measured: two weeks
Secondary outcomes (1)
PWC170 Index
This study employed a two-stage quantitative load stepping exercise. The first stage involved stepping at a height of 30cm, a speed of 24 steps/min, and a duration of 4 minutes. After a 4-minute rest, the second stage was performed with the same step height and duration as the first stage but at a speed of 35 steps/min controlled by a metronome. Power and PWC170 were calculated using the following formulas: Power (Kg · m / min) = 4/3 [Body weight (Kg) × Step height (m) × Total number of step-ups and step-downs (b/min)] PWC170 (Kg · m / min) = N1 + (N2 - N1) [(170 - f1) / (f2 - f1)] Where N1 and N2 represent the power in the first and second stage loads, and f1 and f2 are the immediate pulse rate at the first and second stage loads (b/min).
Measured: one day
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted9 Jul 2025
- Study start1 May 2022
- Primary completion10 Oct 2024
- Study completion11 Nov 2024
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Negative Air IonsStudies 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
- Prevention
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Enrolment
- 60 participants (actual)
Sponsor and investigators
- Lead sponsor
- The First Hospital of Putian City, Putian, Fujian
- Sponsor type
- Other government
- Responsible party
- Principal investigator, Zhizhong Chen, The First Hospital of Putian City, Putian, Fujian
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT07056751
- Sponsor's protocol ID
- FirstHPCF
- Acronym
- 2022JW
- Status last verified
- Jul 2025
- First submitted
- 22 Jun 2025
- Last updated
- 15 Jul 2025
- Results posted
- No
- Data monitoring committee
- Yes
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- Yes
Study at a glance
From the registry record, last updated by the sponsor on 15 Jul 2025. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- The Effects of Artificial Air Negative Ions on High-Altitude Acclimatization
- ClinicalTrials.gov ID
- NCT07056751
- Acronym / sponsor ID
- 2022JW / FirstHPCF
- Keywords
- Air negative ions, High-Altitude Adaptation, high-altitude reactions, PWC170
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 60 participants (actual)
- Lead sponsor
- The First Hospital of Putian City, Putian, FujianOther government
- Study start
- 1 May 2022 (actual)
- Primary completion
- 10 Oct 2024 (actual)
- Study completion
- 11 Nov 2024 (actual)
- First posted
- 9 Jul 2025 (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.
To explore the effects of negative ions generated by an ion converter on the high-altitude acclimatization of healthy populations and their impact on serum HIF1 (hypoxia-inducible factor 1) and PWC170 index after entering high-altitude areas.
Detailed description
Objective: To explore the effects of negative ions generated by an ion converter on the high-altitude acclimatization of healthy populations and their impact on serum HIF1 and PWC170 index after entering high-altitude areas.
Methods: Sixty healthy adults were randomly divided into two groups: an air negative ion intervention group (observation group) of 30 participants and a non-air negative ion intervention group (control group) of 30 participants. Air negative ion intervention was conducted one week before entering high-altitude areas, lasting for 8 hours each day. Before entering high-altitude areas, measurements were taken for height, weight, blood pressure, heart rate, routine blood tests, routine urine tests, biochemical profiles, blood oxygen saturation, and HIF1 (hypoxia-inducible factor 1). One week after entering high-altitude areas, the above indicators were retested, and the PWC170 index was calculated to evaluate changes in endurance during high-altitude activities.
Study design
- Primary purpose
- Prevention
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Air negative ion intervention study | Experimental | Device: Air negative ion intervention studyArm 1: observation group (air negative ion intervention group) consisting of 30 individuals |
| No air negative ion intervention | Placebo comparator | Device: No air negative ion interventionArm 2: control group (no air negative ion intervention group) consisting of 30 individuals |
Who may qualify
- Ages
- 18 to 30 years
- Sex
- Male only
- Healthy volunteers
- Accepted
- Age groups
- Adult
Key inclusion criteria (1 listed)
- healthy non-smoking men aged 18 or above and long-term residents of the plains no history of high-altitude exposure in the past 6 months no cardiovascular or pulmonary diseases not currently taking any medications.
Key exclusion criteria (1 listed)
- Tibetan ethnicity long-term residents of high altitudes history of high-altitude exposure in the past 6 months currently taking cold medicine, vitamins, corticosteroids, or other drugs presence of acute or chronic illnesses
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 |
|---|---|---|
| Air negative ion intervention studyThe observation group received air negative ion intervention every night for one week before entering the plateau (from 22:00 to 06:00). Before entering the plateau, they were in Putian City, China, where the temperature was about 28°C, humidity was about 68%, and the concentration of negative ions was approximately 800/cm³. The air negative ion converter used was the Mi Energy ET-21 model from RELTEC Medical Devices Corporation. Air negative and positive ion concentrations were measured using an ion detector (NKMH-103, HOKUTO, Japan) to ensure that each participant's room had a negative ion concentration of around 100,000/cm³. | Device | Air negative ion intervention study |
| No air negative ion interventionNo air negative ion intervention | Device | No air negative ion intervention |
Primary outcome
High-Altitude Acclimatization
Time frame: two weeks
Following their ascent to high altitudes, all participants completed the Acute Mountain Sickness (AMS) questionnaire daily, with AMS diagnosis based on the Lake Louise Criteria.
1 secondary outcome
PWC170 Index
Time frame: one day
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 15 Jul 2025.
- Individual participant dataSharing planned: Yes
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.
The record lists no contact. Use the official record to reach the sponsor.
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Air negative ion intervention study and No air negative ion intervention in people with Negative Air Ions and Altitude Sickness, run by The First Hospital of Putian City, Putian, Fujian 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 1 inclusion and 1 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: finished, as of the sponsor's last update on 15 Jul 2025. 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. Some participants in this study may receive a placebo. 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?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
High-Altitude Acclimatization (time frame: two weeks). 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 15 Jul 2025.