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Completed

NCT Number: NCT07056751

The Effects of Artificial Air Negative Ions on High-Altitude Acclimatization, Serum HIF1, and PWC170 Index

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.

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Key information

Conditions

Negative Air Ions Altitude Sickness High-altitude Adaptation Respiration Disorders Respiratory Tract Diseases

Age range

18 year–30 year

Sex eligibility

Male

Study type

Interventional

Phase

Not applicable

Primary location

The Ethics Committee of Putian 95 Hospital

Putian, Fujian, 351100, China

About this study

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.

Who can participate

Healthy volunteers accepted: Yes

Only the study team can determine whether someone qualifies for participation.

Inclusion criteria

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.

Exclusion criteria

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

Treatment and study plan

Air negative ion intervention study

Device

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 intervention

Device

No air negative ion intervention

Primary outcomes

  1. 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.

Secondary outcomes

  1. PWC170 Index

    Time frame: one day

    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).

Sponsors and collaborators

Lead sponsor

The First Hospital of Putian City, Putian, Fujian

Other Gov

Registry information

Official study title

The Effects of Artificial Air Negative Ions on High-Altitude Acclimatization

Acronym: 2022JW

Important dates

Study start
2022
Primary completion
2024
Study completion
2024
First posted
Jul 9, 2025
Registry last updated
Jul 15, 2025

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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