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

NCT ID: NCT07056751

Last Updated: 2025-07-15

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

Get a concise snapshot of the trial, including recruitment status, study phase, enrollment targets, and key timeline milestones.

Recruitment Status

COMPLETED

Clinical Phase

NA

Total Enrollment

60 participants

Study Classification

INTERVENTIONAL

Study Start Date

2022-05-01

Study Completion Date

2024-11-11

Brief Summary

Review the sponsor-provided synopsis that highlights what the study is about and why it is being conducted.

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

Dive into the extended narrative that explains the scientific background, objectives, and procedures in greater depth.

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.

Conditions

See the medical conditions and disease areas that this research is targeting or investigating.

Negative Air Ions Altitude Sickness High-altitude Adaptation

Study Design

Understand how the trial is structured, including allocation methods, masking strategies, primary purpose, and other design elements.

Allocation Method

RANDOMIZED

Intervention Model

PARALLEL

Primary Study Purpose

PREVENTION

Blinding Strategy

NONE

Study Groups

Review each arm or cohort in the study, along with the interventions and objectives associated with them.

Air negative ion intervention study

Arm 1: observation group (air negative ion intervention group) consisting of 30 individuals

Group Type EXPERIMENTAL

Air negative ion intervention study

Intervention Type 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

Arm 2: control group (no air negative ion intervention group) consisting of 30 individuals

Group Type PLACEBO_COMPARATOR

No air negative ion intervention

Intervention Type DEVICE

No air negative ion intervention

Interventions

Learn about the drugs, procedures, or behavioral strategies being tested and how they are applied within this trial.

Air negative ion intervention study

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.

Intervention Type DEVICE

No air negative ion intervention

No air negative ion intervention

Intervention Type DEVICE

Eligibility Criteria

Check the participation requirements, including inclusion and exclusion rules, age limits, and whether healthy volunteers are accepted.

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
Minimum Eligible Age

18 Years

Maximum Eligible Age

30 Years

Eligible Sex

MALE

Accepts Healthy Volunteers

Yes

Sponsors

Meet the organizations funding or collaborating on the study and learn about their roles.

The First Hospital of Putian City, Putian, Fujian

OTHER_GOV

Sponsor Role lead

Responsible Party

Identify the individual or organization who holds primary responsibility for the study information submitted to regulators.

Zhizhong Chen

Doctor

Responsibility Role PRINCIPAL_INVESTIGATOR

Locations

Explore where the study is taking place and check the recruitment status at each participating site.

The Ethics Committee of Putian 95 Hospital

Putian, Fujian, China

Site Status

Countries

Review the countries where the study has at least one active or historical site.

China

Other Identifiers

Review additional registry numbers or institutional identifiers associated with this trial.

FirstHPCF

Identifier Type: -

Identifier Source: org_study_id

More Related Trials

Additional clinical trials that may be relevant based on similarity analysis.