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

NCT07056751 | Completed DMC

• 1 other identifier: FirstHPCF
• Study Type: interventional
• Target: 60
• Locations: 1 country
• Sites: 1

Brief 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.

Conditions

Negative Air Ions; Altitude Sickness; High-altitude Adaptation

Keywords

Air negative ions; High-Altitude Adaptation; high-altitude reactions; PWC170

Outcome Measures

Primary Outcomes (1)

• 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.

  two weeks

Secondary Outcomes (1)

• PWC170 Index

  one day

Study Arms (2)

Air negative ion intervention study

EXPERIMENTAL

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

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

Device: No air negative ion intervention

Interventions

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.

Air negative ion intervention study

No air negative ion intervention DEVICE

No air negative ion intervention

No air negative ion intervention

Eligibility Criteria

• Age: 18 Years - 30 Years
• Sex: male
• Healthy Volunteers: Yes
• Age Groups: Adult (18-64)

You may qualify if:

• 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.

You may not qualify if:

• 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

Sponsors & Collaborators

• The First Hospital of Putian City, Putian, Fujian: lead

Study Sites (1)

The Ethics Committee of Putian 95 Hospital

Putian, Fujian, 351100, China

Location

MeSH Terms

Conditions

Altitude Sickness

Condition Hierarchy (Ancestors)

Respiration Disorders; Respiratory Tract Diseases

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: NONE
• Purpose: PREVENTION
• Intervention Model: PARALLEL
• Sponsor Type: OTHER GOV
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Doctor

Study Record Dates

• First Submitted: June 22, 2025
• First Posted: July 9, 2025
• Study Start: May 1, 2022
• Primary Completion: October 10, 2024
• Study Completion: November 11, 2024
• Last Updated: July 15, 2025

Record last verified: 2025-07

Data Sharing

• IPD Sharing: Will share
• Shared Documents: STUDY PROTOCOL
• Time Frame: 07.01.2025-no end date
• Access Criteria: Scientific researcher

Locations

CN (1)