High-Altitude Polycythemia Study (NIV-HAPC)

Clinical Study on the Therapeutic Effect of Non-Invasive Ventilator in the Treatment of High-Altitude Polycythemia

This study aims to evaluate the clinical efficacy of non-invasive ventilation (NIV) in treating patients with high-altitude polycythemia (HAPC).

Participants will be enrolled according to the international diagnostic criteria for high-altitude polycythemia. The study will use both retrospective cohort and prospective study methods.

All participants will receive standard basic care. In addition, the intervention group will receive non-invasive ventilation treatment using either BiPAP or CPAP mode.

Key measurements, including routine blood tests, liver function, renal function, uric acid, blood lipid profile, electrocardiogram and echocardiography, will be collected as primary and secondary outcome measures to assess the effects of the treatment.

Study Overview

• Status: Not yet recruiting
• Conditions: High-altitude Polycythemia; HAPC
• Intervention / Treatment: Other: Non-invasive ventilator

• Study Type: Interventional
• Enrollment (Estimated): 70
• Phase: Not Applicable

Contacts and Locations

• Study Contact: Name: Gesang Luobu, MD; Phone Number: 8618108912487; Email: kelsangnorbu@hotmail.com

Study Locations

• China
  • Xizang, China
    • People's Hospital of Xizang Autonomous Region；Lhasa, Xizang Autonomous Region, China, 850000
  • Xizang, China
    • Xizang Autonomous Region People's Hospital
    • Contact: Yang li hui; Phone Number: 13638992795; Email: 1640794768@qq.com

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: Adult; Older Adult
• Accepts Healthy Volunteers: No

Description

Inclusion Criteria:

1. Diagnosed with high-altitude polycythemia (HAPC).
2. Aged 18 years or older, with no gender restriction.
3. Voluntarily participate in the study and sign the informed consent form.

Exclusion Criteria:

1. Disturbance of consciousness.
2. Inability to independently clear airway secretions, with the risk of aspiration.
3. Severe upper gastrointestinal bleeding.
4. Hemodynamic instability.
5. Upper airway obstruction.
6. Un drained pneumothorax or mediastinal emphysema.
7. Conditions that prevent mask wearing, such as facial trauma or deformity.
8. Patient non-compliance.

Study Plan

How is the study designed?

Design Details

• Primary Purpose: Treatment
• Allocation: Randomized
• Interventional Model: Parallel Assignment
• Masking: None (Open Label)

Number of Arms

2

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
Experimental: Intervention Group (NIV Treatment); Patients receive standard basic care plus long-term non-invasive ventilation (NIV) therapy with CPAP or BiPAP mode. Treatment is administered daily, and efficacy is evaluated 3 to 6 months after the intervention.	Other: Non-invasive ventilator; Treatment with non-invasive ventilator (CPAP, BiPAP) in the intervention group.
No Intervention: Control Group (Standard Care Only); Patients receive only standard basic care without non-invasive ventilation therapy. Efficacy is evaluated at the same time points (3 and 6 months) as the intervention group for comparison.

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Change in Hemoglobin (Hb) Concentration	The primary endpoint is the absolute change in blood hemoglobin concentration (g/dL) from baseline to 3-month and 6-month follow-up. A reduction in hemoglobin level is defined as a clinically significant improvement in high altitude polycythemia status.	Baseline, 3 months, 6 months after treatment initiation

Secondary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Change in Serum uric acid and blood lipid levels	Changes in serum uric acid, total cholesterol, triglycerides, high-density lipoprotein cholesterol (HDL-C), and low-density lipoprotein cholesterol (LDL-C) will be measured.	Baseline, 6 months

Collaborators and Investigators

• Sponsor: Tibet Autonomous Region People's Hospital

Study record dates

Study Major Dates

• Study Start (Estimated): May 1, 2026
• Primary Completion (Estimated): March 1, 2027
• Study Completion (Estimated): December 1, 2028

Study Registration Dates

• First Submitted: May 14, 2026
• First Submitted That Met QC Criteria: May 14, 2026
• First Posted (Actual): May 20, 2026

Study Record Updates

• Last Update Posted (Actual): May 20, 2026
• Last Update Submitted That Met QC Criteria: May 14, 2026
• Last Verified: May 1, 2026

More Information

Terms related to this study

• Other Study ID Numbers: ME-TBHP-25-014

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: NO

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: No