High-altitude PolycythemiaNIV-HAPCNCT07600086
High-Altitude Polycythemia Study
A study testing Non-invasive ventilator in people with High-altitude Polycythemia and HAPC, run by Tibet Autonomous Region People's Hospital at 2 sites in China.
Trial summary
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. Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- High-altitude Polycythemia, HAPC
- What is being tested?
- Non-invasive ventilator
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 70 participants
- Where
- 2 sitesChina
- Study dates
- May 2026to Dec 2028
- Phase
- Interventional
- Are there results?
- Not yet: the study is under way
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 years and older
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- Diagnosed with high-altitude polycythemia (HAPC).
- Aged 18 years or older, with no gender restriction.
- Voluntarily participate in the study and sign the informed consent form.
Who cannot join
- Disturbance of consciousness.
- Inability to independently clear airway secretions, with the risk of aspiration.
- Severe upper gastrointestinal bleeding.
- Hemodynamic instability.
- Upper airway obstruction.
- Un drained pneumothorax or mediastinal emphysema.
- Conditions that prevent mask wearing, such as facial trauma or deformity.
- Patient non-compliance.
Trial locations and contacts
2 sites in 1 country. Contact the study team or a site near you to ask about taking part.
China2 sites
People's Hospital of Xizang Autonomous Region；Lhasa, Xizang Autonomous Region, China, 850000
Xizang
Xizang Autonomous Region People's Hospital
Xizang
Yang li hui, 13638992795, 1640794768@qq.com
About this study
Official title: 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.
Read more
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.
- Conditions
- High-altitude Polycythemia, HAPC
- Being tested
- Non-invasive ventilator
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Non-invasive ventilatorOther
Treatment with non-invasive ventilator (CPAP, BiPAP) in the intervention group.
| Study group | Role | What they receive |
|---|---|---|
| Intervention Group (NIV Treatment) | Experimental | 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. Receives: Other: Non-invasive ventilator |
| Control Group (Standard Care Only) | No intervention | 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 being measured
The primary outcome is the main question the study is designed to answer.
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.
Measured: Baseline, 3 months, 6 months after treatment initiation
Secondary outcomes (1)
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.
Measured: Baseline, 6 months
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted20 May 2026
- Study startMay 2026 (estimated)
- Primary completionMar 2027 (estimated)
- Study completionDec 2028 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for High-altitude PolycythemiaStudies 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
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Enrolment
- 70 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Tibet Autonomous Region People's Hospital
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Gesang Lobb, Tibet Autonomous Region People's Hospital
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT07600086
- Sponsor's protocol ID
- ME-TBHP-25-014
- Acronym
- NIV-HAPC
- Status last verified
- May 2026
- First submitted
- 14 May 2026
- Last updated
- 20 May 2026
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Study at a glance
From the registry record, last updated by the sponsor on 20 May 2026. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Clinical Study on the Therapeutic Effect of Non-Invasive Ventilator in the Treatment of High-Altitude Polycythemia
- ClinicalTrials.gov ID
- NCT07600086
- Acronym / sponsor ID
- NIV-HAPC / ME-TBHP-25-014
- Conditions
- High-altitude Polycythemia, HAPC
- Study type
- Interventional
- Recruitment status
- Not yet recruiting
- Enrolment
- 70 participants (estimated)
- Lead sponsor
- Tibet Autonomous Region People's HospitalUniversity, hospital or other
- Study start
- May 2026 (estimated)
- Primary completion
- Mar 2027 (estimated)
- Study completion
- Dec 2028 (estimated)
- First posted
- 20 May 2026 (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.
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 design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Intervention Group (NIV Treatment) | Experimental | Other: Non-invasive ventilatorPatients 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. |
| Control Group (Standard Care Only) | No intervention | –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. |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (3 listed)
- Diagnosed with high-altitude polycythemia (HAPC).
- Aged 18 years or older, with no gender restriction.
- Voluntarily participate in the study and sign the informed consent form.
Key exclusion criteria (8 listed)
- Disturbance of consciousness.
- Inability to independently clear airway secretions, with the risk of aspiration.
- Severe upper gastrointestinal bleeding.
- Hemodynamic instability.
- Upper airway obstruction.
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 |
|---|---|---|
| Non-invasive ventilatorTreatment with non-invasive ventilator (CPAP, BiPAP) in the intervention group. | Other | Intervention Group (NIV Treatment) |
Primary outcome
Change in Hemoglobin (Hb) Concentration
Time frame: Baseline, 3 months, 6 months after treatment initiation
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.
1 secondary outcome
Change in Serum uric acid and blood lipid levels
Time frame: Baseline, 6 months
Results and safety
This study is still under way. Results are not available in the source record yet.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 20 May 2026.
- Individual participant dataSharing planned: No
Related trials for High-altitude Polycythemia
Not yet recruitingPhase 3
Remote Ischemic Conditioning for High Altitude Polycythemia in High-Altitude Immigrant Populations
High Altitude Polycythemia
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.
2 sites in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Non-invasive ventilator in people with High-altitude Polycythemia and HAPC, run by Tibet Autonomous Region People's Hospital at 2 sites 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 3 inclusion and 8 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: opening soon, as of the sponsor's last update on 20 May 2026. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 2 sites 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. 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?
This study is still under way. Results are not available in the source record yet.
How can a doctor refer a patient or contact the research team?
Contact Gesang Luobu, MD (8618108912487, kelsangnorbu@hotmail.com), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Change in Hemoglobin (Hb) Concentration (time frame: Baseline, 3 months, 6 months after treatment initiation). 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 20 May 2026.