High Altitude Pulmonary HypertensionNCT06489717
High Altitude Residents With High Altitude Pulmonary Hypertension (HAPH), SDB Assessed at HA (3200 m) vs LA (760 m)
A study testing SDB assessment in people with High Altitude Pulmonary Hypertension, run by University of Zurich at 1 site in Kyrgyzstan.
Trial summary
To study the effect of relocation from 3200m (Aksay) to 760m (Bishkek) in highlanders with High Altitude Pulmonary Hypertension (HAPH) who permanently live >2500m on sleep disordered breathing Read more about this study
- Who is it for?
- Ages 18 to 80 years
- Conditions the study is for
- High Altitude Pulmonary Hypertension
- What is being tested?
- SDB assessment
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 24 participants
- Where
- 1 siteKyrgyzstan
- Study dates
- 2 Jul 2024to 12 Jul 2024
- Phase
- Interventional
- Are there results?
- None posted in the registry
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 to 80 years
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- Permanently living >2500 m
- HAPH diagnosed with a minimum RV/RA of 30 mmHg assessed by echocardiography at an altitude of 3200 m
- Written informed consent
Who cannot join
- Highlanders who cannot follow the study investigations,
- Patients with moderate to severe concomitant lung disease (FEV1<70% or forced vital capacity <70%), severe parenchymal lung disease, heavy smoking >20 cigarettes/day or >20 pack-years.
- Coexistent unstable systemic hypertension or coronary artery disease that required adjustment of medication within the last 2 months
- Regular use of medication that affects control of breathing (benzodiazepines, opioids, acetazolamide)
Trial locations and contacts
1 site in 1 country.
About this study
Official title: Comparative Study of Sleep Disordered Breathing (SDB) in Patients With High Altitude Pulmonary Hypertension Permanently Residing Above 2500 Meters When Assessed Near Resident High Altitude (HA) at 3200 m vs. at Low Altitude (LA) 760 m
To study the effect of relocation from 3200m (Aksay) to 760m (Bishkek) in highlanders with High Altitude Pulmonary Hypertension (HAPH) who permanently live >2500m on sleep disordered breathing
Read the detailed description
This research in highlanders with HAPH diagnosed by echocardiography and defined by a RV/RA >30 mmHg who permanently live at HA >2500 m will have nocturnal respiratory sleep studies near their living altitude in Aksay at 3200 m and on night 1 and 6 at 760m after relocation.
- Conditions
- High Altitude Pulmonary Hypertension
- Being tested
- SDB assessment
- Keywords
- Pulmonary Hypertension, Hypoxia, High Altitude, Sleep disordered breathing
- Medical subject headings
- Pulmonary edema of mountaineers, Hypertension, Pulmonary, Hypoxia, Altitude Sickness, Sleep Apnea Syndromes
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
SDB assessmentOther
SDB will be assessed by respiratory polygraphy according to clinical standards
| Study group | Role | What they receive |
|---|---|---|
| Assessments at 3200 m and 760 m, respectively | Experimental | Participants will have a SDB assessment near their resident altitude at 3200 m and after relocation to 760 m after 1 and 7 days Receives: Other: SDB assessment |
What is being measured
The primary outcome is the main question the study is designed to answer.
Mean nocturnal SpO2 during the first night at LA vs HA
Change in mean nocturnal SpO2 (%) between LA (760 m) vs HA (3200 m)
Measured: night 1 at 760 m compared to 3200 m.
Secondary outcomes (8)
Mean nocturnal SpO2 during the sixth night at LA vs HA
Change in mean nocturnal SpO2 (%) between LA (760 m) vs HA (3200 m)
Measured: night 6 at 760 m compared to 3200 m.
Time spent with SpO2<90% at LA vs HA
Change in time spent with SpO2<90% between LA (760 m) vs HA (3200 m)
Measured: night 1 and night 6 at 760 m compared to 3200 m.
AHI at LA vs HA
Change in apnea-hypopnea index (AHI) between LA (760 m) vs HA (3200 m)
Measured: night 1 and night 6 at 760 m compared to 3200 m.
ODI at LA vs. HA
Change in oxygen desaturation index (ODI) between LA (760 m) vs HA (3200 m)
Measured: night 1 and night 6 at 760 m compared to 3200 m.
Time spent with periodic breathing at LA vs. HA
Change in time spent with periodic breathingbetween LA (760 m) vs HA (3200 m)
Measured: night 1 and night 6 at 760 m compared to 3200 m.
Heart rate variability at LA vs. HA
Change in heart rate variability between LA (760 m) vs HA (3200 m)
Measured: night 1 and night 6 at 760 m compared to 3200 m.
ECG markers of repolarization at LA vs. HA
Change in electrocardiogram (ECG) markers of repolarization (QT time) between LA (760 m) vs HA (3200 m)
Measured: night 1 and night 6 at 760 m compared to 3200 m.
pulse transit time drops at LA vs. HA
Change in pulse transit time drops between LA (760 m) vs HA (3200 m)
Measured: night 1 and night 6 at 760 m compared to 3200 m.
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted8 Jul 2024
- Study start2 Jul 2024
- Primary completion12 Jul 2024
- Study completion12 Jul 2024
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for High Altitude Pulmonary HypertensionStudies of the same condition, open and under way.
- More trials run by University of ZurichThe sponsor's other registered studies.
- 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
- Supportive care
- Allocation
- Not applicable
- Intervention model
- Single group
- Model description
- Each highlander with HAPH will be assessed for SDB at 3200 m and at 760 m according to a prospective study design
- Masking
- None (open label)
- Enrolment
- 24 participants (actual)
Sponsor and investigators
- Lead sponsor
- University of Zurich
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor
- Investigators
- Talant M Sooronbaev, Prof. Dr., Principal investigator, National Center of Cardiology and Internal Medicine named after academician M.MirrakhimovSilvia Ulrich, Prof. Dr., Principal investigator, University Hospital Zurich, Department of Pulmonology
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT06489717
- Sponsor's protocol ID
- HAPH_HAvsLA_SDB
- Status last verified
- Jan 2026
- First submitted
- 28 Jun 2024
- Last updated
- 22 Jan 2026
- Results posted
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- Undecided
Study at a glance
From the registry record, last updated by the sponsor on 22 Jan 2026. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Comparative Study of Sleep Disordered Breathing (SDB) in Patients With High Altitude Pulmonary Hypertension Permanently Residing Above 2500 Meters When Assessed Near Resident High Altitude (HA) at 3200 m vs. at Low Altitude (LA) 760 m
- ClinicalTrials.gov ID
- NCT06489717
- Acronym / sponsor ID
- HAPH_HAvsLA_SDB
- Conditions
- High Altitude Pulmonary Hypertension
- Keywords
- Pulmonary Hypertension, Hypoxia, High Altitude, Sleep disordered breathing
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 24 participants (actual)
- Lead sponsor
- University of ZurichUniversity, hospital or other
- Study start
- 2 Jul 2024 (actual)
- Primary completion
- 12 Jul 2024 (actual)
- Study completion
- 12 Jul 2024 (actual)
- First posted
- 8 Jul 2024 (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.
To study the effect of relocation from 3200m (Aksay) to 760m (Bishkek) in highlanders with High Altitude Pulmonary Hypertension (HAPH) who permanently live >2500m on sleep disordered breathing
Detailed description
This research in highlanders with HAPH diagnosed by echocardiography and defined by a RV/RA >30 mmHg who permanently live at HA >2500 m will have nocturnal respiratory sleep studies near their living altitude in Aksay at 3200 m and on night 1 and 6 at 760m after relocation.
Study design
- Primary purpose
- Supportive care
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Number of arms
- 1
- Model description
- Each highlander with HAPH will be assessed for SDB at 3200 m and at 760 m according to a prospective study design
| Arm | Type | Receives |
|---|---|---|
| Assessments at 3200 m and 760 m, respectively | Experimental | Other: SDB assessmentParticipants will have a SDB assessment near their resident altitude at 3200 m and after relocation to 760 m after 1 and 7 days |
Who may qualify
- Ages
- 18 to 80 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (3 listed)
- Permanently living >2500 m
- HAPH diagnosed with a minimum RV/RA of 30 mmHg assessed by echocardiography at an altitude of 3200 m
- Written informed consent
Key exclusion criteria (4 listed)
- Highlanders who cannot follow the study investigations,
- Patients with moderate to severe concomitant lung disease (FEV1<70% or forced vital capacity <70%), severe parenchymal lung disease, heavy smoking >20 cigarettes/day or >20 pack-years.
- Coexistent unstable systemic hypertension or coronary artery disease that required adjustment of medication within the last 2 months
- Regular use of medication that affects control of breathing (benzodiazepines, opioids, acetazolamide)
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 |
|---|---|---|
| SDB assessmentSDB will be assessed by respiratory polygraphy according to clinical standards | Other | Assessments at 3200 m and 760 m, respectively |
Primary outcome
Mean nocturnal SpO2 during the first night at LA vs HA
Time frame: night 1 at 760 m compared to 3200 m.
Change in mean nocturnal SpO2 (%) between LA (760 m) vs HA (3200 m)
8 secondary outcomes
Mean nocturnal SpO2 during the sixth night at LA vs HA
Time frame: night 6 at 760 m compared to 3200 m.
Time spent with SpO2<90% at LA vs HA
Time frame: night 1 and night 6 at 760 m compared to 3200 m.
AHI at LA vs HA
Time frame: night 1 and night 6 at 760 m compared to 3200 m.
ODI at LA vs. HA
Time frame: night 1 and night 6 at 760 m compared to 3200 m.
Time spent with periodic breathing at LA vs. HA
Time frame: night 1 and night 6 at 760 m compared to 3200 m.
Heart rate variability at LA vs. HA
Time frame: night 1 and night 6 at 760 m compared to 3200 m.
ECG markers of repolarization at LA vs. HA
Time frame: night 1 and night 6 at 760 m compared to 3200 m.
pulse transit time drops at LA vs. HA
Time frame: night 1 and night 6 at 760 m compared to 3200 m.
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 22 Jan 2026.
- Individual participant dataSharing planned: Undecided
Related trials for High Altitude Pulmonary Hypertension
Not yet recruiting
Assessment of Total Pulmonary Resistance sPAP/CO Between High Altitude HA vs. Sea Level LA in Healthy Individuals H
High Altitude, Healthy Adult
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Assessment of Total Pulmonary Resistance sPAP/CO Between Sea Level LA vs. High Altitude HA After Re-ascent in Patients With Pulmonary Arterial Hypertension PAH
Pulmonary Arterial Hypertension (PAH), Pulmonary Vascular Disease
Not yet recruiting
Assessment of Total Pulmonary Resistance sPAP/CO Between Sea Level LA vs. High Altitude HA After Re-ascent in Healthy Individuals
High Altitude, Healthy
Not yet recruiting
Assessment of Six-minute Walking Distance 6MWD Between High Altitude HA vs. Sea Level LA in Patients With Pulmonary Arterial Hypertension PAH
Pulmonary Arterial Hypertension (PAH), Pulmonary Vascular Disease
Not yet recruiting
Assessment of Total Pulmonary Resistance sPAP/CO Between High Altitude HA vs. Sea Level LA in Patients With Pulmonary Arterial Hypertension PAH
Pulmonary Arterial Hypertension (PAH), Pulmonary Vascular Disease
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. This study is not recruiting at the moment.
Talant M Sooronbaev, Prof. Dr. principal investigator
National Center of Cardiology and Internal Medicine named after academician M.Mirrakhimov
Silvia Ulrich, Prof. Dr. principal investigator
University Hospital Zurich, Department of Pulmonology
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing SDB assessment in people with High Altitude Pulmonary Hypertension, run by University of Zurich at 1 site in Kyrgyzstan.
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 4 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: finished, as of the sponsor's last update on 22 Jan 2026. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in Kyrgyzstan. 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?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Mean nocturnal SpO2 during the first night at LA vs HA (time frame: night 1 at 760 m compared to 3200 m.). 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 22 Jan 2026.