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.

Completed

Finished. The study has ended and is not enrolling. Results may be posted on the official record.

Official record

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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

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.

Kyrgyzstan1 site

Aksay Medical Center
Aksay Plateau, Naryn, Kyrgyzstan

Other trials in Kyrgyzstan

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 groups in NCT06489717
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.

2 Jul 202412 Jul 2024

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.
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)

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

Want to know more?

The sponsor has not listed a contact. The official record may have more details.

Talk to your doctor first and take this page with you. Only the study team can confirm whether you can join.

Questions to ask the study team

What is the study trying to find out?
What would I need to do, and how often would I visit?
Could I receive a placebo instead of the treatment?
What are the possible risks and benefits for me?
Will it cost me anything? Are travel or time paid for?
Can I keep seeing my own doctor during the study?
What happens when the study ends?

See locations

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