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Pulmonary Arterial Hypertension (PAH)NCT07801963

Sleep-Assessment in Patients Between High Altitude HA vs. Sea Level LA in Patients With Pulmonary Arterial Hypertension PAH

A study testing Descent to sea level in people with Pulmonary Arterial Hypertension (PAH) and Pulmonary Vascular Disease, run by Silvia Ulrich Somaini at 1 site in Switzerland.

Not yet recruiting

Opening soon. The study is approved but enrolment has not started yet. Sites may already take enquiries.

Sites and contacts
Official record
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Trial summary

To study the effect of relocation from high altitude (Quito Ecuador: 2850m) to sea level on sleeping parameters by polygraphy in patients with pulmonary arterial hypertension PAH, who live permanently >2600m. Read more about this study

Who is it for?
Ages 18 to 80 years
What is being tested?
Descent to sea level
Could I receive a placebo?
No, everyone receives an active treatment
How many people
20 participants
Where
1 siteSwitzerland
Study dates
25 Sep 2026to 31 Dec 2026
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 to 80 years
  • All sexes
  • No healthy volunteers
  • Adult, Older adult

Who may be able to join

  • Adult patients aged 18-80 years and of all genders
  • Permanent residence > 2600 m
  • Diagnosis of pulmonary arterial hypertension PAH (PAHHA-Group) according to guidelines
  • Patients are stable on therapy
  • NYHA (new york heart association) functional class I-III.
  • written informed consent to participate in the study.

Who cannot join

  • Age <18 years or >80 years
  • unstable condition
  • Patients who cannot follow the study investigations
  • Patient permanently living < 2600m.
  • Patients who traveled and stayed overnight at altitudes <2000 m in the past 4 weeks.
  • Patients with moderate to severe concomitant lung disease (FEV1<70% or forced vital capacity <70%), severe parenchymal lung disease, severe smokers (>20 cigarettes/day)
Show all 9Show fewer
  • Severely hypoxemic patients at Quito permanently having persistent SpO2 (oxygen saturation by pulseoximetry) <80% on ambient air.
  • Patient with a non-corrected ventricular septum defect
  • Relevant concomitant other disease of the heart, kidney, liver, blood (anemia hemoglobin<11 g/dl)

Trial locations and contacts

1 site in 1 country. Contact the study team or a site near you to ask about taking part.

Silvia Ulrich, Prof. Dr. med. contact

+41442552220

silvia.ulrich@usz.ch

Michael Furian, Prof. Dr. sc. ETH contact

+41442552220

Switzerland1 site

  • University Hospital of Zurich

    Zurich, 8091

Other trials in Switzerland

About this study

Official title: Effect of a One-week Descent From 2850m to Sea Level and Re-ascent in Patients With Pulmonary Arterial Hypertension and Healthy Controls Permanently Living > 2600m on Pulmonary Hemodynamics, Exercise Capacity, Blood Oxygenation, Sleep Disordered Breathing and Further Outcomes

To study the effect of relocation from high altitude (Quito Ecuador: 2850m) to sea level on sleeping parameters by polygraphy in patients with pulmonary arterial hypertension PAH, who live permanently >2600m.

Read the detailed description

The aim of this research is to investigate sleeping parameters by polygraphy before and after relocation (high altitude near their living altitude vs. sea level) in patients with diagnosed pulmonary arterial hypertension according to guidelines, who permanently live at high altitude over 2600m

Being tested
Descent to sea level
Keywords
Pulmonary Arterial Hypertension (PAH), Hypoxia, High Altitude, Pulmonary Hypertension, Polygraphy, Sleep, Sleep disordered breathing SDB, Pulmonary vascular disease
Medical subject headings
Pulmonary Arterial Hypertension, Sleep Apnea Syndromes, Altitude Sickness, Hypoxia, Hypertension, Pulmonary

What participants receive

What participants receive. In a randomised study each person is assigned to one group by chance.

  • Descent to sea levelBehavioural

    Descent from 2850m to sea level with a stay for 7 days and re-ascent back to 2850m

Study groups in NCT07801963
Study groupRoleWhat they receive
Sleep-parameters at 2850m and at sea levelExperimentalAssessment of sleep-parameters by polygraphy in patients with pulmonary arterial hypertension at 2850m and at sea level
Receives: Behavioral: Descent to sea level

What is being measured

The primary outcome is the main question the study is designed to answer.

  1. Mean nocturnal SpO2 after 7 days at sea level

    Difference in mean nocturnal SpO2 between 2850m and Night 7 at sea level in patients with pulmonary arterial hypertension

    Measured: From high altitude (2850m) to night 7 at sea level

Secondary outcomes (19)

  1. Time spent with low SpO2 after 7 days at sea level

    Difference/change in time spent with low SpO2 (< 90% and < 80%) between 2850m and night 7 at sea level in patients with pulmonary arterial hypertension

    Measured: From high altitude (2850m) to night 7 at sea level

  2. Apnoea-Hypopnoea-Index AHI after 7 days at sea level

    Difference/change in nocturnal apnoea-hypopnoea-index between 2850m and night 7 at sea level in patients with pulmonary arterial hypertension

    Measured: From high altitude (2850m) to night 7 at sea level

  3. Oxygen-Desaturation-Index ODI after 7 days at sea level

    Difference/change in nocturnal Oxygen-Desaturation-Index ODI between 2850m and night 7 at sea level in patients with pulmonary arterial hypertension

    Measured: From high altitude (2850m) to night 7 at sea level

  4. Nocturnal cardiovascular autonomic control after 7 days at sea level

    Difference/change in nocturnal cardiovascular autonomic control by heart rate (variability) between 2850m and night 7 at sea level in patients with pulmonary arterial hypertension

    Measured: From high altitude (2850m) to night 7 at sea level

  5. Acclimatization-Effect of mean nocturnal SpO2 at sea level

    Difference/change in mean nocturnal SpO2 at night 1 and night 7 within a stay at sea level of 7 days (after relocation from high altitude) in patients with pulmonary arterial hypertension

    Measured: From Night 1 to Night 7 at sea level

  6. Acclimatization-Effect of time spent with low SpO2 at sea level

    Difference/change in time spent with low SpO2 (< 90% and < 80%) at night 1 and night 7 within a stay at sea level of 7 days (after relocation from high altitude) in patients with pulmonary arterial hypertension

    Measured: From Night 1 to Night 7 at sea level

  7. Acclimatization-Effect of Apnoea-Hypopnoea-Index AHI at sea level

    Difference/change in nocturnal apnoea-hypopnoea-index at night 1 and night 7 within a stay at sea level of 7 days (after relocation from high altitude) in patients with pulmonary arterial hypertension

    Measured: From Night 1 to Night 7 at sea level

  8. Acclimatization-Effect of Oxygen-Desaturation-Index ODI at sea level

    Difference/change in nocturnal oxygen-desaturation-index ODI at night 1 and night 7 within a stay at sea level of 7 days (after relocation from high altitude) in patients with pulmonary arterial hypertension

    Measured: From Night 1 to Night 7 at sea level

  9. Acclimatization-Effect of nocturnal cardiovascular autonomic control at sea level

    Difference/change in nocturnal cardiovascular autonomic control by heart rate (variability) at night 1 and night 7 within a stay at sea level of 7 days (after relocation from high altitude) in patients with pulmonary arterial hypertension

    Measured: From Night 1 to Night 7 at sea level

  10. Mean nocturnal SpO2 after re-ascent to 2850m

    Difference/change in mean nocturnal SpO2 between sea level (after one-week stay) and night after re-ascent to 2850m in patients with pulmonary arterial hypertension

    Measured: From Night 7 at sea level to night after reascent (time frame of 3 days)

  11. Time spent with low SpO2 after re-ascent to 2850m

    Difference/change in time spent with low SpO2 (< 90% and < 80%) between sea level (after one-week stay) and night after re-ascent to 2850m in patients with pulmonary arterial hypertension

    Measured: From Night 7 at sea level to night after re-ascent (time frame of 3 days)

  12. Apnoea-Hypopnoea-Index AHI after re-ascent to 2850m

    Difference/change in nocturnal apnoea-hypopnoea-index between sea level (after one-week stay) and night after re-ascent to 2850m in patients with pulmonary arterial hypertension

    Measured: From Night 7 at sea level to night after re-ascent (time frame of 3 days)

  13. Oxygen-Desaturation-Index ODI after re-ascent to 2850m

    Difference/change in nocturnal oxygen-desaturation-index between sea level (after one-week stay) and night after re-ascent to 2850m in patients with pulmonary arterial hypertension

    Measured: From Night 7 at sea level to night after re-ascent (time frame of 3 days)

  14. Nocturnal cardiovascular autonomic control after re-ascent to 2850m

    Difference/change in nocturnal cardiovascular autonomic control by heart rate (variability) between sea level (after one-week stay) and night after re-ascent to 2850m in patients with pulmonary arterial hypertension

    Measured: From Night 7 at sea level to night after re-ascent (time frame of 3 days)

  15. Mean nocturnal SpO2 pre-descent and after re-ascent (2850m)

    Difference/change in mean nocturnal SpO2 between the night at 2850m prior to the descent to sea level (stay of 7 days at sea level in between) and the night at 2850m after re-ascent in patients with pulmonary arterial hypertension

    Measured: From the night at 2850m prior to the descent, stay at sea level of one week in between to the night after re-ascent to 2850m (time frame approximately 11 days)

  16. Time spent with low SpO2 pre-descent and after re-ascent (2850m)

    Difference/change in time spent with low SpO2 (< 90% and < 80%) between the night at 2850m prior to the descent to sea level (stay of 7 days at sea level in between) and the night at 2850m after re-ascent in patients with pulmonary arterial hypertension

    Measured: From the night at 2850m prior to the descent, stay at sea level of one week in between to the night after re-ascent to 2850m (time frame approximately 11 days)

  17. Apnoea-Hypopnoea-Index AHI pre-descent and after re-ascent (2850m)

    Difference/change in nocturnal apnoea-hypopnoea-index between the night at 2850m prior to the descent to sea level (stay of 7 days at sea level in between) and the night at 2850m after re-ascent in patients with pulmonary arterial hypertension

    Measured: From the night at 2850m prior to the descent, stay at sea level of one week in between to the night after re-ascent to 2850m (time frame approximately 11 days)

  18. Oxygen-Desaturation-Index ODI pre-descent and after re-ascent (2850m)

    Difference/change in nocturnal oxygen-desaturation-index between the night at 2850m prior to the descent to sea level (stay of 7 days at sea level in between) and the night at 2850m after re-ascent in patients with pulmonary arterial hypertension

    Measured: From the night at 2850m prior to the descent, stay at sea level of one week in between to the night after re-ascent to 2850m (time frame approximately 11 days)

  19. Nocturnal cardiovascular autonomic control pre-descent and after re-ascent (2850m)

    Difference/change in nocturnal cardiovascular autonomic control by heart rate (variability) between the night at 2850 prior to the descent to sea level (stay of 7 days at sea level in between) and the night at 2850m after re-ascent in patients with pulmonary arterial hypertension

    Measured: From the night at 2850m prior to the descent, stay at sea level of one week in between to the night after re-ascent to 2850m (time frame approximately 11 days)

Timeline

From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.

  1. First posted3 Sep 2026
  2. Study start25 Sep 2026 (estimated)
  3. Primary completion4 Oct 2026 (estimated)
  4. Study completion31 Dec 2026 (estimated)

Resources

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
Patients with pulmonary arterial hypertension living permanently \> 2600m around Quito (Ecuador) will be assessed at 2850m, after relocation to sea level for 7 days and after re-ascent
Masking
None (open label)
Enrolment
20 participants (estimated)
IDs, dates and publications
ClinicalTrials.gov ID
NCT07801963
Sponsor's protocol ID
Ec_HAvsLA_sleep_PAH
Status last verified
Aug 2026
First submitted
17 Aug 2026
Last updated
3 Sep 2026
Results posted
No
Data monitoring committee
No
FDA-regulated drug
No
FDA-regulated device
No
Individual data sharing
Yes: Data will be provided upon request and based on a clear intention reviewed by an ethical review board.

Questions about this trial

What is this clinical trial studying?

A study testing Descent to sea level in people with Pulmonary Arterial Hypertension (PAH) and Pulmonary Vascular Disease, run by Silvia Ulrich Somaini at 1 site in Switzerland.

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 6 inclusion and 9 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 3 Sep 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 Switzerland. 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 Silvia Ulrich, Prof. Dr. med. (+41442552220, silvia.ulrich@usz.ch), or a site near the patient. AzTrials does not enrol participants or take referrals.

What does the primary outcome measure?

Mean nocturnal SpO2 after 7 days at sea level (time frame: From high altitude (2850m) to night 7 at sea level). It is what the study was designed to measure, not a finding.

Where can I read the original study information?

On the ClinicalTrials.gov record for NCT07801963.

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 3 Sep 2026.

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