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Not yet recruitingNCT07804537Updated Sep 4, 2026

Assessment of Lung Function (Lufu) at Sea Level LA vs. High Altitude HA in Healthy Individuals

An interventional study of Re-ascent from sea level to 2850m in Healthy, Healthy Adult and High Altitude Effects, sponsored by Silvia Ulrich Somaini. Not yet recruiting at 1 site in Switzerland. Open to participants aged 18 Years to 80 Years, including healthy volunteers. Per ClinicalTrials.gov, last updated 2026-09-04.

Sponsored by Silvia Ulrich Somaini · Not applicable, Interventional, and Supportive care

Phase
Not applicable
Study type
Interventional
Enrollment
14
Allocation
Not applicable
Ages
18 Years to 80 Years
Sex
All
01

Study summary

To study the effect of a re-ascent to high altitude (Quito Ecuador: 2850m) after a one-week stay at sea level (after prior descent from 2850m) on lung function and pulmonary resistance/reactance in healthy individuals, who live permanently > 2600m.

Read the detailed description

The aim of this research is to investigate the lung function and pulmonary resistance/reactance before and after re-ascent (sea level for 7 days after prior descent from 2850m vs. re-ascent to 2850m) in healthy individuals, who permanently live at high altitude over 2600m.

02

Conditions studied

  • Healthy
  • Healthy Adult
  • High Altitude Effects
  • High Altitude
  • Lung Function Tests
  • Lung Function Changes

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Keywords

  • Health
  • High altitude
  • Lung function
  • Forced oscillation technique
03

In context

Altitude Sickness

216 studies on the registry are indexed under Altitude Sickness; 46 are open to participants now.

This study's planned enrollment of 14 is below the median of 34 across 178 interventional studies indexed under Altitude Sickness.

Browse Altitude Sickness studies →

Lead sponsor

Silvia Ulrich Somaini is the lead sponsor of 17 studies on the registry; 16 are open to participants now.

Counted across the registry records on this site, refreshed daily.

04

Who can participate

Ages eligible
18 Years to 80 Years
Sexes eligible
All
Accepts healthy volunteers
Yes

Go through the criteria one by one — yes, no or not sure — and take the list to your doctor or the study team. Kept in this browser only.

Inclusion criteria

  • Adults aged 18-80 years and of all genders
  • Permanent residence > 2600 m
  • healthy: no self perceived cardiopulmonary disease limiting daily activities
  • written to participate in the study.

Exclusion criteria

Exclusion Criteria:

  • Age \<18 years or >80 years
  • Participants who cannot follow the study investigations
  • Participants permanently living \< 2600m
  • Participants who traveled and stayed overnight at altitudes \<2000 m in the past 4 weeks.
  • any self-perceived cardiopulmonary disease limiting daily activities
Terms in these criteria, in plain language(1)

Underlined terms in the criteria open these too. Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.

Informed consent

Before you join, the study team explains what taking part involves — its purpose, what happens, the risks and possible benefits — and answers your questions, so you can decide freely. Consent is usually recorded on a form (the informed consent form, ICF) signed by you or, where the law allows, by someone legally authorised to decide for you.

You can keep asking questions during the study, you are told of new information that matters, and you can choose to leave at any time.

05

Study design

Phase
Not applicable
Primary purpose
Supportive care
Allocation
Not applicable
Intervention model
Single group
Masking
None (open label)
Enrollment
14 participants (estimated)

Study arms

  • Experimental
    Lung function at sea level and at 2850m

    Assessment of lung function and pulmonary resistance/reactance on day four at sea level (after prior descent from 2850m) and after re-ascent (after totally one week at sea level) back to 2850m by bus (in one day)

    Behavioral: Re-ascent from sea level to 2850m

Interventions

  • BehavioralRe-ascent from sea level to 2850m

    Descent from 2850m to sea level with a stay for 7 days and re-ascent/return back to their usual living altitude at 2850m

06

What researchers measure

Primary outcomes

  1. FEV1 after re-ascent to 2850m

    Difference/change in forced expiratory volume in one second FEV1 between sea level (measurement on the 4th day) and day after re-ascent to 2850m in healthy individuals

    Time frame: From Day 4 at sea level to the day after re-ascent (Day 9)

Secondary outcomes

  1. Forced Vital Capacity FVC after re-ascent to 2850m

    Difference/change in forced vital capacity FVC between sea level (measurement on the 4th day) and day after re-ascent to 2850m in healthy individuals

    Time frame: From Day 4 at sea level to the day after re-ascent (Day 9)

  2. FEV1/FVC after re-ascent to 2850m

    Difference/change in FEV1/FVC between sea level (measurement on the 4th day) and day after re-ascent to 2850m in healthy individuals

    Time frame: From Day 4 at sea level to the day after re-ascent (Day 9)

  3. Respiratory Impedance (forced oscillation technique) after re-ascent to 2850m

    Difference/change in respiratory impedance (forced oscillation technique) between sea level (measurement on the 4th day) and day after re-ascent to 2850m in healthy individuals

    Time frame: From Day 4 at sea level to the day after re-ascent (Day 9)

  4. Respiratory resistance (forced oscillation technique) after re-ascent to 2850m

    Difference/change in respiratory resistance (forced oscillation technique) between sea level (measurement on the 4th day) and day after re-ascent to 2850m in healthy individuals

    Time frame: From Day 4 at sea level to the day after re-ascent (Day 9)

  5. Respiratory reactance (forced oscillation technique) after re-ascent to 2850m

    Difference/change in respiratory reactance (forced oscillation technique) between sea level (measurement on the 4th day) and day after re-ascent to 2850m in healthy individuals

    Time frame: From Day 4 at sea level to the day after re-ascent (Day 9)

  6. FEV1 after 4 days at sea level

    Difference/change in FEV1 between 2850m (prior to descent) and day 4 at sea level in healthy individuals

    Time frame: From high altitude (2850m) to day 4 at sea level

  7. Forced Vital Capacity FVC after 4 days at sea level

    Difference/change in forced vital capacity FVC between 2850m (prior to descent) and day 4 at sea level in healthy individuals

    Time frame: From high altitude (2850m) to day 4 at sea level

  8. FEV1/FVC after 4 days at sea level

    Difference/change in FEV1/FVC between 2850m (prior to descent) and day 4 at sea level in healthy individuals

    Time frame: From high altitude (2850m) to day 4 at sea level

  9. Respiratory Impedance (forced oscillation technique) after 4 days at sea level

    Difference/change in respiratory Impedance (forced oscillation technique) between 2850m (prior to descent) and day 4 at sea level in healthy individuals

    Time frame: From high altitude (2850m) to day 4 at sea level

  10. Respiratory resistance (forced oscillation technique) after 4 days at sea level

    Difference/change in respiratory resistance (forced oscillation technique) between 2850m (prior to descent) and day 4 at sea level in healthy individuals

    Time frame: From high altitude (2850m) to day 4 at sea level

  11. Respiratory reactance (forced oscillation technique) after 4 days at sea level

    Difference/change in respiratory reactance (forced oscillation technique) between 2850m (prior to descent) and day 4 at sea level in healthy individuals

    Time frame: From high altitude (2850m) to day 4 at sea level

  12. FEV1 pre-descent and after re-ascent (2850m)

    Difference/change in FEV1 at 2850m with a one-week stay at sea level in between (day pre-descent vs. day after re-ascent) in healthy individuals

    Time frame: Baseline at 2850m followed by a one-week stay at sea level to the day after re-ascent back to 2850m (time frame approximately 11 days)

  13. Forced Vital Capacity FVC pre-descent and after re-ascent (2850m)

    Difference/change in forced vital capacity FVC at 2850m with a one-week stay at sea level in between (day pre-descent vs. day after re-ascent) in healthy individuals

    Time frame: Baseline at 2850m followed by a one-week stay at sea level to the day after re-ascent back to 2850m (time frame approximately 11 days)

  14. FEV1/FVC pre-descent and after re-ascent (2850m)

    Difference/change in FEV1/FVC at 2850m with a one-week stay at sea level in between (day pre-descent vs. day after re-ascent) in healthy individuals

    Time frame: Baseline at 2850m followed by a one-week stay at sea level to the day after re-ascent back to 2850m (time frame approximately 11 days)

  15. Respiratory Impedance (forced oscillation technique) pre-descent and after re-ascent (2850m)

    Difference/change in respiratory impedance (forced oscillation technique) at 2850m with a one-week stay at sea level in between (day pre-descent vs. day after re-ascent) in healthy individuals

    Time frame: Baseline at 2850m followed by a one-week stay at sea level to the day after re-ascent back to 2850m (time frame approximately 11 days)

  16. Respiratory resistance (forced oscillation technique) pre-descent and after re-ascent (2850m)

    Difference/change in respiratory resistance (forced oscillation technique) at 2850m with a one-week stay at sea level in between (day pre-descent vs. day after re-ascent) in healthy individuals

    Time frame: Baseline at 2850m followed by a one-week stay at sea level to the day after re-ascent back to 2850m (time frame approximately 11 days)

  17. Respiratory reactance (forced oscillation technique) pre-descent and after re-ascent (2850m)

    Difference/change in respiratory reactance (forced oscillation technique) at 2850m with a one-week stay at sea level in between (day pre-descent vs. day after re-ascent) in healthy individuals

    Time frame: Baseline at 2850m followed by a one-week stay at sea level to the day after re-ascent back to 2850m (time frame approximately 11 days)

07

Study locations

1 site
08

References and documents

Individual participant data

Plan to share: Yes — Data will be provided upon request and based on a clear intention reviewed by an ethical review board.

No publications or documents are linked to this record.

09

Timeline

Tracking since Sep 25, 2026
ElapsedEstimatedEstimated, not yet reachedSimilar studies: half by the dot; the band is the middle halfHalf of similar studies reached it by the dot; the band is the middle half, from a quarter to three quarters

Start is estimated for Sep 2026; primary completion for Oct 2026, 0 months later.

Of 76 non-industry interventional studies with no phase under Altitude Sickness, half reached primary completion within 9 months of starting (the median), counting those still running; a quarter within 3 and three quarters within 21. This study's planned 0 months is below that.

Counting every sponsor, half of 76 studies reached it within 9 months; a quarter within 3 and three quarters within 21.

How these figures are worked out, and which studies are left out of them.

Registered
Aug 17, 2026
First posted
Sep 4, 2026
StartEst.
Sep 25, 2026
Primary completionEst.
Oct 4, 2026
CompletionEst.
Dec 31, 2026
Last update
Sep 4, 2026
What these dates mean
Start.
When the first participant enrolled; while estimated, when the study expects to open to recruitment.
Primary completion.
When the last participant was examined or treated to collect data for the study's main question, its primary outcome. A study that stopped early gives the date its data collection stopped.
Completion.
When the last participant's last visit took place, for every outcome, secondary ones and side effects included: the end of the study. Often later than primary completion, sometimes the same day.
Actual and Est.
Actual means the registry says the date has happened. Est. (estimated) is a date the sponsor plans or expects. It can still move, and the sponsor is expected to change it to actual once it has passed.
No changes since tracking began. The registry record was last updated on Sep 4, 2026, before this site started recording changes on Sep 25, 2026. Its history is on ClinicalTrials.gov ↗
10

Registry details

Key details

Study ID
NCT07804537
Lead sponsor
Silvia Ulrich Somaini
Responsible party
Silvia Ulrich Somaini (Prof. Dr. med., University of Zurich) — Sponsor-investigator
First posted
Sep 4, 2026
Start date
Sep 25, 2026 (estimated)
Primary completion
Oct 4, 2026 (estimated)
Completion
Dec 31, 2026 (estimated)
Last update
Sep 4, 2026

Study contacts

Silvia Ulrich, Prof. Dr. med.
Contact
silvia.ulrich@usz.ch
+41442552220
Michael Furian, Prof. Dr. sc. ETH
Contact
+41442552220
Silvia Ulrich
principal investigator · University Hospital Zurich, Departement of Pulmonology
Rodrigo Hoyos
principal investigator · Hospital Carlos Andrade Marin of Quito, Ecuador

Oversight

Data monitoring committee
No
FDA-regulated drug
No
FDA-regulated device
No
View the source record on ClinicalTrials.gov ↗

Not currently enrolling

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