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Not yet recruitingNCT07801846Updated Sep 3, 2026

Assessment of Heart Rate Variability HRV During Descent DE From 2850m to Sea Level and During Re-ascent A From Sea Level to 2850m in Healthy Individuals H

An interventional study of Descent and re-ascent (2850m, sea level) 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 2026-09-03.

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 relocation from high altitude (Quito Ecuador: 2850m) to sea level and re-ascent from sea level to 2850m on heart rate variability and other hemodynamic parameters in healthy individuals, who live permanently >2600m.

Read the detailed description

The aim of this research is to investigate the heart rate variability and other hemodynamic outcomes during the descent from 2850m to sea level and during re-ascent from sea level to 2850m in healthy individuals, who permanently live at high altitude over 2600m

02

Conditions studied

  • Healthy
  • Healthy Adult
  • High Altitude Effects
  • High Altitude
  • Heart Rate Variability (HRV)
  • ECG Abnormalities

Keywords

  • Health
  • High altitude
  • Heart rate variability
  • ECG
  • Arrhythmias
  • Pulse transit time
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
    Heart rate variability HRV during descent and re-ascent

    Assessment of heart rate variability and other hemodynamic outcomes in healthy individuals during descent from 2850m to sea level and during re-ascent from sea level (after one week stay) back to their living altitude at 2850m

    Behavioral: Descent and re-ascent (2850m, sea level)

Interventions

  • BehavioralDescent and re-ascent (2850m, sea level)

    Descent from 2850m to sea level (in one day by bus) and re-ascent after 7 days from sea level to 2850m (in one day by bus)

06

What researchers measure

Primary outcomes

  1. Heart rate variability HRV during descent and re-ascent

    Difference/change in heart rate variability at different altitudes during descent (2850m to sea level) and during re-ascent after 7 days (sea level to 2850m) in healthy individuals

    Time frame: From day of descent (day 1) and day of re-ascent (day 8)

Secondary outcomes

  1. SpO2 during descent and re-ascent

    Difference/change in SpO2 at different altitudes during descent (2850m to sea level) and during re-ascent after 7 days (sea level to 2850m) in healthy individuals

    Time frame: From day of descent (day 1) and day of re-ascent (day 8)

  2. ECG-Repolarization during descent and re-ascent

    Occurrence/changes in cardial arrhythmias at different altitudes during descent (2850m to sea level) and during re-ascent after 7 days (sea level to 2850m) in healthy individuals

    Time frame: From day of descent (day 1) and day of re-ascent (day 8)

  3. Cardial arrhythmias during descent and re-ascent

    Occurrence/changes in cardial arrhythmias at different altitudes during descent (2850m to sea level) and during re-ascent after 7 days (sea level to 2850m) in healthy individuals

    Time frame: From day of descent (day 1) and day of re-ascent (day 8)

  4. Pulse transit time during descent and re-ascent

    Occurrence and difference/change in pulse transit time (drops) at different altitudes during descent (2850m to sea level) and during re-ascent after 7 days (sea level to 2850m) in healthy individuals

    Time frame: From day of descent (day 1) and day of re-ascent (day 8)

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 3, 2026
StartEst.
Sep 25, 2026
Primary completionEst.
Oct 4, 2026
CompletionEst.
Dec 31, 2026
Last update
Sep 3, 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 3, 2026, before this site started recording changes on Sep 25, 2026. Its history is on ClinicalTrials.gov ↗
10

Registry details

Key details

Study ID
NCT07801846
Lead sponsor
Silvia Ulrich Somaini
Responsible party
Silvia Ulrich Somaini (Prof. Dr. med., University of Zurich) — Sponsor-investigator
First posted
Sep 3, 2026
Start date
Sep 25, 2026 (estimated)
Primary completion
Oct 4, 2026 (estimated)
Completion
Dec 31, 2026 (estimated)
Last update
Sep 3, 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

This study is not yet recruiting, as verified in Aug 2026. You cannot join it, but the record below documents what was studied.

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