CClinicalTrials.gg
Not yet recruitingNCT07801950Updated Sep 3, 2026

Sleep-Assessment in Patients Between High Altitude HA vs. Sea Level LA in Healthy Individuals H

An interventional study of Descent from 2850m to sea level and re-ascent back 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 2026-09-03.

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 on sleeping parameters by polygraphy in healthy individuals, 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 healthy individuals, who permanently live at high altitude over 2600m

02

Conditions studied

  • Healthy
  • Healthy Adult
  • High Altitude Effects
  • High Altitude
  • Polygraphy
  • Sleep
  • Sleep Disordered Breathing (SDB)

Keywords

  • Health
  • High Altitude
  • Polygraphy
  • Sleep
  • Sleep disordered breathing
03

Who can participate

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

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 informed consent 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
04

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
    Sleep-parameters at 2850m and at sea level

    Assessment of sleep-parameters by polygraphy in healthy individuals at 2850m (pre-descent and after re-ascent) and at sea level in between

    Behavioral: Descent from 2850m to sea level and re-ascent back to 2850m

Interventions

  • BehavioralDescent from 2850m to sea level and re-ascent back to 2850m

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

05

What researchers measure

Primary outcomes

  1. Mean nocturnal SpO2 after 7 days at sea level

    Difference/change in mean nocturnal SpO2 between 2850m and Night 7 at sea level in healthy individuals

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

Secondary outcomes

  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 healthy individuals

    Time frame: 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 healthy individuals

    Time frame: 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 healthy individuals

    Time frame: 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 healthy individuals

    Time frame: 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 healthy individuals

    Time frame: 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 healthy individuals

    Time frame: 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 healthy individuals

    Time frame: 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 at night 1 and night 7 within a stay at sea level of 7 days (after relocation from high altitude) in healthy individuals

    Time frame: 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 healthy individuals

    Time frame: 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 healthy individuals

    Time frame: 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 healthy individuals

    Time frame: 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 healthy individuals

    Time frame: 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 healthy individuals

    Time frame: 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 healthy individuals

    Time frame: 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 healthy individuals

    Time frame: 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 healthy individuals

    Time frame: 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 healthy individuals

    Time frame: 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 healthy individuals

    Time frame: 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 healthy individuals

    Time frame: 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)

06

Study locations

1 site
  • University Hospital of Zurich
    Zurich, 8091, Switzerland
07

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.

08

Registry details

Key details

Study ID
NCT07801950
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.

Follow this study

Get an email when the registry record changes — status, dates, results — or when someone posts here.

Sign in to follow

Discussion

Questions and observations about this study, from anyone following it. Not medical advice, and not a channel to the study team — their contact details are on the registry record.

Sign in to join the discussion. Reading takes no account; posting does. You choose a display name, and a pseudonym is the default.

Nothing here yet. If you are running this trial, taking part in it, or weighing whether to, this is the place to say so.

Start the discussion