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

August 31, 2026 updated by: Silvia Ulrich Somaini

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 healthy individuals, who live permanently >2600m.

Study Overview

Status

Not yet recruiting

Conditions

Intervention / Treatment

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

Study Type

Interventional

Enrollment (Estimated)

14

Phase

  • Not Applicable

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Contact

Study Contact Backup

  • Name: Michael Furian, Prof. Dr. sc. ETH
  • Phone Number: +41442552220

Study Locations

  • Switzerland
      • Zurich, Switzerland, 8091
        • University Hospital of Zurich

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

  • Adult
  • Older Adult

Accepts Healthy Volunteers

Yes

Description

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:

  • 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

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: Supportive Care
  • Allocation: N/A
  • Interventional Model: Single Group Assignment
  • Masking: None (Open Label)

Arms and Interventions

Participant Group / Arm
Intervention / Treatment
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
Descent from 2850m to sea level with a stay for 7 days and re-ascent back to 2850m

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Mean nocturnal SpO2 after 7 days at sea level
Time Frame: From high altitude (2850m) to night 7 at sea level
Difference/change in mean nocturnal SpO2 between 2850m and Night 7 at sea level in healthy individuals
From high altitude (2850m) to night 7 at sea level

Secondary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Time spent with low SpO2 after 7 days at sea level
Time Frame: From high altitude (2850m) to night 7 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
From high altitude (2850m) to night 7 at sea level
Apnoea-Hypopnoea-Index AHI after 7 days at sea level
Time Frame: From high altitude (2850m) to night 7 at sea level
Difference/change in nocturnal apnoea-hypopnoea-index between 2850m and night 7 at sea level in healthy individuals
From high altitude (2850m) to night 7 at sea level
Oxygen-Desaturation-Index ODI after 7 days at sea level
Time Frame: From high altitude (2850m) to night 7 at sea level
Difference/change in nocturnal Oxygen-Desaturation-Index ODI between 2850m and night 7 at sea level in healthy individuals
From high altitude (2850m) to night 7 at sea level
Nocturnal cardiovascular autonomic control after 7 days at sea level
Time Frame: From high altitude (2850m) to night 7 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
From high altitude (2850m) to night 7 at sea level
Acclimatization-Effect of mean nocturnal SpO2 at sea level
Time Frame: From Night 1 to Night 7 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
From Night 1 to Night 7 at sea level
Acclimatization-Effect of time spent with low SpO2 at sea level
Time Frame: From Night 1 to Night 7 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
From Night 1 to Night 7 at sea level
Acclimatization-Effect of Apnoea-Hypopnoea-Index AHI at sea level
Time Frame: From Night 1 to Night 7 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
From Night 1 to Night 7 at sea level
Acclimatization-Effect of Oxygen-Desaturation-Index ODI at sea level
Time Frame: From Night 1 to Night 7 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
From Night 1 to Night 7 at sea level
Acclimatization-Effect of nocturnal cardiovascular autonomic control at sea level
Time Frame: From Night 1 to Night 7 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
From Night 1 to Night 7 at sea level
Mean nocturnal SpO2 after re-ascent to 2850m
Time Frame: From Night 7 at sea level to night after reascent (time frame of 3 days)
Difference/change in mean nocturnal SpO2 between sea level (after one-week stay) and night after re-ascent to 2850m in healthy individuals
From Night 7 at sea level to night after reascent (time frame of 3 days)
Time spent with low SpO2 after re-ascent to 2850m
Time Frame: From Night 7 at sea level to night after re-ascent (time frame of 3 days)
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
From Night 7 at sea level to night after re-ascent (time frame of 3 days)
Apnoea-Hypopnoea-Index AHI after re-ascent to 2850m
Time Frame: From Night 7 at sea level to night after re-ascent (time frame of 3 days)
Difference/change in nocturnal apnoea-hypopnoea-index between sea level (after one-week stay) and night after re-ascent to 2850m in healthy individuals
From Night 7 at sea level to night after re-ascent (time frame of 3 days)
Oxygen-Desaturation-Index ODI after re-ascent to 2850m
Time Frame: From Night 7 at sea level to night after re-ascent (time frame of 3 days)
Difference/change in nocturnal oxygen-desaturation-index between sea level (after one-week stay) and night after re-ascent to 2850m in healthy individuals
From Night 7 at sea level to night after re-ascent (time frame of 3 days)
Nocturnal cardiovascular autonomic control after re-ascent to 2850m
Time Frame: From Night 7 at sea level to night after re-ascent (time frame of 3 days)
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
From Night 7 at sea level to night after re-ascent (time frame of 3 days)
Mean nocturnal SpO2 pre-descent and after re-ascent (2850m)
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)
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
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)
Time spent with low SpO2 pre-descent and after re-ascent (2850m)
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)
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
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)
Apnoea-Hypopnoea-Index AHI pre-descent and after re-ascent (2850m)
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)
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
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)
Oxygen-Desaturation-Index ODI pre-descent and after re-ascent (2850m)
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)
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
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)
Nocturnal cardiovascular autonomic control pre-descent and after re-ascent (2850m)
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)
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
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)

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Silvia Ulrich Somaini

Investigators

  • Principal Investigator: Silvia Ulrich, University Hospital Zurich, Departement of Pulmonology
  • Principal Investigator: Rodrigo Hoyos, Hospital Carlos Andrade Marin of Quito, Ecuador

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start (Estimated)

September 25, 2026

Primary Completion (Estimated)

October 4, 2026

Study Completion (Estimated)

December 31, 2026

Study Registration Dates

First Submitted

August 17, 2026

First Submitted That Met QC Criteria

August 31, 2026

First Posted (Actual)

September 3, 2026

Study Record Updates

Last Update Posted (Actual)

September 3, 2026

Last Update Submitted That Met QC Criteria

August 31, 2026

Last Verified

August 1, 2026

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

  • Ec_HAvsLA_sleep_H

Plan for Individual participant data (IPD)

Plan to Share Individual Participant Data (IPD)?

YES

IPD Plan Description

Data will be provided upon request and based on a clear intention reviewed by an ethical review board.

Drug and device information, study documents

Studies a U.S. FDA-regulated drug product

No

Studies a U.S. FDA-regulated device product

No

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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