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

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

Status
Not yet recruiting
Phases
Unknown
Study type
Interventional
Source
ClinicalTrials.gov
Registry ID
NCT07801950
Enrollment
14
Registered
2026-09-03
Start date
2026-09-25
Completion date
2026-12-31
Last updated
2026-09-03

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

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

Keywords

Health, High Altitude, Polygraphy, Sleep, Sleep disordered breathing

Brief 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.

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

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

Sponsors

Silvia Ulrich Somaini
Lead SponsorOTHER

Study design

Allocation
NA
Intervention model
SINGLE_GROUP
Primary purpose
SUPPORTIVE_CARE
Masking
NONE

Intervention model description

Healthy individuals living permanently \> 2600m around Quito (Ecuador) will be assessed at 2850m, after relocation to sea level for 7 days and after re-ascent

Eligibility

Sex/Gender
ALL
Age
18 Years to 80 Years
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

* 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

Design outcomes

Primary

MeasureTime frameDescription
Mean nocturnal SpO2 after 7 days at sea levelFrom high altitude (2850m) to night 7 at sea levelDifference/change in mean nocturnal SpO2 between 2850m and Night 7 at sea level in healthy individuals

Secondary

MeasureTime frameDescription
Apnoea-Hypopnoea-Index AHI after 7 days at sea levelFrom high altitude (2850m) to night 7 at sea levelDifference/change in nocturnal apnoea-hypopnoea-index between 2850m and night 7 at sea level in healthy individuals
Oxygen-Desaturation-Index ODI after 7 days at sea levelFrom high altitude (2850m) to night 7 at sea levelDifference/change in nocturnal Oxygen-Desaturation-Index ODI between 2850m and night 7 at sea level in healthy individuals
Nocturnal cardiovascular autonomic control after 7 days at sea levelFrom high altitude (2850m) to night 7 at sea levelDifference/change in nocturnal cardiovascular autonomic control by heart rate (variability) between 2850m and night 7 at sea level in healthy individuals
Acclimatization-Effect of mean nocturnal SpO2 at sea levelFrom Night 1 to Night 7 at sea levelDifference/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
Acclimatization-Effect of time spent with low SpO2 at sea levelFrom Night 1 to Night 7 at sea levelDifference/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
Acclimatization-Effect of Apnoea-Hypopnoea-Index AHI at sea levelFrom Night 1 to Night 7 at sea levelDifference/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
Acclimatization-Effect of Oxygen-Desaturation-Index ODI at sea levelFrom Night 1 to Night 7 at sea levelDifference/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
Acclimatization-Effect of nocturnal cardiovascular autonomic control at sea levelFrom Night 1 to Night 7 at sea levelDifference/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
Mean nocturnal SpO2 after re-ascent to 2850mFrom 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
Time spent with low SpO2 after 7 days at sea levelFrom high altitude (2850m) to night 7 at sea levelDifference/change in time spent with low SpO2 (\< 90% and \< 80%) between 2850m and night 7 at sea level in healthy individuals
Apnoea-Hypopnoea-Index AHI after re-ascent to 2850mFrom 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
Oxygen-Desaturation-Index ODI after re-ascent to 2850mFrom 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
Nocturnal cardiovascular autonomic control after re-ascent to 2850mFrom 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
Mean nocturnal SpO2 pre-descent and after re-ascent (2850m)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
Time spent with low SpO2 pre-descent and after re-ascent (2850m)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
Apnoea-Hypopnoea-Index AHI pre-descent and after re-ascent (2850m)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
Oxygen-Desaturation-Index ODI pre-descent and after re-ascent (2850m)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
Nocturnal cardiovascular autonomic control pre-descent and after re-ascent (2850m)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
Time spent with low SpO2 after re-ascent to 2850mFrom 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

Countries

Switzerland

Contacts

CONTACTSilvia Ulrich, Prof. Dr. med.
silvia.ulrich@usz.ch+41442552220
CONTACTMichael Furian, Prof. Dr. sc. ETH
+41442552220
PRINCIPAL_INVESTIGATORSilvia Ulrich

University Hospital Zurich, Departement of Pulmonology

PRINCIPAL_INVESTIGATORRodrigo Hoyos

Hospital Carlos Andrade Marin of Quito, Ecuador

Outcome results

None listed

Source: ClinicalTrials.gov · Data processed: Sep 4, 2026