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

N/ANot Yet RecruitingNCT07801950

Silvia Ulrich Somaini14 enrolled

Overview

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.

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

Allocation

Purpose

SUPPORTIVE_CARE

Masking

NONE

Enrollment

Conditions

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

Interventions

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

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

Eligibility

Sex: ALLMin age: 18 YearsMax age: 80 YearsHealthy volunteers:

Medical Language ↔ Plain English

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

Locations (1)

University Hospital of Zurich

Zurich, Switzerland

Outcomes

Primary Outcomes

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

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

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

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

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

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

Central Contacts

Silvia Ulrich, Prof. Dr. med.

CONTACT

+41442552220 silvia.ulrich@usz.ch

Michael Furian, Prof. Dr. sc. ETH

CONTACT

+41442552220

Data from ClinicalTrials.gov

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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

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

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

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

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)

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)

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)

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)

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)

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)

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)

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)

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)

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)