Sleep-Assessment in Patients Between High Altitude HA vs. Sea Level LA in Healthy Individuals H
2026. augusztus 31. frissítette: 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.
A tanulmány áttekintése
Állapot
Még nincs toborzás
Körülmények
Beavatkozás / kezelés
Részletes leírás
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
Tanulmány típusa
Beavatkozó
Beiratkozás (Becsült)
14
Fázis
- Nem alkalmazható
Kapcsolatok és helyek
Ez a rész a vizsgálatot végzők elérhetőségeit, valamint a vizsgálat lefolytatásának helyére vonatkozó információkat tartalmazza.
Tanulmányi kapcsolat
- Név: Silvia Ulrich, Prof. Dr. med.
- Telefonszám: +41442552220
- E-mail: silvia.ulrich@usz.ch
Tanulmányozza a kapcsolattartók biztonsági mentését
- Név: Michael Furian, Prof. Dr. sc. ETH
- Telefonszám: +41442552220
Tanulmányi helyek
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Zurich, Svájc, 8091
- University Hospital of Zurich
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Részvételi kritériumok
A kutatók olyan embereket keresnek, akik megfelelnek egy bizonyos leírásnak, az úgynevezett jogosultsági kritériumoknak. Néhány példa ezekre a kritériumokra a személy általános egészségi állapota vagy a korábbi kezelések.
Jogosultsági kritériumok
Tanulmányozható életkorok
- Felnőtt
- Idősebb felnőtt
Egészséges önkénteseket fogad
Igen
Leírás
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
Tanulási terv
Ez a rész a vizsgálati terv részleteit tartalmazza, beleértve a vizsgálat megtervezését és a vizsgálat mérését.
Hogyan készül a tanulmány?
Tervezési részletek
- Elsődleges cél: Támogató gondoskodás
- Kiosztás: N/A
- Beavatkozó modell: Egyetlen csoportos hozzárendelés
- Maszkolás: Nincs (Open Label)
Fegyverek és beavatkozások
Résztvevő csoport / kar |
Beavatkozás / kezelés |
|---|---|
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Kísérleti: 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
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Descent from 2850m to sea level with a stay for 7 days and re-ascent back to 2850m
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Mit mér a tanulmány?
Elsődleges eredményintézkedések
Eredménymérő |
Intézkedés leírása |
Időkeret |
|---|---|---|
|
Mean nocturnal SpO2 after 7 days at sea level
Időkeret: From high altitude (2850m) to night 7 at sea level
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Difference/change in mean nocturnal SpO2 between 2850m and Night 7 at sea level in healthy individuals
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From high altitude (2850m) to night 7 at sea level
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Másodlagos eredményintézkedések
Eredménymérő |
Intézkedés leírása |
Időkeret |
|---|---|---|
|
Time spent with low SpO2 after 7 days at sea level
Időkeret: From high altitude (2850m) to night 7 at sea level
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Difference/change in time spent with low SpO2 (< 90% and < 80%) between 2850m and night 7 at sea level in healthy individuals
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From high altitude (2850m) to night 7 at sea level
|
|
Apnoea-Hypopnoea-Index AHI after 7 days at sea level
Időkeret: From high altitude (2850m) to night 7 at sea level
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Difference/change in nocturnal apnoea-hypopnoea-index between 2850m and night 7 at sea level in healthy individuals
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From high altitude (2850m) to night 7 at sea level
|
|
Oxygen-Desaturation-Index ODI after 7 days at sea level
Időkeret: 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
Időkeret: From high altitude (2850m) to night 7 at sea level
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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
|
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Acclimatization-Effect of mean nocturnal SpO2 at sea level
Időkeret: From Night 1 to Night 7 at sea level
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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
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From Night 1 to Night 7 at sea level
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Acclimatization-Effect of time spent with low SpO2 at sea level
Időkeret: From Night 1 to Night 7 at sea level
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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
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From Night 1 to Night 7 at sea level
|
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Acclimatization-Effect of Apnoea-Hypopnoea-Index AHI at sea level
Időkeret: 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
|
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Acclimatization-Effect of Oxygen-Desaturation-Index ODI at sea level
Időkeret: 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
Időkeret: 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
Időkeret: From Night 7 at sea level to night after reascent (time frame of 3 days)
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Difference/change in mean nocturnal SpO2 between sea level (after one-week stay) and night after re-ascent to 2850m in healthy individuals
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From Night 7 at sea level to night after reascent (time frame of 3 days)
|
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Time spent with low SpO2 after re-ascent to 2850m
Időkeret: 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
Időkeret: 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
Időkeret: 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
Időkeret: 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)
Időkeret: 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)
|
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Time spent with low SpO2 pre-descent and after re-ascent (2850m)
Időkeret: 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)
Időkeret: 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)
Időkeret: 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)
Időkeret: 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)
|
Együttműködők és nyomozók
Itt találhatja meg a tanulmányban érintett személyeket és szervezeteket.
Szponzor
Nyomozók
- Kutatásvezető: Silvia Ulrich, University Hospital Zurich, Departement of Pulmonology
- Kutatásvezető: Rodrigo Hoyos, Hospital Carlos Andrade Marin of Quito, Ecuador
Tanulmányi rekorddátumok
Ezek a dátumok nyomon követik a ClinicalTrials.gov webhelyre benyújtott vizsgálati rekordok és összefoglaló eredmények benyújtásának folyamatát. A vizsgálati feljegyzéseket és a jelentett eredményeket a Nemzeti Orvostudományi Könyvtár (NLM) felülvizsgálja, hogy megbizonyosodjon arról, hogy megfelelnek-e az adott minőség-ellenőrzési szabványoknak, mielőtt közzéteszik őket a nyilvános weboldalon.
Tanulmány főbb dátumok
Tanulmány kezdete (Becsült)
2026. szeptember 25.
Elsődleges befejezés (Becsült)
2026. október 4.
A tanulmány befejezése (Becsült)
2026. december 31.
Tanulmányi regisztráció dátumai
Először benyújtva
2026. augusztus 17.
Először nyújtották be, amely megfelel a minőségbiztosítási kritériumoknak
2026. augusztus 31.
Első közzététel (Tényleges)
2026. szeptember 3.
Tanulmányi rekordok frissítései
Utolsó frissítés közzétéve (Tényleges)
2026. szeptember 3.
Az utolsó frissítés elküldve, amely megfelel a minőségbiztosítási kritériumoknak
2026. augusztus 31.
Utolsó ellenőrzés
2026. augusztus 1.
Több információ
A tanulmányhoz kapcsolódó kifejezések
Kulcsszavak
További vonatkozó MeSH feltételek
Egyéb vizsgálati azonosító számok
- Ec_HAvsLA_sleep_H
Terv az egyéni résztvevői adatokhoz (IPD)
Tervezi megosztani az egyéni résztvevői adatokat (IPD)?
IGEN
IPD terv leírása
Data will be provided upon request and based on a clear intention reviewed by an ethical review board.
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Egy amerikai FDA által szabályozott gyógyszerkészítményt tanulmányoz
Nem
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Nem
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