Assessment of Lung Function (Lufu) at Sea Level LA vs. High Altitude HA in Healthy Individuals
31. srpna 2026 aktualizováno: 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 a re-ascent to high altitude (Quito Ecuador: 2850m) after a one-week stay at sea level (after prior descent from 2850m) on lung function and pulmonary resistance/reactance in healthy individuals, who live permanently > 2600m.
Přehled studie
Postavení
Zatím nenabíráme
Podmínky
Intervence / Léčba
Detailní popis
The aim of this research is to investigate the lung function and pulmonary resistance/reactance before and after re-ascent (sea level for 7 days after prior descent from 2850m vs. re-ascent to 2850m) in healthy individuals, who permanently live at high altitude over 2600m.
Typ studie
Intervenční
Zápis (Odhadovaný)
14
Fáze
- Nelze použít
Kontakty a umístění
Tato část poskytuje kontaktní údaje pro ty, kteří studii provádějí, a informace o tom, kde se tato studie provádí.
Studijní kontakt
- Jméno: Silvia Ulrich, Prof. Dr. med.
- Telefonní číslo: +41442552220
- E-mail: silvia.ulrich@usz.ch
Studijní záloha kontaktů
- Jméno: Michael Furian, Prof. Dr. sc. ETH
- Telefonní číslo: +41442552220
Studijní místa
-
-
-
Zurich, Švýcarsko, 8091
- University Hospital of Zurich
-
-
Kritéria účasti
Výzkumníci hledají lidi, kteří odpovídají určitému popisu, kterému se říká kritéria způsobilosti. Některé příklady těchto kritérií jsou celkový zdravotní stav osoby nebo předchozí léčba.
Kritéria způsobilosti
Věk způsobilý ke studiu
- Dospělý
- Starší dospělý
Přijímá zdravé dobrovolníky
Ano
Popis
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
Studijní plán
Tato část poskytuje podrobnosti o studijním plánu, včetně toho, jak je studie navržena a co studie měří.
Jak je studie koncipována?
Detaily designu
- Primární účel: Podpůrná péče
- Přidělení: N/A
- Intervenční model: Přiřazení jedné skupiny
- Maskování: Žádné (otevřený štítek)
Zbraně a zásahy
Skupina účastníků / Arm |
Intervence / Léčba |
|---|---|
|
Experimentální: Lung function at sea level and at 2850m
Assessment of lung function and pulmonary resistance/reactance on day four at sea level (after prior descent from 2850m) and after re-ascent (after totally one week at sea level) back to 2850m by bus (in one day)
|
Descent from 2850m to sea level with a stay for 7 days and re-ascent/return back to their usual living altitude at 2850m
|
Co je měření studie?
Primární výstupní opatření
Měření výsledku |
Popis opatření |
Časové okno |
|---|---|---|
|
FEV1 after re-ascent to 2850m
Časové okno: From Day 4 at sea level to the day after re-ascent (Day 9)
|
Difference/change in forced expiratory volume in one second FEV1 between sea level (measurement on the 4th day) and day after re-ascent to 2850m in healthy individuals
|
From Day 4 at sea level to the day after re-ascent (Day 9)
|
Sekundární výstupní opatření
Měření výsledku |
Popis opatření |
Časové okno |
|---|---|---|
|
Forced Vital Capacity FVC after re-ascent to 2850m
Časové okno: From Day 4 at sea level to the day after re-ascent (Day 9)
|
Difference/change in forced vital capacity FVC between sea level (measurement on the 4th day) and day after re-ascent to 2850m in healthy individuals
|
From Day 4 at sea level to the day after re-ascent (Day 9)
|
|
FEV1/FVC after re-ascent to 2850m
Časové okno: From Day 4 at sea level to the day after re-ascent (Day 9)
|
Difference/change in FEV1/FVC between sea level (measurement on the 4th day) and day after re-ascent to 2850m in healthy individuals
|
From Day 4 at sea level to the day after re-ascent (Day 9)
|
|
Respiratory Impedance (forced oscillation technique) after re-ascent to 2850m
Časové okno: From Day 4 at sea level to the day after re-ascent (Day 9)
|
Difference/change in respiratory impedance (forced oscillation technique) between sea level (measurement on the 4th day) and day after re-ascent to 2850m in healthy individuals
|
From Day 4 at sea level to the day after re-ascent (Day 9)
|
|
Respiratory resistance (forced oscillation technique) after re-ascent to 2850m
Časové okno: From Day 4 at sea level to the day after re-ascent (Day 9)
|
Difference/change in respiratory resistance (forced oscillation technique) between sea level (measurement on the 4th day) and day after re-ascent to 2850m in healthy individuals
|
From Day 4 at sea level to the day after re-ascent (Day 9)
|
|
Respiratory reactance (forced oscillation technique) after re-ascent to 2850m
Časové okno: From Day 4 at sea level to the day after re-ascent (Day 9)
|
Difference/change in respiratory reactance (forced oscillation technique) between sea level (measurement on the 4th day) and day after re-ascent to 2850m in healthy individuals
|
From Day 4 at sea level to the day after re-ascent (Day 9)
|
|
FEV1 after 4 days at sea level
Časové okno: From high altitude (2850m) to day 4 at sea level
|
Difference/change in FEV1 between 2850m (prior to descent) and day 4 at sea level in healthy individuals
|
From high altitude (2850m) to day 4 at sea level
|
|
Forced Vital Capacity FVC after 4 days at sea level
Časové okno: From high altitude (2850m) to day 4 at sea level
|
Difference/change in forced vital capacity FVC between 2850m (prior to descent) and day 4 at sea level in healthy individuals
|
From high altitude (2850m) to day 4 at sea level
|
|
FEV1/FVC after 4 days at sea level
Časové okno: From high altitude (2850m) to day 4 at sea level
|
Difference/change in FEV1/FVC between 2850m (prior to descent) and day 4 at sea level in healthy individuals
|
From high altitude (2850m) to day 4 at sea level
|
|
Respiratory Impedance (forced oscillation technique) after 4 days at sea level
Časové okno: From high altitude (2850m) to day 4 at sea level
|
Difference/change in respiratory Impedance (forced oscillation technique) between 2850m (prior to descent) and day 4 at sea level in healthy individuals
|
From high altitude (2850m) to day 4 at sea level
|
|
Respiratory resistance (forced oscillation technique) after 4 days at sea level
Časové okno: From high altitude (2850m) to day 4 at sea level
|
Difference/change in respiratory resistance (forced oscillation technique) between 2850m (prior to descent) and day 4 at sea level in healthy individuals
|
From high altitude (2850m) to day 4 at sea level
|
|
Respiratory reactance (forced oscillation technique) after 4 days at sea level
Časové okno: From high altitude (2850m) to day 4 at sea level
|
Difference/change in respiratory reactance (forced oscillation technique) between 2850m (prior to descent) and day 4 at sea level in healthy individuals
|
From high altitude (2850m) to day 4 at sea level
|
|
FEV1 pre-descent and after re-ascent (2850m)
Časové okno: Baseline at 2850m followed by a one-week stay at sea level to the day after re-ascent back to 2850m (time frame approximately 11 days)
|
Difference/change in FEV1 at 2850m with a one-week stay at sea level in between (day pre-descent vs. day after re-ascent) in healthy individuals
|
Baseline at 2850m followed by a one-week stay at sea level to the day after re-ascent back to 2850m (time frame approximately 11 days)
|
|
Forced Vital Capacity FVC pre-descent and after re-ascent (2850m)
Časové okno: Baseline at 2850m followed by a one-week stay at sea level to the day after re-ascent back to 2850m (time frame approximately 11 days)
|
Difference/change in forced vital capacity FVC at 2850m with a one-week stay at sea level in between (day pre-descent vs. day after re-ascent) in healthy individuals
|
Baseline at 2850m followed by a one-week stay at sea level to the day after re-ascent back to 2850m (time frame approximately 11 days)
|
|
FEV1/FVC pre-descent and after re-ascent (2850m)
Časové okno: Baseline at 2850m followed by a one-week stay at sea level to the day after re-ascent back to 2850m (time frame approximately 11 days)
|
Difference/change in FEV1/FVC at 2850m with a one-week stay at sea level in between (day pre-descent vs. day after re-ascent) in healthy individuals
|
Baseline at 2850m followed by a one-week stay at sea level to the day after re-ascent back to 2850m (time frame approximately 11 days)
|
|
Respiratory Impedance (forced oscillation technique) pre-descent and after re-ascent (2850m)
Časové okno: Baseline at 2850m followed by a one-week stay at sea level to the day after re-ascent back to 2850m (time frame approximately 11 days)
|
Difference/change in respiratory impedance (forced oscillation technique) at 2850m with a one-week stay at sea level in between (day pre-descent vs. day after re-ascent) in healthy individuals
|
Baseline at 2850m followed by a one-week stay at sea level to the day after re-ascent back to 2850m (time frame approximately 11 days)
|
|
Respiratory resistance (forced oscillation technique) pre-descent and after re-ascent (2850m)
Časové okno: Baseline at 2850m followed by a one-week stay at sea level to the day after re-ascent back to 2850m (time frame approximately 11 days)
|
Difference/change in respiratory resistance (forced oscillation technique) at 2850m with a one-week stay at sea level in between (day pre-descent vs. day after re-ascent) in healthy individuals
|
Baseline at 2850m followed by a one-week stay at sea level to the day after re-ascent back to 2850m (time frame approximately 11 days)
|
|
Respiratory reactance (forced oscillation technique) pre-descent and after re-ascent (2850m)
Časové okno: Baseline at 2850m followed by a one-week stay at sea level to the day after re-ascent back to 2850m (time frame approximately 11 days)
|
Difference/change in respiratory reactance (forced oscillation technique) at 2850m with a one-week stay at sea level in between (day pre-descent vs. day after re-ascent) in healthy individuals
|
Baseline at 2850m followed by a one-week stay at sea level to the day after re-ascent back to 2850m (time frame approximately 11 days)
|
Spolupracovníci a vyšetřovatelé
Zde najdete lidi a organizace zapojené do této studie.
Sponzor
Vyšetřovatelé
- Vrchní vyšetřovatel: Silvia Ulrich, University Hospital Zurich, Departement of Pulmonology
- Vrchní vyšetřovatel: Rodrigo Hoyos, Hospital Carlos Andrade Marin of Quito, Ecuador
Termíny studijních záznamů
Tato data sledují průběh záznamů studie a předkládání souhrnných výsledků na ClinicalTrials.gov. Záznamy ze studií a hlášené výsledky jsou před zveřejněním na veřejné webové stránce přezkoumány Národní lékařskou knihovnou (NLM), aby se ujistily, že splňují specifické standardy kontroly kvality.
Hlavní termíny studia
Začátek studia (Odhadovaný)
25. září 2026
Primární dokončení (Odhadovaný)
4. října 2026
Dokončení studie (Odhadovaný)
31. prosince 2026
Termíny zápisu do studia
První předloženo
17. srpna 2026
První předloženo, které splnilo kritéria kontroly kvality
31. srpna 2026
První zveřejněno (Aktuální)
4. září 2026
Aktualizace studijních záznamů
Poslední zveřejněná aktualizace (Aktuální)
4. září 2026
Odeslaná poslední aktualizace, která splnila kritéria kontroly kvality
31. srpna 2026
Naposledy ověřeno
1. srpna 2026
Více informací
Termíny související s touto studií
Klíčová slova
Další relevantní podmínky MeSH
Další identifikační čísla studie
- Ec_LAvsHA_Lufu_H
Plán pro data jednotlivých účastníků (IPD)
Plánujete sdílet data jednotlivých účastníků (IPD)?
ANO
Popis plánu IPD
Data will be provided upon request and based on a clear intention reviewed by an ethical review board.
Informace o lécích a zařízeních, studijní dokumenty
Studuje lékový produkt regulovaný americkým FDA
Ne
Studuje produkt zařízení regulovaný americkým úřadem FDA
Ne
Tyto informace byly beze změn načteny přímo z webu clinicaltrials.gov. Máte-li jakékoli požadavky na změnu, odstranění nebo aktualizaci podrobností studie, kontaktujte prosím register@clinicaltrials.gov. Jakmile bude změna implementována na clinicaltrials.gov, bude automaticky aktualizována i na našem webu .