Assessment of Lung Function (Lufu) at Sea Level LA vs. High Altitude HA in Healthy Individuals
31 sierpnia 2026 zaktualizowane przez: 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.
Przegląd badań
Status
Jeszcze nie rekrutacja
Warunki
Interwencja / Leczenie
Szczegółowy opis
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 studiów
Interwencyjne
Zapisy (Szacowany)
14
Faza
- Nie dotyczy
Kontakty i lokalizacje
Ta sekcja zawiera dane kontaktowe osób prowadzących badanie oraz informacje o tym, gdzie badanie jest przeprowadzane.
Kontakt w sprawie studiów
- Nazwa: Silvia Ulrich, Prof. Dr. med.
- Numer telefonu: +41442552220
- E-mail: silvia.ulrich@usz.ch
Kopia zapasowa kontaktu do badania
- Nazwa: Michael Furian, Prof. Dr. sc. ETH
- Numer telefonu: +41442552220
Lokalizacje studiów
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Zurich, Szwajcaria, 8091
- University Hospital of Zurich
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Kryteria uczestnictwa
Badacze szukają osób, które pasują do określonego opisu, zwanego kryteriami kwalifikacyjnymi. Niektóre przykłady tych kryteriów to ogólny stan zdrowia danej osoby lub wcześniejsze leczenie.
Kryteria kwalifikacji
Wiek uprawniający do nauki
- Dorosły
- Starszy dorosły
Akceptuje zdrowych ochotników
Tak
Opis
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
Plan studiów
Ta sekcja zawiera szczegółowe informacje na temat planu badania, w tym sposób zaprojektowania badania i jego pomiary.
Jak projektuje się badanie?
Szczegóły projektu
- Główny cel: Leczenie podtrzymujące
- Przydział: Nie dotyczy
- Model interwencyjny: Zadanie dla jednej grupy
- Maskowanie: Brak (otwarta etykieta)
Broń i interwencje
Grupa uczestników / Arm |
Interwencja / Leczenie |
|---|---|
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Eksperymentalny: 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)
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Descent from 2850m to sea level with a stay for 7 days and re-ascent/return back to their usual living altitude at 2850m
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Co mierzy badanie?
Podstawowe miary wyniku
Miara wyniku |
Opis środka |
Ramy czasowe |
|---|---|---|
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FEV1 after re-ascent to 2850m
Ramy czasowe: From Day 4 at sea level to the day after re-ascent (Day 9)
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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
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From Day 4 at sea level to the day after re-ascent (Day 9)
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Miary wyników drugorzędnych
Miara wyniku |
Opis środka |
Ramy czasowe |
|---|---|---|
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Forced Vital Capacity FVC after re-ascent to 2850m
Ramy czasowe: From Day 4 at sea level to the day after re-ascent (Day 9)
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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
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From Day 4 at sea level to the day after re-ascent (Day 9)
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FEV1/FVC after re-ascent to 2850m
Ramy czasowe: From Day 4 at sea level to the day after re-ascent (Day 9)
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Difference/change in FEV1/FVC between sea level (measurement on the 4th day) and day after re-ascent to 2850m in healthy individuals
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From Day 4 at sea level to the day after re-ascent (Day 9)
|
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Respiratory Impedance (forced oscillation technique) after re-ascent to 2850m
Ramy czasowe: From Day 4 at sea level to the day after re-ascent (Day 9)
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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
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From Day 4 at sea level to the day after re-ascent (Day 9)
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Respiratory resistance (forced oscillation technique) after re-ascent to 2850m
Ramy czasowe: 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
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From Day 4 at sea level to the day after re-ascent (Day 9)
|
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Respiratory reactance (forced oscillation technique) after re-ascent to 2850m
Ramy czasowe: 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
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From Day 4 at sea level to the day after re-ascent (Day 9)
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FEV1 after 4 days at sea level
Ramy czasowe: From high altitude (2850m) to day 4 at sea level
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Difference/change in FEV1 between 2850m (prior to descent) and day 4 at sea level in healthy individuals
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From high altitude (2850m) to day 4 at sea level
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Forced Vital Capacity FVC after 4 days at sea level
Ramy czasowe: From high altitude (2850m) to day 4 at sea level
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Difference/change in forced vital capacity FVC between 2850m (prior to descent) and day 4 at sea level in healthy individuals
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From high altitude (2850m) to day 4 at sea level
|
|
FEV1/FVC after 4 days at sea level
Ramy czasowe: 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
|
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Respiratory Impedance (forced oscillation technique) after 4 days at sea level
Ramy czasowe: 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
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From high altitude (2850m) to day 4 at sea level
|
|
Respiratory resistance (forced oscillation technique) after 4 days at sea level
Ramy czasowe: 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
Ramy czasowe: From high altitude (2850m) to day 4 at sea level
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Difference/change in respiratory reactance (forced oscillation technique) between 2850m (prior to descent) and day 4 at sea level in healthy individuals
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From high altitude (2850m) to day 4 at sea level
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FEV1 pre-descent and after re-ascent (2850m)
Ramy czasowe: 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)
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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
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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)
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Forced Vital Capacity FVC pre-descent and after re-ascent (2850m)
Ramy czasowe: 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)
Ramy czasowe: 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)
Ramy czasowe: 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)
Ramy czasowe: 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)
Ramy czasowe: 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)
|
Współpracownicy i badacze
Tutaj znajdziesz osoby i organizacje zaangażowane w to badanie.
Sponsor
Śledczy
- Główny śledczy: Silvia Ulrich, University Hospital Zurich, Departement of Pulmonology
- Główny śledczy: Rodrigo Hoyos, Hospital Carlos Andrade Marin of Quito, Ecuador
Daty zapisu na studia
Daty te śledzą postęp w przesyłaniu rekordów badań i podsumowań wyników do ClinicalTrials.gov. Zapisy badań i zgłoszone wyniki są przeglądane przez National Library of Medicine (NLM), aby upewnić się, że spełniają określone standardy kontroli jakości, zanim zostaną opublikowane na publicznej stronie internetowej.
Główne daty studiów
Rozpoczęcie studiów (Szacowany)
25 września 2026
Zakończenie podstawowe (Szacowany)
4 października 2026
Ukończenie studiów (Szacowany)
31 grudnia 2026
Daty rejestracji na studia
Pierwszy przesłany
17 sierpnia 2026
Pierwszy przesłany, który spełnia kryteria kontroli jakości
31 sierpnia 2026
Pierwszy wysłany (Rzeczywisty)
4 września 2026
Aktualizacje rekordów badań
Ostatnia wysłana aktualizacja (Rzeczywisty)
4 września 2026
Ostatnia przesłana aktualizacja, która spełniała kryteria kontroli jakości
31 sierpnia 2026
Ostatnia weryfikacja
1 sierpnia 2026
Więcej informacji
Terminy związane z tym badaniem
Słowa kluczowe
Dodatkowe istotne warunki MeSH
Inne numery identyfikacyjne badania
- Ec_LAvsHA_Lufu_H
Plan dla danych uczestnika indywidualnego (IPD)
Planujesz udostępniać dane poszczególnych uczestników (IPD)?
TAK
Opis planu IPD
Data will be provided upon request and based on a clear intention reviewed by an ethical review board.
Informacje o lekach i urządzeniach, dokumenty badawcze
Bada produkt leczniczy regulowany przez amerykańską FDA
Nie
Bada produkt urządzenia regulowany przez amerykańską FDA
Nie
Te informacje zostały pobrane bezpośrednio ze strony internetowej clinicaltrials.gov bez żadnych zmian. Jeśli chcesz zmienić, usunąć lub zaktualizować dane swojego badania, skontaktuj się z register@clinicaltrials.gov. Gdy tylko zmiana zostanie wprowadzona na stronie clinicaltrials.gov, zostanie ona automatycznie zaktualizowana również na naszej stronie internetowej .