Sleep-Assessment in Patients Between High Altitude HA vs. Sea Level LA in Healthy Individuals H
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 relocation from high altitude (Quito Ecuador: 2850m) to sea level on sleeping parameters by polygraphy 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 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
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: 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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Co mierzy badanie?
Podstawowe miary wyniku
Miara wyniku |
Opis środka |
Ramy czasowe |
|---|---|---|
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Mean nocturnal SpO2 after 7 days at sea level
Ramy czasowe: 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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Miary wyników drugorzędnych
Miara wyniku |
Opis środka |
Ramy czasowe |
|---|---|---|
|
Time spent with low SpO2 after 7 days at sea level
Ramy czasowe: 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
Ramy czasowe: From high altitude (2850m) to night 7 at sea level
|
Difference/change in nocturnal apnoea-hypopnoea-index between 2850m and night 7 at sea level in healthy individuals
|
From high altitude (2850m) to night 7 at sea level
|
|
Oxygen-Desaturation-Index ODI after 7 days at sea level
Ramy czasowe: 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
Ramy czasowe: From high altitude (2850m) to night 7 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
|
From high altitude (2850m) to night 7 at sea level
|
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Acclimatization-Effect of mean nocturnal SpO2 at sea level
Ramy czasowe: 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
Ramy czasowe: From Night 1 to Night 7 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
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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
Ramy czasowe: 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
|
|
Acclimatization-Effect of Oxygen-Desaturation-Index ODI at sea level
Ramy czasowe: 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
Ramy czasowe: 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
Ramy czasowe: 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)
|
|
Time spent with low SpO2 after re-ascent to 2850m
Ramy czasowe: 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
Ramy czasowe: 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
Ramy czasowe: 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
Ramy czasowe: 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)
Ramy czasowe: 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)
Ramy czasowe: 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)
Ramy czasowe: 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)
Ramy czasowe: 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)
Ramy czasowe: 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)
|
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)
3 września 2026
Aktualizacje rekordów badań
Ostatnia wysłana aktualizacja (Rzeczywisty)
3 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_HAvsLA_sleep_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 .