Sleep-Assessment in Patients Between High Altitude HA vs. Sea Level LA in Patients With Pulmonary Arterial Hypertension PAH
31. August 2026 aktualisiert von: 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 patients with pulmonary arterial hypertension PAH, who live permanently >2600m.
Studienübersicht
Status
Noch keine Rekrutierung
Bedingungen
Intervention / Behandlung
Detaillierte Beschreibung
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 patients with diagnosed pulmonary arterial hypertension according to guidelines, who permanently live at high altitude over 2600m
Studientyp
Interventionell
Einschreibung (Geschätzt)
20
Phase
- Unzutreffend
Kontakte und Standorte
Dieser Abschnitt enthält die Kontaktdaten derjenigen, die die Studie durchführen, und Informationen darüber, wo diese Studie durchgeführt wird.
Studienkontakt
- Name: Silvia Ulrich, Prof. Dr. med.
- Telefonnummer: +41442552220
- E-Mail: silvia.ulrich@usz.ch
Studieren Sie die Kontaktsicherung
- Name: Michael Furian, Prof. Dr. sc. ETH
- Telefonnummer: +41442552220
Studienorte
-
-
-
Zurich, Schweiz, 8091
- University Hospital of Zurich
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-
Teilnahmekriterien
Forscher suchen nach Personen, die einer bestimmten Beschreibung entsprechen, die als Auswahlkriterien bezeichnet werden. Einige Beispiele für diese Kriterien sind der allgemeine Gesundheitszustand einer Person oder frühere Behandlungen.
Zulassungskriterien
Studienberechtigtes Alter
- Erwachsene
- Älterer Erwachsener
Akzeptiert gesunde Freiwillige
Nein
Beschreibung
Inclusion Criteria:
- Adult patients aged 18-80 years and of all genders
- Permanent residence > 2600 m
- Diagnosis of pulmonary arterial hypertension PAH (PAHHA-Group) according to guidelines
- Patients are stable on therapy
- NYHA (new york heart association) functional class I-III.
- written informed consent to participate in the study.
Exclusion Criteria:
- Age <18 years or >80 years
- unstable condition
- Patients who cannot follow the study investigations
- Patient permanently living < 2600m.
- Patients who traveled and stayed overnight at altitudes <2000 m in the past 4 weeks.
- Patients with moderate to severe concomitant lung disease (FEV1<70% or forced vital capacity <70%), severe parenchymal lung disease, severe smokers (>20 cigarettes/day)
- Severely hypoxemic patients at Quito permanently having persistent SpO2 (oxygen saturation by pulseoximetry) <80% on ambient air.
- Patient with a non-corrected ventricular septum defect
- Relevant concomitant other disease of the heart, kidney, liver, blood (anemia hemoglobin<11 g/dl)
Studienplan
Dieser Abschnitt enthält Einzelheiten zum Studienplan, einschließlich des Studiendesigns und der Messung der Studieninhalte.
Wie ist die Studie aufgebaut?
Designdetails
- Hauptzweck: Unterstützende Pflege
- Zuteilung: N / A
- Interventionsmodell: Einzelgruppenzuweisung
- Maskierung: Keine (Offenes Etikett)
Waffen und Interventionen
Teilnehmergruppe / Arm |
Intervention / Behandlung |
|---|---|
|
Experimental: Sleep-parameters at 2850m and at sea level
Assessment of sleep-parameters by polygraphy in patients with pulmonary arterial hypertension at 2850m and at sea level
|
Descent from 2850m to sea level with a stay for 7 days and re-ascent back to 2850m
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Was misst die Studie?
Primäre Ergebnismessungen
Ergebnis Maßnahme |
Maßnahmenbeschreibung |
Zeitfenster |
|---|---|---|
|
Mean nocturnal SpO2 after 7 days at sea level
Zeitfenster: From high altitude (2850m) to night 7 at sea level
|
Difference in mean nocturnal SpO2 between 2850m and Night 7 at sea level in patients with pulmonary arterial hypertension
|
From high altitude (2850m) to night 7 at sea level
|
Sekundäre Ergebnismessungen
Ergebnis Maßnahme |
Maßnahmenbeschreibung |
Zeitfenster |
|---|---|---|
|
Time spent with low SpO2 after 7 days at sea level
Zeitfenster: From high altitude (2850m) to night 7 at sea level
|
Difference/change in time spent with low SpO2 (< 90% and < 80%) between 2850m and night 7 at sea level in patients with pulmonary arterial hypertension
|
From high altitude (2850m) to night 7 at sea level
|
|
Apnoea-Hypopnoea-Index AHI after 7 days at sea level
Zeitfenster: 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 patients with pulmonary arterial hypertension
|
From high altitude (2850m) to night 7 at sea level
|
|
Oxygen-Desaturation-Index ODI after 7 days at sea level
Zeitfenster: 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 patients with pulmonary arterial hypertension
|
From high altitude (2850m) to night 7 at sea level
|
|
Nocturnal cardiovascular autonomic control after 7 days at sea level
Zeitfenster: 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 patients with pulmonary arterial hypertension
|
From high altitude (2850m) to night 7 at sea level
|
|
Acclimatization-Effect of mean nocturnal SpO2 at sea level
Zeitfenster: From Night 1 to Night 7 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 patients with pulmonary arterial hypertension
|
From Night 1 to Night 7 at sea level
|
|
Acclimatization-Effect of time spent with low SpO2 at sea level
Zeitfenster: 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 patients with pulmonary arterial hypertension
|
From Night 1 to Night 7 at sea level
|
|
Acclimatization-Effect of Apnoea-Hypopnoea-Index AHI at sea level
Zeitfenster: 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 patients with pulmonary arterial hypertension
|
From Night 1 to Night 7 at sea level
|
|
Acclimatization-Effect of Oxygen-Desaturation-Index ODI at sea level
Zeitfenster: From Night 1 to Night 7 at sea level
|
Difference/change in nocturnal oxygen-desaturation-index ODI at night 1 and night 7 within a stay at sea level of 7 days (after relocation from high altitude) in patients with pulmonary arterial hypertension
|
From Night 1 to Night 7 at sea level
|
|
Acclimatization-Effect of nocturnal cardiovascular autonomic control at sea level
Zeitfenster: 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 patients with pulmonary arterial hypertension
|
From Night 1 to Night 7 at sea level
|
|
Mean nocturnal SpO2 after re-ascent to 2850m
Zeitfenster: From Night 7 at sea level to night after reascent (time frame of 3 days)
|
Difference/change in mean nocturnal SpO2 between sea level (after one-week stay) and night after re-ascent to 2850m in patients with pulmonary arterial hypertension
|
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
Zeitfenster: 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 patients with pulmonary arterial hypertension
|
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
Zeitfenster: 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 patients with pulmonary arterial hypertension
|
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
Zeitfenster: 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 patients with pulmonary arterial hypertension
|
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
Zeitfenster: 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 patients with pulmonary arterial hypertension
|
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)
Zeitfenster: 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 patients with pulmonary arterial hypertension
|
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)
Zeitfenster: 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 patients with pulmonary arterial hypertension
|
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)
Zeitfenster: 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 patients with pulmonary arterial hypertension
|
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)
Zeitfenster: 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 patients with pulmonary arterial hypertension
|
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)
Zeitfenster: 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 patients with pulmonary arterial hypertension
|
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)
|
Mitarbeiter und Ermittler
Hier finden Sie Personen und Organisationen, die an dieser Studie beteiligt sind.
Sponsor
Ermittler
- Hauptermittler: Silvia Ulrich, University Hospital Zurich, Departement of Pulmonology
- Hauptermittler: Rodrigo Hoyos, Hospital Carlos Andrade Marin of Quito, Ecuador
Studienaufzeichnungsdaten
Diese Daten verfolgen den Fortschritt der Übermittlung von Studienaufzeichnungen und zusammenfassenden Ergebnissen an ClinicalTrials.gov. Studienaufzeichnungen und gemeldete Ergebnisse werden von der National Library of Medicine (NLM) überprüft, um sicherzustellen, dass sie bestimmten Qualitätskontrollstandards entsprechen, bevor sie auf der öffentlichen Website veröffentlicht werden.
Haupttermine studieren
Studienbeginn (Geschätzt)
25. September 2026
Primärer Abschluss (Geschätzt)
4. Oktober 2026
Studienabschluss (Geschätzt)
31. Dezember 2026
Studienanmeldedaten
Zuerst eingereicht
17. August 2026
Zuerst eingereicht, das die QC-Kriterien erfüllt hat
31. August 2026
Zuerst gepostet (Tatsächlich)
3. September 2026
Studienaufzeichnungsaktualisierungen
Letztes Update gepostet (Tatsächlich)
3. September 2026
Letztes eingereichtes Update, das die QC-Kriterien erfüllt
31. August 2026
Zuletzt verifiziert
1. August 2026
Mehr Informationen
Begriffe im Zusammenhang mit dieser Studie
Schlüsselwörter
Zusätzliche relevante MeSH-Bedingungen
- Erkrankungen des Nervensystems
- Gefäßerkrankungen
- Herz-Kreislauf-Erkrankungen
- Erkrankungen der Atemwege
- Lungenkrankheit
- Atemstörungen
- Schlaf-Wach-Störungen
- Anzeichen und Symptome, Atmung
- Apnoe
- Schlafstörungen, intrinsisch
- Dyssomnien
- Hypertonie
- Pathologische Zustände, Anzeichen und Symptome
- Anzeichen und Symptome
- Pulmonale Hypertonie
- Hypoxie
- Schlafapnoe-Syndrome
- Bluthochdruck, Lungen
- Höhenkrankheit
Andere Studien-ID-Nummern
- Ec_HAvsLA_sleep_PAH
Plan für individuelle Teilnehmerdaten (IPD)
Planen Sie, individuelle Teilnehmerdaten (IPD) zu teilen?
JA
Beschreibung des IPD-Plans
Data will be provided upon request and based on a clear intention reviewed by an ethical review board.
Arzneimittel- und Geräteinformationen, Studienunterlagen
Studiert ein von der US-amerikanischen FDA reguliertes Arzneimittelprodukt
Nein
Studiert ein von der US-amerikanischen FDA reguliertes Geräteprodukt
Nein
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