Sleep-Assessment in Patients Between High Altitude HA vs. Sea Level LA in Patients With Pulmonary Arterial Hypertension PAH
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
Studienübersicht
Status
Status
Bedingungen
Bedingungen
Intervention / Behandlung
Intervention / Behandlung
Detaillierte Beschreibung
Studientyp
Studientyp
Einschreibung (Geschätzt)
Einschreibung
Phase
Phase
- Unzutreffend
Kontakte und Standorte
Studienkontakt
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
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-
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Zurich, Schweiz, 8091
- University Hospital of Zurich
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Teilnahmekriterien
Zulassungskriterien
Zulassungskriterien
Studienberechtigtes Alter
- Erwachsene
- Älterer Erwachsener
Akzeptiert gesunde Freiwillige
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
Wie ist die Studie aufgebaut?
Designdetails
- Hauptzweck: Unterstützende Pflege
- Zuteilung: N / A
- Interventionsmodell: Einzelgruppenzuweisung
- Maskierung: Keine (Offenes Etikett)
Anzahl der Arme
Waffen und Interventionen
Teilnehmergruppe / ArmTeilnehmergruppe / Arm |
Intervention / BehandlungIntervention / Behandlung |
|---|---|
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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
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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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Was misst die Studie?
Primäre Ergebnismessungen
Primäre Ergebnismessungen
Ergebnis Maßnahme |
Maßnahmenbeschreibung |
Zeitfenster |
|---|---|---|
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Mean nocturnal SpO2 after 7 days at sea level
Zeitfenster: From high altitude (2850m) to night 7 at sea level
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Difference in mean nocturnal SpO2 between 2850m and Night 7 at sea level in patients with pulmonary arterial hypertension
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From high altitude (2850m) to night 7 at sea level
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Sekundäre Ergebnismessungen
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
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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
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From high altitude (2850m) to night 7 at sea level
|
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Apnoea-Hypopnoea-Index AHI after 7 days at sea level
Zeitfenster: 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 patients with pulmonary arterial hypertension
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From high altitude (2850m) to night 7 at sea level
|
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Oxygen-Desaturation-Index ODI after 7 days at sea level
Zeitfenster: From high altitude (2850m) to night 7 at sea level
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Difference/change in nocturnal Oxygen-Desaturation-Index ODI between 2850m and night 7 at sea level in patients with pulmonary arterial hypertension
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From high altitude (2850m) to night 7 at sea level
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Nocturnal cardiovascular autonomic control after 7 days at sea level
Zeitfenster: 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 patients with pulmonary arterial hypertension
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From high altitude (2850m) to night 7 at sea level
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Acclimatization-Effect of mean nocturnal SpO2 at sea level
Zeitfenster: 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 patients with pulmonary arterial hypertension
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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
Zeitfenster: 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 patients with pulmonary arterial hypertension
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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
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
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From Night 1 to Night 7 at sea level
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Mean nocturnal SpO2 after re-ascent to 2850m
Zeitfenster: 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 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
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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
Sponsor
Sponsor
Ermittler
Ermittler
- Hauptermittler: Silvia Ulrich, University Hospital Zurich, Departement of Pulmonology
- Hauptermittler: Rodrigo Hoyos, Hospital Carlos Andrade Marin of Quito, Ecuador
Studienaufzeichnungsdaten
Haupttermine studieren
Studienbeginn (Geschätzt)
Studienbeginn
Primärer Abschluss (Geschätzt)
Primärer Abschluss
Studienabschluss (Geschätzt)
Studienabschluss
Studienanmeldedaten
Zuerst eingereicht
Zuerst eingereicht
Zuerst eingereicht, das die QC-Kriterien erfüllt hat
Zuerst eingereicht, das die QC-Kriterien erfüllt hat
Zuerst gepostet (Tatsächlich)
Zuerst gepostet
Studienaufzeichnungsaktualisierungen
Letztes Update gepostet (Tatsächlich)
Letztes Update gepostet
Letztes eingereichtes Update, das die QC-Kriterien erfüllt
Letztes eingereichtes Update, das die QC-Kriterien erfüllt
Zuletzt verifiziert
Zuletzt verifiziert
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
Andere Studien-ID-Nummern
- Ec_HAvsLA_sleep_PAH
Plan für individuelle Teilnehmerdaten (IPD)
Planen Sie, individuelle Teilnehmerdaten (IPD) zu teilen?
Beschreibung des IPD-Plans
Arzneimittel- und Geräteinformationen, Studienunterlagen
Studiert ein von der US-amerikanischen FDA reguliertes Arzneimittelprodukt
Studiert ein von der US-amerikanischen FDA reguliertes Geräteprodukt
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