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Sleep-Assessment in Patients Between High Altitude HA vs. Sea Level LA in Healthy Individuals H

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 healthy individuals, 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 healthy individuals, who permanently live at high altitude over 2600m

Studientyp

Interventionell

Einschreibung (Geschätzt)

14

Phase

  • Unzutreffend

Kontakte und Standorte

Dieser Abschnitt enthält die Kontaktdaten derjenigen, die die Studie durchführen, und Informationen darüber, wo diese Studie durchgeführt wird.

Studienkontakt

Studieren Sie die Kontaktsicherung

  • Name: Michael Furian, Prof. Dr. sc. ETH
  • Telefonnummer: +41442552220

Studienorte

  • Schweiz
      • Zurich, Schweiz, 8091
        • University Hospital of Zurich

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

Ja

Beschreibung

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

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 healthy individuals at 2850m (pre-descent and after re-ascent) and at sea level in between
Verhalten: Descent from 2850m to sea level and re-ascent back to 2850m
Descent from 2850m to sea level with a stay for 7 days and re-ascent back to 2850m

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/change in mean nocturnal SpO2 between 2850m and Night 7 at sea level in healthy individuals
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 healthy individuals
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 healthy individuals
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 healthy individuals
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 healthy individuals
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 healthy individuals
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 healthy individuals
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 healthy individuals
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 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
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 healthy individuals
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 healthy individuals
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 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
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 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
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 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
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 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)
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 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)
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 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)
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 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)
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 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)
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 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)

Mitarbeiter und Ermittler

Hier finden Sie Personen und Organisationen, die an dieser Studie beteiligt sind.

Sponsor

Silvia Ulrich Somaini

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

Andere Studien-ID-Nummern

  • Ec_HAvsLA_sleep_H

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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