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Sleep-Assessment in Patients Between High Altitude HA vs. Sea Level LA in Patients With Pulmonary Arterial Hypertension PAH

maanantai 31. elokuuta 2026 päivittänyt: 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.

Tutkimuksen yleiskatsaus

Tila

Ei vielä rekrytointia

Ehdot

Interventio / Hoito

Yksityiskohtainen kuvaus

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

Opintotyyppi

Interventio

Ilmoittautuminen (Arvioitu)

20

Vaihe

  • Ei sovellettavissa

Yhteystiedot ja paikat

Tässä osiossa on tutkimuksen suorittajien yhteystiedot ja tiedot siitä, missä tämä tutkimus suoritetaan.

Opiskeluyhteys

  • Nimi: Silvia Ulrich, Prof. Dr. med.
  • Puhelinnumero: +41442552220
  • Sähköposti: silvia.ulrich@usz.ch

Tutki yhteystietojen varmuuskopiointi

  • Nimi: Michael Furian, Prof. Dr. sc. ETH
  • Puhelinnumero: +41442552220

Opiskelupaikat

  • Sveitsi
      • Zurich, Sveitsi, 8091
        • University Hospital of Zurich

Osallistumiskriteerit

Tutkijat etsivät ihmisiä, jotka sopivat tiettyyn kuvaukseen, jota kutsutaan kelpoisuuskriteereiksi. Joitakin esimerkkejä näistä kriteereistä ovat henkilön yleinen terveydentila tai aiemmat hoidot.

Kelpoisuusvaatimukset

Opintokelpoiset iät

  • Aikuinen
  • Vanhempi Aikuinen

Hyväksyy terveitä vapaaehtoisia

Ei

Kuvaus

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)

Opintosuunnitelma

Tässä osiossa on tietoja tutkimussuunnitelmasta, mukaan lukien kuinka tutkimus on suunniteltu ja mitä tutkimuksella mitataan.

Miten tutkimus on suunniteltu?

Suunnittelun yksityiskohdat

  • Ensisijainen käyttötarkoitus: Tukevaa hoitoa
  • Jako: Ei käytössä
  • Inventiomalli: Yksittäinen ryhmätehtävä
  • Naamiointi: Ei mitään (avoin tarra)

Aseet ja interventiot

Osallistujaryhmä / Arm
Interventio / Hoito
Kokeellinen: 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
Käyttäytyminen: Descent to sea level
Descent from 2850m to sea level with a stay for 7 days and re-ascent back to 2850m

Mitä tutkimuksessa mitataan?

Ensisijaiset tulostoimenpiteet

Tulosmittaus
Toimenpiteen kuvaus
Aikaikkuna
Mean nocturnal SpO2 after 7 days at sea level
Aikaikkuna: 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

Toissijaiset tulostoimenpiteet

Tulosmittaus
Toimenpiteen kuvaus
Aikaikkuna
Time spent with low SpO2 after 7 days at sea level
Aikaikkuna: 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
Aikaikkuna: 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
Aikaikkuna: 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
Aikaikkuna: 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
Aikaikkuna: 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
Aikaikkuna: 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
Aikaikkuna: 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
Aikaikkuna: 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
Aikaikkuna: 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
Aikaikkuna: 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
Aikaikkuna: 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
Aikaikkuna: 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
Aikaikkuna: 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
Aikaikkuna: 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)
Aikaikkuna: 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)
Aikaikkuna: 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)
Aikaikkuna: 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)
Aikaikkuna: 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)
Aikaikkuna: 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)

Yhteistyökumppanit ja tutkijat

Täältä löydät tähän tutkimukseen osallistuvat ihmiset ja organisaatiot.

Sponsori

Silvia Ulrich Somaini

Tutkijat

  • Päätutkija: Silvia Ulrich, University Hospital Zurich, Departement of Pulmonology
  • Päätutkija: Rodrigo Hoyos, Hospital Carlos Andrade Marin of Quito, Ecuador

Opintojen ennätyspäivät

Nämä päivämäärät seuraavat ClinicalTrials.gov-sivustolle lähetettyjen tutkimustietueiden ja yhteenvetojen edistymistä. National Library of Medicine (NLM) tarkistaa tutkimustiedot ja raportoidut tulokset varmistaakseen, että ne täyttävät tietyt laadunvalvontastandardit, ennen kuin ne julkaistaan ​​julkisella verkkosivustolla.

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Avainsanat

Muita asiaankuuluvia MeSH-ehtoja

Muut tutkimustunnusnumerot

  • Ec_HAvsLA_sleep_PAH

Yksittäisten osallistujien tietojen suunnitelma (IPD)

Aiotko jakaa yksittäisten osallistujien tietoja (IPD)?

JOO

IPD-suunnitelman kuvaus

Data will be provided upon request and based on a clear intention reviewed by an ethical review board.

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