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

31. august 2026 oppdatert av: 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.

Studieoversikt

Status

Har ikke rekruttert ennå

Forhold

Intervensjon / Behandling

Detaljert beskrivelse

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

Studietype

Intervensjonell

Registrering (Antatt)

20

Fase

  • Ikke aktuelt

Kontakter og plasseringer

Denne delen inneholder kontaktinformasjon for de som utfører studien, og informasjon om hvor denne studien blir utført.

Studiekontakt

Studer Kontakt Backup

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

Studiesteder

  • Sveits
      • Zurich, Sveits, 8091
        • University Hospital of Zurich

Deltakelseskriterier

Forskere ser etter personer som passer til en bestemt beskrivelse, kalt kvalifikasjonskriterier. Noen eksempler på disse kriteriene er en persons generelle helsetilstand eller tidligere behandlinger.

Kvalifikasjonskriterier

Alder som er kvalifisert for studier

  • Voksen
  • Eldre voksen

Tar imot friske frivillige

Nei

Beskrivelse

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)

Studieplan

Denne delen gir detaljer om studieplanen, inkludert hvordan studien er utformet og hva studien måler.

Hvordan er studiet utformet?

Designdetaljer

  • Primært formål: Støttende omsorg
  • Tildeling: N/A
  • Intervensjonsmodell: Enkeltgruppeoppdrag
  • Masking: Ingen (Open Label)

Våpen og intervensjoner

Deltakergruppe / Arm
Intervensjon / Behandling
Eksperimentell: 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
Atferdsmessig: Descent to sea level
Descent from 2850m to sea level with a stay for 7 days and re-ascent back to 2850m

Hva måler studien?

Primære resultatmål

Resultatmål
Tiltaksbeskrivelse
Tidsramme
Mean nocturnal SpO2 after 7 days at sea level
Tidsramme: 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

Sekundære resultatmål

Resultatmål
Tiltaksbeskrivelse
Tidsramme
Time spent with low SpO2 after 7 days at sea level
Tidsramme: 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
Tidsramme: 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
Tidsramme: 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
Tidsramme: 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
Tidsramme: 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
Tidsramme: 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
Tidsramme: 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
Tidsramme: 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
Tidsramme: 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
Tidsramme: 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
Tidsramme: 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
Tidsramme: 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
Tidsramme: 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
Tidsramme: 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)
Tidsramme: 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)
Tidsramme: 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)
Tidsramme: 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)
Tidsramme: 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)
Tidsramme: 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)

Samarbeidspartnere og etterforskere

Det er her du vil finne personer og organisasjoner som er involvert i denne studien.

Sponsor

Silvia Ulrich Somaini

Etterforskere

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

Studierekorddatoer

Disse datoene sporer fremdriften for innsending av studieposter og sammendragsresultater til ClinicalTrials.gov. Studieposter og rapporterte resultater gjennomgås av National Library of Medicine (NLM) for å sikre at de oppfyller spesifikke kvalitetskontrollstandarder før de legges ut på det offentlige nettstedet.

Studer hoveddatoer

Studiestart (Antatt)

25. september 2026

Primær fullføring (Antatt)

4. oktober 2026

Studiet fullført (Antatt)

31. desember 2026

Datoer for studieregistrering

Først innsendt

17. august 2026

Først innsendt som oppfylte QC-kriteriene

31. august 2026

Først lagt ut (Faktiske)

3. september 2026

Oppdateringer av studieposter

Sist oppdatering lagt ut (Faktiske)

3. september 2026

Siste oppdatering sendt inn som oppfylte QC-kriteriene

31. august 2026

Sist bekreftet

1. august 2026

Mer informasjon

Begreper knyttet til denne studien

Nøkkelord

Ytterligere relevante MeSH-vilkår

Andre studie-ID-numre

  • Ec_HAvsLA_sleep_PAH

Plan for individuelle deltakerdata (IPD)

Planlegger du å dele individuelle deltakerdata (IPD)?

JA

IPD-planbeskrivelse

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

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Nei

Studerer et amerikansk FDA-regulert enhetsprodukt

Nei

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