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

31 agosto 2026 aggiornato da: 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.

Panoramica dello studio

Stato

Non ancora reclutamento

Condizioni

Intervento / Trattamento

Descrizione dettagliata

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

Tipo di studio

Interventistico

Iscrizione (Stimato)

20

Fase

  • Non applicabile

Contatti e Sedi

Questa sezione fornisce i recapiti di coloro che conducono lo studio e informazioni su dove viene condotto lo studio.

Contatto studio

Backup dei contatti dello studio

  • Nome: Michael Furian, Prof. Dr. sc. ETH
  • Numero di telefono: +41442552220

Luoghi di studio

  • Svizzera
      • Zurich, Svizzera, 8091
        • University Hospital of Zurich

Criteri di partecipazione

I ricercatori cercano persone che corrispondano a una certa descrizione, chiamata criteri di ammissibilità. Alcuni esempi di questi criteri sono le condizioni generali di salute di una persona o trattamenti precedenti.

Criteri di ammissibilità

Età idonea allo studio

  • Adulto
  • Adulto più anziano

Accetta volontari sani

No

Descrizione

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)

Piano di studio

Questa sezione fornisce i dettagli del piano di studio, compreso il modo in cui lo studio è progettato e ciò che lo studio sta misurando.

Come è strutturato lo studio?

Dettagli di progettazione

  • Scopo principale: Terapia di supporto
  • Assegnazione: N / A
  • Modello interventistico: Assegnazione di gruppo singolo
  • Mascheramento: Nessuno (etichetta aperta)

Armi e interventi

Gruppo di partecipanti / Arm
Intervento / Trattamento
Sperimentale: 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
Comportamentale: Descent to sea level
Descent from 2850m to sea level with a stay for 7 days and re-ascent back to 2850m

Cosa sta misurando lo studio?

Misure di risultato primarie

Misura del risultato
Misura Descrizione
Lasso di tempo
Mean nocturnal SpO2 after 7 days at sea level
Lasso di tempo: 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

Misure di risultato secondarie

Misura del risultato
Misura Descrizione
Lasso di tempo
Time spent with low SpO2 after 7 days at sea level
Lasso di tempo: 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
Lasso di tempo: 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
Lasso di tempo: 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
Lasso di tempo: 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
Lasso di tempo: 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
Lasso di tempo: 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
Lasso di tempo: 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
Lasso di tempo: 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
Lasso di tempo: 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
Lasso di tempo: 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
Lasso di tempo: 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
Lasso di tempo: 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
Lasso di tempo: 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
Lasso di tempo: 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)
Lasso di tempo: 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)
Lasso di tempo: 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)
Lasso di tempo: 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)
Lasso di tempo: 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)
Lasso di tempo: 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)

Collaboratori e investigatori

Qui è dove troverai le persone e le organizzazioni coinvolte in questo studio.

Sponsor

Silvia Ulrich Somaini

Investigatori

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

Studiare le date dei record

Queste date tengono traccia dell'avanzamento della registrazione dello studio e dell'invio dei risultati di sintesi a ClinicalTrials.gov. I record degli studi e i risultati riportati vengono esaminati dalla National Library of Medicine (NLM) per assicurarsi che soddisfino specifici standard di controllo della qualità prima di essere pubblicati sul sito Web pubblico.

Studia le date principali

Inizio studio (Stimato)

25 settembre 2026

Completamento primario (Stimato)

4 ottobre 2026

Completamento dello studio (Stimato)

31 dicembre 2026

Date di iscrizione allo studio

Primo inviato

17 agosto 2026

Primo inviato che soddisfa i criteri di controllo qualità

31 agosto 2026

Primo Inserito (Effettivo)

3 settembre 2026

Aggiornamenti dei record di studio

Ultimo aggiornamento pubblicato (Effettivo)

3 settembre 2026

Ultimo aggiornamento inviato che soddisfa i criteri QC

31 agosto 2026

Ultimo verificato

1 agosto 2026

Maggiori informazioni

Termini relativi a questo studio

Parole chiave

Termini MeSH pertinenti aggiuntivi

Altri numeri di identificazione dello studio

  • Ec_HAvsLA_sleep_PAH

Piano per i dati dei singoli partecipanti (IPD)

Hai intenzione di condividere i dati dei singoli partecipanti (IPD)?

SÌ

Descrizione del piano IPD

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

Informazioni su farmaci e dispositivi, documenti di studio

Studia un prodotto farmaceutico regolamentato dalla FDA degli Stati Uniti

No

Studia un dispositivo regolamentato dalla FDA degli Stati Uniti

No

Queste informazioni sono state recuperate direttamente dal sito web clinicaltrials.gov senza alcuna modifica. In caso di richieste di modifica, rimozione o aggiornamento dei dettagli dello studio, contattare register@clinicaltrials.gov. Non appena verrà implementata una modifica su clinicaltrials.gov, questa verrà aggiornata automaticamente anche sul nostro sito web .

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