Assessment of Lung Function (Lufu) at Sea Level LA vs. High Altitude HA in Healthy Individuals
31 août 2026 mis à jour par: 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 a re-ascent to high altitude (Quito Ecuador: 2850m) after a one-week stay at sea level (after prior descent from 2850m) on lung function and pulmonary resistance/reactance in healthy individuals, who live permanently > 2600m.
Aperçu de l'étude
Statut
Pas encore de recrutement
Les conditions
Intervention / Traitement
Description détaillée
The aim of this research is to investigate the lung function and pulmonary resistance/reactance before and after re-ascent (sea level for 7 days after prior descent from 2850m vs. re-ascent to 2850m) in healthy individuals, who permanently live at high altitude over 2600m.
Type d'étude
Interventionnel
Inscription (Estimé)
14
Phase
- N'est pas applicable
Contacts et emplacements
Cette section fournit les coordonnées de ceux qui mènent l'étude et des informations sur le lieu où cette étude est menée.
Coordonnées de l'étude
- Nom: Silvia Ulrich, Prof. Dr. med.
- Numéro de téléphone: +41442552220
- E-mail: silvia.ulrich@usz.ch
Sauvegarde des contacts de l'étude
- Nom: Michael Furian, Prof. Dr. sc. ETH
- Numéro de téléphone: +41442552220
Lieux d'étude
-
-
-
Zurich, Suisse, 8091
- University Hospital of Zurich
-
-
Critères de participation
Les chercheurs recherchent des personnes qui correspondent à une certaine description, appelée critères d'éligibilité. Certains exemples de ces critères sont l'état de santé général d'une personne ou des traitements antérieurs.
Critère d'éligibilité
Âges éligibles pour étudier
- Adulte
- Adulte plus âgé
Accepte les volontaires sains
Oui
La description
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
Plan d'étude
Cette section fournit des détails sur le plan d'étude, y compris la façon dont l'étude est conçue et ce que l'étude mesure.
Comment l'étude est-elle conçue ?
Détails de conception
- Objectif principal: Soins de soutien
- Répartition: N / A
- Modèle interventionnel: Affectation à un seul groupe
- Masquage: Aucun (étiquette ouverte)
Armes et Interventions
Groupe de participants / Bras |
Intervention / Traitement |
|---|---|
|
Expérimental: Lung function at sea level and at 2850m
Assessment of lung function and pulmonary resistance/reactance on day four at sea level (after prior descent from 2850m) and after re-ascent (after totally one week at sea level) back to 2850m by bus (in one day)
|
Descent from 2850m to sea level with a stay for 7 days and re-ascent/return back to their usual living altitude at 2850m
|
Que mesure l'étude ?
Principaux critères de jugement
Mesure des résultats |
Description de la mesure |
Délai |
|---|---|---|
|
FEV1 after re-ascent to 2850m
Délai: From Day 4 at sea level to the day after re-ascent (Day 9)
|
Difference/change in forced expiratory volume in one second FEV1 between sea level (measurement on the 4th day) and day after re-ascent to 2850m in healthy individuals
|
From Day 4 at sea level to the day after re-ascent (Day 9)
|
Mesures de résultats secondaires
Mesure des résultats |
Description de la mesure |
Délai |
|---|---|---|
|
Forced Vital Capacity FVC after re-ascent to 2850m
Délai: From Day 4 at sea level to the day after re-ascent (Day 9)
|
Difference/change in forced vital capacity FVC between sea level (measurement on the 4th day) and day after re-ascent to 2850m in healthy individuals
|
From Day 4 at sea level to the day after re-ascent (Day 9)
|
|
FEV1/FVC after re-ascent to 2850m
Délai: From Day 4 at sea level to the day after re-ascent (Day 9)
|
Difference/change in FEV1/FVC between sea level (measurement on the 4th day) and day after re-ascent to 2850m in healthy individuals
|
From Day 4 at sea level to the day after re-ascent (Day 9)
|
|
Respiratory Impedance (forced oscillation technique) after re-ascent to 2850m
Délai: From Day 4 at sea level to the day after re-ascent (Day 9)
|
Difference/change in respiratory impedance (forced oscillation technique) between sea level (measurement on the 4th day) and day after re-ascent to 2850m in healthy individuals
|
From Day 4 at sea level to the day after re-ascent (Day 9)
|
|
Respiratory resistance (forced oscillation technique) after re-ascent to 2850m
Délai: From Day 4 at sea level to the day after re-ascent (Day 9)
|
Difference/change in respiratory resistance (forced oscillation technique) between sea level (measurement on the 4th day) and day after re-ascent to 2850m in healthy individuals
|
From Day 4 at sea level to the day after re-ascent (Day 9)
|
|
Respiratory reactance (forced oscillation technique) after re-ascent to 2850m
Délai: From Day 4 at sea level to the day after re-ascent (Day 9)
|
Difference/change in respiratory reactance (forced oscillation technique) between sea level (measurement on the 4th day) and day after re-ascent to 2850m in healthy individuals
|
From Day 4 at sea level to the day after re-ascent (Day 9)
|
|
FEV1 after 4 days at sea level
Délai: From high altitude (2850m) to day 4 at sea level
|
Difference/change in FEV1 between 2850m (prior to descent) and day 4 at sea level in healthy individuals
|
From high altitude (2850m) to day 4 at sea level
|
|
Forced Vital Capacity FVC after 4 days at sea level
Délai: From high altitude (2850m) to day 4 at sea level
|
Difference/change in forced vital capacity FVC between 2850m (prior to descent) and day 4 at sea level in healthy individuals
|
From high altitude (2850m) to day 4 at sea level
|
|
FEV1/FVC after 4 days at sea level
Délai: From high altitude (2850m) to day 4 at sea level
|
Difference/change in FEV1/FVC between 2850m (prior to descent) and day 4 at sea level in healthy individuals
|
From high altitude (2850m) to day 4 at sea level
|
|
Respiratory Impedance (forced oscillation technique) after 4 days at sea level
Délai: From high altitude (2850m) to day 4 at sea level
|
Difference/change in respiratory Impedance (forced oscillation technique) between 2850m (prior to descent) and day 4 at sea level in healthy individuals
|
From high altitude (2850m) to day 4 at sea level
|
|
Respiratory resistance (forced oscillation technique) after 4 days at sea level
Délai: From high altitude (2850m) to day 4 at sea level
|
Difference/change in respiratory resistance (forced oscillation technique) between 2850m (prior to descent) and day 4 at sea level in healthy individuals
|
From high altitude (2850m) to day 4 at sea level
|
|
Respiratory reactance (forced oscillation technique) after 4 days at sea level
Délai: From high altitude (2850m) to day 4 at sea level
|
Difference/change in respiratory reactance (forced oscillation technique) between 2850m (prior to descent) and day 4 at sea level in healthy individuals
|
From high altitude (2850m) to day 4 at sea level
|
|
FEV1 pre-descent and after re-ascent (2850m)
Délai: Baseline at 2850m followed by a one-week stay at sea level to the day after re-ascent back to 2850m (time frame approximately 11 days)
|
Difference/change in FEV1 at 2850m with a one-week stay at sea level in between (day pre-descent vs. day after re-ascent) in healthy individuals
|
Baseline at 2850m followed by a one-week stay at sea level to the day after re-ascent back to 2850m (time frame approximately 11 days)
|
|
Forced Vital Capacity FVC pre-descent and after re-ascent (2850m)
Délai: Baseline at 2850m followed by a one-week stay at sea level to the day after re-ascent back to 2850m (time frame approximately 11 days)
|
Difference/change in forced vital capacity FVC at 2850m with a one-week stay at sea level in between (day pre-descent vs. day after re-ascent) in healthy individuals
|
Baseline at 2850m followed by a one-week stay at sea level to the day after re-ascent back to 2850m (time frame approximately 11 days)
|
|
FEV1/FVC pre-descent and after re-ascent (2850m)
Délai: Baseline at 2850m followed by a one-week stay at sea level to the day after re-ascent back to 2850m (time frame approximately 11 days)
|
Difference/change in FEV1/FVC at 2850m with a one-week stay at sea level in between (day pre-descent vs. day after re-ascent) in healthy individuals
|
Baseline at 2850m followed by a one-week stay at sea level to the day after re-ascent back to 2850m (time frame approximately 11 days)
|
|
Respiratory Impedance (forced oscillation technique) pre-descent and after re-ascent (2850m)
Délai: Baseline at 2850m followed by a one-week stay at sea level to the day after re-ascent back to 2850m (time frame approximately 11 days)
|
Difference/change in respiratory impedance (forced oscillation technique) at 2850m with a one-week stay at sea level in between (day pre-descent vs. day after re-ascent) in healthy individuals
|
Baseline at 2850m followed by a one-week stay at sea level to the day after re-ascent back to 2850m (time frame approximately 11 days)
|
|
Respiratory resistance (forced oscillation technique) pre-descent and after re-ascent (2850m)
Délai: Baseline at 2850m followed by a one-week stay at sea level to the day after re-ascent back to 2850m (time frame approximately 11 days)
|
Difference/change in respiratory resistance (forced oscillation technique) at 2850m with a one-week stay at sea level in between (day pre-descent vs. day after re-ascent) in healthy individuals
|
Baseline at 2850m followed by a one-week stay at sea level to the day after re-ascent back to 2850m (time frame approximately 11 days)
|
|
Respiratory reactance (forced oscillation technique) pre-descent and after re-ascent (2850m)
Délai: Baseline at 2850m followed by a one-week stay at sea level to the day after re-ascent back to 2850m (time frame approximately 11 days)
|
Difference/change in respiratory reactance (forced oscillation technique) at 2850m with a one-week stay at sea level in between (day pre-descent vs. day after re-ascent) in healthy individuals
|
Baseline at 2850m followed by a one-week stay at sea level to the day after re-ascent back to 2850m (time frame approximately 11 days)
|
Collaborateurs et enquêteurs
C'est ici que vous trouverez les personnes et les organisations impliquées dans cette étude.
Parrainer
Les enquêteurs
- Chercheur principal: Silvia Ulrich, University Hospital Zurich, Departement of Pulmonology
- Chercheur principal: Rodrigo Hoyos, Hospital Carlos Andrade Marin of Quito, Ecuador
Dates d'enregistrement des études
Ces dates suivent la progression des dossiers d'étude et des soumissions de résultats sommaires à ClinicalTrials.gov. Les dossiers d'étude et les résultats rapportés sont examinés par la Bibliothèque nationale de médecine (NLM) pour s'assurer qu'ils répondent à des normes de contrôle de qualité spécifiques avant d'être publiés sur le site Web public.
Dates principales de l'étude
Début de l'étude (Estimé)
25 septembre 2026
Achèvement primaire (Estimé)
4 octobre 2026
Achèvement de l'étude (Estimé)
31 décembre 2026
Dates d'inscription aux études
Première soumission
17 août 2026
Première soumission répondant aux critères de contrôle qualité
31 août 2026
Première publication (Réel)
4 septembre 2026
Mises à jour des dossiers d'étude
Dernière mise à jour publiée (Réel)
4 septembre 2026
Dernière mise à jour soumise répondant aux critères de contrôle qualité
31 août 2026
Dernière vérification
1 août 2026
Plus d'information
Termes liés à cette étude
Termes MeSH pertinents supplémentaires
Autres numéros d'identification d'étude
- Ec_LAvsHA_Lufu_H
Plan pour les données individuelles des participants (IPD)
Prévoyez-vous de partager les données individuelles des participants (DPI) ?
OUI
Description du régime IPD
Data will be provided upon request and based on a clear intention reviewed by an ethical review board.
Informations sur les médicaments et les dispositifs, documents d'étude
Étudie un produit pharmaceutique réglementé par la FDA américaine
Non
Étudie un produit d'appareil réglementé par la FDA américaine
Non
Ces informations ont été extraites directement du site Web clinicaltrials.gov sans aucune modification. Si vous avez des demandes de modification, de suppression ou de mise à jour des détails de votre étude, veuillez contacter register@clinicaltrials.gov. Dès qu'un changement est mis en œuvre sur clinicaltrials.gov, il sera également mis à jour automatiquement sur notre site Web .