Assessment of Lung Function (Lufu) at Sea Level LA vs. High Altitude HA in Healthy Individuals
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 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.
Studieoversikt
Status
Har ikke rekruttert ennå
Intervensjon / Behandling
Detaljert beskrivelse
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.
Studietype
Intervensjonell
Registrering (Antatt)
14
Fase
- Ikke aktuelt
Kontakter og plasseringer
Denne delen inneholder kontaktinformasjon for de som utfører studien, og informasjon om hvor denne studien blir utført.
Studiekontakt
- Navn: Silvia Ulrich, Prof. Dr. med.
- Telefonnummer: +41442552220
- E-post: silvia.ulrich@usz.ch
Studer Kontakt Backup
- Navn: Michael Furian, Prof. Dr. sc. ETH
- Telefonnummer: +41442552220
Studiesteder
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-
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Zurich, Sveits, 8091
- University Hospital of Zurich
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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
Ja
Beskrivelse
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
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: 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
|
Hva måler studien?
Primære resultatmål
Resultatmål |
Tiltaksbeskrivelse |
Tidsramme |
|---|---|---|
|
FEV1 after re-ascent to 2850m
Tidsramme: 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)
|
Sekundære resultatmål
Resultatmål |
Tiltaksbeskrivelse |
Tidsramme |
|---|---|---|
|
Forced Vital Capacity FVC after re-ascent to 2850m
Tidsramme: 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
Tidsramme: 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
Tidsramme: 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
Tidsramme: 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
Tidsramme: 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
Tidsramme: 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
Tidsramme: 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
Tidsramme: 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
Tidsramme: 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
Tidsramme: 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
Tidsramme: 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)
Tidsramme: 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)
Tidsramme: 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)
Tidsramme: 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)
Tidsramme: 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)
Tidsramme: 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)
Tidsramme: 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)
|
Samarbeidspartnere og etterforskere
Det er her du vil finne personer og organisasjoner som er involvert i denne studien.
Sponsor
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)
4. september 2026
Oppdateringer av studieposter
Sist oppdatering lagt ut (Faktiske)
4. 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
Ytterligere relevante MeSH-vilkår
Andre studie-ID-numre
- Ec_LAvsHA_Lufu_H
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.
Legemiddel- og utstyrsinformasjon, studiedokumenter
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Nei
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