Sleep-Assessment in Patients Between High Altitude HA vs. Sea Level LA in Healthy Individuals H
31. august 2026 opdateret af: 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 healthy individuals, who live permanently >2600m.
Studieoversigt
Status
Ikke rekrutterer endnu
Betingelser
Intervention / Behandling
Detaljeret 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 healthy individuals, who permanently live at high altitude over 2600m
Undersøgelsestype
Interventionel
Tilmelding (Anslået)
14
Fase
- Ikke anvendelig
Kontakter og lokationer
Dette afsnit indeholder kontaktoplysninger for dem, der udfører undersøgelsen, og oplysninger om, hvor denne undersøgelse udføres.
Studiekontakt
- Navn: Silvia Ulrich, Prof. Dr. med.
- Telefonnummer: +41442552220
- E-mail: silvia.ulrich@usz.ch
Undersøgelse Kontakt Backup
- Navn: Michael Furian, Prof. Dr. sc. ETH
- Telefonnummer: +41442552220
Studiesteder
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-
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Zurich, Schweiz, 8091
- University Hospital of Zurich
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Deltagelseskriterier
Forskere leder efter personer, der passer til en bestemt beskrivelse, kaldet berettigelseskriterier. Nogle eksempler på disse kriterier er en persons generelle helbredstilstand eller tidligere behandlinger.
Berettigelseskriterier
Aldre berettiget til at studere
- Voksen
- Ældre voksen
Tager imod sunde 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
Dette afsnit indeholder detaljer om studieplanen, herunder hvordan undersøgelsen er designet, og hvad undersøgelsen måler.
Hvordan er undersøgelsen tilrettelagt?
Design detaljer
- Primært formål: Støttende pleje
- Tildeling: N/A
- Interventionel model: Enkelt gruppeopgave
- Maskning: Ingen (Åben etiket)
Våben og indgreb
Deltagergruppe / Arm |
Intervention / Behandling |
|---|---|
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Eksperimentel: Sleep-parameters at 2850m and at sea level
Assessment of sleep-parameters by polygraphy in healthy individuals at 2850m (pre-descent and after re-ascent) and at sea level in between
|
Descent from 2850m to sea level with a stay for 7 days and re-ascent back to 2850m
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Hvad måler undersøgelsen?
Primære resultatmål
Resultatmål |
Foranstaltningsbeskrivelse |
Tidsramme |
|---|---|---|
|
Mean nocturnal SpO2 after 7 days at sea level
Tidsramme: From high altitude (2850m) to night 7 at sea level
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Difference/change in mean nocturnal SpO2 between 2850m and Night 7 at sea level in healthy individuals
|
From high altitude (2850m) to night 7 at sea level
|
Sekundære resultatmål
Resultatmål |
Foranstaltningsbeskrivelse |
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 healthy individuals
|
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 healthy individuals
|
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 healthy individuals
|
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 healthy individuals
|
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 healthy individuals
|
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 healthy individuals
|
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 healthy individuals
|
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 at night 1 and night 7 within a stay at sea level of 7 days (after relocation from high altitude) in healthy individuals
|
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 healthy individuals
|
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 healthy individuals
|
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 healthy individuals
|
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 healthy individuals
|
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 healthy individuals
|
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 healthy individuals
|
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 healthy individuals
|
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 healthy individuals
|
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 healthy individuals
|
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 healthy individuals
|
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 healthy individuals
|
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)
|
Samarbejdspartnere og efterforskere
Det er her, du vil finde personer og organisationer, der er involveret i denne undersøgelse.
Sponsor
Efterforskere
- Ledende efterforsker: Silvia Ulrich, University Hospital Zurich, Departement of Pulmonology
- Ledende efterforsker: Rodrigo Hoyos, Hospital Carlos Andrade Marin of Quito, Ecuador
Datoer for undersøgelser
Disse datoer sporer fremskridtene for indsendelser af undersøgelsesrekord og resumeresultater til ClinicalTrials.gov. Studieregistreringer og rapporterede resultater gennemgås af National Library of Medicine (NLM) for at sikre, at de opfylder specifikke kvalitetskontrolstandarder, før de offentliggøres på den offentlige hjemmeside.
Studer store datoer
Studiestart (Anslået)
25. september 2026
Primær færdiggørelse (Anslået)
4. oktober 2026
Studieafslutning (Anslået)
31. december 2026
Datoer for studieregistrering
Først indsendt
17. august 2026
Først indsendt, der opfyldte QC-kriterier
31. august 2026
Først opslået (Faktiske)
3. september 2026
Opdateringer af undersøgelsesjournaler
Sidste opdatering sendt (Faktiske)
3. september 2026
Sidste opdatering indsendt, der opfyldte kvalitetskontrolkriterier
31. august 2026
Sidst verificeret
1. august 2026
Mere information
Begreber relateret til denne undersøgelse
Yderligere relevante MeSH-vilkår
Andre undersøgelses-id-numre
- Ec_HAvsLA_sleep_H
Plan for individuelle deltagerdata (IPD)
Planlægger du at dele individuelle deltagerdata (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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