Nocturnal Breathing and Sleep in Patients With Chronic Obstructive Pulmonary Disease Staying at Altitude
18. maj 2015 opdateret af: University of Zurich
The purpose of this study is to evaluate whether nocturnal breathing and sleep of patients with chronic obstructive pulmonary disease (COPD) are disturbed during a stay at moderate altitude.
Studieoversigt
Status
Afsluttet
Betingelser
Intervention / Behandling
Detaljeret beskrivelse
This randomized cross-over trial evaluates the hypothesis that patients with chronic obstructive pulmonary disease experience nocturnal hypoxemia, periodic breathing and sleep disturbances when staying at moderate altitude.
Sleep studies and clinical evaluations will be performed during 2 days in Zurich (490 m, low altitude baseline) and during 2 days at Davos Clavadel (1650 m), and 2 days at Davos Jakobshorn (2590 m).
Undersøgelsestype
Interventionel
Tilmelding (Faktiske)
50
Fase
- Ikke anvendelig
Kontakter og lokationer
Dette afsnit indeholder kontaktoplysninger for dem, der udfører undersøgelsen, og oplysninger om, hvor denne undersøgelse udføres.
Studiesteder
-
-
-
Zurich, Schweiz, CH-8091
- University Hospital Zurich, Pulmonary Division
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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
18 år til 75 år (Voksen, Ældre voksen)
Tager imod sunde frivillige
Ingen
Køn, der er berettiget til at studere
Alle
Beskrivelse
Inclusion Criteria:
- chronic obstructive pulmonary disease (COPD), GOLD grade 2-3
- residents at low altitude (<800 m)
Exclusion Criteria:
- Unstable condition, COPD exacerbation
- Mild (GOLD 1) or very severe COPD (GOLD 4)
- requirement for oxygen therapy at low altitude residence
- hypoventilation
- pulmonary hypertension
- more than mild or unstable cardiovascular disease
- use of drugs that affect respiratory center drive
- internal, neurologic or psychiatric disease that interfere with protocol compliance including current heavy smoking (>20 cigarettes per day), inability to perform 6 min walk test.
- previous intolerance to moderate altitude (<2600m).
- Exposure to altitudes >1500m for >2 days within the last 4 weeks before the study.
- Pregnant or nursing patients
Studieplan
Dette afsnit indeholder detaljer om studieplanen, herunder hvordan undersøgelsen er designet, og hvad undersøgelsen måler.
Hvordan er undersøgelsen tilrettelagt?
Design detaljer
- Tildeling: Randomiseret
- Interventionel model: Crossover opgave
- Maskning: Ingen (Åben etiket)
Våben og indgreb
Deltagergruppe / Arm |
Intervention / Behandling |
|---|---|
|
Andet: A: low-intermediate-high altitude
Altitude exposure sequence A, 490-1650-2590m
|
Stay at different altitudes: 490, 1650, 2590 m
|
|
Andet: B: low-high-intermediate altitude
Altitude exposure sequence B, 490-2590-1650m
|
Stay at different altitudes: 490, 1650, 2590 m
|
|
Andet: C: intermediate-high-low altitude
Altitude exposure sequence C, 1650-2590-490m
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Stay at different altitudes: 490, 1650, 2590 m
|
|
Andet: D: high-intermediate-low altitude
Altitude exposure sequence D, 2590-1650-490m
|
Stay at different altitudes: 490, 1650, 2590 m
|
Hvad måler undersøgelsen?
Primære resultatmål
Resultatmål |
Foranstaltningsbeskrivelse |
Tidsramme |
|---|---|---|
|
Change in mean nocturnal oxygen saturation from baseline measured at 490 m
Tidsramme: Change in mean nocturnal oxygen saturation from 490 m baseline during 2 days at 2590 m
|
mean nocturnal oxygen saturation measured by pulse oximetry
|
Change in mean nocturnal oxygen saturation from 490 m baseline during 2 days at 2590 m
|
|
Change in apnea/hypopnea index from baseline measured at 490 m
Tidsramme: Change in apnea/hypopnea index from 490 m baseline during 2 days at 2590 m
|
apnea/hypopnea index measured by polysomnography
|
Change in apnea/hypopnea index from 490 m baseline during 2 days at 2590 m
|
Sekundære resultatmål
Resultatmål |
Foranstaltningsbeskrivelse |
Tidsramme |
|---|---|---|
|
Change in mean nocturnal oxygen saturation from baseline measured at 490 m
Tidsramme: Change in mean nocturnal oxygen saturation from 490 m baseline during 2 days at 1650 m
|
apnea/hypopnea measured by polysomnography
|
Change in mean nocturnal oxygen saturation from 490 m baseline during 2 days at 1650 m
|
|
Change in apnea/hypopnea index from baseline measured at 490 m
Tidsramme: Change in apnea/hypopnea index from 490 m baseline during stay at 1650 m
|
apnea/hypopnea index measured by polysomnography
|
Change in apnea/hypopnea index from 490 m baseline during stay at 1650 m
|
|
Change in subjective sleep quality from baseline measured at 490 m
Tidsramme: Change in subjective sleep quality from 490 m during 2 days at 2590 m
|
Visual analog scale of sleep quality
|
Change in subjective sleep quality from 490 m during 2 days at 2590 m
|
|
Change in subjective sleep quality from baseline measured at 490 m
Tidsramme: Change in subjective sleep quality from 490 m baseline during 2 days at 1650 m
|
Visual analog scale of sleep quality
|
Change in subjective sleep quality from 490 m baseline during 2 days at 1650 m
|
|
Change in reaction time from baseline measured at 490 m
Tidsramme: Change in reaction time from 490 m baseline during 2 days at 2590 m
|
psychomotor vigilance test reaction time
|
Change in reaction time from 490 m baseline during 2 days at 2590 m
|
|
Change in reaction time from baseline measured at 490 m
Tidsramme: Change in reaction time from 490 m baseline during 2 days at 1650 m
|
Psychomotor vigilance test reaction time
|
Change in reaction time from 490 m baseline during 2 days at 1650 m
|
Samarbejdspartnere og efterforskere
Det er her, du vil finde personer og organisationer, der er involveret i denne undersøgelse.
Sponsor
Efterforskere
- Ledende efterforsker: Tsogyal D Latshang, MD, University Hospital, Zürich
- Studiestol: Konrad E Bloch, MD, University Hsopital Zurich, Switzerland
Publikationer og nyttige links
Den person, der er ansvarlig for at indtaste oplysninger om undersøgelsen, leverer frivilligt disse publikationer. Disse kan handle om alt relateret til undersøgelsen.
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
1. juni 2013
Primær færdiggørelse (Faktiske)
1. december 2013
Studieafslutning (Faktiske)
1. december 2013
Datoer for studieregistrering
Først indsendt
3. juni 2013
Først indsendt, der opfyldte QC-kriterier
5. juni 2013
Først opslået (Skøn)
6. juni 2013
Opdateringer af undersøgelsesjournaler
Sidste opdatering sendt (Skøn)
19. maj 2015
Sidste opdatering indsendt, der opfyldte kvalitetskontrolkriterier
18. maj 2015
Sidst verificeret
1. maj 2015
Mere information
Begreber relateret til denne undersøgelse
Yderligere relevante MeSH-vilkår
Andre undersøgelses-id-numre
- 2013-088B
Disse oplysninger blev hentet direkte fra webstedet clinicaltrials.gov uden ændringer. Hvis du har nogen anmodninger om at ændre, fjerne eller opdatere dine undersøgelsesoplysninger, bedes du kontakte register@clinicaltrials.gov. Så snart en ændring er implementeret på clinicaltrials.gov, vil denne også blive opdateret automatisk på vores hjemmeside .