Nocturnal Breathing and Sleep in Patients With Chronic Obstructive Pulmonary Disease Staying at Altitude

NCT ID: NCT01870830

Last Updated: 2015-05-19

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

COMPLETED

Clinical Phase

NA

Total Enrollment

50 participants

Study Classification

INTERVENTIONAL

Study Start Date

2013-06-30

Study Completion Date

2013-12-31

Brief Summary

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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.

Detailed Description

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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).

Conditions

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Chronic Obstructive Pulmonary Disease

Study Design

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Allocation Method

RANDOMIZED

Intervention Model

CROSSOVER

Blinding Strategy

NONE

Study Groups

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A: low-intermediate-high altitude

Altitude exposure sequence A, 490-1650-2590m

Group Type OTHER

Altitude exposure

Intervention Type OTHER

Stay at different altitudes: 490, 1650, 2590 m

B: low-high-intermediate altitude

Altitude exposure sequence B, 490-2590-1650m

Group Type OTHER

Altitude exposure

Intervention Type OTHER

Stay at different altitudes: 490, 1650, 2590 m

C: intermediate-high-low altitude

Altitude exposure sequence C, 1650-2590-490m

Group Type OTHER

Altitude exposure

Intervention Type OTHER

Stay at different altitudes: 490, 1650, 2590 m

D: high-intermediate-low altitude

Altitude exposure sequence D, 2590-1650-490m

Group Type OTHER

Altitude exposure

Intervention Type OTHER

Stay at different altitudes: 490, 1650, 2590 m

Interventions

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Altitude exposure

Stay at different altitudes: 490, 1650, 2590 m

Intervention Type OTHER

Eligibility Criteria

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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
Minimum Eligible Age

18 Years

Maximum Eligible Age

75 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

No

Sponsors

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University of Zurich

OTHER

Sponsor Role lead

Responsible Party

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Responsibility Role SPONSOR

Principal Investigators

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Konrad E Bloch, MD

Role: STUDY_CHAIR

University Hsopital Zurich, Switzerland

Tsogyal D Latshang, MD

Role: PRINCIPAL_INVESTIGATOR

University Hospital, Zürich

Locations

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University Hospital Zurich, Pulmonary Division

Zurich, , Switzerland

Site Status

Countries

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Switzerland

References

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Latshang TD, Tardent RPM, Furian M, Flueck D, Segitz SD, Mueller-Mottet S, Kohler M, Ulrich S, Bloch KE. Sleep and breathing disturbances in patients with chronic obstructive pulmonary disease traveling to altitude: a randomized trial. Sleep. 2019 Jan 1;42(1). doi: 10.1093/sleep/zsy203.

Reference Type DERIVED
PMID: 30517695 (View on PubMed)

Other Identifiers

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2013-088B

Identifier Type: -

Identifier Source: org_study_id

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