NCT01870830

Brief Summary

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.

Trial Health

87
On Track

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
50

participants targeted

Target at P25-P50 for not_applicable chronic-obstructive-pulmonary-disease

Timeline
Completed

Started Jun 2013

Shorter than P25 for not_applicable chronic-obstructive-pulmonary-disease

Geographic Reach
1 country

1 active site

Status
completed

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

Study Start

First participant enrolled

June 1, 2013

Completed
2 days until next milestone

First Submitted

Initial submission to the registry

June 3, 2013

Completed
3 days until next milestone

First Posted

Study publicly available on registry

June 6, 2013

Completed
6 months until next milestone

Primary Completion

Last participant's last visit for primary outcome

December 1, 2013

Completed
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

December 1, 2013

Completed
Last Updated

May 19, 2015

Status Verified

May 1, 2015

Enrollment Period

6 months

First QC Date

June 3, 2013

Last Update Submit

May 18, 2015

Conditions

Chronic Obstructive Pulmonary Disease

Outcome Measures

Primary Outcomes (2)

  • Change in mean nocturnal oxygen saturation from baseline measured at 490 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

    apnea/hypopnea index measured by polysomnography

    Change in apnea/hypopnea index from 490 m baseline during 2 days at 2590 m

Secondary Outcomes (6)

  • Change in mean nocturnal oxygen saturation from baseline measured at 490 m

    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

    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

    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

    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

    Change in reaction time from 490 m baseline during 2 days at 2590 m

  • +1 more secondary outcomes

Study Arms (4)

A: low-intermediate-high altitude

OTHER

Altitude exposure sequence A, 490-1650-2590m

Other: Altitude exposure

B: low-high-intermediate altitude

OTHER

Altitude exposure sequence B, 490-2590-1650m

Other: Altitude exposure

C: intermediate-high-low altitude

OTHER

Altitude exposure sequence C, 1650-2590-490m

Other: Altitude exposure

D: high-intermediate-low altitude

OTHER

Altitude exposure sequence D, 2590-1650-490m

Other: Altitude exposure

Interventions

Altitude exposureOTHER

Stay at different altitudes: 490, 1650, 2590 m

A: low-intermediate-high altitudeB: low-high-intermediate altitudeC: intermediate-high-low altitudeD: high-intermediate-low altitude

Eligibility Criteria

Age18 Years - 75 Years
Sexall
Healthy VolunteersNo
Age GroupsAdult (18-64), Older Adult (65+)

You may qualify if:

  • chronic obstructive pulmonary disease (COPD), GOLD grade 2-3
  • residents at low altitude (\<800 m)

You may not qualify if:

  • 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

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

University Hospital Zurich, Pulmonary Division

Zurich, CH-8091, Switzerland

Location

Related Publications (1)

  • 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.

    PMID: 30517695DERIVED

MeSH Terms

Conditions

Pulmonary Disease, Chronic Obstructive

Condition Hierarchy (Ancestors)

Lung Diseases, ObstructiveLung DiseasesRespiratory Tract DiseasesChronic DiseaseDisease AttributesPathologic ProcessesPathological Conditions, Signs and Symptoms

Study Officials

  • Konrad E Bloch, MD

    University Hsopital Zurich, Switzerland

    STUDY CHAIR

  • Tsogyal D Latshang, MD

    University Hospital, Zürich

    PRINCIPAL INVESTIGATOR

Study Design

Study Type
interventional
Phase
not applicable
Allocation
RANDOMIZED
Masking
NONE
Intervention Model
CROSSOVER
Sponsor Type
OTHER
Responsible Party
SPONSOR

Study Record Dates

First Submitted

June 3, 2013

First Posted

June 6, 2013

Study Start

June 1, 2013

Primary Completion

December 1, 2013

Study Completion

December 1, 2013

Last Updated

May 19, 2015

Record last verified: 2015-05

Locations

CH(1)