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

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.

Study Overview

• Status: Completed
• Conditions: Chronic Obstructive Pulmonary Disease
• Intervention / Treatment: Other: Altitude exposure

Detailed Description

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).

• Study Type: Interventional
• Enrollment (Actual): 50
• Phase: Not Applicable

Contacts and Locations

Study Locations

• Switzerland
  • Zurich, Switzerland, CH-8091
    • University Hospital Zurich, Pulmonary Division

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 18 years to 75 years (Adult, Older Adult)
• Accepts Healthy Volunteers: No
• Genders Eligible for Study: All

Description

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

Study Plan

How is the study designed?

Design Details

• Allocation: Randomized
• Interventional Model: Crossover Assignment
• Masking: None (Open Label)

Number of Arms

4

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
Other: A: low-intermediate-high altitude; Altitude exposure sequence A, 490-1650-2590m	Other: Altitude exposure; Stay at different altitudes: 490, 1650, 2590 m
Other: B: low-high-intermediate altitude; Altitude exposure sequence B, 490-2590-1650m	Other: Altitude exposure; Stay at different altitudes: 490, 1650, 2590 m
Other: C: intermediate-high-low altitude; Altitude exposure sequence C, 1650-2590-490m	Other: Altitude exposure; Stay at different altitudes: 490, 1650, 2590 m
Other: D: high-intermediate-low altitude; Altitude exposure sequence D, 2590-1650-490m	Other: Altitude exposure; Stay at different altitudes: 490, 1650, 2590 m

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
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 Outcome Measures

Outcome Measure	Measure Description	Time Frame
Change in mean nocturnal oxygen saturation from baseline measured at 490 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	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	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	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	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	Psychomotor vigilance test reaction time	Change in reaction time from 490 m baseline during 2 days at 1650 m

Collaborators and Investigators

• Sponsor: University of Zurich
• Investigators: Principal Investigator: Tsogyal D Latshang, MD, University Hospital, Zürich; Study Chair: Konrad E Bloch, MD, University Hsopital Zurich, Switzerland

Publications and helpful links

General Publications

• 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.

Study record dates

Study Major Dates

• Study Start: June 1, 2013
• Primary Completion (Actual): December 1, 2013
• Study Completion (Actual): December 1, 2013

Study Registration Dates

• First Submitted: June 3, 2013
• First Submitted That Met QC Criteria: June 5, 2013
• First Posted (Estimate): June 6, 2013

Study Record Updates

• Last Update Posted (Estimate): May 19, 2015
• Last Update Submitted That Met QC Criteria: May 18, 2015
• Last Verified: May 1, 2015

More Information

Terms related to this study

• Additional Relevant MeSH Terms: Respiratory Tract Diseases; Lung Diseases; Lung Diseases, Obstructive; Pulmonary Disease, Chronic Obstructive
• Other Study ID Numbers: 2013-088B