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

Chronic Obstructive Pulmonary Disease Clinical Trial

Official title:

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

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT01870830
• Other study ID #: 2013-088B
• Status: Completed
• Phase: N/A
• First received: June 3, 2013
• Last updated: May 18, 2015
• Start date: June 2013
• Est. completion date: December 2013

Study information

• Verified date: May 2015
• Source: University of Zurich
• Contact: n/a
• Is FDA regulated: No
• Health authority: Switzerland: Ethikkommission
• Study type: Interventional

Clinical Trial 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.

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).

Recruitment information / eligibility

• Status: Completed
• Enrollment: 50
• Est. completion date: December 2013
• Est. primary completion date: December 2013
• Accepts healthy volunteers: No
• Gender: Both
• Age group: 18 Years to 75 Years

Eligibility

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 Design

Allocation: Randomized, Intervention Model: Crossover Assignment, Masking: Open Label

Related Conditions & MeSH terms

• Chronic Obstructive Pulmonary Disease
• Lung Diseases
• Lung Diseases, Obstructive
• Pulmonary Disease, Chronic Obstructive

Intervention

Other:
• Altitude exposure
Stay at different altitudes: 490, 1650, 2590 m

Locations

Country	Name	City	State
Switzerland	University Hospital Zurich, Pulmonary Division	Zurich

Sponsors (1)

Lead Sponsor	Collaborator
University of Zurich

Country where clinical trial is conducted

Switzerland, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	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	No
Primary	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	No
Secondary	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	No
Secondary	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	No
Secondary	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	No
Secondary	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	No
Secondary	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	No
Secondary	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	No