Patients With Chronic Obstructive Pulmonary Disease at Altitude - Effect of Nocturnal Oxygen on Breathing and Sleep

Chronic Obstructive Pulmonary Disease (COPD) Clinical Trial

Official title:

Patients With Chronic Obstructive Pulmonary Disease Staying at Altitude - Effect of Nocturnal Oxygen Therapy on Breathing and Sleep in

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT02150590
• Other study ID #: 2013-0088V2A3B
• Status: Completed
• Phase: Phase 4
• Start date: June 1, 2014
• Est. completion date: October 31, 2014

Study information

• Verified date: May 2017
• Source: University of Zurich
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial Summary

The purpose of this study is to investigate the effect of nocturnal oxygen therapy during a stay at moderate altitude on breathing and sleep of patients with chronic obstructive lung disease.

Description:

Patients with moderate to severe chronic obstructive pulmonary disease living below 800 m will be invited to participate in a randomized, cross-over field trial evaluating the hypothesis that nocturnal breathing and sleep during nights spent at moderate altitude are improved by oxygen therapy via a nasal cannula compared to room air (sham oxygen). Outcomes will be assessed at low altitude (Zurich, 490 m, baseline), and during 2 study periods of 2 nights each spent at moderate altitude (St. Moritz Salastrains, 2048 m) separated by a wash-out period of at least 2 weeks spent at low altitude (<800 m).

Recruitment information / eligibility

• Status: Completed
• Enrollment: 32
• Est. completion date: October 31, 2014
• Est. primary completion date: October 31, 2014
• Accepts healthy volunteers: No
• Gender: All
• 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

Related Conditions & MeSH terms

• Chronic Obstructive Pulmonary Disease (COPD)
• Lung Diseases
• Lung Diseases, Obstructive
• Pulmonary Disease, Chronic Obstructive

Intervention

Drug:
• Oxygen
Nocturnal nasal oxygen during stay at 2048 m
• sham oxygen (room air)

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	Mean nocturnal oxygen saturation measured by pulse oximetry	Difference in mean nocturnal oxygen saturation between measurements at 2048 m (altitude) and 490 m (baseline); and between the oxygen and sham oxygen treatment periods at 2048 m.	Approximately 8 hours (during the first night at 2048 m)
Primary	Apnea/hypopnea index measured by polysomnography	Difference in apnea/hypopnea index between measurements at 2048 m (altitude) and 490 m (baseline); and between the oxygen and sham oxygen treatment periods at 2048 m.	Approximately 8 hours (during the first night at 2048 m)
Secondary	Mean nocturnal oxygen saturation measured by pulse oximetry	Difference in mean nocturnal oxygen saturation between measurements at 2048 m (altitude) and 490 m (baseline); and between the oxygen and sham oxygen treatment periods at 2048 m.	Approximately 8 hours (during the second night at 2048 m)
Secondary	Apnea/hypopnea index measured by polygraphy	Difference in apnea/hypopnea index between measurements at 2048 m (altitude) and 490 m (baseline); and between the oxygen and sham oxygen treatment periods at 2048 m.	Approximately 8 hours (during the second night at 2048 m)
Secondary	Subjective sleep quality visual analog scale score	Difference in subjective sleep quality visual analog scale scores between measurements at 2048 m (altitude) and 490 m (baseline); and between the oxygen and sham oxygen treatment periods at 2048 m.	Approximately 8 hours (during the first night at 2048 m)
Secondary	Psychomotor vigilance test reaction time	Difference in subjective sleep quality between visual analog scale measurements at 2048 m (altitude) and 490 m (baseline); and between the oxygen and sham oxygen treatment periods at 2048 m.	Approximately at 10 a.m. on the second day at 2048 m
Secondary	Severe hypoxemia	Number of participants in whom arterial oxygen saturation measured by pulse oximetry is less than 75% for more than 30 min during the oxygen and sham oxygen treatment periods at 2028 m.	Approximately 72 hours (day 1 to 3 at 2048 m)
Secondary	Subjective sleep quality visual analog scale score	Difference in subjective sleep quality visual analog scale scores between measurements at 2048 m (altitude) and 490 m (baseline); and between the oxygen and sham oxygen treatment periods at 2048 m.	Approximately 8 hours (during the second night at 2048 m)