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

Study Overview
=================
Brief 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.

Detailed 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).

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

Conditions
-----------------
Chronic Obstructive Pulmonary Disease (COPD)

Intervention / Treatment
-----------------
* Drug: Oxygen
* Drug: sham oxygen (room air)


Participation Criteria
=================
Eligibility Criteria
-----------------
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

Ages Eligible for Study
-----------------
Minimum Age: 18 Years
Maximum Age: 75 Years

Sexes Eligible for Study
-----------------
All

Accepts Healthy Volunteers
-----------------
No

Study Plan
=================
How is the study designed?
-----------------

Design Details

Primary Purpose: Treatment
Allocation: Randomized
Intervention Model: Crossover Assignment
Masking: Double


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Active Comparator: Oxygen<br>oxygen administration via a nasal cannula at a rate of 3 L/min during nights spent at 2048 m | Drug: Oxygen<br>* Nocturnal nasal oxygen during stay at 2048 m<br>Drug: sham oxygen (room air)<br> <br> * Other names: Nocturnal nasal room air during stay at 2048 m;|
| Placebo Comparator: Sham oxygen<br>Sham oxygen (room air) administration via a nasal cannula at a rate of 3 L/min during nights spent at 2048 m | Drug: Oxygen<br>* Nocturnal nasal oxygen during stay at 2048 m<br>Drug: sham oxygen (room air)<br> <br> * Other names: Nocturnal nasal room air during stay at 2048 m;|

What is the study measuring?
-----------------
Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| 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) | 
| 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 Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| 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) | 
| 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) | 
| 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) | 
| 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 | 
| 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) | 
| 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) | 

 Terms related to the study
=================
Keywords Provided by Centre Hospitalier Valida
-----------------
airway disease, bronchitis, emphysema, lung