Effect of Dexamethasone on Sleep Related Breathing Disturbances in Patients With COPD at Altitude

Study Overview
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Brief Summary
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Randomized, placebo controlled trial evaluating efficacy of dexamethasone in preventing sleep related breathing disturbances in lowlanders with chronic obstructive lung disease travelling from 700 m to 3200 m.

Detailed Description
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This is a randomized, placebo-controlled, double-blind parallel trial evaluating the efficacy of dexamethasone prophylaxis in sleep related breathing disturbances in lowlanders with chronic obstructive pulmonary disease travelling to altitude. Participants living in the Bishkek area, Kyrgyzstan (700m), will be transferred by car within 4h to the Tuja Ashu high altitude clinic (3200 m), and stay there for 2 days. Dexamethasone 2x4mg/day (or placebo), will be administered before departure at 700 m and during the stay at altitude. Outcomes will be assessed during the stay at 3200 m

Official Title
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Dexamethasone for Prophylaxis of Sleep Related Breathing Disturbances in Patients With Chronic Obstructive Pulmonary Disease (COPD) Travelling to Altitude

Conditions
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Chronic Obstructive Pulmonary Disease (COPD)

Intervention / Treatment
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* Drug: Dexamethasone
* Drug: Placebo


Participation Criteria
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Eligibility Criteria
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Inclusion Criteria: Chronic obstructive pulmonary disease (COPD), GOLD grade 1-2 Living at low altitude (<800m) Exclusion Criteria: COPD exacerbation severe COPD, GOLD grade 3 or 4 arterial oxygen saturation <92% at low altitude (<800 m) Diabetes, uncontrolled cardiovascular disease such as systemic arterial hypertension, coronary artery disease; previous stroke; pneumothorax in the last 2 months, untreated or symptomatic peptic ulcer disease, glaucoma, obstructive sleep apnea. Internal, neurologic or psychiatric disease that interfere with protocol compliance including current heavy smoking (>20 cigarettes per day). pregnant or nursing patients

Ages Eligible for Study
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Minimum Age: 20 Years
Maximum Age: 75 Years

Sexes Eligible for Study
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All

Accepts Healthy Volunteers
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No

Study Plan
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How is the study designed?
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Design Details

Primary Purpose: Prevention
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Quadruple


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Active Comparator: Dexamethasone<br>Dexamethasone 4 mg capsules, twice per day, orally | Drug: Dexamethasone<br> <br> |
| Placebo Comparator: Placebo<br>Placebo capsules twice per day, orally | Drug: Placebo<br> <br> |

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Mean nocturnal oxygen saturation measured by pulse oximetry | Difference in mean nocturnal oxygen saturation between dexamethasone and placebo group | night 1 at 3200 m | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Oxygen desaturation index | Difference in oxygen desaturation index (>3%) between dexamethasone and placebo group | night 1 at 3200 m | 
| Mean nocturnal oxygen saturation measured by pulse oximetry | Difference in mean nocturnal oxygen saturation between dexamethasone and placebo group | night 2 at 3200 m | 
| Apnea/hypopnea index | Difference in mean apneas/hypopneas per hour between the dexamethasone and placebo group | night 2 at 3200 m | 
| Apnea/hypopnea index | Difference in mean apneas/hypopneas per hour between the dexamethasone and placebo group | night 1 at 3200 m | 
| Oxygen desaturation index | Difference in oxygen desaturation index (>3%) between dexamethasone and placebo group | night 2 at 3200 m | 
| Mean nocturnal oxygen saturation measured by pulse oximetry | Difference in mean nocturnal oxygen saturation between dexamethasone and placebo group | night 1 at 700 m | 
| Oxygen desaturation index | Difference in oxygen desaturation index (>3%) between dexamethasone and placebo group | night 1 at 700 m | 
| Apnea/hypopnea index | Difference in mean apneas/hypopneas per hour between the dexamethasone and placebo group | night 1 at 700 m | 
| Psychomotor vigilance test reaction time | Difference in reaction time during psychomotor vigilance test between dexamethasone and placebo group | day 2 at 700 m | 
| Subjective sleepiness | Difference in subjective sleepiness and sleep quality assessed by a visual analog scale between dexamethasone and placebo group | day 2 at 700 m | 
| Subjective sleepiness | Difference in subjective sleepiness and sleep quality assessed by a visual analog scale between dexamethasone and placebo group | day 2 at 3200 m | 

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