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

University of Zurich124 enrolled

Overview

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.

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

Study Type

INTERVENTIONAL

Allocation

RANDOMIZED

Purpose

PREVENTION

Masking

QUADRUPLE

Enrollment

124

Conditions

Chronic Obstructive Pulmonary Disease (COPD)

Interventions

DexamethasoneDRUG

PlaceboDRUG

Eligibility

Sex: ALLMin age: 20 YearsMax age: 75 Years

Medical Language ↔ Plain English

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

Locations (1)

National Center of Cardiology and Internal Medicine

Bishkek, Kyrgyzstan

Outcomes

Primary Outcomes

Mean nocturnal oxygen saturation measured by pulse oximetry

Difference in mean nocturnal oxygen saturation between dexamethasone and placebo group

Time frame: night 1 at 3200 m

Secondary Outcomes

Oxygen desaturation index

Difference in oxygen desaturation index (\>3%) between dexamethasone and placebo group

Time frame: night 1 at 3200 m

Mean nocturnal oxygen saturation measured by pulse oximetry

Difference in mean nocturnal oxygen saturation between dexamethasone and placebo group

Time frame: night 2 at 3200 m

Apnea/hypopnea index

Difference in mean apneas/hypopneas per hour between the dexamethasone and placebo group

Time frame: night 2 at 3200 m

Apnea/hypopnea index

Difference in mean apneas/hypopneas per hour between the dexamethasone and placebo group

Time frame: night 1 at 3200 m

Oxygen desaturation index

Difference in oxygen desaturation index (\>3%) between dexamethasone and placebo group

Time frame: night 2 at 3200 m

Mean nocturnal oxygen saturation measured by pulse oximetry

Difference in mean nocturnal oxygen saturation between dexamethasone and placebo group

Time frame: night 1 at 700 m

Oxygen desaturation index

Difference in oxygen desaturation index (\>3%) between dexamethasone and placebo group

Data from ClinicalTrials.gov

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