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

Phase 4

Completed

• Conditions: Chronic Obstructive Pulmonary Disease (COPD)
• Interventions: Drug: Placebo; Drug: Dexamethasone

• Registration Number: NCT02450994
• Lead Sponsor: University of Zurich

Brief Summary

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

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 Timeline

• Study Start: 2015-05
• Study First Submitted: 2015-05-18
• Study First Submitted QC: 2015-05-18
• Study First Posted: 2015-05-21
• Primary Completion: 2015-09
• Study Completion: 2015-09
• Status Verified: 2015-12
• Last Update Submitted: 2015-12-18
• Last Update Posted: 2015-12-21

Recruitment & Eligibility

• Status: COMPLETED
• Sex: All
• Target Recruitment: 124

Inclusion Criteria

• Chronic obstructive pulmonary disease (COPD), GOLD grade 1-2
• Living at low altitude (<800m)

Read More

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

Read More

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: PARALLEL

Arm && Interventions

Group	Intervention	Description
Placebo	Placebo	Placebo capsules twice per day, orally
Dexamethasone	Dexamethasone	Dexamethasone 4 mg capsules, twice per day, orally

Primary Outcome Measures

Name	Time	Method
Mean nocturnal oxygen saturation measured by pulse oximetry	night 1 at 3200 m	Difference in mean nocturnal oxygen saturation between dexamethasone and placebo group

Secondary Outcome Measures

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

Trial Locations

Locations (1)

National Center of Cardiology and Internal Medicine; 🇰🇬 Bishkek, Kyrgyzstan