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

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

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.

Study Overview

• Status: Completed
• Conditions: Chronic Obstructive Pulmonary Disease (COPD)
• Intervention / Treatment: Drug: Placebo; Drug: Dexamethasone

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 Type: Interventional
• Enrollment (Actual): 124
• Phase: Phase 4

Contacts and Locations

Study Locations

• Kyrgyzstan
  • Bishkek, Kyrgyzstan, 720040
    • National Center of Cardiology and Internal Medicine

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 20 years to 75 years (Adult, Older Adult)
• Accepts Healthy Volunteers: No
• Genders Eligible for Study: All

Description

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

Study Plan

How is the study designed?

Design Details

• Primary Purpose: Prevention
• Allocation: Randomized
• Interventional Model: Parallel Assignment
• Masking: Quadruple

Number of Arms

2

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
Active Comparator: Dexamethasone; Dexamethasone 4 mg capsules, twice per day, orally	Drug: Dexamethasone
Placebo Comparator: Placebo; Placebo capsules twice per day, orally	Drug: Placebo

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 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

Collaborators and Investigators

• Sponsor: University of Zurich
• Collaborators: National Center of Cardiology and Internal Medicine named after academician M.Mirrakhimov

Publications and helpful links

General Publications

• Furian M, Lichtblau M, Aeschbacher SS, Estebesova B, Emilov B, Sheraliev U, Marazhapov NH, Mademilov M, Osmonov B, Bisang M, Ulrich S, Latshang TD, Ulrich S, Sooronbaev TM, Bloch KE. Effect of Dexamethasone on Nocturnal Oxygenation in Lowlanders With Chronic Obstructive Pulmonary Disease Traveling to 3100 Meters: A Randomized Clinical Trial. JAMA Netw Open. 2019 Feb 1;2(2):e190067. doi: 10.1001/jamanetworkopen.2019.0067.

Study record dates

Study Major Dates

• Study Start: May 1, 2015
• Primary Completion (Actual): September 1, 2015
• Study Completion (Actual): September 1, 2015

Study Registration Dates

• First Submitted: May 18, 2015
• First Submitted That Met QC Criteria: May 18, 2015
• First Posted (Estimate): May 21, 2015

Study Record Updates

• Last Update Posted (Estimate): December 21, 2015
• Last Update Submitted That Met QC Criteria: December 18, 2015
• Last Verified: December 1, 2015

More Information

Terms related to this study

• Keywords: treatment; lung; sleep; emphysema; airway disease; bronchitis
• Additional Relevant MeSH Terms: Respiratory Tract Diseases; Lung Diseases; Lung Diseases, Obstructive; Pulmonary Disease, Chronic Obstructive; Physiological Effects of Drugs; Autonomic Agents; Peripheral Nervous System Agents; Anti-Inflammatory Agents; Antineoplastic Agents; Antiemetics; Gastrointestinal Agents; Glucocorticoids; Hormones; Hormones, Hormone Substitutes, and Hormone Antagonists; Antineoplastic Agents, Hormonal; Dexamethasone
• Other Study ID Numbers: EK15-2015_V1