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

This study has been completed.
Sponsor:
Collaborator:
National Center of Cardiology and Internal Medicine, Kyrgyzstan
Information provided by (Responsible Party):
University of Zurich
ClinicalTrials.gov Identifier:
NCT02450994
First received: May 18, 2015
Last updated: December 18, 2015
Last verified: December 2015
  Purpose
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.

Condition Intervention Phase
Chronic Obstructive Pulmonary Disease (COPD)
Drug: Dexamethasone
Drug: Placebo
Phase 4

Study Type: Interventional
Study Design: Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Double Blind (Subject, Caregiver, Investigator, Outcomes Assessor)
Primary Purpose: Prevention
Official Title: Dexamethasone for Prophylaxis of Sleep Related Breathing Disturbances in Patients With Chronic Obstructive Pulmonary Disease (COPD) Travelling to Altitude

Resource links provided by NLM:


Further study details as provided by University of Zurich:

Primary Outcome Measures:
  • Mean nocturnal oxygen saturation measured by pulse oximetry [ Time Frame: night 1 at 3200 m ]
    Difference in mean nocturnal oxygen saturation between dexamethasone and placebo group


Secondary Outcome Measures:
  • Oxygen desaturation index [ Time Frame: night 1 at 3200 m ]
    Difference in oxygen desaturation index (>3%) between dexamethasone and placebo group

  • Mean nocturnal oxygen saturation measured by pulse oximetry [ Time Frame: night 2 at 3200 m ]
    Difference in mean nocturnal oxygen saturation between dexamethasone and placebo group

  • Apnea/hypopnea index [ Time Frame: night 2 at 3200 m ]
    Difference in mean apneas/hypopneas per hour between the dexamethasone and placebo group

  • Apnea/hypopnea index [ Time Frame: night 1 at 3200 m ]
    Difference in mean apneas/hypopneas per hour between the dexamethasone and placebo group

  • Oxygen desaturation index [ Time Frame: night 2 at 3200 m ]
    Difference in oxygen desaturation index (>3%) between dexamethasone and placebo group

  • Mean nocturnal oxygen saturation measured by pulse oximetry [ Time Frame: night 1 at 700 m ]
    Difference in mean nocturnal oxygen saturation between dexamethasone and placebo group

  • Oxygen desaturation index [ Time Frame: night 1 at 700 m ]
    Difference in oxygen desaturation index (>3%) between dexamethasone and placebo group

  • Apnea/hypopnea index [ Time Frame: night 1 at 700 m ]
    Difference in mean apneas/hypopneas per hour between the dexamethasone and placebo group

  • Psychomotor vigilance test reaction time [ Time Frame: day 2 at 700 m ]
    Difference in reaction time during psychomotor vigilance test between dexamethasone and placebo group

  • Subjective sleepiness [ Time Frame: day 2 at 700 m ]
    Difference in subjective sleepiness and sleep quality assessed by a visual analog scale between dexamethasone and placebo group

  • Subjective sleepiness [ Time Frame: day 2 at 3200 m ]
    Difference in subjective sleepiness and sleep quality assessed by a visual analog scale between dexamethasone and placebo group


Enrollment: 124
Study Start Date: May 2015
Study Completion Date: September 2015
Primary Completion Date: September 2015 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
Active Comparator: Dexamethasone
Dexamethasone 4 mg capsules, twice per day, orally
Drug: Dexamethasone
Placebo Comparator: Placebo
Placebo capsules twice per day, orally
Drug: Placebo

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
  Eligibility

Ages Eligible for Study:   20 Years to 75 Years   (Adult, Senior)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
Criteria

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
  Contacts and Locations
Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the Contacts provided below. For general information, see Learn About Clinical Studies.

Please refer to this study by its ClinicalTrials.gov identifier: NCT02450994

Locations
Kyrgyzstan
National Center of Cardiology and Internal Medicine
Bishkek, Kyrgyzstan, 720040
Sponsors and Collaborators
University of Zurich
National Center of Cardiology and Internal Medicine, Kyrgyzstan
Investigators
Study Chair: Konrad E Bloch, MD University Hospital, Zürich
Study Director: Talant M Sooronbaev, MD National Center of Cardiology and Internal Medicine, Bishkek, Kyrgyzstan
  More Information

Responsible Party: University of Zurich
ClinicalTrials.gov Identifier: NCT02450994     History of Changes
Other Study ID Numbers: EK15-2015_V1
Study First Received: May 18, 2015
Last Updated: December 18, 2015

Keywords provided by University of Zurich:
airway disease
bronchitis
emphysema
lung
treatment
sleep

Additional relevant MeSH terms:
Lung Diseases
Lung Diseases, Obstructive
Pulmonary Disease, Chronic Obstructive
Respiratory Tract Diseases
Dexamethasone acetate
Dexamethasone
Dexamethasone 21-phosphate
BB 1101
Anti-Inflammatory Agents
Antiemetics
Autonomic Agents
Peripheral Nervous System Agents
Physiological Effects of Drugs
Gastrointestinal Agents
Glucocorticoids
Hormones
Hormones, Hormone Substitutes, and Hormone Antagonists
Antineoplastic Agents, Hormonal
Antineoplastic Agents
Protease Inhibitors
Enzyme Inhibitors
Molecular Mechanisms of Pharmacological Action

ClinicalTrials.gov processed this record on March 24, 2017