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NCT Number: NCT02450994

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

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Key information

Conditions

Chronic Obstructive Pulmonary Disease (COPD) Bronchial Diseases Bronchitis Chronic Disease Disease Attributes Emphysema Infections Lung Diseases Lung Diseases, Obstructive Pathologic Processes Pathological Conditions, Signs and Symptoms Pulmonary Disease, Chronic Obstructive Respiratory Tract Diseases Respiratory Tract Infections

Age range

20 year–75 year

Sex eligibility

All sexes

Study type

Interventional

Phase

Phase 4

Primary location

National Center of Cardiology and Internal Medicine

Bishkek, 720040, Kyrgyzstan

About this study

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

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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

Treatment and study plan

Dexamethasone

Drug

Placebo

Drug

Primary outcomes

  1. 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 outcomes

  1. Oxygen desaturation index

    Time frame: night 1 at 3200 m

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

  2. 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

  3. Apnea/hypopnea index

    Time frame: night 2 at 3200 m

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

  4. Apnea/hypopnea index

    Time frame: night 1 at 3200 m

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

  5. Oxygen desaturation index

    Time frame: night 2 at 3200 m

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

  6. 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

  7. Oxygen desaturation index

    Time frame: night 1 at 700 m

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

  8. Apnea/hypopnea index

    Time frame: night 1 at 700 m

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

  9. 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

  10. 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

  11. 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

Sponsors and collaborators

Lead sponsor

University of Zurich

Other

Collaborators

  • National Center of Cardiology and Internal Medicine named after academician M.Mirrakhimov

Registry information

Official study title

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

Important dates

Study start
2015
Primary completion
2015
Study completion
2015
First posted
May 21, 2015
Registry last updated
Dec 21, 2015

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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