Chronic Obstructive Pulmonary Disease (COPD)
Conditions
Keywords
airway disease, bronchitis, emphysema, lung, treatment, sleep
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
Interventions
DRUGDexamethasone
DRUGPlacebo
Sponsors
National Center of Cardiology and Internal Medicine named after academician M.Mirrakhimov
University of Zurich
Study design
Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
PREVENTION
Masking
QUADRUPLE (Subject, Caregiver, Investigator, Outcomes Assessor)
Eligibility
Sex/Gender
ALL
Age
20 Years to 75 Years
Healthy volunteers
No
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
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| 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
| Measure | Time frame | Description |
|---|---|---|
| Oxygen desaturation index | night 1 at 3200 m | Difference in oxygen desaturation index (\>3%) between dexamethasone and placebo group |
| Mean nocturnal oxygen saturation measured by pulse oximetry | night 2 at 3200 m | Difference in mean nocturnal oxygen saturation between dexamethasone and placebo group |
| Apnea/hypopnea index | night 2 at 3200 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 700 m | Difference in subjective sleepiness and sleep quality assessed by a visual analog scale between dexamethasone and placebo group |
Countries
Kyrgyzstan
Outcome results
None listed