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| Name | Class |
|---|---|
| National Center of Cardiology and Internal Medicine named after academician M.Mirrakhimov | OTHER_GOV |
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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.
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
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Dexamethasone | Active Comparator | Dexamethasone 4 mg capsules, twice per day, orally |
|
| Placebo | Placebo Comparator | Placebo capsules twice per day, orally |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Dexamethasone | Drug |
| ||
| Placebo |
| 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 |
| 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 |
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Inclusion Criteria:
Exclusion Criteria:
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| Name | Affiliation | Role |
|---|---|---|
| Konrad E Bloch, MD | University Hospital, Zürich | Study Chair |
| Talant M Sooronbaev, MD | National Center of Cardiology and Internal Medicine, Bishkek, Kyrgyzstan | Study Director |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| National Center of Cardiology and Internal Medicine | Bishkek | 720040 | Kyrgyzstan |
| PubMed Identifier | Type | Citation | Retractions |
|---|---|---|---|
| 30794302 | Derived | 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. |
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| ID | Term |
|---|---|
| D029424 | Pulmonary Disease, Chronic Obstructive |
| D001991 | Bronchitis |
| D004646 | Emphysema |
| ID | Term |
|---|---|
| D008173 | Lung Diseases, Obstructive |
| D008171 | Lung Diseases |
| D012140 | Respiratory Tract Diseases |
| D002908 | Chronic Disease |
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| ID | Term |
|---|---|
| D003907 | Dexamethasone |
| ID | Term |
|---|---|
| D011246 | Pregnadienetriols |
| D011245 | Pregnadienes |
| D011278 | Pregnanes |
| D013256 | Steroids |
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|
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 |
| D020969 |
| Disease Attributes |
| D010335 | Pathologic Processes |
| D013568 | Pathological Conditions, Signs and Symptoms |
| D012141 | Respiratory Tract Infections |
| D007239 | Infections |
| D001982 | Bronchial Diseases |
| D000072473 |
| Fused-Ring Compounds |
| D011083 | Polycyclic Compounds |
| D013259 | Steroids, Fluorinated |