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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 the effect of acetazolamide on sleep disordered breathing in lowlanders older than 40 years travelling from 760 m to 3'100 m.
This is a randomized, placebo-controlled, double-blind parallel trial evaluating the effect of preventive acetazolamide intake on the sleep disordered breathing in lowlanders older than 40 years travelling to altitude. Participants living in the Bishkek area, Kyrgyzstan (760m), will be transferred by car within 4h to the Tuja Ashu high altitude clinic (3'100 m), and stay there for 2 days. Acetazolamide 375mg/day (or placebo), will be administered before departure at 760 m and during the stay at altitude. Outcomes will be assessed during the stay at 3'100 m.
An interim analysis will be carried out when 80 participants will have completed the study or after the first year. The Peto's method will be used and the trial will be stopped when pre-specified futility boundaries were crossed.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| ACETAZOLAMIDE oral capsule | Active Comparator | Acetazolamide 375mg/day (capsule @125 mg: 1 in the morning, 2 in the evening), orally. Medication starts 24 hours before ascent to 3'100m until the morning after the second night at 3'100m |
|
| PLACEBO oral capsule | Placebo Comparator | Placebo (capsules identically looking as acetazolamide capsules: 1 in the morning, 2 in the evening), orally. Medication starts 24 hours before ascent to 3'100m until the morning after the second night at 3'100m |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| ACETAZOLAMIDE oral capsule | Drug | Administration of 1x125mg acetazolamide in the morning, 2x125mg in the evening, starting 24 hours before departure to 3'100m |
|
| Measure | Description | Time Frame |
|---|---|---|
| Change in nocturnal oxygen desaturation index | Difference in altitude-induced change in the mean number of cyclic dips in oxygen saturation measured by pulse oximetry between acetazolamide and placebo group | night 1 at 760m and night 1 at 3'100 m |
| Measure | Description | Time Frame |
|---|---|---|
| Change in nocturnal oxygen saturation night 1 at 3'100m | Difference in altitude-induced change in mean nocturnal oxygen saturation measured by pulse oximetry between acetazolamide and placebo group | night 1 at 760m and night 1 at 3'100 m |
| Change in nocturnal oxygen saturation night 2 at 3'100m |
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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 |
| Michael Furian, MSc | University Hospital, Zürich | Principal Investigator |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| National Center of Cardiology and Internal Medicine | Bishkek | 720040 | Kyrgyzstan |
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| ID | Term |
|---|---|
| D000532 | Altitude Sickness |
| D012891 | Sleep Apnea Syndromes |
| ID | Term |
|---|---|
| D012120 | Respiration Disorders |
| D012140 | Respiratory Tract Diseases |
| D001049 | Apnea |
| D020919 | Sleep Disorders, Intrinsic |
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| ID | Term |
|---|---|
| D000086 | Acetazolamide |
| ID | Term |
|---|---|
| D013830 | Thiadiazoles |
| D013844 | Thiazoles |
| D013457 | Sulfur Compounds |
| D009930 | Organic Chemicals |
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| Placebo oral capsule | Drug | Administration of equally looking placebo capsules in the morning and evening, starting 24 hours before departure to 3'100m |
|
Difference in altitude-induced change in mean nocturnal oxygen saturation measured by pulse oximetry between acetazolamide and placebo group |
| night 1 at 760m and night 2 at 3'100 m |
| Change in nocturnal oxygen desaturation index | Difference in altitude-induced change in the mean number of cyclic dips in oxygen saturation measured by pulse oximetry between acetazolamide and placebo group | night 1 at 760m and night 2 at 3'100 m |
| Change in apnea/hypopnea index night 1 at 3'100m | Difference in altitude-induced change in mean number of apneas/hypopneas per hour between the acetazolamide and placebo group | night 1 at 760m and night 1 at 3'100 m |
| Change in apnea/hypopnea index night 2 at 3'100m | Difference in altitude-induced change in mean number of apneas/hypopneas per hour between the acetazolamide and placebo group | night 1 at 760m and night 2 at 3'100 m |
| Change in subjective sleepiness and sleep quality | Difference in altitude-induced change in subjective sleepiness and sleep quality assessed by a visual analog scale between acetazolamide and placebo group | Day 1 and 2 at 760m and 3'100m |
| D020920 |
| Dyssomnias |
| D012893 | Sleep Wake Disorders |
| D009422 | Nervous System Diseases |
| D001393 |
| Azoles |
| D006573 | Heterocyclic Compounds, 1-Ring |
| D006571 | Heterocyclic Compounds |