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| Name | Class |
|---|---|
| National Center of Cardiology and Internal Medicine named after academician M.Mirrakhimov | OTHER_GOV |
| University Hospital Heidelberg | OTHER |
| Laboratoire des Adaptations Métaboliques à l'Exercice en conditions Physiologiques et Pathologiques |
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Randomized clinical trial evaluating the effect of acetazolamide on sleep disordered breathing in women compared to men travelling to 3600 m.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| WOMEN - ACETAZOLAMIDE oral capsule | Active Comparator | Acetazolamide 250 mg/day (capsules @125 mg; 1 in the morning, 1 in the evening), orally. Medication starts 24 hours before ascent to 3600 m until the morning after the second night at 3600 m. |
|
| MEN - ACETAZOLAMIDE oral capsule | Active Comparator | Acetazolamide 250 mg/day (capsules @125 mg; 1 in the morning, 1 in the evening), orally. Medication starts 24 hours before ascent to 3600 m until the morning after the second night at 3600 m. |
|
| WOMEN - PLACEBO oral capsule | Placebo Comparator | Placebo (capsules identically looking as acetazolamide capsules; 1 in the morning, 1 in the evening), orally. Medication starts 24 hours before ascent to 3600 m until the morning after the second night at 3600 m. |
|
| MEN - PLACEBO oral capsule | Placebo Comparator | Placebo (capsules identically looking as acetazolamide capsules; 1 in the morning, 1 in the evening), orally. Medication starts 24 hours before ascent to 3600 m until the morning after the second night at 3600 m. |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Acetazolamide | Drug | Administration of 1x125mg acetazolamide in the morning, 1x125mg in the evening, starting 24 hours before departure to 3600 m. |
|
| Measure | Description | Time Frame |
|---|---|---|
| Nocturnal oxygen desaturation index (ODI) | Sex-related difference in the altitude-induced change in the ODI (number of ∆SpO2 >3% per hour time in bed measured by pulse oximetry) between acetazolamide and placebo group. | Night 1 at 760 m and Night 1 at 3600 m |
| Measure | Description | Time Frame |
|---|---|---|
| Nocturnal oxygen saturation (SpO2) | Sex-related difference in the altitude-induced change in the mean nocturnal oxygen saturation measured by pulse oximetry between acetazolamide and placebo group. | Night 1 at 760 m and Night 1 at 3600 m |
| Nocturnal oxygen saturation (SpO2) |
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Inclusion Criteria:
Exclusion Criteria:
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| Name | Affiliation | Role |
|---|---|---|
| Michael Furian, Prof. Dr. | University of Zurich | Study Chair |
| Talant Sooronbaev, Prof. Dr. | National Center of Cardiology and Internal Medicine, Bishkek, Kyrgyzstan | Study Director |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| National Center for Cardiology and Internal Medicine | Bishkek | Bishkek | 720040 | Kyrgyzstan |
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| ID | Term |
|---|---|
| D012891 | Sleep Apnea Syndromes |
| D000860 | Hypoxia |
| ID | Term |
|---|---|
| D001049 | Apnea |
| D012120 | Respiration Disorders |
| D012140 | Respiratory Tract Diseases |
| 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 | Drug | Administration of equally looking placebo capsules in the morning and in the evening, starting 24 hours before departure to 3600 m. |
|
Sex-related difference in the altitude-induced change in the mean nocturnal oxygen saturation measured by pulse oximetry between acetazolamide and placebo group. |
| Night 1 at 760 m and Night 2 at 3600 m |
| Apnea/hypopnea index (AHI) | Sex-related difference in the altitude-induced change in the mean number of apneas/hypopneas per hour between the acetazolamide and placebo group. | Night 1 at 760 m and Night 1 at 3600 m |
| Apnea/hypopnea index (AHI) | Sex-related difference in the altitude-induced change in the mean number of apneas/hypopneas per hour between the acetazolamide and placebo group. | Night 1 at 760 m and Night 2 at 3600 m |
| Subjective sleep quality | Sex-related difference in the altitude-induced change in subjective sleep quality assessed by a 100-mm visual analog scale between the acetazolamide and placebo group. | Night 1 at 760 m and Night 1 at 3600 m |
| Subjective sleep quality | Sex-related difference in the altitude-induced change in subjective sleep quality assessed by a 100-mm visual analog scale between the acetazolamide and placebo group. | Night 1 at 760 m and Night 2 at 3600 m |
| Nocturnal oxygen desaturation index (ODI) | Sex-related difference in the altitude-induced change in the ODI (number of ∆SpO2 >3% per hour time in bed measured by pulse oximetry) between acetazolamide and placebo group. | Night 1 at 760 m and Night 2 at 3600 m |
| D020920 |
| Dyssomnias |
| D012893 | Sleep Wake Disorders |
| D009422 | Nervous System Diseases |
| D012818 | Signs and Symptoms, Respiratory |
| D012816 | Signs and Symptoms |
| D013568 | Pathological Conditions, Signs and Symptoms |
| D001393 |
| Azoles |
| D006573 | Heterocyclic Compounds, 1-Ring |
| D006571 | Heterocyclic Compounds |