RECRUITINGPhase 4INTERVENTIONAL
HighCycle Study: Effect of Acetazolamide on Sleep Disordered Breathing in Women Compared to Men
HighCycle Study: Effect of Acetazolamide on Sleep Disordered Breathing in Women. A Randomized, Placebo-Controlled, Double-Blind Parallel Trial.
About This Trial
Randomized clinical trial evaluating the effect of acetazolamide on sleep disordered breathing in women compared to men travelling to 3600 m.
Who May Be Eligible (Plain English)
Who May Qualify:
- Healthy, non-smoking men and women, age 18-44 years, without any diseases and need of regular medication (including oral contraceptives).
- BMI \>18 kg/m2 and \<30 kg/m2
- Born, raised and currently living at altitudes \<1000 m
- Written willing to sign a consent form
- Premenopausal women with an eumenorrheic cycle
Who Should NOT Join This Trial:
- Other types of contraceptvies (hormonal intrauterine device, vaginal ring, subcutaneous injections or implants, among others)
- Pregnancy or nursing
- Anaemic (haemoglobin concentration \<10g/dl)
- Any altitude trip \<4 weks before the study
- Allergy to acetazolamide and other sulfonamides
Always talk to your doctor about whether this trial is right for you.
Original Eligibility Criteria
View original clinical language
Inclusion Criteria:
* Healthy, non-smoking men and women, age 18-44 years, without any diseases and need of regular medication (including oral contraceptives).
* BMI \>18 kg/m2 and \<30 kg/m2
* Born, raised and currently living at altitudes \<1000 m
* Written informed consent
* Premenopausal women with an eumenorrheic cycle
Exclusion Criteria:
* Other types of contraceptvies (hormonal intrauterine device, vaginal ring, subcutaneous injections or implants, among others)
* Pregnancy or nursing
* Anaemic (haemoglobin concentration \<10g/dl)
* Any altitude trip \<4 weks before the study
* Allergy to acetazolamide and other sulfonamides
Treatments Being Tested
DRUG
Acetazolamide
Administration of 1x125mg acetazolamide in the morning, 1x125mg in the evening, starting 24 hours before departure to 3600 m.
DRUG
Placebo
Administration of equally looking placebo capsules in the morning and in the evening, starting 24 hours before departure to 3600 m.
Locations (1)
National Center for Cardiology and Internal Medicine
Bishkek, Gorod Bishkek, Kyrgyzstan