Sleep-Disordered Breathing
Conditions
Keywords
Sleep disordered breathing, Periodic breathing, Prevention, Acetazolamide, Altitude, Hypoxia, Women
Brief summary
Randomized clinical trial evaluating the effect of acetazolamide on sleep disordered breathing in women compared to men travelling to 3600 m.
Interventions
DRUGAcetazolamide
Administration of 1x125mg acetazolamide in the morning, 1x125mg in the evening, starting 24 hours before departure to 3600 m.
DRUGPlacebo
Administration of equally looking placebo capsules in the morning and in the evening, starting 24 hours before departure to 3600 m.
Sponsors
University of Zurich
National Center of Cardiology and Internal Medicine named after academician M.Mirrakhimov
University Hospital Heidelberg
Laboratoire des Adaptations Métaboliques à l'Exercice en conditions Physiologiques et Pathologiques
Study design
Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
PREVENTION
Masking
QUADRUPLE (Subject, Caregiver, Investigator, Outcomes Assessor)
Eligibility
Sex/Gender
ALL
Age
18 Years to 44 Years
Healthy volunteers
Yes
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
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| Nocturnal oxygen desaturation index (ODI) | Night 1 at 760 m and Night 1 at 3600 m | 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. |
Secondary
| Measure | Time frame | Description |
|---|---|---|
| Nocturnal oxygen saturation (SpO2) | Night 1 at 760 m and Night 1 at 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. |
| Apnea/hypopnea index (AHI) | Night 1 at 760 m and Night 1 at 3600 m | Sex-related difference in the altitude-induced change in the mean number of apneas/hypopneas per hour between the acetazolamide and placebo group. |
| Subjective sleep quality | Night 1 at 760 m and Night 1 at 3600 m | 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. |
| Nocturnal oxygen desaturation index (ODI) | Night 1 at 760 m and Night 2 at 3600 m | 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. |
Countries
Kyrgyzstan
Contacts
STUDY_CHAIRMichael Furian, Prof. Dr.
University of Zurich
STUDY_DIRECTORTalant Sooronbaev, Prof. Dr.
National Center of Cardiology and Internal Medicine, Bishkek, Kyrgyzstan
Outcome results
None listed