Фаза 2 – изследване на ефективността и дозировката
Заболявания:
Sleep Apnea, Obstructive
Спонсор: Flinders University
Налично на:
БГ
Обобщение
This pilot study will establish the feasibility of a larger trial to investigate whether reboxetine, a medication used to treat depression, can reduce the severity of obstructive sleep apnea (OSA) including increased blood oxygenation in post-surgical OSA patients where positive airway pressure (CPAP) therapy is either frequently poorly tolerated or not an option immediately post surgery. In this randomized, placebo-controlled, double-blind study, participants will use at-home sleep monitoring equipment before and after surgery plus measures of oxygenation. They will be prescribed either reboxetine or a placebo for seven days after surgery and complete questionnaires at the beginning and end of the study.
Кой може да участва
Inclusion Criteria:
* Age \>18 years
* Undergoing elective upper airway surgery
* History of obstructive sleep apnoea (OSA)
Exclusion Criteria:
* Clinically significant cardiac disease (e.g., arrhythmia, coronary artery disease, or cardiac failure)
* History of clinically significant urinary retention, bladder outlet obstruction, or benign prostatic hyperplasia
* Poorly controlled hypertension
* Epilepsy
* History of schizophrenia, schizoaffective disorder or bipolar disorder according to Diagnostic and Statistical Manual of Mental Disorders-V or International Classification of Disease 10th edition criteria
* History of attempted suicide or suicidal ideation within 1 year prior to screening, or current suicidal ideation
* Narrow angle glaucoma
Места на провеждане
1
Австралия (1)
Flinders, Private and Public Hospitals and Flinders University