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Recruiting Phase 2 NCT05978505

Reboxetine for Sleep Apnoea After ENT Surgery

Phase 2 – studying effectiveness and dosage
Conditions: Sleep Apnea, Obstructive

Sponsor: Flinders University

trial.available_in: БГ
Overview
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.
Who can participate
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
Locations 1
Australia (1)
Flinders, Private and Public Hospitals and Flinders University
Bedford Park , South Australia
Technical details
Status
Recruiting
Phase
Phase 2
Study type
INTERVENTIONAL
Sex
Male and female
Minimum age
18 Years
Healthy volunteers
No
Start date
10.08.2023
Completion date
01.07.2025
Registry ID
NCT05978505
Source
anzctr
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