Actively Recruiting
Reboxetine for Sleep Apnoea After ENT Surgery
Led by Flinders University · Updated on 2024-10-03
20
Participants Needed
1
Research Sites
98 weeks
Total Duration
On this page
Sponsors
F
Flinders University
Lead Sponsor
F
Flinders Medical Centre
Collaborating Sponsor
AI-Summary
What this Trial Is About
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.
CONDITIONS
Official Title
Reboxetine for Sleep Apnoea After ENT Surgery
Who Can Participate
Eligibility Criteria
You may qualify if you...
- Age >18 years
- Undergoing elective upper airway surgery
- History of obstructive sleep apnoea (OSA)
You will not qualify if you...
- Clinically significant cardiac disease such as 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
- History of attempted suicide or suicidal ideation within 1 year prior to screening, or current suicidal ideation
- Narrow angle glaucoma
AI-Screening
AI-Powered Screening
Complete this quick 3-step screening to check your eligibility
Trial Site Locations
Total: 1 location
1
Flinders, Private and Public Hospitals and Flinders University
Bedford Park, South Australia, Australia, 5042
Actively Recruiting
Research Team
E
Emma Thomas
CONTACT
C
Carolin Tran
CONTACT
How is the study designed?
Study Type
INTERVENTIONAL
Masking
QUADRUPLE
Allocation
RANDOMIZED
Model
CROSSOVER
Primary Purpose
OTHER
Number of Arms
2
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