RecruitingPhase 2NCT05978505

Reboxetine for Sleep Apnoea After ENT Surgery

Reboxetine for Obstructive Sleep Apnoea After Upper Airway Surgery: a Randomised, Double-blind, Placebo-controlled Study

Sponsor

Flinders University

Enrollment

20 participants

Start Date

Aug 10, 2023

Study Type

INTERVENTIONAL

Conditions

Sleep Apnea, Obstructive

Summary

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.

Eligibility

Min Age: 18 Years

Inclusion Criteria3

Age >18 years
Undergoing elective upper airway surgery
History of obstructive sleep apnoea (OSA)

Exclusion Criteria7

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