RECRUITINGPhase 2INTERVENTIONAL

Reboxetine for Sleep Apnoea After ENT Surgery

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

About This Trial

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 May Be Eligible (Plain English)

Who May Qualify: - Age \>18 years - Undergoing elective upper airway surgery - History of obstructive sleep apnoea (OSA) Who Should NOT Join This Trial: - 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 Always talk to your doctor about whether this trial is right for you.

Original Eligibility Criteria

View original clinical language

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

Treatments Being Tested

DRUG

Reboxetine 4 MG Oral Tablet

7 nightly doses (4mg) to commence after surgery.

DRUG

Placebo

7 nightly doses to commence after surgery.

Locations (1)

Flinders, Private and Public Hospitals and Flinders University

Bedford Park, South Australia, Australia