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Reboxetine for Sleep Apnoea After ENT Surgery

Reboxetine for Sleep Apnoea After ENT Surgery

Recruiting
18 years and older
All
Phase 2

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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.

Eligibility

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

Study details
    Sleep Apnea
    Obstructive

NCT05978505

Flinders University

21 October 2025

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