Reboxetine for Sleep Apnoea After ENT Surgery

Last updated: October 2, 2024
Sponsor: Flinders University
Overall Status: Active - Recruiting

Phase

2

Condition

Sleep Apnea Syndromes

Treatment

Placebo

Reboxetine 4 MG Oral Tablet

Clinical Study ID

NCT05978505
2023/HRE00060
  • Ages > 18
  • All Genders

Study 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 Criteria

Inclusion

Inclusion Criteria:

  • Age >18 years

  • Undergoing elective upper airway surgery

  • History of obstructive sleep apnoea (OSA)

Exclusion

Exclusion Criteria:

  • Clinically significant cardiac disease (e.g., arrhythmia, coronary artery disease,or cardiac failure)

  • History of clinically significant urinary retention, bladder outlet obstruction, orbenign prostatic hyperplasia

  • Poorly controlled hypertension

  • Epilepsy

  • History of schizophrenia, schizoaffective disorder or bipolar disorder according toDiagnostic and Statistical Manual of Mental Disorders-V or InternationalClassification 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 Design

Total Participants: 20
Treatment Group(s): 2
Primary Treatment: Placebo
Phase: 2
Study Start date:
August 10, 2023
Estimated Completion Date:
July 31, 2025

Connect with a study center

  • Flinders, Private and Public Hospitals and Flinders University

    Bedford Park, South Australia 5042
    Australia

    Active - Recruiting

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