Using reboxetine to treat sleep apnea after ENT surgery
Reboxetine for Obstructive Sleep Apnoea After Upper Airway Surgery: a Randomised, Double-blind, Placebo-controlled Study
PHASE2 · Flinders University · NCT05978505
This study is testing if the medication reboxetine can help reduce sleep apnea symptoms in patients recovering from throat surgery.
Quick facts
| Phase | PHASE2 |
|---|---|
| Study type | Interventional |
| Enrollment | 20 (estimated) |
| Ages | 18 Years and up |
| Sex | All |
| Sponsor | Flinders University (other) |
| Locations | 1 site (Bedford Park, South Australia) |
| Trial ID | NCT05978505 on ClinicalTrials.gov |
What this trial studies
This pilot study aims to assess the feasibility of a larger trial investigating the effects of reboxetine, a medication typically used for depression, on reducing the severity of obstructive sleep apnea (OSA) in patients recovering from elective upper airway surgery. Participants will be randomly assigned to receive either reboxetine or a placebo for seven days post-surgery, and their sleep and oxygenation levels will be monitored using at-home equipment. The study will also involve questionnaires to evaluate changes in symptoms before and after the intervention.
Who should consider this trial
Good fit: Ideal candidates include adults over 18 years old who are undergoing elective upper airway surgery and have a history of obstructive sleep apnea.
Not a fit: Patients with significant cardiac disease, poorly controlled hypertension, or a history of certain psychiatric disorders may not benefit from this study.
Why it matters
Potential benefit: If successful, this study could provide an alternative treatment option for patients with obstructive sleep apnea who struggle with traditional CPAP therapy after surgery.
How similar studies have performed: While the use of reboxetine for sleep apnea is a novel approach, similar studies exploring alternative treatments for OSA have shown promise, indicating potential for success.
Eligibility criteria
Show full inclusion / exclusion criteria
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
Where this trial is running
Bedford Park, South Australia
- Flinders, Private and Public Hospitals and Flinders University — Bedford Park, South Australia, Australia (RECRUITING)
Study contacts
- Principal investigator: Danny J. Eckert, PhD — Flinders University
- Study coordinator: Emma Thomas
- Email: ethomas@flinders.edu.au
- Phone: +61882012912
How to participate
- Review the eligibility criteria above with your treating physician.
- Visit the official trial page on ClinicalTrials.gov for the most current contact information and recruitment status.
- Contact the listed study coordinator or principal investigator to request pre-screening. Pre-screening is free and never obligates you to enroll.
Conditions: Sleep Apnea, Obstructive, sleep apnea, obstructive, upper airway surgery, ENT surgery, reboxetine, noradrenaline reuptake inhibitor, randomised, feasibility