NCT05978505

Reboxetine for Sleep Apnoea After ENT Surgery

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

• Status: Recruiting
• Phase: Phase 2
• Study type: Interventional
• Enrollment: 20 (estimated)
• Sponsor: Flinders University · Academic / Other
• Sex: All
• Age: 18 Years
• Healthy volunteers: Not accepted

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.

Conditions

• Sleep Apnea, Obstructive

Interventions

Type	Name	Description
DRUG	Reboxetine 4 MG Oral Tablet	7 nightly doses (4mg) to commence after surgery.
DRUG	Placebo	7 nightly doses to commence after surgery.

Timeline

• Start date: 2023-08-10
• Primary completion: 2025-07-01
• Completion: 2025-07-01
• First posted: 2023-08-07
• Last updated: 2024-10-03

Locations

1 site across 1 country: Australia