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

Status: Recruiting
Location: See location...
Intervention Type: Drug
Study Type: Interventional
Study Phase: Phase 2
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
Participation Requirements
Sex: All
Minimum Age: 18
Healthy Volunteers: f
View:

• Age \>18 years

• Undergoing elective upper airway surgery

• History of obstructive sleep apnoea (OSA)

Locations
Other Locations
Australia
Flinders, Private and Public Hospitals and Flinders University
RECRUITING
Bedford Park
Contact Information
Primary
Emma Thomas
ethomas@flinders.edu.au
+61882012912
Backup
Carolin Tran
carolin.tran@flinders.edu.au
+61874219873
Time Frame
Start Date: 2023-08-10
Estimated Completion Date: 2025-07
Participants
Target number of participants: 20
Treatments
Experimental: Reboxetine
7-day course of 4mg reboxetine, taken nightly before bed time. Reboxetine will be taken for 7-nights post-surgery.
Placebo_comparator: Placebo
Placebo sugar pill in the form of one capsule, taken before bedtime. Dosage is taken for 7 nights post-surgery.
Related Therapeutic Areas
Sponsors
Collaborators: Flinders Medical Centre
Leads: Flinders University

This content was sourced from clinicaltrials.gov