Clinical Trial

Reboxetine for Sleep Apnoea After ENT Surgery

Study acronym: RENTOSA

Recruiting Phase 2

Record status

This record was last updated October 3, 2024 (before its estimated July 2025 completion). Its status may not reflect the trial's current state.

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.

Protocol Amendment History 1 amendment

This ClinicalTrials.gov record has been amended once since 2023-07-28.

Status change: Not Yet Recruiting → Recruiting 2024-10-02

Trial Details

NCT Number	NCT05978505
Lead Sponsor	Flinders University Collaborators: Flinders Medical Centre
Conditions	Sleep Apnea, Obstructive
Enrollment	20 participants
Start Date	2023-08-10
Primary Completion	2025-07 (estimated)
Study Completion	2025-07 (estimated)
Updated on ClinicalTrials.gov	2024-10-03