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Reboxetine for Sleep Apnoea After ENT Surgery

NCT05978505 · Status: RECRUITING · Phase: PHASE2 · Type: INTERVENTIONAL · Enrollment: 20

Last updated 2024-10-03

No results posted yet for this 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.

Conditions

  • Sleep Apnea, Obstructive

Interventions

DRUG

Reboxetine 4 MG Oral Tablet

7 nightly doses (4mg) to commence after surgery.

DRUG

Placebo

7 nightly doses to commence after surgery.

Sponsors & Collaborators

  • Flinders Medical Centre

    collaborator OTHER_GOV

  • Flinders University

    lead OTHER

Principal Investigators

  • Danny J. Eckert, PhD · Flinders University

Study Design

Allocation
RANDOMIZED
Purpose
OTHER
Masking
QUADRUPLE
Model
CROSSOVER

Eligibility

Min Age
18 Years
Sex
ALL
Healthy Volunteers
No

Timeline & Regulatory

Start
2023-08-10
Primary Completion
2025-07-31
Completion
2025-07-31

Countries

  • Australia

Study Locations

More Related Trials

Entities

Drugs

Read the full study record

This page highlights key information. For complete eligibility criteria, study locations, investigator contacts, and the full protocol, visit the original record on ClinicalTrials.gov.

View NCT05978505 on ClinicalTrials.gov