Reboxetine for Sleep Apnoea After ENT Surgery (RENTOSA)

Flinders University

Status and phase: Enrolling; Phase 2

Conditions: Sleep Apnea, Obstructive

Treatments: Drug: Placebo; Drug: Reboxetine 4 MG Oral Tablet

Study type: Interventional

Funder types: Other

Identifiers

NCT05978505

2023/HRE00060

Details and patient eligibility

About

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.

Enrollment: 20 estimated patients

Sex: All

Ages: 18+ years old

Volunteers: No Healthy Volunteers

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

Trial design

Primary purpose: Other

Allocation: Randomized

Interventional model: Crossover Assignment

Masking: Quadruple Blind

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20 participants in 2 patient groups, including a placebo group

Reboxetine

Experimental group

Description:

7-day course of 4mg reboxetine, taken nightly before bed time. Reboxetine will be taken for 7-nights post-surgery.

Treatment:

Drug: Reboxetine 4 MG Oral Tablet

Placebo

Placebo Comparator group

Description:

Placebo sugar pill in the form of one capsule, taken before bedtime. Dosage is taken for 7 nights post-surgery.

Treatment:

Drug: Placebo