Reboxetine for Sleep Apnoea After ENT Surgery

ConditionSleep Apnea, Obstructive

Trial statusRecruiting

Trial phasePhase 2

Trial typeInterventional

Biological sexAll

Age18+

SponsorFlinders University

About this trial

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 criteria

This trial does not accept healthy volunteers

Qualifiers

Age >18 years

Undergoing elective upper airway surgery

History of obstructive sleep apnoea (OSA)

Disqualifiers

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

Trial design

Design model

Crossover

Treatments tested in this trial

Reboxetine 4 MG Oral Tablet
Drug
7 nightly doses (4mg) to commence after surgery.
Placebo
Drug
7 nightly doses to commence after surgery.

Treatment groups

20 Participants

are divided into 2 treatment groups

Group A: ReboxetineExperimental treatment 1 intervention

Group B: PlaceboPlacebo comparator 1 intervention

Trial outcomes

Primary outcomes

Treatment protocol adherence

The percentage of total doses of the study drug (reboxetine or placebo) that were taken versus prescribed (assessed via pill counts) for this feasibility study.

Time frame

7 days

Data capture efficiency

The percentage of successful data collection nights versus missed nights of at-home oximetry for this feasibility study.

Time frame

14 days

Secondary outcomes

Oxygen desaturation index (ODI)

Number of times per hour that a participant has a drop in blood oxygen levels during sleep

Time frame

14 days

nadir SpO2

The lowest oxygen saturation value the patient drops to in a night.

Time frame

14 days

Time spent below 90% SpO2

The total amount of time per night for which oxygen saturation falls below 90%.

Time frame

14 days

mean SpO2

Average nightly oxygen level

Time frame

14 days

Other outcomes

Reboxetine-related side effects

Documented via adverse-event forms.

Time frame

14 days

Sponsors and contacts

Click on the lead sponsor to view all of their trials.

Flinders University

Lead sponsor

Flinders Medical Centre

Collaborator

Source ClinicalTrials.gov

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