Reboxetine for Sleep Apnoea After ENT Surgery

Phase 2

Recruiting

• Conditions: Sleep Apnea, Obstructive
• Interventions: Drug: Reboxetine 4 MG Oral Tablet; Drug: Placebo

• Registration Number: NCT05978505
• Lead Sponsor: Flinders University

Brief 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.

Detailed Description

Not available

Study Timeline

• Study First Submitted: 2023-06-02
• Study First Submitted QC: 2023-07-28
• Study First Posted: 2023-08-07
• Study Start: 2023-08-10
• Status Verified: 2024-10
• Last Update Submitted: 2024-10-02
• Last Update Posted: 2024-10-03
• Primary Completion: 2025-07
• Study Completion: 2025-07

Recruitment & Eligibility

• Status: RECRUITING
• Sex: All
• Target Recruitment: 20

Inclusion Criteria

• Age >18 years
• Undergoing elective upper airway surgery
• History of obstructive sleep apnoea (OSA)

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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

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Study & Design

• Study Type: INTERVENTIONAL
• Study Design: CROSSOVER

Arm && Interventions

Group	Intervention	Description
Reboxetine	Reboxetine 4 MG Oral Tablet	7-day course of 4mg reboxetine, taken nightly before bed time. Reboxetine will be taken for 7-nights post-surgery.
Placebo	Placebo	Placebo sugar pill in the form of one capsule, taken before bedtime. Dosage is taken for 7 nights post-surgery.

Primary Outcome Measures

Name	Time	Method
Data capture efficiency	14 days	The percentage of successful data collection nights versus missed nights of at-home oximetry for this feasibility study.
Treatment protocol adherence	7 days	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.

Secondary Outcome Measures

Name	Time	Method
Apnoea-hypopnea hndex (AHI)	14 days	Change in OSA severity (AHI estimated via the Withings under mattress sensor number of events/hour) between placebo and reboxetine
Time spent below 90% SpO2	14 days	The total amount of time per night for which oxygen saturation falls below 90%.
Perceived sleep quality measured via the Leeds Sleep Evaluation Questionnaire	14 days	This questionnaire asks participants to rate their perceived sleep across 4 domains on a visual analog scale as follows: 1) getting to sleep, 2) quality of sleep, 3) Awake following sleep, 4) Behavior following wakening. Higher scores indicate better perceived sleep.
Daytime sleepiness	14 days	Measured via Karolinska Sleepiness Scale Questionnaire (9 point scale where 1 = extremely alert and 9 = extremely sleepy - fighting sleep)
nadir SpO2	14 days	The lowest oxygen saturation value the patient drops to in a night.
mean SpO2	14 days	Average nightly oxygen level
Sleep efficiency (%)	14 days	The estimated percentage of time in bed spent asleep performed using an under mattress sensor device.
Study enrolment rate	12 months	The number of referred patients successfully enrolled into this feasibility study
Oxygen desaturation index (ODI)	14 days	Number of times per hour that a participant has a drop in blood oxygen levels during sleep
Sleep duration	14 days	Total amount of time spent asleep per night, sleep tracking performed using an under mattress sensor device.
Insomnia Severity Score	14 days	A patient-reported measure of insomnia symptoms using the Insomnia Severity Index- A 28 point scale where 0 indicates no clinically significant insomnia and 28 indicates maximally severe clinical insomnia.

Trial Locations

Locations (1)

Flinders, Private and Public Hospitals and Flinders University; 🇦🇺 Bedford Park, South Australia, Australia