Reboxetine for Sleep Apnoea After ENT Surgery

Study Overview
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Brief Summary
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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.

Official Title
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Reboxetine for Obstructive Sleep Apnoea After Upper Airway Surgery: a Randomised, Double-blind, Placebo-controlled Study

Conditions
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Sleep Apnea, Obstructive

Intervention / Treatment
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* Drug: Reboxetine 4 MG Oral Tablet
* Drug: Placebo


Participation Criteria
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Eligibility Criteria
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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

Ages Eligible for Study
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Minimum Age: 18 Years

Sexes Eligible for Study
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All

Accepts Healthy Volunteers
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No

Study Plan
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How is the study designed?
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Design Details

Primary Purpose: Other
Allocation: Randomized
Intervention Model: Crossover Assignment
Interventional Model Description: Double-blind, randomized, placebo-controlled, cross-over study
Masking: Quadruple


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Experimental: Reboxetine<br>7-day course of 4mg reboxetine, taken nightly before bed time. Reboxetine will be taken for 7-nights post-surgery. | Drug: Reboxetine 4 MG Oral Tablet<br>* 7 nightly doses (4mg) to commence after surgery.<br>* Other names: Edronax;|
| Placebo Comparator: Placebo<br>Placebo sugar pill in the form of one capsule, taken before bedtime. Dosage is taken for 7 nights post-surgery. | Drug: Placebo<br>* 7 nightly doses to commence after surgery.<br>* Other names: Sugar pill;|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| 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. | 7 days | 
| Data capture efficiency | The percentage of successful data collection nights versus missed nights of at-home oximetry for this feasibility study. | 14 days | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Oxygen desaturation index (ODI) | Number of times per hour that a participant has a drop in blood oxygen levels during sleep | 14 days | 
| nadir SpO2 | The lowest oxygen saturation value the patient drops to in a night. | 14 days | 
| Time spent below 90% SpO2 | The total amount of time per night for which oxygen saturation falls below 90%. | 14 days | 
| mean SpO2 | Average nightly oxygen level | 14 days | 
| Sleep duration | Total amount of time spent asleep per night, sleep tracking performed using an under mattress sensor device. | 14 days | 
| Sleep efficiency (%) | The estimated percentage of time in bed spent asleep performed using an under mattress sensor device. | 14 days | 
| Daytime sleepiness | Measured via Karolinska Sleepiness Scale Questionnaire (9 point scale where 1 = extremely alert and 9 = extremely sleepy - fighting sleep) | 14 days | 
| Perceived sleep quality measured via the Leeds Sleep Evaluation Questionnaire | 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. | 14 days | 
| Insomnia Severity Score | 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. | 14 days | 
| Apnoea-hypopnea hndex (AHI) | Change in OSA severity (AHI estimated via the Withings under mattress sensor number of events/hour) between placebo and reboxetine | 14 days | 
| Study enrolment rate | The number of referred patients successfully enrolled into this feasibility study | 12 months | 

 Terms related to the study
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Keywords Provided by Centre Hospitalier Valida
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sleep apnea, obstructive, upper airway surgery, ENT surgery, reboxetine, noradrenaline reuptake inhibitor, randomised, feasibility, placebo, double-blind