RENTOSA: Reboxetine for Sleep Apnoea After ENT Surgery

Sponsor

Flinders University (Other)

Overall Status

Not yet recruiting

CT.gov ID

NCT05978505

Collaborator

Flinders Medical Centre (Other)

Enrollment

Arms

15.6

Anticipated Duration (Months)

Study Details

Study Description

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.

Condition or Disease	Intervention/Treatment	Phase
Sleep Apnea, Obstructive	Drug: Reboxetine 4 MG Oral Tablet Drug: Placebo	Phase 2

Study Design

Study Type:

Interventional

Anticipated Enrollment :

20 participants

Allocation:

Randomized

Intervention Model:

Crossover Assignment

Intervention Model Description:

Double-blind, randomized, placebo-controlled, cross-over studyDouble-blind, randomized, placebo-controlled, cross-over study

Masking:

Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor)

Masking Description:

Identical capsule for placebo and study drug prepared by study pharmacist

Primary Purpose:

Other

Official Title:

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

Anticipated Study Start Date :

Aug 15, 2023

Anticipated Primary Completion Date :

Dec 1, 2024

Anticipated Study Completion Date :

Dec 1, 2024

Arms and Interventions

Arm	Intervention/Treatment
Experimental: Reboxetine 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 7 nightly doses (4mg) to commence after surgery. Other Names: Edronax
Placebo Comparator: Placebo Placebo sugar pill in the form of one capsule, taken before bedtime. Dosage is taken for 7 nights post-surgery.	Drug: Placebo 7 nightly doses to commence after surgery. Other Names: Sugar pill

Arm

Intervention/Treatment

Experimental: Reboxetine

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

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

Other Names:

Edronax

Placebo Comparator: Placebo

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

Drug: Placebo

7 nightly doses to commence after surgery.

Other Names:

Sugar pill

Outcome Measures

Primary Outcome Measures

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.
Data capture efficiency [14 days]
The percentage of successful data collection nights versus missed nights of at-home oximetry for this feasibility study.

Secondary Outcome Measures

Oxygen desaturation index (ODI) [14 days]
Number of times per hour that a participant has a drop in blood oxygen levels during sleep
nadir SpO2 [14 days]
The lowest oxygen saturation value the patient drops to in a night.
Time spent below 90% SpO2 [14 days]
The total amount of time per night for which oxygen saturation falls below 90%.
mean SpO2 [14 days]
Average nightly oxygen level
Sleep duration [14 days]
Total amount of time spent asleep per night, sleep tracking performed using an under mattress sensor device.
Sleep efficiency (%) [14 days]
The estimated percentage of time in bed spent asleep performed using an under mattress sensor device.
Daytime sleepiness [14 days]
Measured via Karolinska Sleepiness Scale Questionnaire (9 point scale where 1 = extremely alert and 9 = extremely sleepy - fighting sleep)
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.
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.
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
Study enrolment rate [12 months]
The number of referred patients successfully enrolled into this feasibility study

Other Outcome Measures

Reboxetine-related side effects [14 days]
Documented via adverse-event forms.

Eligibility Criteria

Criteria

Ages Eligible for Study:

18 Years and Older

Sexes Eligible for Study:

All

Accepts 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