Back to resultsReboxetine for Sleep Apnoea After ENT Surgery (RENTOSA)
Primary Purpose
Sleep Apnea, Obstructive
Status
Not yet recruiting
Phase
Phase 2
Locations
Study Type
Interventional
Intervention
Reboxetine 4 MG Oral Tablet
Placebo
Sponsored by
About this trial
This is an interventional other trial for Sleep Apnea, Obstructive focused on measuring sleep apnea, obstructive, upper airway surgery, ENT surgery, reboxetine, noradrenaline reuptake inhibitor, randomised, feasibility, placebo, double-blind
Eligibility Criteria
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
Sites / Locations
Arms of the Study
Arm 1
Arm 2
Arm Type
Experimental
Placebo Comparator
Arm Label
Reboxetine
Placebo
Arm Description
7-day course of 4mg reboxetine, taken nightly before bed time. Reboxetine will be taken for 7-nights post-surgery.
Placebo sugar pill in the form of one capsule, taken before bedtime. Dosage is taken for 7 nights post-surgery.
Outcomes
Primary Outcome Measures
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.
Data capture efficiency
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)
Number of times per hour that a participant has a drop in blood oxygen levels during sleep
nadir SpO2
The lowest oxygen saturation value the patient drops to in a night.
Time spent below 90% SpO2
The total amount of time per night for which oxygen saturation falls below 90%.
mean SpO2
Average nightly oxygen level
Sleep duration
Total amount of time spent asleep per night, sleep tracking performed using an under mattress sensor device.
Sleep efficiency (%)
The estimated percentage of time in bed spent asleep performed using an under mattress sensor device.
Daytime sleepiness
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
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
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)
Change in OSA severity (AHI estimated via the Withings under mattress sensor number of events/hour) between placebo and reboxetine
Study enrolment rate
The number of referred patients successfully enrolled into this feasibility study
Full Information
NCT ID
NCT05978505
First Posted
June 2, 2023
Last Updated
July 28, 2023
Sponsor
Flinders University
Collaborators
Flinders Medical Centre
1. Study Identification
Unique Protocol Identification Number
NCT05978505
Brief Title
Reboxetine for Sleep Apnoea After ENT Surgery
Acronym
RENTOSA
Official Title
Reboxetine for Obstructive Sleep Apnoea After Upper Airway Surgery: a Randomised, Double-blind, Placebo-controlled Study
Study Type
Interventional
2. Study Status
Record Verification Date
July 2023
Overall Recruitment Status
Not yet recruiting
Study Start Date
August 15, 2023 (Anticipated)
Primary Completion Date
December 2024 (Anticipated)
Study Completion Date
December 2024 (Anticipated)
3. Sponsor/Collaborators
Responsible Party, by Official Title
Principal Investigator
Name of the Sponsor
Flinders University
Collaborators
Flinders Medical Centre
4. Oversight
Studies a U.S. FDA-regulated Drug Product
No
Studies a U.S. FDA-regulated Device Product
No
Product Manufactured in and Exported from the U.S.
No
Data Monitoring Committee
No
5. 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.
6. Conditions and Keywords
Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Sleep Apnea, Obstructive
Keywords
sleep apnea, obstructive, upper airway surgery, ENT surgery, reboxetine, noradrenaline reuptake inhibitor, randomised, feasibility, placebo, double-blind
7. Study Design
Primary Purpose
Other
Study Phase
Phase 2
Interventional Study Model
Crossover Assignment
Model Description
Double-blind, randomized, placebo-controlled, cross-over study
Masking
ParticipantCare ProviderInvestigatorOutcomes Assessor
Masking Description
Identical capsule for placebo and study drug prepared by study pharmacist
Allocation
Randomized
Enrollment
20 (Anticipated)
8. Arms, Groups, and Interventions
Arm Title
Reboxetine
Arm Type
Experimental
Arm Description
7-day course of 4mg reboxetine, taken nightly before bed time. Reboxetine will be taken for 7-nights post-surgery.
Arm Title
Placebo
Arm Type
Placebo Comparator
Arm Description
Placebo sugar pill in the form of one capsule, taken before bedtime. Dosage is taken for 7 nights post-surgery.
Intervention Type
Drug
Intervention Name(s)
Reboxetine 4 MG Oral Tablet
Other Intervention Name(s)
Edronax
Intervention Description
7 nightly doses (4mg) to commence after surgery.
Intervention Type
Drug
Intervention Name(s)
Placebo
Other Intervention Name(s)
Sugar pill
Intervention Description
7 nightly doses to commence after surgery.
Primary Outcome Measure Information:
Title
Treatment protocol adherence
Description
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
Title
Data capture efficiency
Description
The percentage of successful data collection nights versus missed nights of at-home oximetry for this feasibility study.
Time Frame
14 days
Secondary Outcome Measure Information:
Title
Oxygen desaturation index (ODI)
Description
Number of times per hour that a participant has a drop in blood oxygen levels during sleep
Time Frame
14 days
Title
nadir SpO2
Description
The lowest oxygen saturation value the patient drops to in a night.
Time Frame
14 days
Title
Time spent below 90% SpO2
Description
The total amount of time per night for which oxygen saturation falls below 90%.
Time Frame
14 days
Title
mean SpO2
Description
Average nightly oxygen level
Time Frame
14 days
Title
Sleep duration
Description
Total amount of time spent asleep per night, sleep tracking performed using an under mattress sensor device.
Time Frame
14 days
Title
Sleep efficiency (%)
Description
The estimated percentage of time in bed spent asleep performed using an under mattress sensor device.
Time Frame
14 days
Title
Daytime sleepiness
Description
Measured via Karolinska Sleepiness Scale Questionnaire (9 point scale where 1 = extremely alert and 9 = extremely sleepy - fighting sleep)
Time Frame
14 days
Title
Perceived sleep quality measured via the Leeds Sleep Evaluation Questionnaire
Description
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.
Time Frame
14 days
Title
Insomnia Severity Score
Description
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.
Time Frame
14 days
Title
Apnoea-hypopnea hndex (AHI)
Description
Change in OSA severity (AHI estimated via the Withings under mattress sensor number of events/hour) between placebo and reboxetine
Time Frame
14 days
Title
Study enrolment rate
Description
The number of referred patients successfully enrolled into this feasibility study
Time Frame
12 months
Other Pre-specified Outcome Measures:
Title
Reboxetine-related side effects
Description
Documented via adverse-event forms.
Time Frame
14 days
10. Eligibility
Sex
All
Minimum Age & Unit of Time
18 Years
Accepts Healthy Volunteers
No
Eligibility Criteria
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
Central Contact Person:
First Name & Middle Initial & Last Name or Official Title & Degree
Emma J Thomas
Phone
+61 8 8201 2912
Email
ethomas@flinders.edu.au
First Name & Middle Initial & Last Name or Official Title & Degree
Carolin Tran
Phone
+61 8 7421 9873
Email
carolin.tran@flinders.edu.au
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Danny J Eckert, PhD
Organizational Affiliation
Flinders University
Official's Role
Principal Investigator
12. IPD Sharing Statement
Plan to Share IPD
Yes
IPD Sharing Plan Description
Participants will be informed in plain language through the consent form that their deidentified data may be made available to other researchers. Deidentified participant data will only be shared with other researchers upon request to the chief investigator after study publication and subject to ethical approval
IPD Sharing Time Frame
At conclusion of the study and any related publications
IPD Sharing Access Criteria
IPD may be shared for research purposes on application to the chief investigator and subject to applicable ethical review.
Citations:
PubMed Identifier
27101493
Citation
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Reboxetine for Sleep Apnoea After ENT Surgery
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