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Trial details imported from ClinicalTrials.gov

For full trial details, please see the original record at https://clinicaltrials.gov/study/NCT05978505




Registration number
NCT05978505
Ethics application status
Date submitted
2/06/2023
Date registered
7/08/2023

Titles & IDs
Public title
Reboxetine for Sleep Apnoea After ENT Surgery
Scientific title
Reboxetine for Obstructive Sleep Apnoea After Upper Airway Surgery: a Randomised, Double-blind, Placebo-controlled Study
Secondary ID [1] 0 0
2023/HRE00060
Universal Trial Number (UTN)
Trial acronym
RENTOSA
Linked study record

Health condition
Health condition(s) or problem(s) studied:
Sleep Apnea, Obstructive 0 0
Condition category
Condition code
Respiratory 0 0 0 0
Sleep apnoea

Intervention/exposure
Study type
Interventional
Description of intervention(s) / exposure
Treatment: Drugs - Reboxetine 4 MG Oral Tablet
Treatment: Drugs - Placebo

Experimental: Reboxetine - 7-day course of 4mg reboxetine, taken nightly before bed time. Reboxetine will be taken for 7-nights post-surgery.

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


Treatment: Drugs: Reboxetine 4 MG Oral Tablet
7 nightly doses (4mg) to commence after surgery.

Treatment: Drugs: Placebo
7 nightly doses to commence after surgery.
Intervention code [1] 0 0
Treatment: Drugs
Comparator / control treatment
Control group

Outcomes
Primary outcome [1] 0 0
Treatment protocol adherence
Timepoint [1] 0 0
7 days
Primary outcome [2] 0 0
Data capture efficiency
Timepoint [2] 0 0
14 days
Secondary outcome [1] 0 0
Oxygen desaturation index (ODI)
Timepoint [1] 0 0
14 days
Secondary outcome [2] 0 0
nadir SpO2
Timepoint [2] 0 0
14 days
Secondary outcome [3] 0 0
Time spent below 90% SpO2
Timepoint [3] 0 0
14 days
Secondary outcome [4] 0 0
mean SpO2
Timepoint [4] 0 0
14 days
Secondary outcome [5] 0 0
Sleep duration
Timepoint [5] 0 0
14 days
Secondary outcome [6] 0 0
Sleep efficiency (%)
Timepoint [6] 0 0
14 days
Secondary outcome [7] 0 0
Daytime sleepiness
Timepoint [7] 0 0
14 days
Secondary outcome [8] 0 0
Perceived sleep quality measured via the Leeds Sleep Evaluation Questionnaire
Timepoint [8] 0 0
14 days
Secondary outcome [9] 0 0
Insomnia Severity Score
Timepoint [9] 0 0
14 days
Secondary outcome [10] 0 0
Apnoea-hypopnea hndex (AHI)
Timepoint [10] 0 0
14 days
Secondary outcome [11] 0 0
Study enrolment rate
Timepoint [11] 0 0
12 months

Eligibility
Key inclusion criteria
* Age >18 years
* Undergoing elective upper airway surgery
* History of obstructive sleep apnoea (OSA)
Minimum age
18 Years
Maximum age
No limit
Sex
Both males and females
Can healthy volunteers participate?
No
Key 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

Study design
Purpose of the study
Other
Allocation to intervention
Randomised controlled trial
Procedure for enrolling a subject and allocating the treatment (allocation concealment procedures)
Methods used to generate the sequence in which subjects will be randomised (sequence generation)
Masking / blinding
Blinded (masking used)
Who is / are masked / blinded?
The people receiving the treatment/s
The people administering the treatment/s
The people assessing the outcomes
The people analysing the results/data
Intervention assignment
Crossover
Other design features
Phase
Phase 2
Type of endpoint/s
Statistical methods / analysis

Recruitment
Recruitment status
Recruiting
Data analysis
Reason for early stopping/withdrawal
Other reasons
Date of first participant enrolment
Anticipated
Actual
10/08/2023
Date of last participant enrolment
Anticipated
Actual
Date of last data collection
Anticipated
1/07/2025
Actual
Sample size
Target
20
Accrual to date
Final
Recruitment in Australia
Recruitment state(s)
SA
Recruitment hospital [1] 0 0
Flinders, Private and Public Hospitals and Flinders University - Bedford Park
Recruitment postcode(s) [1] 0 0
5042 - Bedford Park

Funding & Sponsors
Primary sponsor type
Other
Name
Flinders University
Address
Country
Other collaborator category [1] 0 0
Government body
Name [1] 0 0
Flinders Medical Centre
Address [1] 0 0
Country [1] 0 0

Ethics approval
Ethics application status

Summary
Brief summary
Trial website
Trial related presentations / publications
Public notes

Contacts
Principal investigator
Name 0 0
Danny J. Eckert, PhD
Address 0 0
Flinders University
Country 0 0
Phone 0 0
Fax 0 0
Email 0 0
Contact person for public queries
Name 0 0
Emma Thomas
Address 0 0
Country 0 0
Phone 0 0
+61882012912
Fax 0 0
Email 0 0
ethomas@flinders.edu.au
Contact person for scientific queries

Data sharing statement
Will individual participant data (IPD) for this trial be available (including data dictionaries)?
Yes
What data in particular will be shared?
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

Supporting document/s available: Study protocol, Informed consent form (ICF)
When will data be available (start and end dates)?
At conclusion of the study and any related publications
Available to whom?
IPD may be shared for research purposes on application to the chief investigator and subject to applicable ethical review.
Available for what types of analyses?
How or where can data be obtained?


What supporting documents are/will be available?

No Supporting Document Provided



Results publications and other study-related documents

No documents have been uploaded by study researchers.


Results not provided in https://clinicaltrials.gov/study/NCT05978505