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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
[email protected]
Contact person for scientific queries

Data sharing statement


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