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New treatment option for Sleep Apnea, Obstructive
Official title Reboxetine for Sleep Apnoea After ENT Surgery
ClinicalTrials.gov ID: NCT05978505
What this study is testing
What is Reboxetine 4 MG Oral Tablet?
Reboxetine 4 MG Oral Tablet is an investigational medicine, being studied as a potential treatment for sleep apnea, obstructive.
Also referred to as Edronax.
Plain-language explanation of the investigational treatment - it is being studied and is not an approved or proven therapy. The study team can confirm the details.
- What it's testing
- 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.
- Phase 2: a mid-size study of how well it works
- You might receive a placebo (an inactive treatment) instead of the study drug, decided by chance. You may not know which one you got.
A plain-language read of the study's public ClinicalTrials.gov listing. The study team confirms the details.
Who can take part
Ages 18 and older
You may be able to join if
- Age \>18 years
- Undergoing elective upper airway surgery
- History of obstructive sleep apnoea (OSA)
You likely can't join if
- 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...
- History of attempted suicide or suicidal ideation within 1 year prior to screening, or current suicidal ideation
See the full eligibility criteria
- Age \>18 years
- Undergoing elective upper airway surgery
- History of obstructive sleep apnoea (OSA)
- 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
The study team makes the final eligibility decision.
Where it's taking place
- Bedford Park, South Australia, Australia
Questions & answers
Do participants get paid in this trial?
This listing doesn't specify compensation. Many trials still reimburse travel or offer a stipend, so it's worth asking the study team when you connect.
Is it free to join, and do I need insurance?
Searching and applying through BridgeMD is free. In clinical trials the study-related treatment and visits are generally provided at no cost to you. You usually don't need insurance to take part - confirm specifics with the study team.
How long does this study last?
The listing doesn't state an exact length. The study team walks you through the schedule and number of visits before you decide to enroll.
Who can join this trial?
This study is enrolling all sexes, 18 years and older. The study team makes the final eligibility decision.
Where is this trial taking place?
Study sites include Bedford Park, South Australia, Australia. Enter your location above to see the nearest site and check your eligibility.
Explore other conditions
BridgeMD is an information and trial-matching tool - not medical advice, and not the study sponsor. Details come from ClinicalTrials.gov; the study team decides eligibility.