A Phase 2 interventional study of Reboxetine 4 MG Oral Tablet and Placebo in Sleep Apnea, Obstructive, sponsored by Flinders University. Recruiting at 1 site in Australia. Open to participants aged 18 Years and older. Per ClinicalTrials.gov, last updated 2024-10-03.
Sponsored by Flinders University · Phase 2, Interventional, and Other
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.
2,240 studies on the registry are indexed under Sleep Apnea, Obstructive; 475 are open to participants now.
This study's planned enrollment of 20 is below the median of 52 across 1,472 interventional studies indexed under Sleep Apnea, Obstructive.
Browse Sleep Apnea, Obstructive studies →Flinders University is the lead sponsor of 13 studies on the registry; 3 are open to participants now.
Counted across the registry records on this site, refreshed daily.
Go through the criteria one by one — yes, no or not sure — and take the list to your doctor or the study team. Kept in this browser only.
Exclusion Criteria:
Underlined terms in the criteria open these too. Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
Judged by the study doctor to matter for your health or for the study. It is a doctor’s decision, so ask the study team if you are unsure whether something counts.
The American Psychiatric Association’s manual of mental health diagnoses. DSM-5 (2013, revised as DSM-5-TR in 2022) replaced DSM-IV, and some studies still name the older edition. “Meets DSM criteria for …” means diagnosed by that edition’s diagnostic criteria, usually by a clinician in an interview.
Clinically significant
Judged by the study doctor to matter for your health or for the study. It is a doctor’s decision, so ask the study team if you are unsure whether something counts.
Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
DSM diagnostic criteria
The American Psychiatric Association’s manual of mental health diagnoses. DSM-5 (2013, revised as DSM-5-TR in 2022) replaced DSM-IV, and some studies still name the older edition. “Meets DSM criteria for …” means diagnosed by that edition’s diagnostic criteria, usually by a clinician in an interview.
Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
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
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 (4mg) to commence after surgery.
Also known as: Edronax
7 nightly doses to commence after surgery.
Also known as: Sugar pill
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.
Time frame: 7 days
Data capture efficiency
The percentage of successful data collection nights versus missed nights of at-home oximetry for this feasibility study.
Time frame: 14 days
Oxygen desaturation index (ODI)
Number of times per hour that a participant has a drop in blood oxygen levels during sleep
Time frame: 14 days
nadir SpO2
The lowest oxygen saturation value the patient drops to in a night.
Time frame: 14 days
Time spent below 90% SpO2
The total amount of time per night for which oxygen saturation falls below 90%.
Time frame: 14 days
mean SpO2
Average nightly oxygen level
Time frame: 14 days
Sleep duration
Total amount of time spent asleep per night, sleep tracking performed using an under mattress sensor device.
Time frame: 14 days
Sleep efficiency (%)
The estimated percentage of time in bed spent asleep performed using an under mattress sensor device.
Time frame: 14 days
Daytime sleepiness
Measured via Karolinska Sleepiness Scale Questionnaire (9 point scale where 1 = extremely alert and 9 = extremely sleepy - fighting sleep)
Time frame: 14 days
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.
Time frame: 14 days
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.
Time frame: 14 days
Apnoea-hypopnea hndex (AHI)
Change in OSA severity (AHI estimated via the Withings under mattress sensor number of events/hour) between placebo and reboxetine
Time frame: 14 days
Study enrolment rate
The number of referred patients successfully enrolled into this feasibility study
Time frame: 12 months
Reboxetine-related side effects
Documented via adverse-event forms.
Time frame: 14 days
Plan to share: Yes — 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 information: Study protocol, Informed consent form
Time frame: At conclusion of the study and any related publications
Access criteria: IPD may be shared for research purposes on application to the chief investigator and subject to applicable ethical review.
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Studies of the drug tested here: Reboxetine
Flinders University