Obstructive Sleep Apnea study: Atomoxetine-plus-oxybutynin
Official title Combination Upper-Airway Electrical and Pharmacological Stimulation for Obstructive Sleep Apnea
ClinicalTrials.gov ID: NCT07577661
What this study is testing
What is Atomoxetine-plus-oxybutynin (80/5 mg) (AtoOxy)?
This is an investigational combination of two oral medicines being studied as a potential treatment for obstructive sleep apnea. It is designed to activate muscles in the throat to help keep the airway open during sleep.
Also referred to as AtoOxy.
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 study aims to find out if combining a new medication with an implanted nerve stimulator reduces breathing pauses during sleep more than using either treatment alone.
- Who it's for
- The study is looking for adults who have obstructive sleep apnea and already have a hypoglossal nerve stimulation device implanted.
- What's involved
- Participants will take part in a cross-over trial where they receive the implanted device stimulation, the new medication, both together, or a placebo in a random order to compare their effects.
- Time commitment
- The study involves multiple visits to test how well each treatment combination works on breathing during sleep.
- 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.
A plain-language read of the study's public ClinicalTrials.gov listing. The study team confirms the details.
Who can take part
Ages 18 to 79
You may be able to join if
- Ages 18 - 79 years
- Diagnosed OSA
- Implantation of a hypoglossal nerve stimulation device (HGNS, Inspire Medical) or scheduled for implantation (implantation required for randomization)
- Willingness to withhold HGNS while testing therapies (up to 6 weeks with HGNS off [with/without pharmacotherapy] to assess benefits of HGNS therapy).
You likely can't join if
- Any uncontrolled medical condition
- Current use of the medications under investigation.
- Issues relating to short-term withdrawal of HGNS therapy
- Excluded: Occupational driving (truck drivers, fork-lift operation, taxi/uber drivers)
- Excluded: History of traffic accidents attributable to sleepiness or fatigue (\<2 years).
- Use of SNRIs/SSRIs or anticholinergic medications during the study.
See the full eligibility criteria
- Ages 18 - 79 years
- Diagnosed OSA
- Implantation of a hypoglossal nerve stimulation device (HGNS, Inspire Medical) or scheduled for implantation (implantation required for randomization)
- Willingness to withhold HGNS while testing therapies (up to 6 weeks with HGNS off [with/without pharmacotherapy] to assess benefits of HGNS therapy).
- Any uncontrolled medical condition
- Current use of the medications under investigation.
- Issues relating to short-term withdrawal of HGNS therapy
- Excluded: Occupational driving (truck drivers, fork-lift operation, taxi/uber drivers)
- Excluded: History of traffic accidents attributable to sleepiness or fatigue (\<2 years).
- Use of SNRIs/SSRIs or anticholinergic medications during the study.
- Conditions likely to affect obstructive sleep apnea physiology: neuromuscular disease or other major neurological disorder, heart failure (also below), or any other unstable major medical condition.
- Respiratory disorders other than sleep disordered breathing: chronic hypoventilation/hypoxemia (awake SaO2 \< 92% by oximetry) due to chronic obstructive pulmonary disease or other respiratory conditions.
- Other sleep disorders: narcolepsy, parasomnias. Insomnia
- hypersensitivity to atomoxetine or oxybutynin (angioedema or urticaria)
- pheochromocytoma
- use of monoamine oxidase inhibitors
- diagnosed benign prostatic hypertrophy, urinary retention
- "During the last month, when urinating, have you had the sensation of not emptying your bladder completely more often than 1 out of 5 times?"
- "During the last month, have you had a weak urinary stream more often than 1 out of 5 times?
- known untreated narrow angle glaucoma
- known bipolar disorder, mania, psychosis
- known history of major depressive disorder (age\<24).
- known history of attempted suicide or suicidal ideation within one year prior to screening
- known clinically significant constipation, gastric retention
- known pre-existing seizure disorders
- known clinically-significant kidney disorders (eGFR\<60 ml/min/1.73m2)
- known clinically-significant liver disorders
- known clinically-significant cardiovascular conditions
- moderate-to-severe hypertension (SBP\>160 mmHg or DBP\>100 mmHg measured at baseline; average of evening and morning measures)
- known cardiomyopathy (LVEF\<50%) or heart failure
- known advanced atherosclerosis
- recent cerebrovascular events (within 2 years)
- recent history of cardiac arrhythmias e.g., atrial fibrillation, QT prolongation (within 2 years)
- other serious cardiac conditions that would raise the consequences of an increase in blood pressure or heart rate
- myasthenia gravis
- pregnancy/breast-feeding
The study team makes the final eligibility decision.
Where it is enrolling
- Boston, Massachusetts, United States
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, but 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 to 79 years. The study team makes the final eligibility decision.
Where is this trial taking place?
This study is enrolling now at Boston, Massachusetts, United States. Enter your location above to see the nearest enrolling site and check your eligibility.
Explore other conditions
BridgeMD is an information and trial-matching tool that is independent of the study sponsor. Details come from ClinicalTrials.gov. The study team decides eligibility, and your own doctor gives medical advice.