Electrical + Pharmacological Stimulation for Sleep Apnea
What You Need to Know Before You Apply
What is the purpose of this trial?
This trial aims to determine if combining a medication called AtoOxy (a mix of atomoxetine and oxybutynin) with a device that stimulates a tongue muscle, known as unilateral hypoglossal nerve stimulation (HGNS), can improve breathing during sleep for people with obstructive sleep apnea (OSA). Participants will test various combinations of the device and medication to identify the most effective treatment. Those with OSA who already have or are acquiring the device and can manage without it for short periods might be suitable candidates. The goal is to reduce sleep disruptions and enhance breathing. As a Phase 1/Phase 2 trial, this research focuses on understanding the treatment's function in people and measuring its effectiveness in an initial, smaller group, offering participants a chance to contribute to early-stage development.
Will I have to stop taking my current medications?
Yes, you will need to stop taking certain medications. The trial excludes participants using SNRIs/SSRIs or anticholinergic medications during the study.
Is there any evidence suggesting that this trial's treatments are likely to be safe?
Research has shown that the combination of atomoxetine and oxybutynin (AtoOxy) is generally safe for treating obstructive sleep apnea (OSA). In one study, participants used this combination for 30 days, which reduced the severity of OSA without major safety issues. Most participants tolerated it well.
The hypoglossal nerve stimulation (HGNS) device is an approved treatment for OSA. Previous studies have demonstrated its effectiveness and safety. Patients using this device experienced significant improvements in sleep quality without major side effects.
Combining AtoOxy with HGNS aims to enhance treatment effectiveness. While researchers continue to study AtoOxy, current data suggest it is well-tolerated, especially for short-term use like in this trial.12345Why are researchers excited about this trial's treatments?
Researchers are excited about these treatments for sleep apnea because they introduce a novel combination approach. Traditional treatments like CPAP machines and oral appliances mainly focus on keeping airways open mechanically. However, HGNS (Hypoglossal Nerve Stimulation) directly stimulates the nerves that control tongue movement, helping to keep the airway open naturally, while AtoOxy (Atomoxetine combined with Oxybutynin) represents a new pharmacological strategy aimed at enhancing airway muscle tone and reducing apneic events. This dual approach could offer a more comprehensive solution by addressing the condition from both a neural and muscular standpoint, potentially improving outcomes for patients who do not respond well to current standard therapies.
What evidence suggests that this trial's treatments could be effective for sleep apnea?
Research has shown that stimulating the hypoglossal nerve (HGNS) effectively treats obstructive sleep apnea (OSA) by keeping airways open during sleep. This treatment can significantly improve sleep quality and reduce daytime tiredness for some individuals. Additionally, the combination of two medications, atomoxetine and oxybutynin (AtoOxy), has shown promise in enhancing throat muscle function, which can alleviate OSA symptoms. Some studies have found that this combination can reduce apnea events by more than 50% in certain patients. In this trial, participants will receive HGNS, AtoOxy, and the combination of HGNS with AtoOxy in different sequences. Using HGNS together with AtoOxy might offer even better results, especially for those who do not experience sufficient relief from HGNS alone. Early research suggests that this combined approach may further reduce the frequency of breathing interruptions during sleep.16789
Who Is on the Research Team?
Scott A Sands, PhD
Principal Investigator
Brigham and Women's Hospital
Are You a Good Fit for This Trial?
This trial is for adults with obstructive sleep apnea who already have a hypoglossal nerve stimulation (HGNS) device implanted. Participants should not have other major health issues that would interfere with the study.Inclusion Criteria
Exclusion Criteria
Timeline for a Trial Participant
Screening
Participants are screened for eligibility to participate in the trial
Treatment
Participants undergo a four-period randomized placebo-controlled cross-over trial assessing HGNS+AtoOxy, HGNS alone, AtoOxy alone, and placebo.
Follow-up
Participants are monitored for safety and effectiveness after treatment
What Are the Treatments Tested in This Trial?
Interventions
- Atomoxetine-plus-oxybutynin (AtoOxy)
- HGNS+AtoOxy
- Unilateral hypoglossal nerve stimulation (HGNS)
Trial Overview
The study compares four treatments: HGNS plus atomoxetine and oxybutynin (AtoOxy), HGNS alone, AtoOxy alone, and placebo. Each participant tries all options in random order to see which works best at reducing sleep apnea events.
How Is the Trial Designed?
4
Treatment groups
Experimental Treatment
Placebo -\> HGNS+AtoOxy -\> AtoOxy -\> HGNS Each participant receives all four treatment conditions ("periods") in randomized order; outcomes are analyzed as within-subject comparisons, not between sequence arms.
AtoOxy -\> HGNS -\> Placebo -\> HGNS+AtoOxy Each participant receives all four treatment conditions ("periods") in randomized order; outcomes are analyzed as within-subject comparisons, not between sequence arms.
HGNS -\> AtoOxy -\> HGNS+AtoOxy -\> Placebo Each participant receives all four treatment conditions ("periods") in randomized order; outcomes are analyzed as within-subject comparisons, not between sequence arms.
HGNS+AtoOxy -\> Placebo -\> HGNS -\> AtoOxy Each participant receives all four treatment conditions ("periods") in randomized order; outcomes are analyzed as within-subject comparisons, not between sequence arms.
Find a Clinic Near You
Who Is Running the Clinical Trial?
Brigham and Women's Hospital
Lead Sponsor
Citations
Atomoxetine plus oxybutynin for obstructive sleep apnoea
Conclusions: AtoOxy reduced AHI over 1 month; although the average response was not clinically meaningful, greater improvements were observed in ...
The Combination of Atomoxetine and Oxybutynin Greatly ...
Accordingly, pilot data collected after 1 week of therapy in six patients showed an 11% reduction in REM sleep on ato–oxy compared with placebo (P = 0.03). It ...
Atomoxetine Plus Oxybutynin for Obstructive Sleep Apnea
AtoOxy modestly reduced OSA severity per AHI over a 1-month treatment period. Greater improvements were evident in patients with a higher arousal threshold.
Efficacy of atomoxetine and oxybutynin in the treatment ...
We report in this manuscript an improvement of OSA severity with a greater reduction of 50% of AHI in two patients receiving atomoxetine and oxybutynin for 1 ...
5.
pulmonologyadvisor.com
pulmonologyadvisor.com/news/obstructive-sleep-apnea-outcomes-with-atomoxetine-plus-oxybutynin/Atomoxetine Plus Oxybutynin Improves Multiple Variables ...
Atomoxetine plus oxybutynin demonstrated efficacy in improving upper airway collapsibility, increasing breathing stability, and reducing the ...
Efficacy of atomoxetine and oxybutynin in the treatment ... - PMC
In two cases, the combination of atomoxetine and oxybutynin significantly reduced the severity of OSA and was well tolerated. Despite the ...
Effects of the Combination of Atomoxetine and Oxybutynin ...
Ato-oxy markedly improved the measures of upper airway collapsibility, increased breathing stability, and slightly reduced the arousal threshold.
Atomoxetine and Oxybutynin in Obstructive Sleep Apnea
The combination of atomoxetine and oxybutynin greatly reduces obstructive sleep apnea severity. A randomized, placebo-controlled, double-blind crossover trial.
Obstructive sleep apnea combination drug safe, reduces ...
A combination of atomoxetine and oxybutynin taken for 30 days lowered baseline obstructive sleep apnea severity, according to results published in Annals of ...
Unbiased Results
We believe in providing patients with all the options.
Your Data Stays Your Data
We only share your information with the clinical trials you're trying to access.
Verified Trials Only
All of our trials are run by licensed doctors, researchers, and healthcare companies.