Atomoxetine + DAW2022 for Obstructive Sleep Apnea

This trial explores a new treatment combination for individuals with moderate-to-severe obstructive sleep apnea (OSA), a condition where breathing repeatedly stops and starts during sleep. Researchers are testing a mix of two drugs, atomoxetine (also known as Strattera) and DAW2020, to determine if they can reduce OSA symptoms without lowering the arousal threshold, which is crucial for maintaining healthy sleep. Participants will receive either the active drug combination or a placebo (inactive substance) to compare the effects. The trial seeks individuals diagnosed with moderate-to-severe OSA who experience frequent breathing disruptions during sleep. As a Phase 1 trial, the research focuses on understanding how the treatment works in people, offering participants the opportunity to be among the first to receive this new treatment combination.

You may need to stop taking certain medications, especially if they stimulate or depress breathing, or if they are SNRIs/SSRIs. The trial does not specify a washout period, but these medications are excluded.

Research has shown that combining atomoxetine with a sleep aid may help reduce the severity of obstructive sleep apnea (OSA). In previous studies, patients experienced fewer breathing interruptions during sleep, suggesting this combination could be effective without causing serious side effects.

For example, one study found that using atomoxetine with another medication reduced the number of times patients stopped breathing during sleep. Although atomoxetine is usually used for attention-deficit disorders, it appears well-tolerated for this new purpose. However, since this combination is still being tested for OSA, researchers are still learning about its complete safety.

DAW2020, the sleep aid being tested with atomoxetine, has also shown promise. Earlier trials demonstrated that it helped people sleep longer without major side effects. The combination of atomoxetine and DAW2020 is still under study, but early results suggest it is safe, with no significant side effects reported so far.

Unlike the standard of care for obstructive sleep apnea, which often includes CPAP machines or oral appliances, the combination of Atomoxetine and DAW2020 offers a pharmacological approach that could simplify treatment. Atomoxetine, typically used for ADHD, is repurposed here to potentially enhance airway muscle tone. DAW2020, a novel compound, is administered alongside Atomoxetine to optimize this effect. Researchers are excited because this combination could provide a non-invasive option that directly targets airway muscle function, potentially increasing patient compliance and offering quicker symptom relief.

This trial will evaluate the combination of Atomoxetine and DAW2020 for obstructive sleep apnea (OSA). Research has shown that atomoxetine, when used with oxybutynin, can significantly reduce OSA severity, with one study showing about a 60% reduction. Atomoxetine affects certain brain chemicals, decreasing the number of breathing interruptions during sleep. In this trial, participants will receive Atomoxetine alongside DAW2020, a sleep aid that has increased total sleep time in people with OSA. Although DAW2020 is a newer drug, its ability to extend sleep duration could enhance results when combined with atomoxetine. These findings offer hope for reducing the impact of OSA with this combination.²⁶⁷⁸⁹