Alesis OSA-1 for Obstructive Sleep Apnea

(OSA Trial)

This trial tests a new device called Alesis OSA-1 to determine its effectiveness in reducing sleep apnea events. The device uses low laser light therapy to treat individuals diagnosed with obstructive sleep apnea (OSA). The trial aims to discover whether using this device twice a week for three weeks can decrease the number of apnea events. Participants with a diagnosis or suspicion of sleep apnea, particularly those with a higher body mass index (BMI of 25 or more), are sought. As an unphased trial, this study provides a unique opportunity to explore innovative treatment options for sleep apnea.

The trial does not specify if you must stop taking your current medications, but it excludes participants on certain medications like diabetes medications (e.g., Metformin) and some antibiotics. It's best to discuss your specific medications with the trial coordinators.

Research shows that low laser light therapy (LLLT) treatments, such as those used with the Alesis OSA-1 device, are generally well-tolerated. The Alesis OSA-1 resembles the Ultraslim device, which the FDA has approved for other uses, suggesting it is likely safe.

In similar treatments, like upper airway stimulation, patients have experienced positive results with few side effects, such as reduced sleepiness and improved sleep quality. Although detailed safety data for the Alesis OSA-1 in treating obstructive sleep apnea is not yet available, its non-invasive nature and basis on an already approved technology indicate a favorable safety profile.

The Alesis OSA-1 is unique because it uses low-level laser therapy (LLLT) at a 635nm wavelength, a non-invasive approach not typically seen in standard obstructive sleep apnea treatments like CPAP machines or dental appliances. Researchers are excited about this treatment because it offers a potential alternative that doesn't rely on mechanical pressure or structural adjustment, which are common in current treatments. By potentially reducing soft tissue and fat in the airway with invisible light, Alesis OSA-1 could provide a more comfortable and less intrusive option for patients.

Research has shown that treatments like upper airway stimulation help people with obstructive sleep apnea (OSA) feel less sleepy and improve sleep quality. In this trial, participants may receive the Alesis OSA-1 device, which uses low laser light therapy to shrink the soft tissues that can block airways during sleep. Early results suggest this method might reduce apnea-hypopnea index (AHI) scores, indicating less severe sleep apnea. This could mean fewer breathing interruptions at night, leading to more restful sleep. Although more research is needed, the Alesis OSA-1 shows promise.¹²³⁵⁶