Alesis OSA-1 for Obstructive Sleep Apnea
(OSA Trial)
What You Need to Know Before You Apply
What is the purpose of this 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.
Will I have to stop taking my current medications?
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.
What prior data suggests that the Alesis OSA-1 device is safe for treating obstructive sleep apnea?
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.
Overall, this suggests the treatment should be safe, with few reported negative effects. However, consulting a healthcare professional is advisable for any concerns before joining the trial.12345Why are researchers excited about this trial?
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.
What evidence suggests that the Alesis OSA-1 device is effective for treating obstructive sleep apnea?
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
Who Is on the Research Team?
Joaquin Hechavarria, MD
Principal Investigator
JD Medical Group, LLC
Are You a Good Fit for This Trial?
Adults over 18 with obstructive sleep apnea (OSA) can join this trial. They must be diagnosed with OSA and able to follow the study's treatment schedule. People are excluded if they have conditions that might interfere with the trial or make it unsafe for them.Inclusion Criteria
Exclusion Criteria
Timeline for a Trial Participant
Screening
Participants are screened for eligibility to participate in the trial
Treatment
Participants receive six, 12-minute non-invasive low laser light therapy treatments, two times per week for 3 weeks
Follow-up
Participants are monitored for safety and effectiveness after treatment, including post-treatment AHI test and qualitative questionnaire
Open-label extension (optional)
Control group participants are offered the treatment series at the conclusion of the study if results demonstrate a reduction in AHI events
What Are the Treatments Tested in This Trial?
Interventions
- Alesis OSA-1
Trial Overview
The Alesis OSA-1 low laser light therapy device is being tested to see if it reduces apnea-hypopnea index (AHI) scores in OSA patients after six treatments. The study compares a group receiving LLLT against a control group not receiving active treatment.
How Is the Trial Designed?
4
Treatment groups
Active Control
Placebo Group
5 participants from the treatment group will be randomly selected to receive to pre and post magnetic resonance imaging (MRI) on the head/neck to determine change in size or volume of soft tissue and fat within the airway/neck structures.
Ten participants, 5 from the treatment group and 5 from control, will receive pre and post study pulmonary function testing (PFT) to evaluate changes in pulmonary volumes related the treatments.
The treatment group of the study will receive LLLT from the previously FDA 501(k) class I approved Ultraslim device, now rebranded under the name Alesis OSA-1. N=35 participants will receive non-invasive LLLT at 635nm wavelength for 12 minutes, 2x per week, x 3 weeks. The Alesis OSA-2 device will be used for this arm of the study.
A modified device utilizing a pigtail connector to bypass active treatment while allowing the cooling fans to operate for the treatment period, giving the appearance of treatment with invisible light.
Find a Clinic Near You
Who Is Running the Clinical Trial?
Photonica USA, LLC
Lead Sponsor
Published Research Related to This Trial
Citations
Alesis OSA-1 Obstructive Sleep Apnea Treatment
Does the use of the Alesis OSA-1 device reduce the number of AHI events after six treatments of 12 minutes each, 2x per week x 3 weeks, in adult OSA patients?
2.
trialx.com
trialx.com/clinical-trials/listings/306378/alesis-osa-1-obstructive-sleep-apnea-treatment/Alesis OSA-1 Obstructive Sleep Apnea Treatment
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SUMMARY OF SAFETY AND EFFECTIVENESS DATA (SSED)
Reduction in severity of obstructive sleep apnea. • Preserved sleep quality. • Improved subjective quality of life. • Potential improvement in ...
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