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Alesis OSA-1 Obstructive Sleep Apnea Treatment
NCT06949969 · View on ClinicalTrials.gov ↗
Study Summary
The goal of randomized clinical trial is to determine if the Alesis OSA-1 low laser light therapy device can reduce apnea-hypopnea index scores and treat sleep apnea in adult participants over the age of 18 who are diagnosed with obstructive sleep apnea (OSA). The main questions it aims to answer are\]: • 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? Researchers will compare results of 35 control group participants who will not receive treatment to a treatment group who will receive six, 12 minute, non-invasive low laser light therapy (LLLT) treatments, two per week for 3 weeks, to see if there is a reduction in the number of AHI events and size of redundant and soft tissues in adult OSA patients. Participants will: * Visit the clinic for assessment and instructions on using the at home sleep study system, WatchPat, and obtain baseline information * Use the WatchPat system to record AHI events pre- and post-treatment. * 10 randomly selected participants will receive a pre-study pulmonary functions test (PFT) and repeated post-treatment. * 5 randomly selected participant will receive a pre-study MRI of the head/neck and repeated post treatment. * For the treatments, the participant lie on a treatment table under a LLLT device for 12 minutes, two times per week, x 3 weeks. * Be offered the treatment series at the conclusion of the study if they were selected for the control group.
Conditions Studied
Interventions
- DEVICE Sham Comparator
- DEVICE OSA LLLT treatment device
Study Locations (2)
Florida
- JD Medical Group, LLC — Miami
- Bioresearch Institute, Llc. — Miramar
Trial Details
| Field | Value |
|---|---|
| Enrollment Target | 70 participants |
| Start Date | 2025-05-01 |
| Est. Completion | 2025-10-01 |
| Phase | NA |
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Full Details on ClinicalTrials.gov ↗What the Registry Record Tells You About NCT06949969
The ClinicalTrials.gov registry entry for NCT06949969 describes a study currently listed as recruiting. It is categorized as NA, which is the standard way researchers label where a study sits along the investigational pathway from early safety work through later efficacy and post-marketing evaluation. The registered enrollment target is 70 participants, a figure that helps gauge the scale of data the investigators plan to collect. The listed sponsor is Photonica USA, which has 1 total studies on file at ClinicalTrials.gov, and sponsors are the parties responsible for study design, oversight, and regulatory filings.
The record links to 1 condition, with Obstructive Sleep Apnea appearing as the primary indexed condition, and to 2 interventions — of which Sham Comparator is the first listed. Interventions can include drugs, devices, procedures, behavioral programs, or observational arms, and each is tracked as a separate registry field so that downstream queries can filter accurately. When a trial lists multiple interventions, it usually reflects a multi-arm design or a comparison protocol rather than a single treatment being tested in isolation. The brief summary published in the registry is the clearest source of protocol intent and should be read before drawing conclusions from any sidebar tags.
Geographic footprint matters for practical reasons: NCT06949969 reports 2 study locations spanning 1 distinct geographic area — top geographies include Florida. A larger site network tends to correlate with broader recruitment capacity, but it does not imply anything about study quality, and site-level enrollment status can diverge from the overall registry status shown above. Every data point on this page comes from the public ClinicalTrials.gov dataset and is reproduced here for reference only; it is not a medical recommendation, an endorsement of the sponsor, or an invitation to enroll. Verify current status, eligibility criteria, and contact details directly at ClinicalTrials.gov, and discuss any participation decision with your own healthcare provider.
Frequently Asked Questions
What is clinical trial NCT06949969 about?
NCT06949969 is a clinical study titled "Alesis OSA-1 Obstructive Sleep Apnea Treatment". The goal of randomized clinical trial is to determine if the Alesis OSA-1 low laser light therapy device can reduce apnea-hypopnea index scores and treat sleep apnea in adult participants over the age of 18 who are diagnosed with obstructive sleep apnea (OSA). The main questions it aims to answer ar...
What is the current status of trial NCT06949969?
This trial is currently recruiting. It is a NA study. The enrollment target is 70 participants. The study started on 2025-05-01. Estimated completion is 2025-10-01.
What conditions does trial NCT06949969 study?
This clinical trial studies the following conditions: Obstructive Sleep Apnea. These conditions were identified from the trial registry and reflect the primary focus areas of the research.
What interventions are being tested in trial NCT06949969?
The interventions under investigation include: Sham Comparator (DEVICE), OSA LLLT treatment device (DEVICE). Each intervention is being evaluated for safety and efficacy as part of this clinical study.
Who is sponsoring clinical trial NCT06949969?
This trial is sponsored by Photonica USA, which has 1 total clinical trials registered on ClinicalTrials.gov. The sponsor is responsible for the study's design, funding, and regulatory compliance.
Where is trial NCT06949969 being conducted?
This trial has 2 study locations across Florida. Contact the study sites directly through ClinicalTrials.gov for enrollment availability.
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