Alesis OSA-1 for Obstructive Sleep Apnea

(OSA Trial)

Recruiting at 3 trial locations

Overseen By Terry J Ward, MHA

Age: 18+

Sex: Any

Trial Phase: Academic

Sponsor: Photonica USA, LLC

Must not be taking: Diabetes medications, Antibiotics, Antidepressants

Disqualifiers: Facial hair, Central sleep apnea, others

Compensation: Varies

Number of Visits: 9

Duration: 3 weeks

70 Participants Needed

Trial Summary

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 data supports the effectiveness of the treatment Alesis OSA-1 for obstructive sleep apnea?

The research on upper airway stimulation (UAS), a similar treatment, shows positive patient outcomes like reduced sleepiness and improved sleep quality, suggesting potential effectiveness for Alesis OSA-1. ^{1 2 3 4 5}

What is the purpose of this trial?

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.

Research Team

Tahir Salmani, MD

Principal Investigator

Tri County Primary Care

Eligibility Criteria

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

STOP BANG score of 3 or greater

BMI >/= 25

I might have sleep apnea.

Exclusion Criteria

Beard or facial hair

Contraindications to MRI (e.g., non-MRI-compatible pacemakers)

Photosensitivity

Timeline

Screening

Participants are screened for eligibility to participate in the trial

2-4 weeks

1 visit (in-person)

Treatment

Participants receive six, 12-minute non-invasive low laser light therapy treatments, two times per week for 3 weeks

3 weeks

6 visits (in-person)

Follow-up

Participants are monitored for safety and effectiveness after treatment, including post-treatment AHI test and qualitative questionnaire

4 weeks

2 visits (in-person)

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

Long-term

Treatment Details

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.

Participant Groups

Group I: MRI Assessment Active Control 1 Intervention

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.

Group II: PFT Assessment Active Control 1 Intervention

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.

Group III: Alesis OSA-1 Effectivness Active Control 1 Intervention

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.

Group IV: OSA-1 Control group Placebo Group 1 Intervention

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.

Who Is Running the Clinical Trial?

Photonica USA, LLC

Lead Sponsor

Findings from Research

The surgical procedure of tongue base reduction with hyoepiglottoplasty (TBRHE) showed an 80% success rate in treating severe obstructive sleep apnea syndrome (OSAS) in 10 male patients, significantly reducing their respiratory disturbance index (RDI) and improving symptoms like snoring and daytime sleepiness.

TBRHE was found to be a safe procedure with no neurovascular complications reported, making it a viable option for patients with tongue base obstruction who have not responded to other treatments.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Tongue base reduction with hyoepiglottoplasty: a treatment for severe obstructive sleep apnea. Chabolle, F., Wagner, I., Blumen, MB., et al.[2022]

References

1. Germany pubmed.ncbi.nlm.nih.gov

Patient-reported outcome: results of the multicenter German post-market study. [2020]

2. Norway pubmed.ncbi.nlm.nih.gov

Long-term surgical follow-up of sleep apnea syndrome. [2022]

3. England pubmed.ncbi.nlm.nih.gov

Short-term results of upper airway stimulation in obstructive sleep apnoea patients: the Amsterdam experience. [2020]

4. United States pubmed.ncbi.nlm.nih.gov

Tongue base reduction with hyoepiglottoplasty: a treatment for severe obstructive sleep apnea. [2022]

5. Germany pubmed.ncbi.nlm.nih.gov

Treatment of obstructive sleep apnea with oral appliances. [2021]