Cryosa Procedure for Obstructive Sleep Apnea

(ARCTIC-3 Trial)

Recruiting at 4 trial locations

Overseen By Cassie Morris

Age: 18+

Sex: Any

Trial Phase: Academic

Sponsor: Cryosa, Inc.

Must not be taking: Benzodiazepines, Opiates, Antipsychotics, others

Disqualifiers: Neuromuscular disease, COPD, Diabetes, others

No Placebo Group All trial participants will receive the active study treatment (no placebo)

Compensation: Varies

Number of Visits: 8

Duration: 1 day

25 Participants Needed

What You Need to Know Before You Apply

What is the purpose of this trial?

This trial tests a new treatment called the Cryosa procedure for individuals with obstructive sleep apnea (OSA), a condition where breathing stops and starts during sleep. The main goal is to determine if this treatment is safe and effective for those with moderate to severe OSA who cannot use or tolerate other treatments like CPAP machines. Ideal participants have a body mass index (BMI) of 30 or higher and have struggled with or refused other OSA treatments. As an unphased trial, this study provides a unique opportunity for participants to explore an innovative treatment option that could enhance their quality of life.

Will I have to stop taking my current medications?

The trial requires that you stop taking certain medications that could affect study results, such as benzodiazepines, Z-drugs, opiates, antipsychotics, phenothiazines, and prescription stimulants.

What prior data suggests that the Cryosa procedure is safe for treating obstructive sleep apnea?

Research is investigating a treatment called the Cryosa procedure for obstructive sleep apnea (OSA). This treatment targets the tongue and soft palate, key areas in OSA. The goal is to determine if the procedure is safe for individuals with moderate to severe OSA.

Studies have collected information on the safety of the Cryosa procedure, assessing how well patients tolerate the treatment. This information is crucial to ensure the treatment's safety for future use.

However, detailed results from these studies are not yet available. As this trial is in an early stage, the primary focus is on collecting safety data and monitoring for any side effects. While researchers closely monitor safety, the treatment is still being tested to ensure patient tolerance. ^{1 2 3 4 5}

Why are researchers excited about this trial?

The Cryosa Procedure is unique because it uses a novel approach to treat obstructive sleep apnea (OSA) by targeting the tongue and soft palate with cryotherapy. Unlike traditional treatments like CPAP machines or surgical interventions, which can be cumbersome or invasive, the Cryosa Procedure aims to be less invasive while potentially offering effective results. Researchers are excited about this treatment because it could provide a new, more comfortable option for patients who struggle with current standard treatments, improving adherence and overall quality of life.

What evidence suggests that the Cryosa Procedure is effective for obstructive sleep apnea?

Research has shown that the Cryosa procedure might help people with obstructive sleep apnea (OSA), a condition where breathing stops and starts during sleep. This trial evaluates the Cryosa system's safety and effectiveness by targeting the tongue and soft palate, which often block the airway. Early results suggest that this treatment could ease breathing during sleep. Although detailed information from human studies remains limited, the procedure appears promising for addressing the main causes of OSA. More research is needed to confirm its effectiveness and long-term safety. ^{1 2 3 4 6}

Are You a Good Fit for This Trial?

Adults aged 22-70 with moderate to severe obstructive sleep apnea who can't or won't use PAP or MAD devices, have a BMI of ≤ 40 kg/m2, and are non-smokers. They must be able to consent and live near the study site. Exclusions include general anesthesia risks, recent upper airway surgery, resistant hypertension, certain heart conditions, neuromuscular diseases, active severe lung disease including COVID-19 complications.

Inclusion Criteria

I likely have or am diagnosed with severe sleep apnea.

I cannot or will not use devices like CPAP or mouthpieces for sleep apnea.

I am between 22 and 70 years old.

Exclusion Criteria

I do not have severe lung blood vessel problems like high blood pressure in lungs or clots.

I have severe kidney failure and am on or will need dialysis soon.

My diabetes is not under control, with an HbA1c level over 9.

Timeline for a Trial Participant

Screening

Participants are screened for eligibility to participate in the trial

2-4 weeks

Treatment

Participants undergo the Cryosa procedure applied to the tongue and soft palate

1 day

1 visit (in-person)

Initial Follow-up

Participants are monitored for safety and effectiveness, with assessments at 7, 30, and 90 days post-procedure

3 months

3 visits (in-person)

Extended Follow-up

Long-term monitoring of safety and effectiveness with assessments at 6, 12, 18, and 24 months post-procedure

21 months

4 visits (in-person)

What Are the Treatments Tested in This Trial?

Interventions

• Cryosa Procedure

Trial Overview The Cryosa procedure is being tested for safety and effectiveness in treating obstructive sleep apnea (OSA). This single-arm study involves participants with moderate to severe OSA who will undergo the procedure and then be monitored to assess its performance over time.

How Is the Trial Designed?

Group I: Cryosa Procedure Experimental Treatment 1 Intervention

The purpose of this study is to evaluate the safety and effectiveness of Cryosa System applied to the tongue and soft palate in patients with clinically diagnosed obstructive sleep apnea (OSA).

Who Is Running the Clinical Trial?

Cryosa, Inc.

Lead Sponsor

Trials

3

Recruited

150+

Published Research Related to This Trial

In a study of 452 adult obstructive sleep apnea patients undergoing head and neck airway surgery, 89% of the surgeries were performed on an outpatient basis, which is contrary to existing guidelines.

The study found a zero catastrophic complication rate among ambulatory patients, indicating that such surgeries can be performed safely, although pain-related emergency room visits were common.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Safety of outpatient surgery for obstructive sleep apnea. Baugh, R., Burke, B., Fink, B., et al.[2013]

Drug-induced sleep endoscopy (DISE) is a safe and effective method for evaluating obstructive sleep apnea (OSA) by identifying specific sites and patterns of airway obstruction, making it a valuable tool for treatment planning.

The study of 99 OSA patients found that common preoperative airway assessments, such as the Mallampati score and overall airway assessment, did not reliably predict patterns of airway collapse observed during DISE, reinforcing the importance of DISE as the gold standard for evaluation.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

The anesthesia airway evaluation: Correlation with sleep endoscopy findings. Eggerstedt, M., Urban, MJ., Chi, E., et al.[2020]

Citations

1. clinicaltrials.gov clinicaltrials.gov/study/NCT07021833

Study Details | NCT07021833 | Clinical Trial of the Cryosa ... This is a prospective, multicenter, non-randomized single-arm safety and performance study to collect data to evaluate the safety of the Cryosa procedure.

2. centerwatch.com centerwatch.com/clinical-trials/listings/NCT06008626/clinical-trial-of-the-cryosa-system-for-the-treatment-of-obstructive-sleep-apnea

Clinical Trial of the Cryosa System for the Treatment ... This is a prospective, multicenter, non-randomized single-arm safety and performance study to collect data to evaluate the safety of the Cryosa procedure.

3. trial.medpath.com trial.medpath.com/clinical-trial/54eb884311c7c2b7/nct06008626-multicenter-pilot-study-cryosa-system-treatment-obstructive-sleep-apnea

Clinical Trial of the Cryosa System for the Treatment of ... This is a prospective, multicenter, non-randomized single-arm safety and performance study to collect data to evaluate the safety of the Cryosa procedure to ...

4. pmc.ncbi.nlm.nih.gov pmc.ncbi.nlm.nih.gov/articles/PMC12486363/

Obstructive Sleep Apnoea Treatments—Where Are We Now? When used as prescribed, PAP therapy reduces OSA severity, daytime sleepiness, and systolic blood pressure [3]. A recent meta‐analysis combining ...

5. withpower.com withpower.com/trial/phase-apnea-8-2023-fb849

Cryosa Procedure for Obstructive Sleep Apnea This is a prospective, multicenter, non-randomized single-arm safety and performance study to collect data to evaluate the safety of the Cryosa procedure to ...

6. sleepdocs.substack.com sleepdocs.substack.com/p/cryosa-a-novel-therapeutic-option

Cryosa: A Novel Therapeutic Option - Night Shift Imaging Predictors of Cryolysis Efficacy for Treatment of Obstructive Sleep Apnea (ICE-OSA): This study opened 6/2024, shortly after Arctic-3 ...