Cryosa Procedure for Obstructive Sleep Apnea

(ARCTIC-3 Trial)

Recruiting at 4 trial locations

Overseen By Beth Duff

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

Trial Summary

What is the purpose of this trial?

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 treat obstructive sleep apnea (OSA) in patients with moderate to severe OSA. The study will also evaluate the chronic performance of the Cryosa system and collect clinical measures for therapy effectiveness that will be used to demonstrate safety and effectiveness in the next clinical study.

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 data supports the effectiveness of the Cryosa Procedure treatment for obstructive sleep apnea?

The Cryosa Procedure may be similar to cryogenic plasma tonsillectomy, which is used to treat obstructive sleep apnea in children by removing tonsils to open the airway. Surgical approaches that enlarge the airway, like tonsillectomy, have shown success in treating obstructive sleep apnea by reducing airway collapsibility. ^{1 2 3 4 5}

Is the Cryosa Procedure safe for humans?

There is a study on a cryosurgery unit named CRYO2, which is similar to the Cryosa Procedure, showing it was assessed for safety in treating airway obstructions. Additionally, a study on a method using ice-slurry for tongue fat reduction in a swine model suggested it could achieve low temperatures without causing harm, indicating potential safety in humans. ^{6 7 8 9 10}

How does the Cryosa Procedure treatment for obstructive sleep apnea differ from other treatments?

The Cryosa Procedure is unique because it likely involves a cryogenic technique, which may target specific areas of the upper airway to reduce obstruction, unlike traditional methods like CPAP (continuous positive airway pressure) or more invasive surgeries. This approach could offer a less invasive alternative with potentially fewer side effects. ^{1 11 12 13 14}

Eligibility Criteria

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

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)

Treatment Details

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.

Participant Groups

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+

Findings from Research

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]

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]

References

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

The efficacy of cryogenic plasma tonsillectomy in the treatment of obstructive sleep apnea-hypopnea syndrome in children: A meta-analysis. [2023]

2. Canada pubmed.ncbi.nlm.nih.gov

Oral appliances for obstructive sleep apnea: an evidence-based analysis. [2022]

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

Non-pressure therapies for obstructive sleep apnea: surgery and oral appliances. [2010]

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

Management of obstructive sleep apnea. [2005]

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

Surgical approaches to obstructive sleep apnea. [2019]

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

The anesthesia airway evaluation: Correlation with sleep endoscopy findings. [2020]

7. Greece pubmed.ncbi.nlm.nih.gov

An Open-label, Single-arm Study of CRYO2 for Debulking at the Site of Central Airway Obstruction or Stenosis. [2020]

8. England pubmed.ncbi.nlm.nih.gov

Multicenter study of a novel adjustable tongue-advancement device for obstructive sleep apnea. [2022]

9. England pubmed.ncbi.nlm.nih.gov

Safety of outpatient surgery for obstructive sleep apnea. [2013]

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

Safety and feasibility of selective tongue fat reduction with injected ice-slurry. [2022]

11. Iran pubmed.ncbi.nlm.nih.gov

Drug Induced Sleep Endoscopy in Obstructive Sleep Apnea. [2022]

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

Genioglossal Advancement, Hyoid Suspension, Tongue Base Radiofrequency, and Endoscopic Partial Midline Glossectomy for Obstructive Sleep Apnea. [2017]

13. Spain pubmed.ncbi.nlm.nih.gov

[Diagnosis and treatment of the phobia due to treatment with air using nasal continuous pressure]. [2022]

14. Poland pubmed.ncbi.nlm.nih.gov

[Treatment of patients with breathing disturbances during sleep in the II ENT Department Silesian Medical University Zabrze]. [2015]