Clinical Trial of the Cryosa System for the Treatment of Obstructive Sleep Apnea (ARCTIC_AUS)

NCT07021833 | Not Yet Recruiting DMC FDA Device

• 1 other identifier: 12458
• Study Type: interventional
• Target: 30
• Locations: 0 countries
• Sites: N/A

Brief Summary

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.

Conditions

Obstructive Sleep Apnea (OSA)

Outcome Measures

Primary Outcomes (1)

• Incidence of Serious Procedure or Device/Treatment Related Events

  Safety will be assessed by evaluating all serious procedure- or device/treatment-related events occurring in the first 90 days post-procedure

  90 days post procedure

Study Arms (1)

Cryosa Procedure

EXPERIMENTAL

Device: Cryosa Procedure

Interventions

Cryosa Procedure DEVICE

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).

Cryosa Procedure

Eligibility Criteria

• Age: 22 Years - 70 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• Willing and capable of providing informed consent
• Willing and capable of receiving the study procedure and returning for all follow-up evaluations and sleep studies
• Willing and capable of completing all questionnaires
• Age is 22 to 70 years old
• Not able to use, refuse to use, or intolerant of Positive Airway Pressure (PAP) or Mandibular Advancement Devices (MAD)
• BMI of ≤ 40 kg/m2 at enrollment
• AHI \>=30 at enrollment based on in-lab polysomnography study OR AHI ≥ 15 and BMI of \>= 30 at enrollment based on in-lab polysomnography study

You may not qualify if:

• Subject currently participating in other premarket investigational studies unless approved by Sponsor in writing
• Any reason the investigator deems the subject unfit for participation in the study
• Actively taking ACEs/ARBs for hypertension AND is either of black race, of female gender or \>65 years of age
• Actively undergoing immunotherapy (Allergy shots), or unwilling to washout of allergy shots at least 2 weeks prior to study procedure
• Patients taking any of the following medication that could affect study endpoints: benzodiazepines, Z-drugs (zolpidem and eszopiclone) opiates, antipsychotics (neuroleptics), phenothiazines, and prescription stimulants (including Sunosi, Provigil, and Nuvigil)
• Currently on stable GLP-1 medication dosing and unwilling to commit to maintaining that dose until completion of the 6-month assessment post-procedure.
• Currently titrating GLP-1 medication and unwilling to discontinue use 1 month prior to procedure date and commit to not to re-start until completion of the 6-month assessment post-procedure
• Prior sleep surgeries, including tongue base reduction or palatoplasty (with exception of tonsillectomy and/or adenoidectomy)
• Previous surgery (non-OSA) within 12 weeks of scheduled procedure performed on the soft tissue of the upper airway (e.g., uvula, soft palate, or tonsils)
• Patients with severe, uncontrolled asthma
• History of angioedema/swelling of the airway
• Hereditary angioedema and other autoimmune disorders that could lead to acquired angioedema confirmed with a compliment component C4 blood test \<13mg/dL
• History or presence of cold urticaria at the time of screening
• History of cryoglobulinemia
• History of allergy to glycerin

Sponsors & Collaborators

• Cryosa, Inc.: lead

MeSH Terms

Conditions

Sleep Apnea, Obstructive

Condition Hierarchy (Ancestors)

Sleep Apnea Syndromes; Apnea; Respiration Disorders; Respiratory Tract Diseases; Sleep Disorders, Intrinsic; Dyssomnias; Sleep Wake Disorders; Nervous System Diseases

Central Study Contacts

Cassie Morris, Ph.D.

CONTACT

612-489-5909; clinical@cryosa.com

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: NA
• Masking: NONE
• Purpose: TREATMENT
• Intervention Model: SINGLE GROUP
• Sponsor Type: INDUSTRY
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: June 6, 2025
• First Posted: June 15, 2025
• Study Start: August 1, 2025
• Primary Completion: May 1, 2026
• Study Completion (Estimated): February 1, 2027
• Last Updated: June 15, 2025

Record last verified: 2025-06

Data Sharing

• IPD Sharing: Will not share