Clinical Trial of the Cryosa System for the Treatment of Obstructive Sleep Apnea (ARCTIC-3)

Multicenter Pilot Study of the Cryosa System for the Treatment of 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 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.

Study Overview

• Status: Recruiting
• Conditions: Obstructive Sleep Apnea of Adult
• Intervention / Treatment: Device: Cryosa Procedure

Detailed Description

The study will treat 25 subjects enrolled at up to 10 sites in the United States. Enrollment is competitive but each site will be limited to 15 subjects treated.

• Study Type: Interventional
• Enrollment (Estimated): 25
• Phase: Not Applicable

Contacts and Locations

• Study Contact: Name: Laura Stoltenberg; Phone Number: 612-489-5909; Email: lstoltenberg@cryosa.com
• Study Contact Backup: Name: Cassie Morris; Phone Number: 612-489-5909; Email: cmorris@cryosa.com

Study Locations

• United States
  • Colorado
    • Aurora, Colorado, United States, 80045
      • Recruiting
      • UCHealth University of Colorado
      • Principal Investigator: Katherine Green, MD
      • Contact: Yosr Doghri; Phone Number: 303-724-6550; Email: yosr.doghri@cuanschutz.edu
  • Florida
    • Miami, Florida, United States, 33136
      • Recruiting
      • University of Miami
      • Principal Investigator: Maria Suurna, MD
      • Contact: Kennedy Williams; Phone Number: 305-243-2815; Email: kxw786@med.miami.edu
  • Illinois
    • Chicago, Illinois, United States, 60612
      • Recruiting
      • Rush University Medical Center
      • Contact: Mahendra Shah, MD, CCRP; Phone Number: 312-942-9967; Email: mahendrakumar_shah@rush.edu
      • Principal Investigator: Michael J Hutz, MD
  • Louisiana
    • New Orleans, Louisiana, United States, 70115
      • Recruiting
      • Ochsner Baptist Medical Center
      • Contact: Shahriar Motazedian, MS; Phone Number: 504-703-9860; Email: shahriar.motazedian@ochsner.org
      • Principal Investigator: Joshua Kay, MD
  • New York
    • Albany, New York, United States, 12205
      • Recruiting
      • Albany ENT & Allergy Services
      • Contact: Julie Baum, LPN; Phone Number: 501-701-2085; Email: jbaum@albanyentandallergy.com
      • Principal Investigator: Gavin Setzen, MD
      • Sub-Investigator: Siobhan Kuhar, MD
      • Sub-Investigator: Nora Perkins, MD
  • Pennsylvania
    • Bethlehem, Pennsylvania, United States, 18017
      • Active, not recruiting
      • Specialty Physician Associates
    • Philadelphia, Pennsylvania, United States, 19104
      • Recruiting
      • University of Pennsylvania
      • Principal Investigator: Raj Dedhia, MD
      • Contact: Everett Seay, B.S.,RPSGT; Phone Number: 215-615-8777; Email: everett.seay@pennmedicine.upenn.edu
  • Tennessee
    • Memphis, Tennessee, United States, 38163
      • Recruiting
      • University of Tennessee Health Sciences Center
      • Principal Investigator: Carey B Wood, MD
      • Contact: Linda Sarinoglu; Phone Number: 901-426-2480; Email: lmaners@uthsc.edu
  • Texas
    • Houston, Texas, United States, 77030
      • Recruiting
      • Houston Methodist Hospital
      • Contact: Stephanie Camey; Phone Number: 832-706-8834; Email: scamey@houstonmethodist.org
      • Principal Investigator: Mas Takashima, MD, FACS

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: Adult; Older Adult
• Accepts Healthy Volunteers: No

Description

Inclusion Criteria:

1. To participate in this study, the subject must meet ALL of the following inclusion criteria:
2. Age 22 - 70 years
3. Not able to use, refuse to use or intolerant of Positive Airway Pressure (PAP) or Mandibular Advancement Device (MAD) if using, must be < 4 hours per night, < 5 days/week.
4. Failed, are not candidates for, or have refused other invasive procedures such as hypoglossal nerve stimulation or pharmacotherapy for the primary treatment of OSA such as Tirzepatide.
5. BMI ≥30 or ≤ 40 kg/m2 at enrollment
6. 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 Is geographically stable and in close proximity to the site
7. Able and willing to provide written consent to participate in the study

Exclusion Criteria:

1. Contraindication to general anesthesia or in the opinion of the Investigator would not be able to tolerate the procedure, including intubation during the procedure or in response to an adverse event
2. Actively taking ACEs/ARBs

3. Actively undergoing immunotherapy (Allergy shots)*, or unwilling to washout of allergy shots at least 2 weeks prior to study procedure.

   * Patients receiving immunotherapy may be eligible if they undergo a 2-week wash-out prior to the study procedure

4. Severe uncontrolled asthma
5. Severe maxillary mandibular insufficiency that in the opinion of the investigator thought to be the primary cause of OSA
6. Obvious severe fixed upper airway obstructions (tumors, polyps, nasal obstruction)
7. Previous surgery within 12 weeks of scheduled procedure performed on the soft tissue of the upper airway (e.g., uvula, soft palate, or tonsils).
8. Oral cancer or non-healing oral wounds
9. Prior sleep surgeries, including tongue base reduction, UPPP and hypoglossal nerve stimulation.
10. History of radiation therapy to neck or upper respiratory tract
11. Surgical resection for cancer or congenital malformations in the larynx, tongue, or throat (with exception of tonsillectomy and/or adenoidectomy)
12. History presence of cold urticaria at the time of screening History of cryoglobulinemia
13. History of allergy to glycerin
14. History of hospitalization with mechanical ventilation due to COVID-19 per investigator discretion
15. Resistant hypertension defined as a blood pressure that remains above goal despite concurrent use of three antihypertensive agents of different classes taken at maximally tolerated doses
16. Patients with diagnosed autoimmune disorders including thyroid disease, lupus, multiple myeloma, chronic lymphocytic leukemia
17. Neuromuscular disease or other neurologic deficits (for example multiple sclerosis, muscular dystrophy, Parkinson's disease, transient ischemic attack, epilepsy or cerebrovascular accident)
18. Diagnosis of any moderate to severe congestive obstructive pulmonary disease (COPD)
19. Active, severe pulmonary vascular disease (for example pulmonary arterial hypertension or pulmonary embolism) History of angioedema of the airway
20. Hereditary angioedema and other autoimmune disorders that could lead to acquired angioedema - confirmed with a compliment component C4 blood test <13mg/dL.
21. Uncontrolled Diabetes (including Diabetes Mellitus [DM] or Insulin Dependent Diabetes Mellitus [IDDM]) with HbA1c >9.
22. Currently receiving treatment for severe cardiac valvular dysfunction, NYHA Class III or IV heart failure, unstable angina or recent (< 12 months) myocardial infarction or severe cardiac arrhythmias
23. Subjects with bleeding event, known bleeding diathesis, impaired immunity for any reason, or heart attack or stroke within the last 12 months
24. Clinical evidence of severe renal failure (Stage 4 or 5) undergoing dialysis or expected to institute dialysis within 6 months
25. History or current clinical evidence of TIA or stroke or muscular dysfunction
26. Current smoker (≥ 1 pack/day)
27. Presence of occupational shift work or anticipation of shift changes during the next 2 years
28. Subject has sleep hygiene behavior that is likely to interfere with measurement outcomes during PSG and/or HSAT
29. Known active substance use disorder
30. Other severe sleep disorders that in the opinion of the investigator, confound functional assessments of sleepiness such as narcolepsy with cataplexy, severe insomnia/insomnia secondary to chronic pain, PTSD
31. 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)
32. Active psychiatric disease (psychotic illness, major depression, or acute anxiety attacks) which prevents subject's ability to meet study requirements and ability to provide study consent
33. Females who are pregnant or females of childbearing age with intention to become pregnant during the study period (≤ 3 months from treatment date)
34. Any other reason the investigator deems subject is unfit for participation in the study
35. Subject currently participating in other premarket investigational studies unless approved by Sponsor in writing

Study Plan

How is the study designed?

Design Details

• Primary Purpose: Treatment
• Allocation: N/A
• Interventional Model: Single Group Assignment
• Masking: None (Open Label)

Number of Arms

1

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
Experimental: Cryosa Procedure; 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).	Device: Cryosa Procedure; Cryotherapy; Other Names: OSA Cryotreatment

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
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. Adverse events (AE), both serious and non-serious, related and unrelated, will be collected from all subjects enrolled for the duration of the study.	First 90 days post-procedure

Secondary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Sleep Testing	Quantify the effect of the Cryosa procedure in reducing the severity of OSA post-procedure by evaluating the change from baseline in the apnea hypopnea index (AHI4) with polysomnography (PSG) testing.	6 Month Follow-up Visit
Patient Reported Outcomes (PRO) Efficacy Measures - Epworth Sleepiness Survey (ESS)	Evaluate change in daytime sleepiness after treatment compared to baseline.	30 Days, 90 Days, 6 Months, 12 Months, 18 Months and 24 Months Post-procedure
Patient Reported Outcomes (PRO) Safety Measures - Pain Numeric Scale (NRS)	Evaluate oropharyngeal pain metrics after treatment compared to baseline.	7 Days, 30 Days, 90 Days, 6 Months, 12 Months, 18 Months and 24 Months Post-procedure
Patient Reported Outcomes (PRO) Safety Measures - Eating Assessment Tool (EAT-10)	Evaluate change in swallowing metrics after treatment compared to baseline.	7 Days, 30 Days, 90 Days, 6 Months, 12 Months, 18 Months and 24 Months Post-procedure
Patient Reported Outcomes (PRO) Safety Measures - PROMIS-Sleep Disturbance (PROMIS-SD)	Assess perception of alertness, sleepiness, and tiredness during usual waking hours, and the perceived functional impairments during wakefulness associated with sleep problems or impaired alertness	30 Days, 90 Days, 6 Months, 12 Months, 18 Months and 24 Months Post-procedure
Patient Reported Outcomes (PRO) Safety Measures - PROMIS-Sleep Related Impairment (PROMIS-SRI)	Assess a range of symptoms, from mild subjective feelings of tiredness to an overwhelming, debilitating, and sustained sense of exhaustion that likely decreases one's ability to execute daily activities and function normally in family or social roles	30 Days, 90 Days, 6 Months, 12 Months, 18 Months and 24 Months Post-procedure

Other Outcome Measures

Outcome Measure	Measure Description	Time Frame
Home Sleep Apnea Testing (HSAT) - Apnea-Hypopnea Index (AHI4)	Two nights of testing will be collected, and the average of the two nights will be used to evaluate the change in AHI4 after treatment compared to baseline.	90 Days, 6 Months, 12 Months, 18 Months and 24 Months Post-procedure
Home Sleep Apnea Testing (HSAT) - Oxygen Desaturation Index (ODI)	Two nights of testing will be collected, and the average of the two nights will be used to evaluate the change in ODI sleep metrics after treatment compared to baseline.	90 Days, 6 Months, 12 Months, 18 Months and 24 Months Post-procedure
Home Sleep Apnea Testing (HSAT) - Oxygen Saturation (SpO2)	Two nights of testing will be collected, and the average of the two nights will be used to evaluate the change in SpO2 sleep metrics after treatment compared to baseline.	90 Days, 6 Months, 12 Months, 18 Months and 24 Months Post-procedure
Home Sleep Apnea Testing (HSAT) - Hypoxic Burden	Two nights of testing will be collected, and the average of the two nights will be used to evaluate the change in hypoxic burden sleep metrics after treatment compared to baseline.	90 Days, 6 Months, 12 Months, 18 Months and 24 Months Post-procedure
Home Sleep Apnea Testing (HSAT) - Snoring	Two nights of testing will be collected, and the average of the two nights will be used to evaluate the change in snoring episodes sleep metrics after treatment compared to baseline.	90 Days, 6 Months, 12 Months, 18 Months and 24 Months Post-procedure

Collaborators and Investigators

• Sponsor: Cryosa, Inc.

Study record dates

Study Major Dates

• Study Start (Actual): September 12, 2023
• Primary Completion (Estimated): December 30, 2026
• Study Completion (Estimated): June 30, 2028

Study Registration Dates

• First Submitted: August 7, 2023
• First Submitted That Met QC Criteria: August 18, 2023
• First Posted (Actual): August 23, 2023

Study Record Updates

• Last Update Posted (Actual): April 30, 2026
• Last Update Submitted That Met QC Criteria: April 27, 2026
• Last Verified: April 1, 2026

More Information

Terms related to this study

• Additional Relevant MeSH Terms: Nervous System Diseases; Respiratory Tract Diseases; Respiration Disorders; Sleep Wake Disorders; Signs and Symptoms, Respiratory; Sleep Disorders, Intrinsic; Dyssomnias; Sleep Apnea Syndromes; Sleep Apnea, Obstructive; Apnea
• Other Study ID Numbers: 11515

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: NO

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: Yes
• product manufactured in and exported from the U.S.: Yes