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

NCT07720219 | Not Yet Recruiting DMC FDA Device

• 1 other identifier: 12499
• Study Type: interventional
• Target: 130
• Locations: 0 countries
• Sites: N/A

Brief Summary

The objective of this study is to evaluate the safety and effectiveness of the Cryosa System when used as intended to perform the Cryosa Procedure.

Conditions

Obstructive Sleep Apnea (OSA); OSA; Sleep Apnea - Obstructive

Keywords

OASIS; Crysoa; OSA; Cryotherapy; Obstructive Sleep Apnea

Outcome Measures

Primary Outcomes (3)

• Primary Safety Endpoint

  The safety of the Cryosa System will be assessed via the description of all reported adverse events. Adverse events will be summarized by seriousness, severity and relatedness to the device and/or procedure

  6 Months, 12 Months

• Primary Co-Efficacy AHI Responder Endpoint

  Reduction in AHI of ≥ 50% or 15 points improvement at 6 months compared to baseline.

  6 Months

• Primary Co-Efficacy ODI Responder Endpoint

  Reduction in ODI of ≥ 25% improvement at 6 months compared to baseline.

  6 Months

Study Arms (1)

Cryosa Procedure

EXPERIMENTAL

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

Interventions

Cryosa Procedure DEVICE

Cryotherapy

Also known as: OSA Cryotreatment

Cryosa Procedure

Eligibility Criteria

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

You may qualify if:

• Participant age is 22 years and older
• Participant has failed, is unable to use, unwilling to use or dissatisfied with Positive Airway Pressure (PAP) or mandibular advancement devices (MAD)
• Participant is diagnosed with Obstructive Sleep Apnea with an AHI ≥30 OR AHI ≥ 15 and BMI of ≥ 30 at enrollment (CA/MA ≤ 25%)
• Participant is willing and capable of receiving the study procedure, completing all the questionnaires and returning for all follow-up evaluations and sleep studies
• Participant is willing and capable of providing informed consent

You may not qualify if:

• Participant is currently participating in other premarket investigational studies unless approved by Sponsor in writing
• Any reason for which, in the judgment of the investigator, the participant is considered to be a poor study candidate, which may include, but is not limited to: any uncontrolled neurological, medical, social, or psychological problems that could complicate the required procedures and evaluations of the study (e.g. uncontrolled Type 1 or 2 diabetes with neuropathy, debilitating acute or chronic cardiac, lung, liver, kidney, central nervous system or psychiatric disease)
• Participant has a BMI \> 40 kg/m2 at enrollment
• Women who are pregnant or of childbearing potential (WOCBP defined as fertile following menarche and until becoming post-menopausal unless permanently sterile) who are unwilling to practice an appropriate method of contraception from screening through 6-month follow-up.
• Participant is actively taking ACEs/ARBs for hypertension AND is either of black race, of female gender, or \>65 years of age
• Participant is actively undergoing immunotherapy (Allergy shots), and unwilling to wash out of allergy shots at least 2 weeks prior to study procedure
• Participant is taking any of the following medications that, in the opinion of the investigator, could affect study endpoints: AD109, benzodiazepines, Z-drugs (zolpidem and eszopiclone), opiates, antipsychotics (neuroleptics), phenothiazines, and prescription stimulants (including Sunosi, Provigil, and Nuvigil)
• Significant Airway Risk Factors
• Participants with severe uncontrolled asthma
• Participants with a history of angioedema
• Participants with hereditary angioedema (confirmed with a Complement Component C4 blood test \<13mg/dL)
• Participant has uncontrolled autoimmune disorders including active thyroid disease, lupus, multiple myeloma, and chronic lymphocytic leukemia that could lead to acquired angioedema
• Participant has a history or presence of cold urticaria at the time of screening
• Participant has a history of cryoglobulinemia or Paradoxical Adipose Hyperplasia (PAH)
• Participant has a history of allergy to glycerin History of Oral/Airway Comorbidities/Interventions

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

Study Officials

• B. Tucker Woodson, MD

  Medical College Wisconsin

  PRINCIPAL INVESTIGATOR

• Michael J Hutz, MD

  Rush University Medical Center

  PRINCIPAL INVESTIGATOR

Central Study Contacts

Andrea Stone

CONTACT

763-232-4877; astone@cryosa.com

Laura Stoltenberg

CONTACT

608-320-2687; lstoltenberg@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: July 16, 2026
• First Posted: July 22, 2026
• Study Start (Estimated): October 1, 2026
• Primary Completion (Estimated): May 1, 2029
• Study Completion (Estimated): November 1, 2029
• Last Updated: July 22, 2026

Record last verified: 2026-07