Obstructive Sleep Apnea (OSA)(OASIS)NCT07720219
Clinical Trial of the Cryosa System for the Treatment of Obstructive Sleep Apnea (OASIS)
A study testing Cryosa Procedure in people with Obstructive Sleep Apnea (OSA) and Sleep Apnea - Obstructive, run by Cryosa, Inc..
Trial 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. Read more about this study
- Who is it for?
- Ages 22 years and older
- Conditions the study is for
- Obstructive Sleep Apnea (OSA), Sleep Apnea - Obstructive, OSA
- What is being tested?
- Cryosa Procedure
- Type of treatment
- Medical device
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 130 participants
- Where
- No sites listed yet
- Study dates
- Oct 2026to Nov 2029
- Phase
- Interventional
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 22 years and older
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- 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
Who cannot join
- 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.
- Concomitant Medication Exclusions
- Participant is actively taking ACEs/ARBs for hypertension AND is either of black race, of female gender, or >65 years of age
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- 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
- Participant has a prior airway interventions that alter or excise the tissue of the soft palate or the tongue base
- Participant has any airway intervention within 12 weeks of scheduled procedure performed to alter or excise the soft tissue of the airway or larynx
- Participant has an active, implanted, nerve stimulator for the treatment of OSA
- Participant has oral cancer or non-healing oral wounds
- Participant has a history of radiation therapy to neck or upper respiratory tract
- Participant has 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
- Major Anatomical Exclusions
- Participant has severe maxillary mandibular insufficiency or obvious severe fixed upper airway obstructions (tumors, polyps, nasal obstruction) that, in the opinion of the investigator, is thought to be the primary cause of OSA
- Participant has obstructions identified at the tonsils (palatine tonsils size 3+ or 4+)
- Participant has lingual tonsils size 4+
- Participant has Friedman tongue position IV
- Participant has a mandibular intermolar width < 32mm
- Participant has trismus as defined by a maximal inter-incisal opening of < 35mm
- Significant Comorbidities that Contraindicate Surgery or General Anesthesia
- Participant has 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
- Diagnosis of any moderate to severe congestive obstructive pulmonary disease (COPD)
- Active, severe pulmonary vascular disease (for example pulmonary arterial hypertension or pulmonary embolism).
- Uncontrolled Diabetes (including Diabetes Mellitus [DM] or Insulin Dependent Diabetes Mellitus [IDDM]) with HbA1c >9 at time of screening.
- 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
- Participants with bleeding event, known bleeding diathesis, impaired immunity for any reason, or heart attack or stroke within the last 12 months
- Clinical evidence of severe renal failure (Stage 4 or 5) undergoing dialysis or expected to institute dialysis within 6 months
- Participant has contraindication to general anesthesia or, in the opinion of the Investigator, would not be able to tolerate the procedure, including intubation during the procedure
- Lifestyle considerations
- Participant is a current smoker or nicotine vaper (>1 pack/day or equivalent)
- Participant conducts work or regular activities requiring vigilance (e.g., commercial driver, heavy machine operator, shift worker, etc.) that does not accommodate untreated OSA.
- Participant has sleep hygiene behavior that is likely to interfere with measurement outcomes during PSG
- Participant exhibits ongoing misuse of alcohol or recreational drugs that would impact either the results of or the participation in a sleep study
Trial locations and contacts
No sites are listed yet. Contact the study team or a site near you to ask about taking part.
About this study
Official title: Obstructive Sleep Apnea Severity Reduction by AdIpose CryolysiS
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.
Read the detailed description
This is a multi-center, prospective, non-randomized, single-arm clinical trial in adult patients with moderate to severe Obstructive Sleep Apnea (OSA)
- Being tested
- Cryosa Procedure
- Keywords
- OASIS, Crysoa, OSA, Cryotherapy, Obstructive Sleep Apnea
- Medical subject headings
- Sleep Apnea, Obstructive
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Cryosa ProcedureDevice
Also called OSA Cryotreatment
Cryotherapy
| Study group | Role | What they receive |
|---|---|---|
| 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). Receives: Device: Cryosa Procedure |
What is being measured
The primary outcome is the main question the study is designed to answer.
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
Measured: 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.
Measured: 6 Months
Primary Co-Efficacy ODI Responder Endpoint
Reduction in ODI of ≥ 25% improvement at 6 months compared to baseline.
Measured: 6 Months
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
Oct 2026Nov 2029
- First posted22 Jul 2026
- Study startOct 2026 (estimated)
- Primary completionMay 2029 (estimated)
- Study completionNov 2029 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Obstructive Sleep Apnea (OSA)Studies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Treatment
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Enrolment
- 130 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Cryosa, Inc.
- Sponsor type
- Industry (pharma, biotech, devices)
- Responsible party
- Sponsor
- Investigators
- B. Tucker Woodson, MD, Principal investigator, Medical College WisconsinMichael J Hutz, MD, Principal investigator, Rush University Medical Center
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT07720219
- Sponsor's protocol ID
- 12499
- Acronym
- (OASIS)
- Status last verified
- Jul 2026
- First submitted
- 16 Jul 2026
- Last updated
- 22 Jul 2026
- Results posted
- No
- Data monitoring committee
- Yes
- FDA-regulated drug
- No
- FDA-regulated device
- Yes
- Individual data sharing
- Undecided