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
- Are there results?
- Not yet: the study is under way
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
Show all 43Show fewer
- 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.
- 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
Study at a glance
From the registry record, last updated by the sponsor on 22 Jul 2026. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Obstructive Sleep Apnea Severity Reduction by AdIpose CryolysiS
- ClinicalTrials.gov ID
- NCT07720219
- Acronym / sponsor ID
- (OASIS) / 12499
- Keywords
- OASIS, Crysoa, OSA, Cryotherapy, Obstructive Sleep Apnea
- Study type
- Interventional
- Recruitment status
- Not yet recruiting
- Enrolment
- 130 participants (estimated)
- Lead sponsor
- Cryosa, Inc.Industry (pharma, biotech, devices)
- Study start
- Oct 2026 (estimated)
- Primary completion
- May 2029 (estimated)
- Study completion
- Nov 2029 (estimated)
- First posted
- 22 Jul 2026 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
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)
Study design
- Primary purpose
- Treatment
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| Cryosa Procedure | Experimental | Device: Cryosa ProcedureThe 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 may qualify
- Ages
- 22 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (5 listed)
- 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
Key exclusion criteria (43 listed)
- 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
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Cryosa ProcedureAlso: OSA CryotreatmentCryotherapy | Device | Cryosa Procedure |
Primary outcome
Primary Safety Endpoint
Time frame: 6 Months, 12 Months
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
Primary Co-Efficacy AHI Responder Endpoint
Time frame: 6 Months
Reduction in AHI of ≥ 50% or 15 points improvement at 6 months compared to baseline.
Primary Co-Efficacy ODI Responder Endpoint
Time frame: 6 Months
Reduction in ODI of ≥ 25% improvement at 6 months compared to baseline.
Results and safety
This study is still under way. Results are not available in the source record yet.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 22 Jul 2026.
- Individual participant dataSharing planned: Undecided
Related trials for Obstructive Sleep Apnea (OSA)
RecruitingObservational study
Development and Validation of a Multimodal Deep Learning Model Using Peripheral Oxygen Saturation and Ballistocardiography Signals for Predicting Apnea-Hypopnea Index in Obstructive Sleep Apnea
Obstructive Sleep Apnea
RecruitingPhase 3
A Study to Learn About the Monthly Dosing Study Medicine Called Berobenatide in Adults With Breathing Problems During Sleep and Overweight or Obesity Who Do Not Use a Breathing Machine (PAP) (VESPER-OSA 2)
Apnea, Sleep Disorders
Not yet recruitingPhase 2
Supplemental Oxygen for Sleep-Disordered Breathing in Adults With Chronic Opioid Use.
Sleep-disordered Breathing, Chronic Opioid Use
Recruiting
Nightly Wearable Monitoring During Home-Based Submental Electrical Stimulation for Obstructive Sleep Apnea
Obstructive Sleep Apnea
RecruitingPhase 1/2
DRonabinol Treatment of OSA
Obstructive Sleep Apnea
Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part.
B. Tucker Woodson, MD principal investigator
Medical College Wisconsin
Michael J Hutz, MD principal investigator
Rush University Medical Center
Questions about this trial
What is this clinical trial studying?
A study testing Cryosa Procedure in people with Obstructive Sleep Apnea (OSA) and Sleep Apnea - Obstructive, run by Cryosa, Inc..
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 5 inclusion and 43 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: opening soon, as of the sponsor's last update on 22 Jul 2026. Status can change between updates, so confirm with the study contact before making plans.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
This study is still under way. Results are not available in the source record yet.
How can a doctor refer a patient or contact the research team?
Contact Andrea Stone (763-232-4877, astone@cryosa.com), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Primary Safety Endpoint (time frame: 6 Months, 12 Months). The study lists 3 primary outcomes in all. It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 22 Jul 2026.