Actively Recruiting
Multicenter Pilot Study of the Cryosa System for the Treatment of Obstructive Sleep Apnea
Led by Cryosa, Inc. · Updated on 2026-04-30
25
Participants Needed
9
Research Sites
78 weeks
Total Duration
On this page
AI-Summary
What this Trial Is About
Researchers are evaluating the Cryosa System, a cryotherapy device, for treating adults with moderate to severe obstructive sleep apnea (OSA). This prospective, multicenter, non-randomized single-arm study aims to collect data on the safety and long-term performance of the Cryosa procedure applied to the tongue and soft palate. The study will also assess clinical measures related to therapy effectiveness to support future clinical studies. The study plans to enroll 25 participants at up to 10 sites across the United States, with a maximum of 15 subjects treated per site. Participants will undergo the Cryosa procedure, which involves cryotherapy treatment targeting areas in the throat that contribute to OSA. This single-arm study does not include a comparison group. The primary safety outcome will be tracked during the first 90 days after the procedure. Participants will be followed closely for up to 24 months, with assessments including sleep testing at six months and patient-reported outcomes such as sleepiness, pain, eating ability, and sleep disturbance measured at multiple time points from 7 days to 24 months post-procedure. Researchers will monitor any serious procedure- or device-related events. This comprehensive follow-up will help evaluate both safety and how the device affects OSA symptoms over time.
CONDITIONS
Brief Title
Clinical Trial of the Cryosa System for the Treatment of Obstructive Sleep Apnea
Who Can Participate
Eligibility Criteria
You may qualify if you...
- Age between 22 and 70 years
- Diagnosed with moderate to severe obstructive sleep apnea
- Unable to use, refuse, or intolerant of positive airway pressure or mandibular advancement device (using less than 4 hours per night, less than 5 days per week)
- Failed, not candidates for, or refused other invasive procedures such as hypoglossal nerve stimulation or pharmacotherapy for OSA
- Body mass index (BMI) between 30 and 40 kg/m2 at enrollment
- Apnea-hypopnea index (AHI) of 30 or more based on sleep study, or AHI of 15 or more with BMI of 30 or greater
- Geographically stable and near the study site
- Able and willing to provide written consent to participate
You will not qualify if you...
- Unable to tolerate general anesthesia or intubation
- Actively taking ACE inhibitors or angiotensin receptor blockers
- Undergoing immunotherapy or unwilling to stop allergy shots at least 2 weeks before procedure
- Severe uncontrolled asthma
- Severe maxillary or mandibular insufficiency causing OSA
- Severe fixed upper airway obstructions such as tumors or nasal blockage
- Recent surgery (within 12 weeks) on upper airway soft tissue
- Oral cancer or non-healing oral wounds
- Prior sleep surgeries including tongue base reduction, UPPP, or hypoglossal nerve stimulation
- History of radiation to neck or upper airway
- Surgical removal of cancer or congenital malformations in throat area (except tonsillectomy or adenoidectomy)
- History of cold urticaria or cryoglobulinemia
- Allergy to glycerin
- Hospitalization with mechanical ventilation due to COVID-19
- Resistant hypertension despite medications
- Autoimmune disorders including thyroid disease, lupus, multiple myeloma, chronic lymphocytic leukemia
- Neuromuscular or neurological disorders like multiple sclerosis or Parkinson's disease
- Moderate to severe COPD
- Severe pulmonary vascular disease or angioedema
- Uncontrolled diabetes with HbA1c over 9
- Severe cardiac conditions or recent heart attack
- Recent bleeding events or impaired immunity
- Severe kidney failure or dialysis
- History of stroke or transient ischemic attack
- Current smoker of 1 pack or more per day
- Shift work or anticipated shift changes during study
- Poor sleep hygiene affecting measurement
- Active substance use disorder
- Other severe sleep disorders affecting assessments
- Use of medications affecting study endpoints like benzodiazepines or stimulants
- Active psychiatric illness preventing consent or participation
- Females who are pregnant or planning pregnancy within 3 months
- Participation in other investigational studies without sponsor approval
- Any other investigator-determined reason for unsuitability for participation
AI-Screening
AI-Powered Screening
Complete this quick 3-step screening to check your eligibility
Your Study Journey
Duration - 2 to 4 weeks
Participants are screened for eligibility to participate in the trial.
1 visit (in-person)
Duration - Day of procedure
Participants receive the Cryosa System procedure applied to the tongue and soft palate to treat obstructive sleep apnea.
1 procedure visit (in-person)
Duration - Up to 24 months post-procedure
Participants are monitored for safety and effectiveness through multiple follow-up visits including patient-reported outcomes and sleep testing.
Visits at 7 days, 30 days, 90 days, 6 months, 12 months, 18 months, and 24 months post-procedure
Trial Site Locations
Total: 9 locations
1
UCHealth University of Colorado
Aurora, Colorado, United States, 80045
Actively Recruiting
2
University of Miami
Miami, Florida, United States, 33136
Actively Recruiting
3
Rush University Medical Center
Chicago, Illinois, United States, 60612
Actively Recruiting
4
Ochsner Baptist Medical Center
New Orleans, Louisiana, United States, 70115
Actively Recruiting
5
Albany ENT & Allergy Services
Albany, New York, United States, 12205
Actively Recruiting
6
Specialty Physician Associates
Bethlehem, Pennsylvania, United States, 18017
Active, Not Recruiting
7
University of Pennsylvania
Philadelphia, Pennsylvania, United States, 19104
Actively Recruiting
8
University of Tennessee Health Sciences Center
Memphis, Tennessee, United States, 38163
Actively Recruiting
9
Houston Methodist Hospital
Houston, Texas, United States, 77030
Actively Recruiting
Research Team
L
Laura Stoltenberg
C
Cassie Morris
How is the study designed?
Study Type
INTERVENTIONAL
Masking
NONE
Allocation
NA
Model
SINGLE_GROUP
Primary Purpose
TREATMENT
Number of Arms
1
Similar Trials
Frequently Asked Questions
Have more questions? Get in touch with our team for quick support
Not the Right Trial for You?
Explore thousands of other clinical trials that might be a better match.
Sign up to get personalized trial recommendations delivered to your inbox.
Already have an account? Log in here