Actively Recruiting
Clinical Trial 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
250 weeks
Total Duration
On this page
AI-Summary
What this Trial Is About
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.
CONDITIONS
Official 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 22 to 70 years
- Unable to use, refuse to use, or intolerant of Positive Airway Pressure (PAP) or Mandibular Advancement Device (MAD) if using, with usage less than 4 hours per night and less than 5 days per week
- Have failed, are not candidates for, or have refused other invasive procedures such as hypoglossal nerve stimulation or pharmacotherapy like Tirzepatide for OSA
- Body Mass Index (BMI) between 30 and 40 kg/m2 at enrollment
- Apnea-Hypopnea Index (AHI) 30 or greater based on in-lab polysomnography OR AHI 15 or greater with BMI 30 or greater based on in-lab polysomnography
- Geographically stable and near the study site
- Able and willing to provide written consent to participate
You will not qualify if you...
- Contraindication to general anesthesia or inability to tolerate the procedure
- Currently taking ACE inhibitors or ARBs
- Currently undergoing immunotherapy (allergy shots) without a 2-week washout prior to procedure
- Severe uncontrolled asthma
- Severe maxillary mandibular insufficiency considered primary cause of OSA
- Severe fixed upper airway obstructions like tumors or nasal obstruction
- Surgery on upper airway soft tissue within 12 weeks before procedure
- Oral cancer or non-healing oral wounds
- Prior sleep surgeries including tongue base reduction, UPPP, hypoglossal nerve stimulation
- History of radiation therapy to neck or upper respiratory tract
- Surgical resection in larynx, tongue, or throat except tonsillectomy or adenoidectomy
- History or presence of cold urticaria or cryoglobulinemia
- Allergy to glycerin
- Hospitalization with mechanical ventilation due to COVID-19
- Resistant hypertension despite three antihypertensive agents
- Diagnosed autoimmune disorders including thyroid disease, lupus, multiple myeloma, chronic lymphocytic leukemia
- Neuromuscular or neurologic diseases such as multiple sclerosis, muscular dystrophy, Parkinson's disease, stroke, epilepsy
- Moderate to severe COPD
- Severe pulmonary vascular disease or history of angioedema
- Uncontrolled diabetes with HbA1c over 9
- Severe cardiac conditions including valvular dysfunction, heart failure NYHA Class III or IV, unstable angina, recent myocardial infarction
- Recent bleeding events or impaired immunity
- Severe renal failure stage 4 or 5 or dialysis
- History or evidence of TIA, stroke, or muscular dysfunction
- Current smoker of one or more packs per day
- Occupational shift work or anticipated shift changes during next 2 years
- Sleep hygiene likely interfering with sleep study measurements
- Active substance use disorder
- Other severe sleep disorders confounding sleepiness assessment
- Use of medications affecting study endpoints such as benzodiazepines, Z-drugs, opiates, antipsychotics, prescription stimulants
- Active psychiatric diseases preventing consent or compliance
- Females pregnant or intending pregnancy within 3 months
- Participation in other investigational studies unless approved by sponsor
- Any other investigator-determined unfitness for participation
AI-Screening
AI-Powered Screening
Complete this quick 3-step screening to check your eligibility
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
CONTACT
C
Cassie Morris
CONTACT
How is the study designed?
Study Type
INTERVENTIONAL
Masking
NONE
Allocation
NA
Model
SINGLE_GROUP
Primary Purpose
TREATMENT
Number of Arms
1
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