Clinical Trial of the Cryosa System for the Treatment of Obstructive Sleep Apnea

Recruiting now · Not applicable

Conditions studied: Obstructive Sleep Apnea of Adult

In brief

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.

Key facts

Study ID: NCT06008626
Run by: Cryosa, Inc.
People needed: 25
Starts: 2023-09-12
Expected to finish: 2028-06-30
Last updated by the study team: 2026-04-30

Who can join

Age: 22 and older, up to 70. Sex: any. Healthy volunteers: not accepted.

You may qualify if…

To participate in this study, the subject must meet ALL of the following inclusion criteria:
Age 22 - 70 years
Not able to use, refuse to use or intolerant of Positive Airway Pressure (PAP) or Mandibular Advancement Device (MAD) if using, must be < 4 hours per night, < 5 days/week.
Failed, are not candidates for, or have refused other invasive procedures such as hypoglossal nerve stimulation or pharmacotherapy for the primary treatment of OSA such as Tirzepatide.
BMI ≥30 or ≤ 40 kg/m2 at enrollment
AHI ≥30 at enrollment based on in-lab polysomnography study OR AHI ≥ 15 and BMI of ≥ 30 at enrollment based on in-lab polysomnography study Is geographically stable and in close proximity to the site
Able and willing to provide written consent to participate in the study

You may not qualify if…

Contraindication to general anesthesia or in the opinion of the Investigator would not be able to tolerate the procedure, including intubation during the procedure or in response to an adverse event
Actively taking ACEs/ARBs
Actively undergoing immunotherapy (Allergy shots)*, or unwilling to washout of allergy shots at least 2 weeks prior to study procedure.
Patients receiving immunotherapy may be eligible if they undergo a 2-week wash-out prior to the study procedure
Severe uncontrolled asthma
Severe maxillary mandibular insufficiency that in the opinion of the investigator thought to be the primary cause of OSA
Obvious severe fixed upper airway obstructions (tumors, polyps, nasal obstruction)
Previous surgery within 12 weeks of scheduled procedure performed on the soft tissue of the upper airway (e.g., uvula, soft palate, or tonsils).
Oral cancer or non-healing oral wounds
Prior sleep surgeries, including tongue base reduction, UPPP and hypoglossal nerve stimulation.
History of radiation therapy to neck or upper respiratory tract
Surgical resection for cancer or congenital malformations in the larynx, tongue, or throat (with exception of tonsillectomy and/or adenoidectomy)
History presence of cold urticaria at the time of screening History of cryoglobulinemia
History of allergy to glycerin
History of hospitalization with mechanical ventilation due to COVID-19 per investigator discretion
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
Patients with diagnosed autoimmune disorders including thyroid disease, lupus, multiple myeloma, chronic lymphocytic leukemia
Neuromuscular disease or other neurologic deficits (for example multiple sclerosis, muscular dystrophy, Parkinson's disease, transient ischemic attack, epilepsy or cerebrovascular accident)
Diagnosis of any moderate to severe congestive obstructive pulmonary disease (COPD)
Active, severe pulmonary vascular disease (for example pulmonary arterial hypertension or pulmonary embolism) History of angioedema of the airway
Hereditary angioedema and other autoimmune disorders that could lead to acquired angioedema - confirmed with a compliment component C4 blood test <13mg/dL.
Uncontrolled Diabetes (including Diabetes Mellitus [DM] or Insulin Dependent Diabetes Mellitus [IDDM]) with HbA1c >9.
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
Subjects 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

Where it is running

Houston Methodist Hospital — Houston, Texas, United States (enrolling)
University of Miami — Miami, Florida, United States (enrolling)
Rush University Medical Center — Chicago, Illinois, United States (enrolling)
Ochsner Baptist Medical Center — New Orleans, Louisiana, United States (enrolling)
Albany ENT & Allergy Services — Albany, New York, United States (enrolling)
UCHealth University of Colorado — Aurora, Colorado, United States (enrolling)
University of Pennsylvania — Philadelphia, Pennsylvania, United States (enrolling)
University of Tennessee Health Sciences Center — Memphis, Tennessee, United States (enrolling)
Specialty Physician Associates — Bethlehem, Pennsylvania, United States

Full record on ClinicalTrials.gov

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