RecruitingObstructive Sleep Apnea of Adult
Clinical Trial of the Cryosa System for the Treatment of Obstructive Sleep Apnea
Eligible age
22–70 yrs
Accepts
All genders
Locations
8 states
Healthy volunteers
No
See if you qualify for this study
Answer a few quick questions about your location and health. Takes about a minute.
About this study
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.
Sponsor: Cryosa, Inc.
You may qualify if…
- ✓ 1. To participate in this study, the subject must meet ALL of the following inclusion criteria:
- ✓ 2. Age 22 - 70 years
- ✓ 3. 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.
- ✓ 4. 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.
- ✓ 5. BMI ≥30 or ≤ 40 kg/m2 at enrollment
- ✓ 6. 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
- ✓ 7. Able and willing to provide written consent to participate in the study
You may not qualify if…
- ✕ 1. 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
- ✕ 2. Actively taking ACEs/ARBs
- ✕ 3. 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
- ✕ 4. Severe uncontrolled asthma
- ✕ 5. Severe maxillary mandibular insufficiency that in the opinion of the investigator thought to be the primary cause of OSA
- ✕ 6. Obvious severe fixed upper airway obstructions (tumors, polyps, nasal obstruction)
- ✕ 7. Previous surgery within 12 weeks of scheduled procedure performed on the soft tissue of the upper airway (e.g., uvula, soft palate, or tonsils).
Where it's recruiting
Source: ClinicalTrials.gov · NCT06008626 · last updated 2026-04-30