The purpose of this study is to evaluate the safety and effectiveness of the Cryosa System applied to the tongue and soft palate in patients with clinically diagnosed obstructive sleep apnea (OSA).
Participants will come into the clinic for a up to 2.5 years. First, they would complete the Screening/Baseline visits where they would be asked questionnaires; the doctor will evaluate your upper airway which includes looking in your mouth, at your tonsils, and in your nasal cavity and upper airway using a flexible endoscope; and you will have an in-clinic sleep test (Polysomnography); you will also have two at-home sleep tests (Home Sleep Apnea Tests); the doctor will examine how your tongue functions and you will have a taste test. For the study procedure visit, you will come in for a Drug Induced Sleep Endoscopy (DISE) or an evaluation of the structures in your throat while you are sleeping. The doctor will then conduct the Cryosa procedure. When you are finished, you will be observed overnight to evaluate your recovery. Medical staff will check on you regularly to monitor the healing of the treatment area and ensure you are recovering and breathing properly. You will be called on the 3rd day after your procedure by study team members to ensure you are healing properly and collect any information about your symptoms. At 7-Day Visit and 30-Day Visit, you will come back to the clinic to be asked questionnaires, have the flexible endoscope procedure, the doctor will examine how your tongue functions and you will have a taste test. At 90-Day Visit and 6-Month Visit you will come back to the clinic to be asked questionnaires, have the flexible endoscope procedure, the doctor will examine how your tongue functions and you will have a taste test. You will also have an in-clinic sleep test and two at-home sleep tests. At 12-Month Visit, 18-Month Visit and 24-Month Visit you will come back to the clinic to be asked questionnaires, have the flexible endoscope procedure, the doctor will examine how your tongue functions and you will have a taste test. You will also have two at-home sleep tests.
These are some of the Inclusion criteria, please contact us to complete a pre-screening questionnaire. You may be able to join the study if you are an adult between the ages of 22 to 70 years old.
Protocol Number: 25-0971
More information available at ClinicalTrials.gov: NCT06008626
Principal Investigator