Exploring the Cryosa System Device as a Treatment Option for Obstructive Sleep Apnea

This research study wants to learn how well and safe the Cryosa system works in people with obstructive sleep apnea (OSA). The Cryosa system is a device used to freeze the base of the tongue and soft palate which reduces the amount of fat in those areas and may improve OSA symptoms.


Why this Research Matters

Obstructive sleep apnea (OSA) is a condition that causes a person to stop and start breathing while they sleep. People with OSA may not sleep well at night and may be tired during the day. The Cryosa system is a device that is used to freeze the base of the tongue and soft palate. This reduces the fat in those areas which may help OSA symptoms improve. We want to see if the Cryosa system helps treat OSA symptoms. If you want to join the study, you will have a visit to see if you qualify. At this visit, we will ask you questions about your medical history, do a physical exam, and have you complete questionnaires. You will also have a cold sensitivity test. After this first visit, you will come back for an overnight sleep study to evaluate your OSA. During this stay, we will look at your mouth and nose by putting a flexible, thin tube with a camera through your nose. If you qualify after these tests, you will do a sleep apnea test at home by wearing a small device while you sleep for two nights. After that, you will come for another visit where you fill out questionnaires, have a taste test, and tongue exam. If you are eligible for the study and choose to participate, you will be scheduled for the Cryosa system procedure. When you come for your procedure, you will have a Drug Induced Sleep Endoscopy to see what is blocking your throat while you are sleeping. You will be put under anesthesia before the Cryosa procedure. After treatment, we will monitor you overnight to make sure you are recovering and breathing properly. You will have follow-up visits for up to two years afterwards. Your first visit will be a telephone visit where somebody from our study team will call you to make sure you are doing okay. The other follow-up visits will be in-person. At these visits, you will fill out questionnaires about your health, sleep, and OSA symptoms. You will also have an endoscopy, complete sleep and taste tests, and have your tongue examined. You will also have four more sleep tests at home in between these visits. You will be in this research study for two and a half years and have 11 study visits. You can earn up to $3,125 for completing all study visits.


Who can Participate

Adult

You may be able to join this study if you are 22 to 70 years old and have OSA. You are not eligible for the study if you smoke, are pregnant, or plan to become pregnant during the study. You may be able to join the study if you are an adult between the ages of 22 to 70 years old.


Study ID

Protocol Number: 25-0971

More information available at ClinicalTrials.gov: NCT06008626


Compensation Information

Compensation
Study Payment: Compensation provided.

Meet the Team

Image of Principal Investigator

Katherine Green, MD, MS

Principal Investigator