Active Studies
Our team is committed to advancing scientific discovery through clinical research.
The studies listed below reflect our ongoing efforts to improve the understanding, diagnosis, and treatment of sleep apnea. Research studies are categorized by their current enrollment status, including both actively recruiting and non-recruiting protocols.
Only active patients are permitted to enroll on our clinical studies.Multicenter Pilot Study of the Cryosa System for the Treatment of Obstructive Sleep Apnea
CURRENTLY RECRUITING
Sponsor: Cryosa, Inc.
ARCTIC-3
Treatment with the Cryosa system is an experimental nonsurgical method with the aim of removing excess fat tissue in the tongue and soft palate through cryolysis (breaking down fat cells through freezing). There are several key procedures as part of this study, including:
The Cryosa procedure, which freezes the fat in the soft palate and base of the tongue
Drug-Induced Sleep Endoscopies
Sleep studies (both in lab and at home)
Imaging Predictors of Cryolysis Efficacy for Treatment of Obstructive Sleep Apnea
CURRENTLY RECRUITING
Sponsor: Cryosa, Inc.
ICE-OSA
The ICE-OSA study is a sub-study to the ARCTIC-3 study. The goal of ICE-OSA is to collect and evaluate data on patients participating in the ARCTIC-3 trial to determine:
If there are patient characteristics that predict improvement of obstructive sleep apnea (OSA) symptoms after treatment with the Cryosa Procedure,
How the Cryosa Procedure affects OSA symptoms.
The Cryosa Procedure is performed as part of the ARCTIC-3 study; the ICE-OSA study primarily calls for additional procedures to visualize and image your airway and tissue, before and after the Cryosa Procedure.
The Impact of Nasal Versus Oral Breathing on Measures of Drug-Induced Sleep Endoscopy
CURRENTLY RECRUITING
Sponsor: The McCabe Fund Advisory Committee
NOB
This research study seeks to understand the relationship between route of breath (nasal, oral, mixed) and airway collapsibility and whether route of breathing during DISE is representative of natural sleep. During study procedures, we will measure nasal and oral breathing utilizing standard sleep study equipment. Participation in this study will include:
In-lab sleep study
Drug-Induced Sleep Endoscopy
Drug-Induced Sleep Endoscopy (DISE): Phenotyping Obstruction Patterns
CURRENTLY RECRUITING
Sponsor: NIH
Dise-PhOP
This research study is being done to better understand how and why the airway collapses during sleep. We would like to find out what types of things (for example, air flow, air pressure, or face shape) affect if someone’s throat closes up during sleep and how well they do after sleep surgery. If you agree to join the study, you will be asked to complete the following research procedures during your planned drug-induced sleep endoscopy (DISE) exam:
Two thin tubes will be passed through your nostrils into your throat to take air pressure measurements. They will be removed at the end of the ~30 minute DISE.
You will have an ultrasound scan of your throat/airway.
Improving Understanding of Sleep Apnea Pathogenesis Using Novel Imaging Techniques During Sleep
No Longer Recruiting
Sponsor: NIH
State Dependent MRI & DISE
This study is being done to understand the mechanisms of upper airway collapse during apneas. Using MRI and phenotyping from DISE data, we aim to identify the specific anatomic structures responsible for upper airway collapse in OSA patients, examine the mechanisms of upper airway collapse, and elucidate the relationship of anatomic movement during sleep with airflow dynamics during DISE.
A multicenter study to assess the safety and effectiveness of the Genio® dual-sided hypoglossal nerve stimulation system for the treatment of obstructive sleep apnea in adult subjects
No Longer Recruiting
Sponsor: Nyxoah, Inc.
DREAM
The aim of this research study is to evaluate the safety and effectiveness of an implanted device called the Genio® bilateral stimulation system for the treatment of obstructive sleep apnea. This device is designed to reduce sleep apnea by stimulating a nerve to move the tongue during sleep so that it no longer blocks breathing. If you agree to join the study, you will be asked to complete the following research procedures:
Have surgery to implant the study device under your chin.
Use the device every night for up to 60 months.
Have several clinical visits that include overnight sleep studies, Drug-Induced Sleep Endoscopy tests, and physical exams.
A multicenter study to assess the safety and effectiveness of the Genio® dual-sided hypoglossal nerve stimulation system for the treatment of obstructive sleep apnea in adult subjects
No Longer Recruiting
Sponsor: Nyxoah, Inc.
ACCCESS
This research study aims to evaluate the safety and effectiveness of an implanted device called the Genio® bilateral stimulation system for the treatment of obstructive sleep apnea in patients with complete circumferential collapse upon drug-induced sleep endoscopy (DISE) exam. This device is designed to reduce sleep apnea by stimulating a nerve to move the tongue during sleep so that it no longer blocks breathing. If you agree to join the study, you will be asked to complete the following research procedures:
Have surgery to implant the study device under your chin.
Use the device every night for up to 36 months.
Have several clinical visits that include overnight sleep studies, DISE tests, and physical exams.
