Active Studies
Characterizing Mechanisms of Upper Airway Obstruction During Drug-Induced Sleep Endoscopy
Sponsor: NIH
Currently recruiting
DISE-CAD
Drug-induced sleep endoscopy (DISE) is a procedure used by Otolaryngologists to evaluate upper airway collapse site(s) of patients with obstructive sleep apnea. Our National Institutes of Health (NIH) sponsored study aims to characterize specific causes of upper airway obstruction during DISE. Our approach involves measuring airway pressures, pharyngeal patency, airflow, and responses to tongue muscle stimulation during DISE. Our goal is to develop personalized solutions that address the pathogenic mechanisms of airway collapse and airflow obstruction during sleep.
Drug-Induced Sleep Endoscopy (DISE): Phenotyping Obstruction Patterns
Sponsor: NIH
Currently recruiting
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:
2 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.
Adherence and Outcome of Upper Airway Stimulation (UAS) for OSA International Registry
Sponsor: Inspire Medical Systems, Inc.
Not currently recruiting
ADHERE
This registry is a multi-center, prospective, observational registry, conducted in the United States and Europe, enrolling up to 5,000 people. The purpose of the registry is to gather information on how the device is used and performs for patients in the commercial setting. Some data may be collected retrospectively in patients currently implanted (implanted prior to enrollment) through the final follow-up timeframe. In addition, the information collected will help to educate physicians who treat obstructive sleep apnea. This protocol does not include any additional stressful or invasive tests, which are not a part of standard of care.
Assessing diagnostic predictors of airway collapse in patients with Obstructive Sleep Apnea
Sponsor: Inspire Medical Systems, Inc.
Not currently recruiting
PREDICTOR
This study is an exploratory, multicenter study of data from up to 600 subjects diagnosed with OSA who are being evaluated for airway surgery and meet indications for implant of the Inspire Upper Airway Stimulation System. Evaluation for airway surgery includes a standard airway assessment and a Drug-Induced Sleep Endoscopy (DISE), to determine appropriate anatomical obstruction for implant (absence vs presence of concentric collapse at the soft palate). The VOTE Classification (based on DISE findings) is used to determine the degree of obstruction. The VOTE Classification for each patient will be recorded at the time of the DISE. During the standard airway assessment, a simple, non-invasive measurement of the pharyngeal width (PW) will be performed.
Multicenter Pilot Study of the Cryosa System for the Treatment of Obstructive Sleep Apnea
Sponsor: Cryosa, Inc.
Not currently recruiting
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
Sponsor: Cryosa, Inc.
Not currently recruiting
ICE-OSA
The purpose of the ICE-OSA study 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 and to investigate how the Cryosa Procedure affects OSA symptoms. The Cryosa Procedure is performed as part of the ARCTIC-3 study. ARCTIC-3 and ICE-OSA are similar in that they both aim to evaluate the efficacy and safety of the Cryosa Procedure, but the ICE-OSA study calls for additional procedures to visualize and image your airway and tissue, before and after the Cryosa Procedure.
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 subjects with complete concentric collapse of the soft palate
Sponsor: Nyxoah, Inc.
Currently recruiting
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.
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
Sponsor: Nyxoah, Inc.
Not currently recruiting
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.
Previous Studies
Hypoglossal Nerve Stimulation for Obstructive Sleep Apnea on Sympathetic and Vascular Function
CARDIOSA-12
The relationship between obstructive sleep apnea (OSA) and cardiovascular diseases is well-established. This study investigates the effect of hypoglossal nerve stimulation (HGNS) on blood pressure and other heart-related measures in people with OSA. Patients who participated had cardiovascular functions tested after a period of “regular” HGNS treatment and after a period of “sham” HGNS treatment. The results of cardiovascular tests were compared between these two periods.