Phase 3 Sleep Disorders Trial, Recruiting

Written by an AI model from the ClinicalTrials.gov eligibility criteria and checked on a sample basis. Please confirm against the original criteria.

Who might be able to join this trial:

For people currently using PAP therapy (such as CPAP):

• People who have been using PAP therapy continuously for at least 3 months before the screening visit and plan to keep using it during the study.

For people not using PAP therapy:

• People who are unable or unwilling to use PAP therapy, and who have not used it for at least 4 weeks before the screening visit.

For all participants:

• People who are 18 years of age or older at the time of signing the consent form.
• People whose overnight sleep study (a test that monitors breathing during sleep) shows 15 or more breathing interruption events per hour.
• People with a body mass index (a measure of body weight relative to height) of 28.0 or above at the screening visit.

Who may not be able to join:

For people currently using PAP therapy:

• People whose personal safety or job responsibilities would make it unsafe to stop PAP therapy for 7 days before certain sleep tests during the study, in the opinion of the study doctor.
• People who are unwilling to pause PAP therapy for 7 days before required sleep tests during the study.

For all participants:

• People who have been diagnosed with type 1 or type 2 diabetes.
• People who have previously had, or are planning to have, surgery for sleep apnea or major surgery on the ear, nose, or throat (including tonsil or adenoid removal) that may still be affecting breathing at the start of the study.
• People who have significant structural differences in the face or skull that may be affecting their breathing at the start of the study.
• People diagnosed with a condition called Obesity Hypoventilation Syndrome, or who have too much carbon dioxide in their blood during the day.
• People currently using another active device-based treatment for sleep apnea (for example, a dental appliance), unless willing to stop that treatment from the start of the study and for its entire duration.
• People with lung or nerve-and-muscle conditions that, in the study doctor's opinion, could affect the trial results.
• People who have already lost more than 5% of their body weight through diet and exercise alone in the 12 weeks before the screening visit.

Important: Always verify eligibility with the trial site directly before applying.