DreamKit Respiratory Effort Signal Validation

The rationale for undertaking this study is to demonstrate the agreement between the respiratory effort signal amplitude derived from DreamKit vs. the gold-standard esophageal manometry. Data collection will be completed within a single visit, in which participants will undergo simultaneous measurement using the DreamKit device and esophageal manometry. Data collection will be completed during wakefulness, while participants undergo a series of breathing maneuvers.

Inclusion criteria

• Aged ≥18 years;
• Fluent in English;
• Able to provide informed consent.

Exclusion criteria

• Contraindication to esophageal pressure monitoring, including a sensitive gag reflex (determined by a positive response to the screening question "do you sometimes or often gag while brushing your teeth?"), dysphagia, nasal obstruction, and/or esophageal disorder likely to impact placement of the balloon;
• Pregnancy or planned pregnancy during the study (self-reported);
• History of allergic reactions to medical adhesives;
• Known allergy to lidocaine;
• Known seizure disorder;
• Severe medical condition (controlled or uncontrolled) impacting breathing including neuromuscular disease, chronic obstructive pulmonary disease, respiratory failure or insufficiency, or requirement for oxygen therapy;
• Chronic cardiopulmonary or renal disease, including a history of irregular heart rhythms or dyspnea;
• At risk for excessive bleeding including use of anticoagulants;
• An employee, or spouse of an employee, of a company that designs, sells, or manufactures sleep related products (including Philips);
• An employee, or spouse of an employee, of Pulmonary & Critical Care Associates of Baltimore.