DreamKit Respiratory Effort Signal Validation

Study Overview
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Brief Summary
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This study has been developed in order to demonstrate the validity of the DreamKit respiratory effort signal.

Detailed Description
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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.

Official Title
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Validation of the DreamKit Plethysmography-derived Respiratory Effort Signal Against Esophageal Pressure

Conditions
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Sleep Apnea, Obstructive, Sleep Apnea, Central

Intervention / Treatment
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* Device: DreamKit


Participation Criteria
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Eligibility Criteria
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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.

Ages Eligible for Study
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Minimum Age: 18 Years

Sexes Eligible for Study
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All

Accepts Healthy Volunteers
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Accepts Healthy Volunteers

Study Plan
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How is the study designed?
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Design Details

Primary Purpose: Diagnostic
Intervention Model: Single Group Assignment
Masking: None (Open Label)


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Experimental: Validation Arm<br>Participants will wear the DreamKit device (test device) while instrumented with an esophageal manometry catheter (reference standard) to record respiratory effort. | Device: DreamKit<br>* The DreamKit device is a single-use device intended to aid the diagnosis of sleep-disordered breathing; however, this study is intended only to validate the respiratory effort signal and does not assess diagnostic performance.<br>|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Breath Amplitude Correlation | The primary endpoint is the intraclass correlation coefficient (ICC) of the peak-to-peak breath amplitude sequences extracted from the DreamKit and esophageal manometry respiratory effort signals during periods of occluded inspiration, end-expiratory breath holds, increased inspiratory resistance, increased expiratory resistance, and unresisted shallow breathing. The DreamKit Home Sleep Test device's effort signal is an uncalibrated signal. The amplitudes derived from the DreamKit Home Sleep Test device's effort signal were scaled for each subject to have the same variance across all tested breathing maneuvers. The lower-bound of the CI was compared against a target of 0.5. | Baseline |