Sparkle Respiratory Effort 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 Sparkle respiratory effort signal.

Detailed Description
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The rationale for undertaking this study is to demonstrate that the agreement between the Sparkle respiratory effort signal amplitude and esophageal manometry is non-inferior to the agreement between the thoracic belt respiratory effort signal amplitude and esophageal manometry. Data collection will be completed within a single visit, in which participants will undergo simultaneous measurement using the Sparkle device, respiratory belts, 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 Sparkle Respiratory Effort Signal Against Esophageal Pressure in Healthy Participants

Conditions
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Sleep Apnea, Obstructive, Sleep Apnea, Central

Intervention / Treatment
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* Device: Sparkle


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; 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; 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 and 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 Sparkle device (test device) while instrumented with an esophageal manometry catheter (reference standard) to record respiratory effort. | Device: Sparkle<br>* The Sparkle 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 average correlation co-efficient of the breath amplitude sequences extracted from the Sparkle and esophageal manometry respiratory effort signals, with respect to the average correlation co-efficient of the breath amplitude sequences extracted from the thoracic belt and esophageal manometry respiratory effort signals. | Baseline |