Sparkle Respiratory Effort Validation

Philips Clinical & Medical Affairs Global

Overview

This study has been developed in order to demonstrate the validity of the Sparkle respiratory effort signal.

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.

Study Type

INTERVENTIONAL

Allocation

Purpose

DIAGNOSTIC

Masking

NONE

Conditions

Sleep Apnea, Obstructive Sleep Apnea, Central

Interventions

SparkleDEVICE

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.

Eligibility

Sex: ALLMin age: 18 YearsHealthy volunteers:

Medical Language ↔ Plain English

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.

Locations (1)

Pulmonary and Critical Care Associates of Baltimore

Baltimore, Maryland, United States

Outcomes

Primary Outcomes

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.

Time frame: Baseline

Data from ClinicalTrials.gov

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