Sparkle Respiratory Effort Validation

Withdrawn before enrolling · Not applicable

Conditions studied: Sleep Apnea, Obstructive, Sleep Apnea, Central

In brief

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

Key facts

Study ID

NCT04630639

Run by

Philips Clinical & Medical Affairs Global

People needed

0

Starts

2021-03-01

Expected to finish

2021-06-01

Last updated by the study team

2021-06-23

Who can join

Age: 18 and older. Sex: any. Healthy volunteers: accepted.

You may qualify if…

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

You may not qualify if…

• 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.

Where it is running

• Pulmonary and Critical Care Associates of Baltimore — Baltimore, Maryland, United States

Full record on ClinicalTrials.gov

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