Sparkle Respiratory Effort Validation

• ClinicalTrials.gov Identifier: NCT04630639
• Recruitment Status: Withdrawn
• First Posted: November 16, 2020
• Last Update Posted: June 23, 2021
• Sponsor: Philips Clinical & Medical Affairs Global
• Collaborator: Pulmonary Critical Care Associates of Baltimore
• Information provided by (Responsible Party): Philips Clinical & Medical Affairs Global

Study Description

Brief Summary:

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

Condition or disease	Intervention/treatment	Phase
Sleep Apnea, Obstructive; Sleep Apnea, Central	Device: Sparkle	Not Applicable

Detailed Description:

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 Design

• Study Type: Interventional (Clinical Trial)
• Actual Enrollment: 0 participants
• Allocation: N/A
• Intervention Model: Single Group Assignment
• Masking: None (Open Label)
• Primary Purpose: Diagnostic
• Official Title: Validation of the Sparkle Respiratory Effort Signal Against Esophageal Pressure in Healthy Participants
• Estimated Study Start Date: March 2021
• Estimated Primary Completion Date: June 2021
• Estimated Study Completion Date: June 2021

Arms and Interventions

Arm	Intervention/treatment
Experimental: Validation Arm; Participants will wear the Sparkle device (test device) while instrumented with an esophageal manometry catheter (reference standard) to record respiratory effort.	Device: Sparkle; 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.

Outcome Measures

Primary Outcome Measures :

1. Breath amplitude correlation [ Time Frame: Baseline ]
   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.

Eligibility Criteria

• Ages Eligible for Study: 18 Years and older (Adult, Older Adult)
• Sexes Eligible for Study: All
• Accepts Healthy Volunteers: Yes

Criteria

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.

Contacts and Locations

Locations

United States, Maryland

Pulmonary and Critical Care Associates of Baltimore

Baltimore, Maryland, United States, 21286

Sponsors and Collaborators

Philips Clinical & Medical Affairs Global

Pulmonary Critical Care Associates of Baltimore

Investigators

• Principal Investigator: Alan Schwartz, MD; Pulmonary and Critical Care Associates of Baltimore

More Information

• Responsible Party: Philips Clinical & Medical Affairs Global
• ClinicalTrials.gov Identifier: NCT04630639
• Other Study ID Numbers: SRC-NBS-Sparkle-EP-2019-10456
• First Posted: November 16, 2020
• Last Update Posted: June 23, 2021
• Last Verified: June 2021

Individual Participant Data (IPD) Sharing Statement:

• Plan to Share IPD: No

• Studies a U.S. FDA-regulated Drug Product: No
• Studies a U.S. FDA-regulated Device Product: Yes
• Device Product Not Approved or Cleared by U.S. FDA: Yes
• Product Manufactured in and Exported from the U.S.: Yes

Additional relevant MeSH terms:

Apnea; Sleep Apnea Syndromes; Sleep Apnea, Obstructive; Sleep Apnea, Central; Respiration Disorders; Respiratory Tract Diseases; Signs and Symptoms, Respiratory; Sleep Disorders, Intrinsic; Dyssomnias; Sleep Wake Disorders; Nervous System Diseases