DreamKit Respiratory Effort Signal Validation

Philips

Status: Completed

Conditions: Sleep Apnea, Obstructive; Sleep Apnea, Central

Treatments: Device: DreamKit

Study type: Interventional

Funder types: Other; Industry

Identifiers

NCT04926077

SRC_SLE_SparkleEP2_2021_11315

Details and patient eligibility

About

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

Full description

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.

Enrollment: 11 patients

Sex: All

Ages: 18+ years old

Volunteers: Accepts Healthy Volunteers

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.

Trial design

Primary purpose: Diagnostic

Allocation: N/A

Interventional model: Single Group Assignment

Masking: None (Open label)

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11 participants in 1 patient group

Validation Arm

Experimental group

Description:

Participants will wear the DreamKit device (test device) while instrumented with an esophageal manometry catheter (reference standard) to record respiratory effort.

Treatment:

Device: DreamKit