DreamKit Respiratory Effort Signal Validation

Not Applicable

Completed

• Conditions: Sleep Apnea, Obstructive; Sleep Apnea, Central
• Interventions: Device: DreamKit

• Registration Number: NCT04926077
• Lead Sponsor: Philips Clinical & Medical Affairs Global

Brief Summary

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

Detailed 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.

Study Timeline

• Study First Submitted: 2021-06-08
• Study First Submitted QC: 2021-06-08
• Study First Posted: 2021-06-14
• Study Start: 2021-06-22
• Primary Completion: 2021-10-07
• Study Completion: 2021-10-07
• Results First Submitted: 2022-10-07
• Status Verified: 2022-11
• Results First Submitted QC: 2022-11-09
• Last Update Submitted: 2022-11-09
• Results First Posted: 2022-11-30
• Last Update Posted: 2022-11-30

Recruitment & Eligibility

• Status: COMPLETED
• Sex: All
• Target Recruitment: 11

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.

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: SINGLE_GROUP

Arm && Interventions

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

Primary Outcome Measures

Name	Time	Method
Breath Amplitude Correlation	Baseline	The primary endpoint is the intraclass correlation coefficient (ICC) of the peak-to-peak breath amplitude sequences extracted from the DreamKit and esophageal manometry respiratory effort signals during periods of occluded inspiration, end-expiratory breath holds, increased inspiratory resistance, increased expiratory resistance, and unresisted shallow breathing. The DreamKit Home Sleep Test device's effort signal is an uncalibrated signal. The amplitudes derived from the DreamKit Home Sleep Test device's effort signal were scaled for each subject to have the same variance across all tested breathing maneuvers. The lower-bound of the CI was compared against a target of 0.5.

Trial Locations

Locations (1)

Pulmonary and Critical Care Associates of Baltimore; 🇺🇸 Baltimore, Maryland, United States