DreamKit Respiratory Effort Signal Validation

Sleep Apnea, Obstructive Clinical Trial

Official title:

Validation of the DreamKit Plethysmography-derived Respiratory Effort Signal Against Esophageal Pressure

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT04926077
• Other study ID #: SRC_SLE_SparkleEP2_2021_11315
• Status: Completed
• Phase: N/A
• Start date: June 22, 2021
• Est. completion date: October 7, 2021

Study information

• Verified date: November 2022
• Source: Philips Clinical & Medical Affairs Global
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial Summary

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

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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 11
• Est. completion date: October 7, 2021
• Est. primary completion date: October 7, 2021
• Accepts healthy volunteers: Accepts Healthy Volunteers
• Gender: All
• Age group: 18 Years and older

Eligibility

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.

Related Conditions & MeSH terms

• Apnea
• Sleep Apnea Syndromes
• Sleep Apnea, Central
• Sleep Apnea, Obstructive

Intervention

Device:
• DreamKit
The DreamKit 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.

Locations

Country	Name	City	State
United States	Pulmonary and Critical Care Associates of Baltimore	Baltimore	Maryland

Sponsors (2)

Lead Sponsor	Collaborator
Philips Clinical & Medical Affairs Global	Pulmonary Critical Care Associates of Baltimore

Country where clinical trial is conducted

United States, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Breath Amplitude Correlation	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.	Baseline