Back to resultsDreamKit Respiratory Effort Signal Validation
Primary Purpose
Sleep Apnea, Obstructive, Sleep Apnea, Central
Status
Completed
Phase
Not Applicable
Locations
United States
Study Type
Interventional
Intervention
DreamKit
Sponsored by
About this trial
This is an interventional diagnostic trial for Sleep Apnea, Obstructive
Eligibility 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;
- 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.
Sites / Locations
- Pulmonary and Critical Care Associates of Baltimore
Arms of the Study
Arm 1
Arm Type
Experimental
Arm Label
Validation Arm
Arm Description
Participants will wear the DreamKit device (test device) while instrumented with an esophageal manometry catheter (reference standard) to record respiratory effort.
Outcomes
Primary Outcome Measures
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.
Secondary Outcome Measures
Full Information
NCT ID
NCT04926077
First Posted
June 8, 2021
Last Updated
November 9, 2022
Sponsor
Philips Clinical & Medical Affairs Global
Collaborators
Pulmonary Critical Care Associates of Baltimore
1. Study Identification
Unique Protocol Identification Number
NCT04926077
Brief Title
DreamKit Respiratory Effort Signal Validation
Official Title
Validation of the DreamKit Plethysmography-derived Respiratory Effort Signal Against Esophageal Pressure
Study Type
Interventional
2. Study Status
Record Verification Date
November 2022
Overall Recruitment Status
Completed
Study Start Date
June 22, 2021 (Actual)
Primary Completion Date
October 7, 2021 (Actual)
Study Completion Date
October 7, 2021 (Actual)
3. Sponsor/Collaborators
Responsible Party, by Official Title
Sponsor
Name of the Sponsor
Philips Clinical & Medical Affairs Global
Collaborators
Pulmonary Critical Care Associates of Baltimore
4. Oversight
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
Data Monitoring Committee
No
5. Study Description
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.
6. Conditions and Keywords
Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Sleep Apnea, Obstructive, Sleep Apnea, Central
7. Study Design
Primary Purpose
Diagnostic
Study Phase
Not Applicable
Interventional Study Model
Single Group Assignment
Masking
None (Open Label)
Allocation
N/A
Enrollment
11 (Actual)
8. Arms, Groups, and Interventions
Arm Title
Validation Arm
Arm Type
Experimental
Arm Description
Participants will wear the DreamKit device (test device) while instrumented with an esophageal manometry catheter (reference standard) to record respiratory effort.
Intervention Type
Device
Intervention Name(s)
DreamKit
Intervention Description
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.
Primary Outcome Measure Information:
Title
Breath Amplitude Correlation
Description
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.
Time Frame
Baseline
10. Eligibility
Sex
All
Minimum Age & Unit of Time
18 Years
Accepts Healthy Volunteers
Accepts Healthy Volunteers
Eligibility 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;
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.
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Alan Schwartz, MD
Organizational Affiliation
Pulmonary Critical Care Associates of Baltimore
Official's Role
Principal Investigator
Facility Information:
Facility Name
Pulmonary and Critical Care Associates of Baltimore
City
Baltimore
State/Province
Maryland
ZIP/Postal Code
21286
Country
United States
12. IPD Sharing Statement
Plan to Share IPD
No
Learn more about this trial
DreamKit Respiratory Effort Signal Validation
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