DreamKit Respiratory Effort Signal Validation

NCT04926077 | Completed Results FDA Device

• 1 other identifier: SRC_SLE_SparkleEP2_2021_11315
• Study Type: interventional
• Target: 11
• Locations: 1 country
• Sites: 1

Brief Summary

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

Conditions

Sleep Apnea, Obstructive; Sleep Apnea, Central

Outcome Measures

Primary Outcomes (1)

• 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

Study Arms (1)

Validation Arm

EXPERIMENTAL

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

Device: DreamKit

Interventions

DreamKit DEVICE

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.

Validation Arm

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: Yes
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• Aged ≥18 years;
• Fluent in English;
• Able to provide informed consent.

You may not qualify if:

• 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.

Sponsors & Collaborators

• Philips Clinical & Medical Affairs Global: lead
• Pulmonary Critical Care Associates of Baltimore: collaborator

Study Sites (1)

Pulmonary and Critical Care Associates of Baltimore

Baltimore, Maryland, 21286, United States

Location

MeSH Terms

Conditions

Sleep Apnea, Obstructive; Sleep Apnea, Central

Condition Hierarchy (Ancestors)

Sleep Apnea Syndromes; Apnea; Respiration Disorders; Respiratory Tract Diseases; Sleep Disorders, Intrinsic; Dyssomnias; Sleep Wake Disorders; Nervous System Diseases

Results Point of Contact

• Title: Bill Hardy
• Organization: Philips

bill.hardy@philips.com

412-874-2710

Study Officials

• Alan Schwartz, MD

  Pulmonary Critical Care Associates of Baltimore

  PRINCIPAL INVESTIGATOR

Publication Agreements

• PI is Sponsor Employee: No
• Restrictive Agreement: No

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: NA
• Masking: NONE
• Purpose: DIAGNOSTIC
• Intervention Model: SINGLE GROUP
• Sponsor Type: INDUSTRY
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: June 8, 2021
• First Posted: June 14, 2021
• Study Start: June 22, 2021
• Primary Completion: October 7, 2021
• Study Completion: October 7, 2021
• Last Updated: November 30, 2022
• Results First Posted: November 30, 2022

Record last verified: 2022-11

Data Sharing

• IPD Sharing: Will not share

Locations

US (1)