DreamKit Diagnostic Validation

Diagnostic Validation of the DreamKit Device Against Polysomnography

This study has been developed in order to demonstrate diagnostic efficacy of the DreamKit device against polysomnography.

Study Overview

• Status: Completed
• Conditions: Sleep Apnea, Obstructive; Sleep Apnea, Central
• Intervention / Treatment: Device: DreamKit

Detailed Description

The primary objective of this study is to assess the diagnostic performance of the DreamKit device against the gold-standard comparator, polysomnography (PSG). Data collection will be completed within a single visit, in which participants will undergo simultaneous measurement using the DreamKit device and in-laboratory PSG.

• Study Type: Interventional
• Enrollment (Actual): 306
• Phase: Not Applicable

Contacts and Locations

Study Locations

• United States
  • Alabama
    • Birmingham, Alabama, United States, 35213
      • Sleep Disorders Center of Alabama
  • Colorado
    • Colorado Springs, Colorado, United States, 80918
      • Delta Waves, Inc.
  • Florida
    • Lehigh Acres, Florida, United States, 33971
      • Florida Lung and Sleep Associates
  • Maryland
    • Towson, Maryland, United States, 21286
      • Pulmonary and Critical Care Association of Baltimore
  • Missouri
    • Maplewood, Missouri, United States, 63143
      • Clayton Sleep Institute
  • Pennsylvania
    • Wyomissing, Pennsylvania, United States, 19610
      • Berks Schuylkill Respiratory Specialists
  • South Carolina
    • Columbia, South Carolina, United States, 29201
      • Bogan Sleep Consultants

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 16 years and older (Adult, Older Adult)
• Accepts Healthy Volunteers: No
• Genders Eligible for Study: All

Description

Inclusion Criteria:

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

Exclusion Criteria:

• Self-reported habitual sleep duration of <4 hours/night on average ("How many hours sleep do you usually get per night?");
• Circadian phase disorder, shift work, or any other issue/condition that would, in the opinion of the site investigator, reduce the likelihood of obtaining at least four hours of sleep during the overnight study;
• History of allergic reactions to medical adhesives;
• Skin rash or other dermatological condition that would impact correct placement of the DreamKit device and/or PSG sensors, and/or would be exacerbated by the presence of the device or sensors;
• Presence of a pacemaker;
• Severe medical condition (controlled or uncontrolled) that would impede data collection in the opinion of the site investigator, including the requirement for oxygen therapy;
• [for those currently using overnight therapy]: Unwilling to withdraw from overnight therapy for a single night and/or clinically unsuitable to withdraw from overnight therapy in the opinion of the site investigator, with overnight therapy including but not limited to any form of PAP or ventilation, oral device including mandibular advancement devices or mouthguard for bruxism, nasal dilator strips, and/or positional device;
• [for those currently using overnight therapy]: Considered by the site investigator to be at risk of an AE resulting from hypersomnolence the day after the overnight visit, such as a high-risk occupation including but not limited to a pilot or commercial driver;
• An employee, or family member of an employee, of a company that designs, sells, or manufactures sleep related products (including Philips).

Study Plan

How is the study designed?

Design Details

• Primary Purpose: Diagnostic
• Allocation: N/A
• Interventional Model: Single Group Assignment
• Masking: None (Open Label)

Number of Arms

1

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
Experimental: Validation Arm; Participants will wear the DreamKit device (test device) while instrumented with polysomnography sensors (gold standard).	Device: DreamKit; The DreamKit device is a single-use device intended to aid the diagnosis of sleep-disordered breathing.

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Apnea hypopnea index	The primary endpoint is the intraclass correlation coefficient (ICC) for absolute agreement between the polysomnography (PSG) apnea-hypopnea index (AHI) and the DreamKit-AHI	Baseline

Secondary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Central apnea index	The secondary endpoint is the ICC for absolute agreement between the PSG-central apnea index (CAI) and the DreamKit-CAI.	Baseline

Collaborators and Investigators

• Sponsor: Philips Clinical & Medical Affairs Global
• Investigators: Study Director: Bill Hardy, Philips Sleep & Respiratory Care

Study record dates

Study Major Dates

• Study Start (Actual): January 14, 2021
• Primary Completion (Actual): December 18, 2021
• Study Completion (Actual): December 18, 2021

Study Registration Dates

• First Submitted: December 9, 2020
• First Submitted That Met QC Criteria: December 15, 2020
• First Posted (Actual): December 17, 2020

Study Record Updates

• Last Update Posted (Actual): March 2, 2022
• Last Update Submitted That Met QC Criteria: March 1, 2022
• Last Verified: March 1, 2022

More Information

Terms related to this study

• Additional Relevant MeSH Terms: Nervous System Diseases; Respiratory Tract Diseases; Respiration Disorders; Sleep Disorders, Intrinsic; Dyssomnias; Sleep Wake Disorders; Signs and Symptoms, Respiratory; Sleep Apnea Syndromes; Sleep Apnea, Obstructive; Apnea; Sleep Apnea, Central
• Other Study ID Numbers: SRC_SLE_Sparkle_PSG_2020_10908

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: No

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: Yes
• product manufactured in and exported from the U.S.: Yes