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DreamKit Diagnostic Validation

Primary Purpose

Sleep Apnea, Obstructive, Sleep Apnea, Central

Status
Completed
Phase
Not Applicable
Locations
United States
Study Type
Interventional
Intervention
DreamKit
Sponsored by
Philips Clinical & Medical Affairs Global
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional diagnostic trial for Sleep Apnea, Obstructive

Eligibility Criteria

18 Years - undefined (Adult, Older Adult)All SexesAccepts Healthy Volunteers

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).

Sites / Locations

  • Sleep Disorders Center of Alabama
  • Delta Waves, Inc.
  • Florida Lung and Sleep Associates
  • Pulmonary and Critical Care Association of Baltimore
  • Clayton Sleep Institute
  • Berks Schuylkill Respiratory Specialists
  • Bogan Sleep Consultants

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 polysomnography sensors (gold standard).

Outcomes

Primary Outcome Measures

Intraclass Correlation Coefficient (ICC) of the 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. The higher ICC indicates higher correlation/agreement between the PSG AHI and DreamKit AHI. The possible range of ICC values is 0 to 1.0. Number was the best option for the measure type because it was a correlation coefficient.

Secondary Outcome Measures

Intraclass Correlation Coefficient (ICC) of the Central Apnea Index
The secondary endpoint is the ICC for absolute agreement between the PSG-central apnea index (CAI) and the DreamKit-CAI. The higher ICC indicates higher correlation/agreement between the PSG CAII and DreamKit CAI. The possible range of ICC values is 0 to 1.0. Number was the best option for the measure type because it was a correlation coefficient.

Full Information

First Posted
December 9, 2020
Last Updated
January 23, 2023
Sponsor
Philips Clinical & Medical Affairs Global
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1. Study Identification

Unique Protocol Identification Number
NCT04671342
Brief Title
DreamKit Diagnostic Validation
Official Title
Diagnostic Validation of the DreamKit Device Against Polysomnography
Study Type
Interventional

2. Study Status

Record Verification Date
January 2023
Overall Recruitment Status
Completed
Study Start Date
January 14, 2021 (Actual)
Primary Completion Date
December 18, 2021 (Actual)
Study Completion Date
December 18, 2021 (Actual)

3. Sponsor/Collaborators

Responsible Party, by Official Title
Sponsor
Name of the Sponsor
Philips Clinical & Medical Affairs Global

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 diagnostic efficacy of the DreamKit device against polysomnography.
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.

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
306 (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 polysomnography sensors (gold standard).
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.
Primary Outcome Measure Information:
Title
Intraclass Correlation Coefficient (ICC) of the Apnea Hypopnea Index
Description
The primary endpoint is the intraclass correlation coefficient (ICC) for absolute agreement between the polysomnography (PSG) apnea-hypopnea index (AHI) and the DreamKit-AHI. The higher ICC indicates higher correlation/agreement between the PSG AHI and DreamKit AHI. The possible range of ICC values is 0 to 1.0. Number was the best option for the measure type because it was a correlation coefficient.
Time Frame
Visit 2 (within six weeks of enrollment)
Secondary Outcome Measure Information:
Title
Intraclass Correlation Coefficient (ICC) of the Central Apnea Index
Description
The secondary endpoint is the ICC for absolute agreement between the PSG-central apnea index (CAI) and the DreamKit-CAI. The higher ICC indicates higher correlation/agreement between the PSG CAII and DreamKit CAI. The possible range of ICC values is 0 to 1.0. Number was the best option for the measure type because it was a correlation coefficient.
Time Frame
Visit 2 (within six weeks of enrollment)

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: 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).
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Bill Hardy
Organizational Affiliation
Philips Sleep & Respiratory Care
Official's Role
Study Director
Facility Information:
Facility Name
Sleep Disorders Center of Alabama
City
Birmingham
State/Province
Alabama
ZIP/Postal Code
35213
Country
United States
Facility Name
Delta Waves, Inc.
City
Colorado Springs
State/Province
Colorado
ZIP/Postal Code
80918
Country
United States
Facility Name
Florida Lung and Sleep Associates
City
Lehigh Acres
State/Province
Florida
ZIP/Postal Code
33971
Country
United States
Facility Name
Pulmonary and Critical Care Association of Baltimore
City
Towson
State/Province
Maryland
ZIP/Postal Code
21286
Country
United States
Facility Name
Clayton Sleep Institute
City
Maplewood
State/Province
Missouri
ZIP/Postal Code
63143
Country
United States
Facility Name
Berks Schuylkill Respiratory Specialists
City
Wyomissing
State/Province
Pennsylvania
ZIP/Postal Code
19610
Country
United States
Facility Name
Bogan Sleep Consultants
City
Columbia
State/Province
South Carolina
ZIP/Postal Code
29201
Country
United States

12. IPD Sharing Statement

Plan to Share IPD
No

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