DreamKit Diagnostic Validation

NCT04671342 | Completed Results FDA Device

• 1 other identifier: SRC_SLE_Sparkle_PSG_2020_10908
• Study Type: interventional
• Target: 306
• Locations: 1 country
• Sites: 7

Brief Summary

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

Conditions

Sleep Apnea, Obstructive; Sleep Apnea, Central

Outcome Measures

Primary Outcomes (1)

• 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.

  Visit 2 (within six weeks of enrollment)

Secondary Outcomes (1)

• Intraclass Correlation Coefficient (ICC) of the Central Apnea Index

  Visit 2 (within six weeks of enrollment)

Study Arms (1)

Validation Arm

EXPERIMENTAL

Participants will wear the DreamKit device (test device) while instrumented with polysomnography sensors (gold standard).

Device: DreamKit

Interventions

DreamKit DEVICE

The DreamKit device is a single-use device intended to aid the diagnosis of sleep-disordered breathing.

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:

• 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).

Sponsors & Collaborators

• Philips Clinical & Medical Affairs Global: lead

Study Sites (7)

Sleep Disorders Center of Alabama

Birmingham, Alabama, 35213, United States

Location

Delta Waves, Inc.

Colorado Springs, Colorado, 80918, United States

Location

Florida Lung and Sleep Associates

Lehigh Acres, Florida, 33971, United States

Location

Pulmonary and Critical Care Association of Baltimore

Towson, Maryland, 21286, United States

Location

Clayton Sleep Institute

Maplewood, Missouri, 63143, United States

Location

Berks Schuylkill Respiratory Specialists

Wyomissing, Pennsylvania, 19610, United States

Location

Bogan Sleep Consultants

Columbia, South Carolina, 29201, 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

• Bill Hardy

  Philips Sleep & Respiratory Care

  STUDY DIRECTOR

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: December 9, 2020
• First Posted: December 17, 2020
• Study Start: January 14, 2021
• Primary Completion: December 18, 2021
• Study Completion: December 18, 2021
• Last Updated: January 31, 2023
• Results First Posted: January 31, 2023

Record last verified: 2023-01

Data Sharing

• IPD Sharing: Will not share

Locations

US (7)