DreamKit Diagnostic Validation

Sleep Apnea, Obstructive Clinical Trial

Official title:

Diagnostic Validation of the DreamKit Device Against Polysomnography

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT04671342
• Other study ID #: SRC_SLE_Sparkle_PSG_2020_10908
• Status: Completed
• Phase: N/A
• Start date: January 14, 2021
• Est. completion date: December 18, 2021

Study information

• Verified date: January 2023
• Source: Philips Clinical & Medical Affairs Global
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial Summary

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

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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 306
• Est. completion date: December 18, 2021
• Est. primary completion date: December 18, 2021
• Accepts healthy volunteers: Accepts Healthy Volunteers
• Gender: All
• Age group: 18 Years and older

Eligibility

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).

Related Conditions & MeSH terms

• Apnea
• Sleep Apnea Syndromes
• Sleep Apnea, Central
• Sleep Apnea, Obstructive

Intervention

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

Locations

Country	Name	City	State
United States	Sleep Disorders Center of Alabama	Birmingham	Alabama
United States	Delta Waves, Inc.	Colorado Springs	Colorado
United States	Bogan Sleep Consultants	Columbia	South Carolina
United States	Florida Lung and Sleep Associates	Lehigh Acres	Florida
United States	Clayton Sleep Institute	Maplewood	Missouri
United States	Pulmonary and Critical Care Association of Baltimore	Towson	Maryland
United States	Berks Schuylkill Respiratory Specialists	Wyomissing	Pennsylvania

Sponsors (1)

Lead Sponsor	Collaborator
Philips Clinical & Medical Affairs Global

Country where clinical trial is conducted

United States, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	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	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.	Visit 2 (within six weeks of enrollment)