DreamKit Diagnostic Validation

Philips

Status

Completed

Conditions

Sleep Apnea, Obstructive

Sleep Apnea, Central

Treatments

Device: DreamKit

Study type

Interventional

Funder types

Industry

Identifiers

NCT04671342

SRC_SLE_Sparkle_PSG_2020_10908

Details and patient eligibility

About

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

Full 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.

Enrollment

306 patients

Sex

All

Ages

18+ years old

Volunteers

Accepts 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).