Clinical trial NCT04671342: DreamKit Diagnostic Validation
Official title: Diagnostic Validation of the DreamKit Device Against Polysomnography
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: Sleep Apnea, Obstructive
Sleep Apnea, Central
Lead sponsor: Philips Clinical & Medical Affairs Global
Sponsor class: INDUSTRY
First posted: 2020-12-17
Enrollment: 306
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: yes
Allocation: NA
Intervention model: SINGLE_GROUP
Primary purpose: DIAGNOSTIC

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.

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).

Primary outcomes:
measure: Intraclass Correlation Coefficient (ICC) of the Apnea Hypopnea Index
timeFrame: Visit 2 (within six weeks of enrollment)
Secondary outcomes:
measure: Intraclass Correlation Coefficient (ICC) of the Central Apnea Index
timeFrame: Visit 2 (within six weeks of enrollment)
Other outcomes:
Locations:
city: Birmingham
country: United States
facility: Sleep Disorders Center of Alabama
state: Alabama
city: Colorado Springs
country: United States
facility: Delta Waves, Inc.
state: Colorado
city: Lehigh Acres
country: United States
facility: Florida Lung and Sleep Associates
state: Florida
city: Towson
country: United States
facility: Pulmonary and Critical Care Association of Baltimore
state: Maryland
city: Maplewood
country: United States
facility: Clayton Sleep Institute
state: Missouri
city: Wyomissing
country: United States
facility: Berks Schuylkill Respiratory Specialists
state: Pennsylvania
city: Columbia
country: United States
facility: Bogan Sleep Consultants
state: South Carolina
Study officials:
affiliation: Philips Sleep & Respiratory Care
name: Bill Hardy
role: STUDY_DIRECTOR
References: