Status:
COMPLETED
DreamKit Diagnostic Validation
Lead Sponsor:
Philips Clinical & Medical Affairs Global
Conditions:
Sleep Apnea, Obstructive
Sleep Apnea, Central
Eligibility:
All Genders
18+ years
Phase:
NA
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...
Eligibility Criteria
Inclusion
- Aged ≥18 years;
- Fluent in English;
- Able to provide informed consent.
Exclusion
- 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).
Key Trial Info
Start Date :
January 14 2021
Trial Type :
INTERVENTIONAL
Allocation :
ACTUAL
End Date :
December 18 2021
Estimated Enrollment :
306 Patients enrolled
Trial Details
Trial ID
NCT04671342
Start Date
January 14 2021
End Date
December 18 2021
Last Update
January 31 2023
Active Locations (7)
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1
Sleep Disorders Center of Alabama
Birmingham, Alabama, United States, 35213
2
Delta Waves, Inc.
Colorado Springs, Colorado, United States, 80918
3
Florida Lung and Sleep Associates
Lehigh Acres, Florida, United States, 33971
4
Pulmonary and Critical Care Association of Baltimore
Towson, Maryland, United States, 21286