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N/A N=306 Diagnostic

DreamKit Diagnostic Validation

Sleep Apnea, Obstructive · Sleep Apnea, Central

Enrolled (actual)
306
Serious AEs
0.0%
Results posted
Jan 2023
Primary outcome: Primary: Intraclass Correlation Coefficient (ICC) of the Apnea Hypopnea Index — 0.964 intraclass correlation coefficient (ICC)

Study Design & Population

Study type
Interventional
Phase
N/A
Interventions
DreamKit (Device)
Age
Adult, Older Adult · 18+ yrs
Sex
All
Sponsor
Philips Clinical & Medical Affairs Global
Primary completion
Dec 2021

Outcome Measures

OutcomeResultp-value
PRIMARY
Intraclass Correlation Coefficient (ICC) of the Apnea Hypopnea Index
0.964
SECONDARY
Intraclass Correlation Coefficient (ICC) of the Central Apnea Index
0.731

Summary

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

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).
View full record on ClinicalTrials.gov →

Data sourced from ClinicalTrials.gov (NCT04671342). Outcome figures and adverse-event rates are extracted automatically from the registry's posted results and are provided for clinician reference, not as a substitute for the primary publication.

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