DreamKit Diagnostic Validation

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

Detailed Description
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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.

Official Title
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Diagnostic Validation of the DreamKit Device Against Polysomnography

Conditions
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Sleep Apnea, Obstructive, Sleep Apnea, Central

Intervention / Treatment
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* Device: DreamKit


Participation Criteria
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Eligibility Criteria
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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).

Ages Eligible for Study
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Minimum Age: 18 Years

Sexes Eligible for Study
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All

Accepts Healthy Volunteers
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Accepts Healthy Volunteers

Study Plan
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How is the study designed?
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Design Details

Primary Purpose: Diagnostic
Intervention Model: Single Group Assignment
Masking: None (Open Label)


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Experimental: Validation Arm<br>Participants will wear the DreamKit device (test device) while instrumented with polysomnography sensors (gold standard). | Device: DreamKit<br>* The DreamKit device is a single-use device intended to aid the diagnosis of sleep-disordered breathing.<br>|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| 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 Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| 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) |