Robustness and Usability of the Dreem 3 System for at Home Sleep Monitoring in an Insomnia Population.

Study Overview
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Brief Summary
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There is an unmet medical need for monitoring sleep for multiple nights in a patient's home, without the inconvenience of traveling and staying overnight in a medical center, and without the need for a technician to set up a polysomnography (PSG) device at the patient's home. Several disorders, and particularly sleep disorders, are associated with insomnia symptoms, and longitudinal sleep assessment may support a better understanding and management of these patients, who currently seldom access sleep lab PSG. On one hand, this study aims at demonstrating whether the final device's user interface supports safe and effective use when being used at home over multiple nights. On the other, the study aims at confirming that stable and consistent data are measured in the device's actual use, for the records to be clinically usable in daily practice.

Official Title
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Assessment of the Stability, Robustness and Usability of the Dreem 3 System for EEG Sleep Monitoring in the Home Setting, in an Insomnia Population.

Conditions
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Insomnia, Secondary, Sleep Disturbance, Sleep, Sleep Initiation and Maintenance Disorders

Intervention / Treatment
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* Device: Dreem 3 System vs WatchPAT One
* Other: Usability Questionnaire


Participation Criteria
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Eligibility Criteria
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Inclusion Criteria: Subjects must be ≥ 22 and ≤ 70 years old inclusive, including: 8 subjects under 55 years old. 7 subjects over 55 years old. Subjects who are under the care of a sleep clinician for experiencing insomnia symptoms. Subjects have wifi connection at their home. Subjects have a smartphone where they can install the Alfin App. Subjects agree to not having abnormal drugs or alcohol consumption 24 hours before the start of the measurement, and during the 3 days of measurement. Able to read, understand and sign an informed consent form. Exclusion Criteria: Under 22 and above 70 years old inclusive. BMI ≥ 40. Obstructive sleep apnea diagnosis with ongoing CPAP therapy. Abnormal drugs or alcohol use during the measurement part of the study. Head circumference < 53 cm or device fitting issues as determined during training. Not able to read, understand and sign an informed consent form.

Ages Eligible for Study
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Minimum Age: 22 Years
Maximum Age: 70 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: Other
Intervention Model: Single Group Assignment
Masking: None (Open Label)


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Experimental: Dreem + WatchPAT One<br>Single arm of 15 subjects wearing simultaneously the Dreem 3 + WatchPAT One devices for 3 nights, and then undergoing an end of study usability questionnaire. | Device: Dreem 3 System vs WatchPAT One<br>* Dreem 3 System and WatchPAT One will be worn simultaneously during 3 nights by each study participant, in order to compare the TST automatically outputted by both devices.<br>Other: Usability Questionnaire<br>* After having undergone the 3 nights of measurement, an end of Study Questionnaire will be performed on a separate day to obtain Usability feedback from participants who have undergone simultaneous recordings with the Dreem 3 + WatchPAT devices.<br>|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| TST Correlation | Pearson's Correlation between the total time (in minutes) the subject spends asleep (TST) as automatically determined by the Dreem 3S compared to the TST automatically determined by the WatchPAT One (WP1) device on the same night. | 3 nights | 
| Dreem 3 System usability | As determined by the System Usability Scale. The System Usability Scale establishes a score (the SUS score), between 0 and 100. A score of 68 indicates average performance of a system. A score > 68 indicated the system's usability is above average. | 1 day | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| ΔTST Correlation | Pearson's correlation on Dreem 3S and WP1 intra-subject, inter-nights TST differences. | 3 nights | 

 Terms related to the study
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Keywords Provided by Centre Hospitalier Valida
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EEG, Polysomnography, Sleep assessment, Dreem, dry EEG, Accuracy