An interventional study of Dreem 3 System vs WatchPAT One and Usability Questionnaire in Insomnia, Secondary, Sleep Disturbance and Sleep, sponsored by Dreem. Completed at 1 site in United States. Open to participants aged 22 Years to 70 Years, including healthy volunteers. Per ClinicalTrials.gov, last updated 2022-11-28.
Sponsored by Dreem · Not applicable, Interventional, and Other
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.
1,856 studies on the registry are indexed under Sleep Initiation and Maintenance Disorders; 594 are open to participants now.
This study's enrollment of 15 is below the median of 73 across 1,631 interventional studies indexed under Sleep Initiation and Maintenance Disorders.
Browse Sleep Initiation and Maintenance Disorders studies →Dreem is the lead sponsor of 5 studies on the registry; none are open to participants now.
Counted across the registry records on this site, refreshed daily.
Subjects must be ≥ 22 and ≤ 70 years old inclusive, including:
Exclusion Criteria:
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 · Other: Usability Questionnaire
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.
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.
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.
Time frame: 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.
Time frame: 1 day
ΔTST Correlation
Pearson's correlation on Dreem 3S and WP1 intra-subject, inter-nights TST differences.
Time frame: 3 nights
Detailed Usability Questionnaire
Quantitative feedback on the critical tasks of the Dreem 3 System over multiple nights in a home environment. Questions are graded from "Strongly Disagree" to "Strongly Agree", where strongly agree means the subject understands how to interact with the different subparts of the Dreem 3S and experiences no usability issue.
Time frame: 1 day
Usability Interview
Qualitative information regarding the perceptions, opinions, beliefs and attitudes of individuals on the overall subjective experience of the Dreem 3 System over multiple nights in a home environment.
Time frame: 1 day
Plan to share: No
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This study is completed, as verified in Nov 2022. You cannot join it, but the record below documents what was studied.
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