NCT05611099

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

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

• Status: Completed
• Phase: N/A
• Study type: Interventional
• Enrollment: 15 (actual)
• Sponsor: Dreem · Industry
• Sex: All
• Age: 22 Years – 70 Years
• Healthy volunteers: Accepted

Summary

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.

Conditions

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

Interventions

Type	Name	Description
DEVICE	Dreem 3 System vs WatchPAT One	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.
OTHER	Usability Questionnaire	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.

Timeline

• Start date: 2022-08-15
• Primary completion: 2022-10-31
• Completion: 2022-11-05
• First posted: 2022-11-09
• Last updated: 2022-11-28

Locations

1 site across 1 country: United States

Regulatory

• FDA-regulated device study