NCT05438017

Performance Evaluation of the Dreem 3 System for Sleep Assessment in Patients With Insomnia

Assessment of the Performance of the Dreem 3 System for EEG Sleep Monitoring in the Lab Setting

• Status: Completed
• Phase: N/A
• Study type: Interventional
• Enrollment: 41 (actual)
• Sponsor: Dreem · Industry
• Sex: All
• Age: 22 Years – 70 Years
• Healthy volunteers: Accepted

Summary

The objective of the clinical investigation is to assess the performance of the Dreem 3 System for sleep assessment compared to a FDA-cleared PSG assessment and human sleep expert scoring in a population experiencing insomnia symptoms.

Detailed description

Subjects enrolled in the study will come to the sleep laboratory around 8 pm. Their involvement in the protocol will only require them to be equipped by the technician with Dreem 3 in addition to the PSG reference system. This involves the technician placing all the PSG electrodes on the subject's head as per normal practice, and then positioning the Dreem 3 headband so that both devices can operate simultaneously. The subject will be allowed to go to his/her room and do quiet activities (reading, film watching, chatting) prior to sleeping. At the end of the night, the technician will remove the Dreem 3 headband and the PSG. A technical quality control will be performed on the collected data in accordance with the standard operating procedures, as defined in the study protocol. Recordings that do not meet the quality control criteria will be excluded from further analysis. Subjects will receive the PSG report at the end of the study.

Conditions

• Insomnia

Interventions

Type	Name	Description
DEVICE	Dreem 3 System vs PSG	Dreem 3 System to be worn by each participant while undergoing in-lab sleep study with PSG.

Timeline

• Start date: 2022-04-21
• Primary completion: 2022-07-08
• Completion: 2022-07-08
• First posted: 2022-06-29
• Last updated: 2022-07-29

Locations

2 sites across 2 countries: United States, France

Regulatory

• FDA-regulated device study