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

Insomnia Clinical Trial

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

Clinical Trial 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.

Clinical Trial 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. ;

Study Design

Related Conditions & MeSH terms

  • Insomnia
  • Sleep Initiation and Maintenance Disorders
Clinical Trial Details
NCT number NCT05438017
Study type Interventional
Source Dreem
Contact
Status Completed
Phase N/A
Start date April 21, 2022
Completion date July 8, 2022
View Details
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