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

NCT05438017 · Status: COMPLETED · Phase: NA · Type: INTERVENTIONAL · Enrollment: 41

Last updated 2022-07-29

No results posted yet for this study

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.

Conditions

Interventions

DEVICE

Dreem 3 System vs PSG

Dreem 3 System to be worn by each participant while undergoing in-lab sleep study with PSG.

Sponsors & Collaborators

  • Dreem

    lead INDUSTRY

Study Design

Allocation
NA
Purpose
OTHER
Masking
NONE
Model
SINGLE_GROUP

Eligibility

Min Age
22 Years
Max Age
70 Years
Sex
ALL
Healthy Volunteers
Yes

Timeline & Regulatory

Start
2022-04-21
Primary Completion
2022-07-08
Completion
2022-07-08
FDA Device
Yes

Countries

  • United States
  • France

Study Locations

More Related Trials

Entities

Diseases

Read the full study record

This page highlights key information. For complete eligibility criteria, study locations, investigator contacts, and the full protocol, visit the original record on ClinicalTrials.gov.

View NCT05438017 on ClinicalTrials.gov