MedTrace Logo

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

NCT05611099 · Status: COMPLETED · Phase: NA · Type: INTERVENTIONAL · Enrollment: 15

Last updated 2022-11-28

No results posted yet for this study

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

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.

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
2022-08-15
Primary Completion
2022-10-31
Completion
2022-11-05
FDA Device
Yes

Countries

  • United States

Study Locations

More Related Trials

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 NCT05611099 on ClinicalTrials.gov