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

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details. Identifier: NCT05611099
Recruitment Status : Completed
First Posted : November 9, 2022
Last Update Posted : November 28, 2022
Information provided by (Responsible Party):

Brief 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.

Condition or disease Intervention/treatment Phase
Insomnia, Secondary Sleep Disturbance Sleep Sleep Initiation and Maintenance Disorders Device: Dreem 3 System vs WatchPAT One Other: Usability Questionnaire Not Applicable

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Study Type : Interventional  (Clinical Trial)
Actual Enrollment : 15 participants
Allocation: N/A
Intervention Model: Single Group Assignment
Masking: None (Open Label)
Primary Purpose: Other
Official Title: Assessment of the Stability, Robustness and Usability of the Dreem 3 System for EEG Sleep Monitoring in the Home Setting, in an Insomnia Population.
Actual Study Start Date : August 15, 2022
Actual Primary Completion Date : October 31, 2022
Actual Study Completion Date : November 5, 2022

Arm Intervention/treatment
Experimental: Dreem + WatchPAT One
Single arm of 15 subjects wearing simultaneously the Dreem 3 + WatchPAT One devices for 3 nights, and then undergoing an end of study usability questionnaire.
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.

Primary Outcome Measures :
  1. TST Correlation [ Time Frame: 3 nights ]
    Pearson's Correlation between the total time (in minutes) the subject spends asleep (TST) as automatically determined by the Dreem 3S compared to the TST automatically determined by the WatchPAT One (WP1) device on the same night.

  2. Dreem 3 System usability [ Time Frame: 1 day ]
    As determined by the System Usability Scale. The System Usability Scale establishes a score (the SUS score), between 0 and 100. A score of 68 indicates average performance of a system. A score > 68 indicated the system's usability is above average.

Secondary Outcome Measures :
  1. ΔTST Correlation [ Time Frame: 3 nights ]
    Pearson's correlation on Dreem 3S and WP1 intra-subject, inter-nights TST differences.

Other Outcome Measures:
  1. Detailed Usability Questionnaire [ Time Frame: 1 day ]
    Quantitative feedback on the critical tasks of the Dreem 3 System over multiple nights in a home environment. Questions are graded from "Strongly Disagree" to "Strongly Agree", where strongly agree means the subject understands how to interact with the different subparts of the Dreem 3S and experiences no usability issue.

  2. Usability Interview [ Time Frame: 1 day ]
    Qualitative information regarding the perceptions, opinions, beliefs and attitudes of individuals on the overall subjective experience of the Dreem 3 System over multiple nights in a home environment.

Information from the National Library of Medicine

Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the contacts provided below. For general information, Learn About Clinical Studies.

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Ages Eligible for Study:   22 Years to 70 Years   (Adult, Older Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   Yes

Inclusion Criteria:

  • Subjects must be ≥ 22 and ≤ 70 years old inclusive, including:

    • 8 subjects under 55 years old.
    • 7 subjects over 55 years old.
  • Subjects who are under the care of a sleep clinician for experiencing insomnia symptoms.
  • Subjects have wifi connection at their home.
  • Subjects have a smartphone where they can install the Alfin App.
  • Subjects agree to not having abnormal drugs or alcohol consumption 24 hours before the start of the measurement, and during the 3 days of measurement.
  • Able to read, understand and sign an informed consent form.

Exclusion Criteria:

  • Under 22 and above 70 years old inclusive.
  • BMI ≥ 40.
  • Obstructive sleep apnea diagnosis with ongoing CPAP therapy.
  • Abnormal drugs or alcohol use during the measurement part of the study.
  • Head circumference < 53 cm or device fitting issues as determined during training.
  • Not able to read, understand and sign an informed consent form.

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its identifier (NCT number): NCT05611099

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United States, California
Dreem Health
Encinitas, California, United States, 92024
Sponsors and Collaborators
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Responsible Party: Dreem Identifier: NCT05611099    
Other Study ID Numbers: LIVIE-1
First Posted: November 9, 2022    Key Record Dates
Last Update Posted: November 28, 2022
Last Verified: November 2022
Individual Participant Data (IPD) Sharing Statement:
Plan to Share IPD: No

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Studies a U.S. FDA-regulated Drug Product: No
Studies a U.S. FDA-regulated Device Product: Yes
Device Product Not Approved or Cleared by U.S. FDA: Yes
Keywords provided by Dreem:
Sleep assessment
dry EEG
Additional relevant MeSH terms:
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Sleep Initiation and Maintenance Disorders
Sleep Disorders, Intrinsic
Sleep Wake Disorders
Nervous System Diseases
Mental Disorders