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

• ClinicalTrials.gov Identifier: NCT05611099
• Recruitment Status: Completed
• First Posted: November 9, 2022
• Last Update Posted: November 28, 2022
• Sponsor: Dreem
• Information provided by (Responsible Party): Dreem

Study Description

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

Study Design

• 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

Arms and Interventions

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.

Outcome Measures

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.

Eligibility Criteria

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

Criteria

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.

Contacts and Locations

Locations

United States, California

Dreem Health

Encinitas, California, United States, 92024

Sponsors and Collaborators

Dreem

More Information

• Responsible Party: Dreem
• ClinicalTrials.gov Identifier: NCT05611099
• Other Study ID Numbers: LIVIE-1
• First Posted: November 9, 2022
• Last Update Posted: November 28, 2022
• Last Verified: November 2022

Individual Participant Data (IPD) Sharing Statement:

• Plan to Share IPD: No

• 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:

Polysomnography; Sleep assessment; Dreem; EEG; dry EEG; Accuracy

Additional relevant MeSH terms:

Sleep Initiation and Maintenance Disorders; Sleep Disorders, Intrinsic; Dyssomnias; Sleep Wake Disorders; Nervous System Diseases; Mental Disorders