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

NCT05611099 | Completed FDA Device

• 1 other identifier: LIVIE-1
• Study Type: interventional
• Target: 15
• Locations: 1 country
• Sites: 1

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.

Conditions

Insomnia, Secondary; Sleep Disturbance; Sleep; Sleep Initiation and Maintenance Disorders

Keywords

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

Outcome Measures

Primary Outcomes (2)

• TST Correlation

  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.

  3 nights

• Dreem 3 System usability

  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.

  1 day

Secondary Outcomes (1)

• ΔTST Correlation

  3 nights

Other Outcomes (2)

• Detailed Usability Questionnaire

  1 day

• Usability Interview

  1 day

Study Arms (1)

Dreem + WatchPAT One

EXPERIMENTAL

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; Other: Usability Questionnaire

Interventions

Dreem 3 System vs WatchPAT One DEVICE

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.

Dreem + WatchPAT One

Usability Questionnaire OTHER

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.

Dreem + WatchPAT One

Eligibility Criteria

• Age: 22 Years - 70 Years
• Sex: all
• Healthy Volunteers: Yes
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• Subjects must be ≥ 22 and ≤ 70 years old inclusive, including:
• subjects under 55 years old.
• 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.

You may not qualify if:

• 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.

Sponsors & Collaborators

• Dreem: lead

Study Sites (1)

Dreem Health

Encinitas, California, 92024, United States

Location

MeSH Terms

Conditions

Sleep Initiation and Maintenance Disorders; Parasomnias

Condition Hierarchy (Ancestors)

Sleep Disorders, Intrinsic; Dyssomnias; Sleep Wake Disorders; Nervous System Diseases; Mental Disorders

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: NA
• Masking: NONE
• Purpose: OTHER
• Intervention Model: SINGLE GROUP
• Sponsor Type: INDUSTRY
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: November 1, 2022
• First Posted: November 9, 2022
• Study Start: August 15, 2022
• Primary Completion: October 31, 2022
• Study Completion: November 5, 2022
• Last Updated: November 28, 2022

Record last verified: 2022-11

Data Sharing

• IPD Sharing: Will not share

Locations

US (1)