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

Sponsor

Dreem (Industry)

Overall Status

Completed

CT.gov ID

NCT05611099

Collaborator

(none)

Enrollment

Location

Arm

2.7

Actual Duration (Months)

5.6

Patients Per Site Per Month

Study Details

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	N/A

Study Design

Study Type:

Interventional

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 :

Aug 15, 2022

Actual Primary Completion Date :

Oct 31, 2022

Actual Study Completion Date :

Nov 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.

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

TST Correlation [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.
Dreem 3 System usability [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

ΔTST Correlation [3 nights]
Pearson's correlation on Dreem 3S and WP1 intra-subject, inter-nights TST differences.

Other Outcome Measures

Detailed Usability Questionnaire [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.
Usability Interview [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

Criteria

Ages Eligible for Study:

22 Years to 70 Years

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.