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

Sleep Clinical Trial

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.

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT05611099
• Other study ID #: LIVIE-1
• Status: Completed
• Phase: N/A
• Start date: August 15, 2022
• Est. completion date: November 5, 2022

Study information

• Verified date: November 2022
• Source: Dreem
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial 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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 15
• Est. completion date: November 5, 2022
• Est. primary completion date: October 31, 2022
• Accepts healthy volunteers: Accepts Healthy Volunteers
• Gender: All
• Age group: 22 Years to 70 Years

Eligibility

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.

Related Conditions & MeSH terms

• Dyssomnias
• Insomnia, Secondary
• Parasomnias
• Sleep
• Sleep Disturbance
• Sleep Initiation and Maintenance Disorders

Intervention

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.

Locations

Country	Name	City	State
United States	Dreem Health	Encinitas	California

Sponsors (1)

Lead Sponsor	Collaborator
Dreem

Country where clinical trial is conducted

United States, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Other	Detailed Usability Questionnaire	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.	1 day
Other	Usability Interview	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.	1 day
Primary	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
Primary	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	?TST Correlation	Pearson's correlation on Dreem 3S and WP1 intra-subject, inter-nights TST differences.	3 nights