Back to resultsRobustness and Usability of the Dreem 3 System for at Home Sleep Monitoring in an Insomnia Population.
Primary Purpose
Insomnia, Secondary, Sleep Disturbance, Sleep
Status
Completed
Phase
Not Applicable
Locations
United States
Study Type
Interventional
Intervention
Dreem 3 System vs WatchPAT One
Usability Questionnaire
Sponsored by
About this trial
This is an interventional other trial for Insomnia, Secondary focused on measuring Polysomnography, Sleep assessment, Dreem, EEG, dry EEG, Accuracy
Eligibility 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.
Sites / Locations
- Dreem Health
Arms of the Study
Arm 1
Arm Type
Experimental
Arm Label
Dreem + WatchPAT One
Arm Description
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.
Outcomes
Primary Outcome Measures
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.
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.
Secondary Outcome Measures
ΔTST Correlation
Pearson's correlation on Dreem 3S and WP1 intra-subject, inter-nights TST differences.
Full Information
1. Study Identification
Unique Protocol Identification Number
NCT05611099
Brief Title
Robustness and Usability of the Dreem 3 System for at Home Sleep Monitoring in an Insomnia Population.
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.
Study Type
Interventional
2. Study Status
Record Verification Date
November 2022
Overall Recruitment Status
Completed
Study Start Date
August 15, 2022 (Actual)
Primary Completion Date
October 31, 2022 (Actual)
Study Completion Date
November 5, 2022 (Actual)
3. Sponsor/Collaborators
Responsible Party, by Official Title
Sponsor
Name of the Sponsor
Dreem
4. Oversight
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
5. 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.
6. Conditions and Keywords
Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Insomnia, Secondary, Sleep Disturbance, Sleep, Sleep Initiation and Maintenance Disorders
Keywords
Polysomnography, Sleep assessment, Dreem, EEG, dry EEG, Accuracy
7. Study Design
Primary Purpose
Other
Study Phase
Not Applicable
Interventional Study Model
Single Group Assignment
Masking
None (Open Label)
Allocation
N/A
Enrollment
15 (Actual)
8. Arms, Groups, and Interventions
Arm Title
Dreem + WatchPAT One
Arm Type
Experimental
Arm Description
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.
Intervention Type
Device
Intervention Name(s)
Dreem 3 System vs WatchPAT One
Intervention Description
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.
Intervention Type
Other
Intervention Name(s)
Usability Questionnaire
Intervention Description
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 Measure Information:
Title
TST Correlation
Description
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.
Time Frame
3 nights
Title
Dreem 3 System usability
Description
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.
Time Frame
1 day
Secondary Outcome Measure Information:
Title
ΔTST Correlation
Description
Pearson's correlation on Dreem 3S and WP1 intra-subject, inter-nights TST differences.
Time Frame
3 nights
Other Pre-specified Outcome Measures:
Title
Detailed Usability Questionnaire
Description
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.
Time Frame
1 day
Title
Usability Interview
Description
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.
Time Frame
1 day
10. Eligibility
Sex
All
Minimum Age & Unit of Time
22 Years
Maximum Age & Unit of Time
70 Years
Accepts Healthy Volunteers
Accepts Healthy Volunteers
Eligibility 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.
Facility Information:
Facility Name
Dreem Health
City
Encinitas
State/Province
California
ZIP/Postal Code
92024
Country
United States
12. IPD Sharing Statement
Plan to Share IPD
No
Learn more about this trial
Robustness and Usability of the Dreem 3 System for at Home Sleep Monitoring in an Insomnia Population.
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