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

Not Applicable

Completed

• Conditions: Sleep Disturbance; Sleep Initiation and Maintenance Disorders; Insomnia, Secondary; Sleep
• Interventions: Device: Dreem 3 System vs WatchPAT One; Other: Usability Questionnaire

• Registration Number: NCT05611099
• Lead Sponsor: Dreem

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.

Detailed Description

Not available

Study Timeline

• Study Start: 2022-08-15
• Primary Completion: 2022-10-31
• Status Verified: 2022-11
• Study First Submitted: 2022-11-01
• Study Completion: 2022-11-05
• Study First Submitted QC: 2022-11-07
• Study First Posted: 2022-11-09
• Last Update Submitted: 2022-11-24
• Last Update Posted: 2022-11-28

Recruitment & Eligibility

• Status: COMPLETED
• Sex: All
• Target Recruitment: 15

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.

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: SINGLE_GROUP

Arm && Interventions

Group	Intervention	Description
Dreem + WatchPAT One	Usability Questionnaire	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.
Dreem + WatchPAT One	Dreem 3 System vs 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.

Primary Outcome Measures

Name	Time	Method
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

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

Trial Locations

Locations (1)

Dreem Health; 🇺🇸 Encinitas, California, United States