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

NCT ID: NCT05611099

Last Updated: 2022-11-28

Basic Information

• Recruitment Status: COMPLETED
• Clinical Phase: NA
• Total Enrollment: 15 participants
• Study Classification: INTERVENTIONAL
• Study Start Date: 2022-08-15
• Study Completion Date: 2022-11-05

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

Study Design

• Allocation Method: NA
• Intervention Model: SINGLE_GROUP
• Primary Study Purpose: OTHER
• Blinding Strategy: NONE

Study Groups

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.

Group Type: EXPERIMENTAL

Dreem 3 System vs WatchPAT One

Intervention Type: 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.

Usability Questionnaire

Intervention Type: 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.

Interventions

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.

Intervention Type: DEVICE

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.

Intervention Type: OTHER

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.

• Minimum Eligible Age: 22 Years
• Maximum Eligible Age: 70 Years
• Eligible Sex: ALL
• Accepts Healthy Volunteers: Yes

Sponsors

Dreem

INDUSTRY

Sponsor Role: lead

Responsible Party

Responsibility Role: SPONSOR

Locations

Dreem Health

Encinitas, California, United States

Countries

United States

Other Identifiers

LIVIE-1

Identifier Type: -

Identifier Source: org_study_id