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

Dreem

Status: Completed

Conditions: Sleep Initiation and Maintenance Disorders; Insomnia, Secondary; Sleep Disturbance; Sleep

Treatments: Other: Usability Questionnaire; Device: Dreem 3 System vs WatchPAT One

Study type: Interventional

Funder types: Industry

Identifiers

NCT05611099

LIVIE-1

Details and patient eligibility

About

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.

Enrollment: 15 patients

Sex: All

Ages: 22 to 70 years old

Volunteers: Accepts Healthy Volunteers

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.

Trial design

Primary purpose: Other

Allocation: N/A

Interventional model: Single Group Assignment

Masking: None (Open label)

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15 participants in 1 patient group

Dreem + WatchPAT One

Experimental group

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.

Treatment:

Other: Usability Questionnaire

Device: Dreem 3 System vs WatchPAT One