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OpenTrials
Completed

NCT Number: NCT05611099

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

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.

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Key information

Conditions

Insomnia, Secondary Dyssomnias Mental Disorders Nervous System Diseases Parasomnias Sleep Sleep Disorders, Intrinsic Sleep Disturbance Sleep Initiation and Maintenance Disorders Sleep Wake Disorders

Age range

22 year–70 year

Sex eligibility

All sexes

Study type

Interventional

Phase

Not applicable

Primary location

Dreem Health

Encinitas, California, 92024, United States

Who can participate

Healthy volunteers accepted: Yes

Only the study team can determine whether someone qualifies for participation.

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.

Treatment and study plan

Dreem 3 System vs WatchPAT One

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

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.

Primary outcomes

  1. TST Correlation

    Time frame: 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.

  2. Dreem 3 System usability

    Time frame: 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 outcomes

  1. ΔTST Correlation

    Time frame: 3 nights

    Pearson's correlation on Dreem 3S and WP1 intra-subject, inter-nights TST differences.

Other outcomes

  1. Detailed Usability Questionnaire

    Time frame: 1 day

    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.

  2. Usability Interview

    Time frame: 1 day

    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.

Sponsors and collaborators

Lead sponsor

Dreem

Industry

Registry information

Official study 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.

Important dates

Study start
2022
Primary completion
2022
Study completion
2022
First posted
Nov 9, 2022
Registry last updated
Nov 28, 2022

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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