Performance Evaluation of the Dreem 3 System for Sleep Assessment in Patients With Insomnia

Completed · Not applicable

Conditions studied: Insomnia

In brief

The objective of the clinical investigation is to assess the performance of the Dreem 3 System for sleep assessment compared to a FDA-cleared PSG assessment and human sleep expert scoring in a population experiencing insomnia symptoms.

Key facts

Study ID

NCT05438017

Run by

Dreem

People needed

41

Starts

2022-04-21

Expected to finish

2022-07-08

Last updated by the study team

2022-07-29

Who can join

Age: 22 and older, up to 70. Sex: any. Healthy volunteers: accepted.

You may qualify if…

• Subjects must be ≥ 22 and ≤ 70 years old inclusive.
• Able to read, understand and sign an informed consent form.
• Subjects with stable disease or/and taking stable medications for at least 2 months can be included under Principal Investigator or Sub-Investigator discretion
• Self-reported insomnia symptoms (by means of a questionnaire completed by the participant before their visit to the sleep lab) as defined by International Classification of Sleep Disorders, third edition (ICSD-3), confirmed by a clinician.

You may not qualify if…

• Female subjects who are pregnant, or breastfeeding.
• Subject under 22 and above 70 years old inclusive.
• Not able to read, understand and sign an informed consent form
• Subjects with BMI ≥ 40
• Taking medications that induce somnolence or wakefulness, or that can interfere with sleep recording:
• If the subject is taking OTC medications that can induce somnolence or wakefulness, he/she must not take it the day of the measurement.
• Prescription only drugs that induce somnolence or wakefulness must be stopped one week before, as PI or Sub-I discretion and/or review with subject's physician.
• Subjects previously diagnosed with Obstructive Sleep Apnea (OSA), REM Sleep Disorder, Narcolepsy, Hypersomnia, or significant difficulty breathing due to underlying condition(s), or subjects diagnosed with Central Nervous System (CNS) disease.
• Subjects that suffer from an unstable disease
• Any incidental finding on the Polysomnography reference system, happening during the study recording, that interferes with eligibility (probable moderate/severe undiagnosed OSA)
• Subjects who may experience fitting difficulties with the headband, including people with head circumference < 53cm, or a hairstyle impeding the sensor placement (tight braids, hair extension, dreadlocks…) as determined by the investigator.

Where it is running

• Biotrial Inc — Newark, New Jersey, United States
• Biotrial Rennes — Rennes, France

Full record on ClinicalTrials.gov

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