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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.
Full description
Subjects enrolled in the study will come to the sleep laboratory around 8 pm. Their involvement in the protocol will only require them to be equipped by the technician with Dreem 3 in addition to the PSG reference system. This involves the technician placing all the PSG electrodes on the subject's head as per normal practice, and then positioning the Dreem 3 headband so that both devices can operate simultaneously. The subject will be allowed to go to his/her room and do quiet activities (reading, film watching, chatting) prior to sleeping. At the end of the night, the technician will remove the Dreem 3 headband and the PSG.
A technical quality control will be performed on the collected data in accordance with the standard operating procedures, as defined in the study protocol. Recordings that do not meet the quality control criteria will be excluded from further analysis.
Subjects will receive the PSG report at the end of the study.
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Inclusion criteria
Exclusion criteria
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:
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.
Primary purpose
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Interventional model
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41 participants in 1 patient group
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Data sourced from clinicaltrials.gov
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