Status:
COMPLETED
Performance Evaluation of the Dreem 3 System for Sleep Assessment in Patients With Insomnia
Lead Sponsor:
Dreem
Conditions:
Insomnia
Eligibility:
All Genders
22-70 years
Phase:
NA
Brief Summary
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 populat...
Detailed 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 ...
Eligibility Criteria
Inclusion
- 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.
Exclusion
- 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.
Key Trial Info
Start Date :
April 21 2022
Trial Type :
INTERVENTIONAL
Allocation :
ACTUAL
End Date :
July 8 2022
Estimated Enrollment :
41 Patients enrolled
Trial Details
Trial ID
NCT05438017
Start Date
April 21 2022
End Date
July 8 2022
Last Update
July 29 2022
Active Locations (2)
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1
Biotrial Inc
Newark, New Jersey, United States, 07103
2
Biotrial Rennes
Rennes, France, 35000