Clinical trial NCT05438017: Performance Evaluation of the Dreem 3 System for Sleep Assessment in Patients With Insomnia
Official title: Assessment of the Performance of the Dreem 3 System for EEG Sleep Monitoring in the Lab Setting
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: Insomnia
Keywords: Dreem
Insomnia symptoms
Sleep
Polysomnography
Performance
EEG
Sleep monitoring
Lead sponsor: Dreem
Sponsor class: INDUSTRY
First posted: 2022-06-29
Enrollment: 41
Sex: ALL
Minimum age (years): 22
Maximum age (years): 70
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: yes
Allocation: NA
Intervention model: SINGLE_GROUP
Primary purpose: OTHER

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 population experiencing insomnia symptoms.

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 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.

Eligibility criteria: Inclusion Criteria:

* 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 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:

  * 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.

Primary outcomes:
measure: Performance of the automatic sleep stage scoring of the Dreem 3 System compared to the consensus of 3 independent certified sleep scorers realized on the polysomnography signal.
timeFrame: Day 1
Secondary outcomes:
measure: TST (Total Sleep Time)
timeFrame: Day 1
measure: SE (Sleep Efficiency)
timeFrame: Day 1
measure: SOL (Sleep Onset Latency)
timeFrame: Day 1
measure: LPS (Latency to Persistent Sleep)
timeFrame: Day 1
measure: WASO (Wake After Sleep Onset)
timeFrame: Day 1
measure: Total time spent in N2 sleep stage
timeFrame: Day 1
measure: Total time spent in N3 sleep stage
timeFrame: Day 1
measure: Total time spent in REM sleep stage
timeFrame: Day 1
measure: Total time spent in N1 sleep stage
timeFrame: Day 1
measure: Respiratory Rate
timeFrame: Day 1
Other outcomes:
Locations:
city: Newark
country: United States
facility: Biotrial Inc
state: New Jersey
city: Rennes
country: France
facility: Biotrial Rennes
Study officials:
References: