Clinical trial NCT03725943: Comparison of Dreem to Clinical PSG for Sleep Monitoring in Healthy Adults
Official title: Assessment of the Performance of the V2 Version of the Dreem Headband for EEG Sleep Monitoring Compared to a Gold Standard Polysomnography.
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: Sleep
Keywords: Automated Sleep Staging
Lead sponsor: Dreem
Sponsor class: INDUSTRY
Collaborators: name: Institut de Recherche Biomedicale des Armees
First posted: 2018-10-31
Enrollment: 31
Sex: ALL
Minimum age (years): 18
Maximum age (years): 65
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: yes
Allocation: NA
Intervention model: SINGLE_GROUP
Intervention model description: Dreem
Primary purpose: DIAGNOSTIC

Brief summary: This study aims to evaluate the accuracy of automated sleep analysis by the Dreem dry-EEG headband and deep learning algorithm in comparison to the consensus of 5 sleep technologists' manual scoring of a gold-standard clinical polysomnogram (PSG) record in healthy adult volunteers during an overnight clinic-based sleep study.

Detailed description: The study will enroll 25 adult volunteers who will undergo a one-night in-lab sleep study. All volunteers are first prescreened over the phone. Upon arrival at the research center, volunteers provide informed consent, are interviewed to confirm eligibility, and complete a detailed demographic, medical, health, sleep, and lifestyle survey. After the survey, participants are fitted with the PSG and the Dreem headband by the sleep technologist. During the PSG sleep study, the Dreem headband records EEG, pulse, oxygen saturation (SO2), movement, and respiratory rate.

Dreem's algorithms will be used to automatically stage the Dreem sleep data, and the results will then be compared to the consensus of 5 sleep technologists' manual scoring of the respective PSG records for the same individuals to determine the accuracy of Dreem's sleep staging algorithms.

Eligibility criteria: Inclusion Criteria:

* Capable of providing informed consent

Exclusion Criteria:

* Pregnant or nursing females
* History of any severe comorbidities such as cardiac, neurologic, or psychiatric diseases/disorders in the last 12 months
* Morbid obesity (BMI \>= 40)
* Use of benzodiazepines, nonbenzodiazepine (Z-drugs), or Gammahydroxybutyrate (GHB) the day/night of the study

Primary outcomes:
measure: Sleep stages accuracy (Dreem vs. PSG consensus)
timeFrame: Day 1
Secondary outcomes:
measure: Total Sleep Time (TST) (accuracy between Dreem and PSG consensus)
timeFrame: Day 1
measure: Wake After Sleep Onset (WASO) time (accuracy between Dreem and PSG consensus)
timeFrame: Day 1
measure: Time in N1 sleep stage (accuracy between Dreem and PSG consensus)
timeFrame: Day 1
measure: Time in N2 sleep stage (accuracy between Dreem and PSG consensus)
timeFrame: Day 1
measure: Time in N3 sleep stage (accuracy between Dreem and PSG consensus)
timeFrame: Day 1
measure: Time in rapid eye movement (REM) sleep stage (accuracy between Dreem and PSG consensus)
timeFrame: Day 1
measure: Number of sleep slow oscillations (accuracy between Dreem and PSG consensus)
timeFrame: Day 1
measure: Number of sleep spindles (accuracy between Dreem and PSG consensus)
timeFrame: Day 1
measure: Number of sleep eye movements (accuracy between Dreem and PSG consensus)
timeFrame: Day 1
measure: Breathing frequency measurement (accuracy between Dreem and PSG consensus)
timeFrame: Day 1
Other outcomes:
Locations:
city: Brétigny-sur-Orge
country: France
facility: Institut de Recherche Biomédicale des Armées
state: D19
Study officials:
affiliation: Institut de Recherche Biomédicale des Armées
name: Fabien Sauvet, M.D., Ph.D.
role: PRINCIPAL_INVESTIGATOR
References:
citation: Arnal PJ, Thorey V, Debellemaniere E, Ballard ME, Bou Hernandez A, Guillot A, Jourde H, Harris M, Guillard M, Van Beers P, Chennaoui M, Sauvet F. The Dreem Headband compared to polysomnography for electroencephalographic signal acquisition and sleep staging. Sleep. 2020 Nov 12;43(11):zsaa097. doi: 10.1093/sleep/zsaa097.