Comparison of Dreem to Clinical PSG for Sleep Monitoring in Healthy Adults
Assessment of the Performance of the V2 Version of the Dreem Headband for EEG Sleep Monitoring Compared to a Gold Standard Polysomnography.
1 other identifier
interventional
31
1 country
1
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.
Trial Health
Trial Health Score
Automated assessment based on enrollment pace, timeline, and geographic reach
participants targeted
Target at P25-P50 for not_applicable
Started Sep 2018
Shorter than P25 for not_applicable
1 active site
Health score is calculated from publicly available data and should be used for screening purposes only.
Trial Relationships
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Study Timeline
Key milestones and dates
Study Start
First participant enrolled
September 4, 2018
CompletedFirst Submitted
Initial submission to the registry
October 29, 2018
CompletedFirst Posted
Study publicly available on registry
October 31, 2018
CompletedPrimary Completion
Last participant's last visit for primary outcome
November 16, 2018
CompletedStudy Completion
Last participant's last visit for all outcomes
November 16, 2018
CompletedNovember 28, 2018
November 1, 2018
2 months
October 29, 2018
November 26, 2018
Conditions
Keywords
Outcome Measures
Primary Outcomes (1)
Sleep stages accuracy (Dreem vs. PSG consensus)
Cohen's kappa comparing the classification of AASM sleep stages at each 30-sec epoch determined automatically by the Dreem headband compared those determined by the consensus of 5 sleep technologists' scoring of each subject's PSG record from the same night.
Day 1
Secondary Outcomes (10)
Total Sleep Time (TST) (accuracy between Dreem and PSG consensus)
Day 1
Wake After Sleep Onset (WASO) time (accuracy between Dreem and PSG consensus)
Day 1
Time in N1 sleep stage (accuracy between Dreem and PSG consensus)
Day 1
Time in N2 sleep stage (accuracy between Dreem and PSG consensus)
Day 1
Time in N3 sleep stage (accuracy between Dreem and PSG consensus)
Day 1
- +5 more secondary outcomes
Study Arms (1)
Healthy adults
EXPERIMENTALDreem
Interventions
Dreem Band to be worn by each participant while undergoing in-lab sleep study with PSG.
Eligibility Criteria
You may qualify if:
- Capable of providing informed consent
You may not qualify if:
- 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
Contact the study team to confirm eligibility.
Sponsors & Collaborators
- Dreemlead
- Institut de Recherche Biomedicale des Armeescollaborator
Study Sites (1)
Institut de Recherche Biomédicale des Armées
Brétigny-sur-Orge, D19, 91220, France
Related Publications (1)
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.
PMID: 32433768DERIVED
Study Officials
- PRINCIPAL INVESTIGATOR
Fabien Sauvet, M.D., Ph.D.
Institut de Recherche Biomédicale des Armées
Study Design
- Study Type
- interventional
- Phase
- not applicable
- Allocation
- NA
- Masking
- NONE
- Purpose
- DIAGNOSTIC
- Intervention Model
- SINGLE GROUP
- Sponsor Type
- INDUSTRY
- Responsible Party
- SPONSOR
Study Record Dates
First Submitted
October 29, 2018
First Posted
October 31, 2018
Study Start
September 4, 2018
Primary Completion
November 16, 2018
Study Completion
November 16, 2018
Last Updated
November 28, 2018
Record last verified: 2018-11