Assessment of the Performance of the V2 Version of the Dreem Headband for EEG Sleep Monitoring Compared to a Gold Standard Polysomnography.
Trial Snapshot
- Phase
- Not Applicable
- Status
- Completed
- Sponsor
- Enrollment
- 31
- Locations
- 2
- Primary Endpoint
- Sleep stages accuracy (Dreem vs. PSG consensus)
Study Overview
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.
Study Design
- Study Type
- Interventional
- Allocation
- Na
- Intervention Model
- Single Group
- Primary Purpose
- Diagnostic
- Masking
- None
Eligibility Criteria
- Ages
- 18 Years to 65 Years (Adult, Older Adult)
- Sex
- All
- Accepts Healthy Volunteers
- Yes
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
Arms & Interventions
Healthy adults
Dreem
Intervention: Dreem (Diagnostic Test)
Outcomes
Primary Outcomes
Sleep stages accuracy (Dreem vs. PSG consensus)
Time Frame: Day 1
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.
Secondary Outcomes
- Number of sleep eye movements (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 rapid eye movement (REM) sleep stage (accuracy between Dreem and PSG consensus)(Day 1)
- Number of sleep spindles (accuracy between Dreem and PSG consensus)(Day 1)
- Breathing frequency measurement (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)
- Total Sleep Time (TST) (accuracy between Dreem and PSG consensus)(Day 1)
- Number of sleep slow oscillations (accuracy between Dreem and PSG consensus)(Day 1)