Comparison of Dreem to Clinical PSG for Sleep Monitoring in Healthy Adults

Dreem

Status

Completed

Conditions

Sleep

Treatments

Diagnostic Test: Dreem

Study type

Interventional

Funder types

Other

Industry

Identifiers

NCT03725943

OCTAVE IRBA

Details and patient eligibility

About

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.

Full 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.

Enrollment

31 patients

Sex

All

Ages

18 to 65 years old

Volunteers

Accepts Healthy Volunteers

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