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Completed

NCT Number: NCT03725943

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

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.

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Key information

Conditions

Sleep

Age range

18 year–65 year

Sex eligibility

All sexes

Study type

Interventional

Phase

Not applicable

Primary location

Institut de Recherche Biomédicale des Armées

Brétigny-sur-Orge, D19, 91220, France

About this study

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.

Who can participate

Healthy volunteers accepted: Yes

Only the study team can determine whether someone qualifies for participation.

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

Treatment and study plan

Dreem

Diagnostic Test

Dreem Band to be worn by each participant while undergoing in-lab sleep study with PSG.

Primary outcomes

  1. 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

  1. Total Sleep Time (TST) (accuracy between Dreem and PSG consensus)

    Time frame: Day 1

    Total time (in minutes) the subject spends asleep as automatically determined by the Dreem headband compared to the TST determined by the consensus of 5 sleep technologists' scoring of the subject's PSG record from the same night.

  2. Wake After Sleep Onset (WASO) time (accuracy between Dreem and PSG consensus)

    Time frame: Day 1

    Total time (in minutes) the subject spends awake from sleep onset to sleep end as automatically determined by the Dreem headband compared to the WASO determined by the consensus of 5 sleep technologists' scoring of the subject's PSG record from the same night.

  3. Time in N1 sleep stage (accuracy between Dreem and PSG consensus)

    Time frame: Day 1

    Total time (in minutes) the subject spends in AASM N1 sleep stage as automatically determined by the Dreem headband compared to the N1 time determined by the consensus of 5 sleep technologists' scoring of the subject's PSG record from the same night.

  4. Time in N2 sleep stage (accuracy between Dreem and PSG consensus)

    Time frame: Day 1

    Total time (in minutes) the subject spends in AASM N2 sleep stage as automatically determined by the Dreem headband compared to the N2 time determined by the consensus of 5 sleep technologists' scoring of the subject's PSG record from the same night.

  5. Time in N3 sleep stage (accuracy between Dreem and PSG consensus)

    Time frame: Day 1

    Total time (in minutes) the subject spends in AASM N3 sleep stage as automatically determined by the Dreem headband compared to the N3 time determined by the consensus of 5 sleep technologists' scoring of the subject's PSG record from the same night.

  6. Time in rapid eye movement (REM) sleep stage (accuracy between Dreem and PSG consensus)

    Time frame: Day 1

    Total time (in minutes) the subject spends in AASM REM sleep stage as automatically determined by the Dreem headband compared to the REM time determined by the consensus of 5 sleep technologists' scoring of the subject's PSG record from the same night.

  7. Number of sleep slow oscillations (accuracy between Dreem and PSG consensus)

    Time frame: Day 1

    Number of sleep slow oscillations counted automatically by the Dreem headband compared to those determined by the consensus of 5 sleep technologists' scoring of the subject's PSG record from the same night.

  8. Number of sleep spindles (accuracy between Dreem and PSG consensus)

    Time frame: Day 1

    Number of sleep spindles counted automatically by the Dreem headband compared to those determined by the consensus of 5 sleep technologists' scoring of the subject's PSG record from the same night.

  9. Number of sleep eye movements (accuracy between Dreem and PSG consensus)

    Time frame: Day 1

    Number of eye movements during sleep counted automatically by the Dreem headband compared to those determined by the consensus of 5 sleep technologists' scoring of the subject's PSG record from the same night.

  10. Breathing frequency measurement (accuracy between Dreem and PSG consensus)

    Time frame: Day 1

    Breathing frequency measured automatically by the Dreem headband's accelerometer compared to those determined by the nasal cannula on the subject's PSG from the same night.

Sponsors and collaborators

Lead sponsor

Dreem

Industry

Collaborators

  • Institut de Recherche Biomedicale des Armees

Registry information

Official study title

Assessment of the Performance of the V2 Version of the Dreem Headband for EEG Sleep Monitoring Compared to a Gold Standard Polysomnography.

Important dates

Study start
2018
Primary completion
2018
Study completion
2018
First posted
Oct 31, 2018
Registry last updated
Nov 28, 2018

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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