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Trial record 1 of 1 for:    03725943
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Comparison of Dreem to Clinical PSG for Sleep Monitoring in Healthy Adults

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ClinicalTrials.gov Identifier: NCT03725943
Recruitment Status : Completed
First Posted : October 31, 2018
Last Update Posted : November 28, 2018
Sponsor:
Collaborator:
Institut de Recherche Biomedicale des Armees
Information provided by (Responsible Party):
Dreem

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.

Condition or disease Intervention/treatment Phase
Sleep Diagnostic Test: Dreem Not Applicable

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.


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Study Type : Interventional  (Clinical Trial)
Actual Enrollment : 31 participants
Intervention Model: Single Group Assignment
Intervention Model Description: Dreem
Masking: None (Open Label)
Primary Purpose: Diagnostic
Official Title: Assessment of the Performance of the V2 Version of the Dreem Headband for EEG Sleep Monitoring Compared to a Gold Standard Polysomnography.
Actual Study Start Date : September 4, 2018
Actual Primary Completion Date : November 16, 2018
Actual Study Completion Date : November 16, 2018

Arm Intervention/treatment
Experimental: Healthy adults
Dreem
Diagnostic Test: Dreem
Dreem Band to be worn by each participant while undergoing in-lab sleep study with PSG.




Primary Outcome Measures :
  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 Outcome Measures :
  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.



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Ages Eligible for Study:   18 Years to 65 Years   (Adult, Older Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   Yes
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

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT03725943


Locations
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France
Institut de Recherche Biomédicale des Armées
Brétigny-sur-Orge, D19, France, 91220
Sponsors and Collaborators
Dreem
Institut de Recherche Biomedicale des Armees
Investigators
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Principal Investigator: Fabien Sauvet, M.D., Ph.D. Institut de Recherche Biomédicale des Armées

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Responsible Party: Dreem
ClinicalTrials.gov Identifier: NCT03725943     History of Changes
Other Study ID Numbers: OCTAVE IRBA
First Posted: October 31, 2018    Key Record Dates
Last Update Posted: November 28, 2018
Last Verified: November 2018
Individual Participant Data (IPD) Sharing Statement:
Plan to Share IPD: Undecided
Plan Description: We plan to share de-identified physiological data in an open-source format to the public. However, this will only occur if the data files are of sufficient quality and likely to be of use to the scientific community. This decision may also depend on certain legal or business constraints.

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Studies a U.S. FDA-regulated Drug Product: No
Studies a U.S. FDA-regulated Device Product: No

Keywords provided by Dreem:
Automated Sleep Staging