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Trial record 2 of 7 for:    dreem

Comparison of Dreem to Clinical PSG for Sleep Monitoring in Apnea Patients

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details.
 
ClinicalTrials.gov Identifier: NCT03657329
Recruitment Status : Completed
First Posted : September 5, 2018
Last Update Posted : November 28, 2018
Sponsor:
Collaborator:
Stanford University
Information provided by (Responsible Party):
Dreem

Tracking Information
First Submitted Date  ICMJE August 31, 2018
First Posted Date  ICMJE September 5, 2018
Last Update Posted Date November 28, 2018
Actual Study Start Date  ICMJE May 7, 2018
Actual Primary Completion Date November 2, 2018   (Final data collection date for primary outcome measure)
Current Primary Outcome Measures  ICMJE
 (submitted: October 30, 2018)
Apnea-Hypopnea Index (AHI) severity agreement [ Time Frame: Day 1 ]
AHI severity (normal [<5], mild [5-14], moderate [15-29], severe [>29]) as automatically determined by the Dreem headband compared to the AHI severity determined by the consensus of 5 sleep technologists' scoring of the subject's PSG record from the same night.
Original Primary Outcome Measures  ICMJE
 (submitted: August 31, 2018)
Apnea-Hypopnea Index (AHI) severity agreement [ Time Frame: One night of observation ]
AHI severity (normal [<5], mild [5-14], moderate [15-29], severe [>29]) as automatically determined by the Dreem headband compared to the AHI severity determined by the consensus of 5 sleep technologists' scoring of the subject's polysomnogram (PSG) data file from the same night.
Change History
Current Secondary Outcome Measures  ICMJE
 (submitted: October 30, 2018)
  • Total Sleep Time (TST) agreement [ 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.
  • EEG Virtual Channel signal quality agreement [ Time Frame: Day 1 ]
    Comparison of a proprietary signal quality metric between Dreem and PSG virtual channel, calculated as a ratio of supra-threshold quality signal time over total time in bed trying to sleep (lights off to lights on).
  • Wake After Sleep Onset (WASO) time agreement [ 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.
  • Time in N1 sleep stage agreement [ 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.
  • Time in N2 sleep stage agreement [ 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.
  • Time in N3 sleep stage agreement [ 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.
  • Time in REM sleep stage agreement [ 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.
Original Secondary Outcome Measures  ICMJE
 (submitted: August 31, 2018)
  • Total Sleep Time (TST) agreement [ Time Frame: One night of observation ]
    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 polysomnogram (PSG) data file from the same night.
  • EEG Virtual Channel signal quality agreement [ Time Frame: One night of observation ]
    Comparison of a proprietary signal quality metric between Dreem and PSG virtual channel, calculated as a ratio of supra-threshold quality signal time over total time in bed trying to sleep (lights off ► lights on).
  • Wake After Sleep Onset (WASO) time agreement [ Time Frame: One night of observation ]
    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 polysomnogram (PSG) data file from the same night.
  • Time in N1 sleep stage agreement [ Time Frame: One night of observation ]
    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 polysomnogram (PSG) data file from the same night.
  • Time in N2 sleep stage agreement [ Time Frame: One night of observation ]
    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 polysomnogram (PSG) data file from the same night.
  • Time in N3 sleep stage agreement [ Time Frame: One night of observation ]
    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 polysomnogram (PSG) data file from the same night.
  • Time in REM sleep stage agreement [ Time Frame: One night of observation ]
    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 polysomnogram (PSG) data file from the same night.
Current Other Pre-specified Outcome Measures Not Provided
Original Other Pre-specified Outcome Measures Not Provided
 
Descriptive Information
Brief Title  ICMJE Comparison of Dreem to Clinical PSG for Sleep Monitoring in Apnea Patients
Official Title  ICMJE Performance of a Wireless Dry-EEG Device for Sleep Monitoring Compared to a Gold Standard Polysomnography in Patients With Suspected Sleep-Disordered Breathing
Brief Summary This study aims to evaluate the accuracy of apnea detection and 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 adults during a physician-referred overnight sleep study due to suspicion of sleep-disordered breathing.
Detailed Description

The study will enroll up to 70 adults who are referred to the Stanford Sleep Medicine Center by their physician for an overnight polysomnographic sleep study due to suspicion of sleep-disordered breathing, with the aim of collecting 60 usable data sets (i.e., eligible subjects with high-quality PSG and Dreem recordings). Upon arrival to the clinic, patients provide informed consent, are interviewed to determine eligibility, and complete a detailed demographic, medical, health, sleep, and lifestyle questionnaire (Alliance Sleep Questionnaire; ASQ). After the ASQ, 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. Many participants may undergo a split-night study with a continuous positive airway pressure (CPAP) device during their participation, as deemed necessary by the clinical staff pursuant to the sleep study.

The PSG data from the first 30 eligible participants will be manually scored by 5 sleep technologists. These manually-scored PSG data files (referred to as the training dataset) will be synchronized with Dreem data files from the same night and the synchronized files will be used to train Dreem's deep learning algorithms. Following training, the algorithms will be deployed to automatically score the final 30 participants' Dreem datasets (testing dataset). Finally, PSG records for the second 30 participants will be provided to the sponsor and manually scored by 5 sleep technologists. The manual scoring results will be compared to the Dreem automatic analysis to determine the accuracy of Dreem's apnea-hypopnea index (AHI) severity detection and sleep staging algorithms.

Study Type  ICMJE Interventional
Study Phase  ICMJE Not Applicable
Study Design  ICMJE Allocation: N/A
Intervention Model: Single Group Assignment
Intervention Model Description:
Dreem
Masking: None (Open Label)
Primary Purpose: Diagnostic
Condition  ICMJE
  • Sleep
  • Sleep Apnea
Intervention  ICMJE Diagnostic Test: Dreem
Dreem Band to be worn by each participant while undergoing in-lab sleep study with PSG. Pursuant to the physician-ordered diagnostic study, clinical staff may determine a split-night study with CPAP to be appropriate for any participant, simultaneous with the PSG and Dreem.
Study Arms  ICMJE Experimental: Suspicion of sleep-disordered breathing
Dreem
Intervention: Diagnostic Test: Dreem
Publications * Not Provided

*   Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.
 
Recruitment Information
Recruitment Status  ICMJE Completed
Actual Enrollment  ICMJE
 (submitted: November 26, 2018)
67
Original Estimated Enrollment  ICMJE
 (submitted: August 31, 2018)
70
Actual Study Completion Date  ICMJE November 2, 2018
Actual Primary Completion Date November 2, 2018   (Final data collection date for primary outcome measure)
Eligibility Criteria  ICMJE

Inclusion Criteria:

  • 18-70 years of age
  • Capable of providing informed consent
  • Suspicion of sleep breathing disorder (both diagnostic and split-night studies)

Exclusion Criteria:

  • Concomitant diagnosis of a sleep disorder other than sleep apnea syndrome or insomnia
  • Morbid obesity (BMI > 39)
  • Use of benzodiazepines, nonbenzodiazepine (Z-drugs), or Gammahydroxybutyrate (GHB) the day/night of the study
  • Concomitant diagnosis of cardiopulmonary or neurological comorbidities (such as heart failure, COPD, neurodegenerative conditions)
Sex/Gender  ICMJE
Sexes Eligible for Study: All
Ages  ICMJE 18 Years to 70 Years   (Adult, Older Adult)
Accepts Healthy Volunteers  ICMJE No
Contacts  ICMJE Contact information is only displayed when the study is recruiting subjects
Listed Location Countries  ICMJE United States
Removed Location Countries  
 
Administrative Information
NCT Number  ICMJE NCT03657329
Other Study ID Numbers  ICMJE OCTAVE Stanford
Has Data Monitoring Committee No
U.S. FDA-regulated Product
Studies a U.S. FDA-regulated Drug Product: No
Studies a U.S. FDA-regulated Device Product: No
IPD Sharing Statement  ICMJE
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.
Responsible Party Dreem
Study Sponsor  ICMJE Dreem
Collaborators  ICMJE Stanford University
Investigators  ICMJE
Principal Investigator: Emmanuel H During, MD Stanford University
PRS Account Dreem
Verification Date November 2018

ICMJE     Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP