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

Performance of a Wireless Dry-EEG Device for Sleep Monitoring Compared to a Gold Standard Polysomnography in Patients With Suspected Sleep-Disordered Breathing

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.

Study Overview

• Status: Completed
• Conditions: Sleep; Sleep Apnea
• Intervention / Treatment: Diagnostic test: Dreem

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: Interventional
• Enrollment (Actual): 67
• Phase: Not Applicable

Contacts and Locations

Study Locations

• United States
  • California
    • Redwood City, California, United States, 94063
      • Stanford Sleep Medicine Center

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 18 years to 70 years (ADULT, OLDER_ADULT)
• Accepts Healthy Volunteers: No
• Genders Eligible for Study: All

Description

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)

Study Plan

How is the study designed?

Design Details

• Primary Purpose: DIAGNOSTIC
• Allocation: NA
• Interventional Model: SINGLE_GROUP
• Masking: NONE

Number of Arms

1

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
EXPERIMENTAL: Suspicion of sleep-disordered breathing; Dreem	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.

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Apnea-Hypopnea Index (AHI) severity agreement	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.	Day 1

Secondary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Total Sleep Time (TST) agreement	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.	Day 1
EEG Virtual Channel signal quality agreement	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).	Day 1
Wake After Sleep Onset (WASO) time agreement	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.	Day 1
Time in N1 sleep stage agreement	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.	Day 1
Time in N2 sleep stage agreement	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.	Day 1
Time in N3 sleep stage agreement	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.	Day 1
Time in REM sleep stage agreement	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.	Day 1

Collaborators and Investigators

• Sponsor: Dreem
• Collaborators: Stanford University
• Investigators: Principal Investigator: Emmanuel H During, MD, Stanford University

Study record dates

Study Major Dates

• Study Start (ACTUAL): May 7, 2018
• Primary Completion (ACTUAL): November 2, 2018
• Study Completion (ACTUAL): November 2, 2018

Study Registration Dates

• First Submitted: August 31, 2018
• First Submitted That Met QC Criteria: August 31, 2018
• First Posted (ACTUAL): September 5, 2018

Study Record Updates

• Last Update Posted (ACTUAL): November 28, 2018
• Last Update Submitted That Met QC Criteria: November 26, 2018
• Last Verified: November 1, 2018

More Information

Terms related to this study

• Keywords: Automated Sleep Staging; Automated Apnea Detection
• Additional Relevant MeSH Terms: Respiratory Tract Diseases; Respiration Disorders; Signs and Symptoms, Respiratory; Apnea
• Other Study ID Numbers: OCTAVE Stanford

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: UNDECIDED
• IPD 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.

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: No