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
1 other identifier
interventional
67
1 country
1
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.
Trial Health
Trial Health Score
Automated assessment based on enrollment pace, timeline, and geographic reach
participants targeted
Target at P50-P75 for not_applicable
Started May 2018
Shorter than P25 for not_applicable
1 active site
Health score is calculated from publicly available data and should be used for screening purposes only.
Trial Relationships
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Study Timeline
Key milestones and dates
Study Start
First participant enrolled
May 7, 2018
CompletedFirst Submitted
Initial submission to the registry
August 31, 2018
CompletedFirst Posted
Study publicly available on registry
September 5, 2018
CompletedPrimary Completion
Last participant's last visit for primary outcome
November 2, 2018
CompletedStudy Completion
Last participant's last visit for all outcomes
November 2, 2018
CompletedNovember 28, 2018
November 1, 2018
6 months
August 31, 2018
November 26, 2018
Conditions
Keywords
Outcome Measures
Primary Outcomes (1)
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 Outcomes (7)
Total Sleep Time (TST) agreement
Day 1
EEG Virtual Channel signal quality agreement
Day 1
Wake After Sleep Onset (WASO) time agreement
Day 1
Time in N1 sleep stage agreement
Day 1
Time in N2 sleep stage agreement
Day 1
- +2 more secondary outcomes
Study Arms (1)
Suspicion of sleep-disordered breathing
EXPERIMENTALDreem
Interventions
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.
Eligibility Criteria
You may qualify if:
- years of age
- Capable of providing informed consent
- Suspicion of sleep breathing disorder (both diagnostic and split-night studies)
You may not qualify if:
- 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)
Contact the study team to confirm eligibility.
Sponsors & Collaborators
- Dreemlead
- Stanford Universitycollaborator
Study Sites (1)
Stanford Sleep Medicine Center
Redwood City, California, 94063, United States
MeSH Terms
Conditions
Condition Hierarchy (Ancestors)
Study Officials
- PRINCIPAL INVESTIGATOR
Emmanuel H During, MD
Stanford University
Study Design
- Study Type
- interventional
- Phase
- not applicable
- Allocation
- NA
- Masking
- NONE
- Purpose
- DIAGNOSTIC
- Intervention Model
- SINGLE GROUP
- Sponsor Type
- INDUSTRY
- Responsible Party
- SPONSOR
Study Record Dates
First Submitted
August 31, 2018
First Posted
September 5, 2018
Study Start
May 7, 2018
Primary Completion
November 2, 2018
Study Completion
November 2, 2018
Last Updated
November 28, 2018
Record last verified: 2018-11