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

Sleep Clinical Trial

Official title:

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

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT03725943
• Other study ID #: OCTAVE IRBA
• Status: Completed
• Phase: N/A
• Start date: September 4, 2018
• Est. completion date: November 16, 2018

Study information

• Verified date: November 2018
• Source: Dreem
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial 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.

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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 31
• Est. completion date: November 16, 2018
• Est. primary completion date: November 16, 2018
• Accepts healthy volunteers: Accepts Healthy Volunteers
• Gender: All
• Age group: 18 Years to 65 Years

Eligibility

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

Related Conditions & MeSH terms

• Sleep

Intervention

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

Locations

Country	Name	City	State
France	Institut de Recherche Biomédicale des Armées	Brétigny-sur-Orge	D19

Sponsors (2)

Lead Sponsor	Collaborator
Dreem	Institut de Recherche Biomedicale des Armees

Country where clinical trial is conducted

France, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Sleep stages accuracy (Dreem vs. PSG consensus)	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.	Day 1
Secondary	Total Sleep Time (TST) (accuracy between Dreem and PSG consensus)	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
Secondary	Wake After Sleep Onset (WASO) time (accuracy between Dreem and PSG consensus)	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
Secondary	Time in N1 sleep stage (accuracy between Dreem and PSG consensus)	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
Secondary	Time in N2 sleep stage (accuracy between Dreem and PSG consensus)	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
Secondary	Time in N3 sleep stage (accuracy between Dreem and PSG consensus)	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
Secondary	Time in rapid eye movement (REM) sleep stage (accuracy between Dreem and PSG consensus)	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
Secondary	Number of sleep slow oscillations (accuracy between Dreem and PSG consensus)	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.	Day 1
Secondary	Number of sleep spindles (accuracy between Dreem and PSG consensus)	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.	Day 1
Secondary	Number of sleep eye movements (accuracy between Dreem and PSG consensus)	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.	Day 1
Secondary	Breathing frequency measurement (accuracy between Dreem and PSG consensus)	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.	Day 1