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

Sleep Clinical Trial

Official title:

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

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT03657329
• Other study ID #: OCTAVE Stanford
• Status: Completed
• Phase: N/A
• Start date: May 7, 2018
• Est. completion date: November 2, 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 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.

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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 67
• Est. completion date: November 2, 2018
• Est. primary completion date: November 2, 2018
• Accepts healthy volunteers: No
• Gender: All
• Age group: 18 Years to 70 Years

Eligibility

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)

Related Conditions & MeSH terms

• Apnea
• Sleep
• Sleep Apnea

Intervention

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.

Locations

Country	Name	City	State
United States	Stanford Sleep Medicine Center	Redwood City	California

Sponsors (2)

Lead Sponsor	Collaborator
Dreem	Stanford University

Country where clinical trial is conducted

United States, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	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	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
Secondary	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
Secondary	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
Secondary	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
Secondary	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
Secondary	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
Secondary	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