SleepNCT03657329
Comparison of Dreem to Clinical PSG for Sleep Monitoring in Apnea Patients
A study testing Dreem in people with Sleep and Sleep Apnea, run by Dreem at 1 site in United States.
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… Read more about this study
- Who is it for?
- Ages 18 to 70 years
- Conditions the study is for
- Sleep, Sleep Apnea
- What is being tested?
- Dreem
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 67 participants
- Where
- 1 siteUnited States
- Study dates
- 7 May 2018to 2 Nov 2018
- Phase
- Interventional
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 to 70 years
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- 18-70 years of age
- Capable of providing informed consent
- Suspicion of sleep breathing disorder (both diagnostic and split-night studies)
Who cannot join
- 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)
Trial locations and contacts
1 site in 1 country.
United States1 site
Stanford Sleep Medicine Center
Redwood City, California, 94063
About this study
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
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.
Read the 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.
- Conditions
- Sleep, Sleep Apnea
- Being tested
- Dreem
- Keywords
- Automated Sleep Staging, Automated Apnea Detection
- Medical subject headings
- Sleep Apnea Syndromes
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
DreemDiagnostic test
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 group | Role | What they receive |
|---|---|---|
| Suspicion of sleep-disordered breathing | Experimental | Dreem Receives: Diagnostic Test: Dreem |
What is being measured
The primary outcome is the main question the study is designed to answer.
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.
Measured: Day 1
Secondary outcomes (7)
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.
Measured: 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).
Measured: 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.
Measured: 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.
Measured: 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.
Measured: 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.
Measured: 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.
Measured: Day 1
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted5 Sep 2018
- Study start7 May 2018
- Primary completion2 Nov 2018
- Study completion2 Nov 2018
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for SleepStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Diagnosis
- Allocation
- Not applicable
- Intervention model
- Single group
- Model description
- Dreem
- Masking
- None (open label)
- Enrolment
- 67 participants (actual)
Sponsor and investigators
- Lead sponsor
- Dreem
- Sponsor type
- Industry (pharma, biotech, devices)
- Collaborators
- Stanford University
- Responsible party
- Sponsor
- Investigators
- Emmanuel H During, MD, Principal investigator, Stanford University
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT03657329
- Sponsor's protocol ID
- OCTAVE Stanford
- Status last verified
- Nov 2018
- First submitted
- 31 Aug 2018
- Last updated
- 28 Nov 2018
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- Undecided: 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.
Study at a glance
From the registry record, last updated by the sponsor on 28 Nov 2018. Recruitment status is as the sponsor reported it: confirm with the study team.
- 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
- ClinicalTrials.gov ID
- NCT03657329
- Acronym / sponsor ID
- OCTAVE Stanford
- Conditions
- Sleep, Sleep Apnea
- Keywords
- Automated Sleep Staging, Automated Apnea Detection
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 67 participants (actual)
- Lead sponsor
- DreemIndustry (pharma, biotech, devices)
- Collaborators
- Stanford University
- Study start
- 7 May 2018 (actual)
- Primary completion
- 2 Nov 2018 (actual)
- Study completion
- 2 Nov 2018 (actual)
- First posted
- 5 Sep 2018 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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 design
- Primary purpose
- Diagnosis
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Number of arms
- 1
- Model description
- Dreem
| Arm | Type | Receives |
|---|---|---|
| Suspicion of sleep-disordered breathing | Experimental | Diagnostic Test: DreemDreem |
Who may qualify
- Ages
- 18 to 70 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (3 listed)
- 18-70 years of age
- Capable of providing informed consent
- Suspicion of sleep breathing disorder (both diagnostic and split-night studies)
Key exclusion criteria (4 listed)
- 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)
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| DreemDreem 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. | Diagnostic test | Suspicion of sleep-disordered breathing |
Primary outcome
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.
7 secondary outcomes
Total Sleep Time (TST) agreement
Time frame: Day 1
EEG Virtual Channel signal quality agreement
Time frame: Day 1
Wake After Sleep Onset (WASO) time agreement
Time frame: Day 1
Time in N1 sleep stage agreement
Time frame: Day 1
Time in N2 sleep stage agreement
Time frame: Day 1
Time in N3 sleep stage agreement
Time frame: Day 1
Time in REM sleep stage agreement
Time frame: Day 1
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 28 Nov 2018.
- Individual participant dataSharing planned: Undecided. 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.
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Emmanuel H During, MD principal investigator
Stanford University
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Dreem in people with Sleep and Sleep Apnea, run by Dreem at 1 site in United States.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 3 inclusion and 4 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 28 Nov 2018. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in United States. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Apnea-Hypopnea Index (AHI) severity agreement (time frame: Day 1). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 28 Nov 2018.