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SleepNCT03725943

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

A study testing Dreem in people with Sleep, run by Dreem at 1 site in France.

Completed

Finished. The study has ended and is not enrolling. Results may be posted on the official record.

Official record
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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… Read more about this study

Who is it for?
Ages 18 to 65 yearsHealthy volunteers can take part
Conditions the study is for
Sleep
What is being tested?
Dreem
Could I receive a placebo?
No, everyone receives an active treatment
How many people
31 participants
Where
1 siteFrance
Study dates
4 Sep 2018to 16 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 65 years
  • All sexes
  • Healthy volunteers accepted
  • Adult, Older adult

Who may be able to join

  • Capable of providing informed consent

Who cannot join

  • 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

Trial locations and contacts

1 site in 1 country.

France1 site

  • Institut de Recherche Biomédicale des Armées

    Brétigny-sur-Orge, D19, 91220

Other trials in France

About this study

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

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.

Read the detailed 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.

Conditions
Sleep
Being tested
Dreem
Keywords
Automated Sleep Staging

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.

Study groups in NCT03725943
Study groupRoleWhat they receive
Healthy adultsExperimentalDreem
Receives: Diagnostic Test: Dreem

What is being measured

The primary outcome is the main question the study is designed to answer.

  1. 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.

    Measured: Day 1

Secondary outcomes (10)

  1. 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.

    Measured: Day 1

  2. 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.

    Measured: Day 1

  3. 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.

    Measured: Day 1

  4. 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.

    Measured: Day 1

  5. 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.

    Measured: Day 1

  6. 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.

    Measured: Day 1

  7. 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.

    Measured: Day 1

  8. 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.

    Measured: Day 1

  9. 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.

    Measured: Day 1

  10. 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.

    Measured: Day 1

Timeline

From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.

  1. First posted31 Oct 2018
  2. Study start4 Sep 2018
  3. Primary completion16 Nov 2018
  4. Study completion16 Nov 2018

Resources

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
31 participants (actual)
IDs, dates and publications
ClinicalTrials.gov ID
NCT03725943
Sponsor's protocol ID
OCTAVE IRBA
Status last verified
Nov 2018
First submitted
29 Oct 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.

Publications

  • Arnal PJ, Thorey V, Debellemaniere E, Ballard ME, Bou Hernandez A, Guillot A, Jourde H, Harris M, Guillard M, Van Beers P, Chennaoui M, Sauvet F. The Dreem Headband compared to polysomnography for electroencephalographic signal acquisition and sleep staging. Sleep. 2020 Nov 12;43(11):zsaa097. doi: 10.1093/sleep/zsaa097.

    PubMed 32433768

Questions about this trial

What is this clinical trial studying?

A study testing Dreem in people with Sleep, run by Dreem at 1 site in France.

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 1 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 France. 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?

Sleep stages accuracy (Dreem vs. PSG consensus) (time frame: Day 1). It is what the study was designed to measure, not a finding.

Where can I read the original study information?

On the ClinicalTrials.gov record for NCT03725943, which also lists 1 linked publication.

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.

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