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Dreem Labs for Clinical Trials

Dreem Labs is a clinically-validated sleep assessment solution for clinical trials that enables digital sleep biomarkers integration in remote and/or traditional clinical trials at-scale.

Dreem Headband
Monitoring and automatic analysis of EEG and biosignals. FDA Class II (510K) exempt medical device.
Dreem App
Provide immediate feedback to ensure strong compliance. Connects the Dreem Headband to smartphone/tablet for the configuration.
Dreem Services
Advanced analytics and cloud-based data services GCP and 21cfr11 compliant. With QC, study support and other services available.

Dreem headband-PSG-quality in a lightweight, easy-to-use device.

Front EEG Sensors

6 EEG sensors (250 Hz): F7, F8, FP1, 01, 02 and the ground in Fp2

Pulse Sensor

A pulse sensor to monitor heart rate


A microphone to detect breathing irregularities


A 3D accelerometer to measure head position and respiratory rate


Soft textiles




A series of state-of-the-art sensors measure your brain activity, heart rate, respiratory frequency and movement. This data is stored in the headband's embedded microcomputer during the night.


Lightweight, soft and flexible, the headband is made of foam and fabric, and adjusts to all head sizes thanks a series of adapters.

Dreem App - Intuitive mobile experience for patients and investigators

User-centric: Easy-to-use in both inpatient and outpatient settings.

Immediate feedback: Allowing patients to make sure the headband is correctly positioned before starting their night.

Increased engagement: Assessment data is available immediately after the end of night (optional).

Direct synchronization: The app connects to the headband via Bluetooth and enables the WIFI configuration.

Dreem Services: Easy access to advanced
sleep endpoints and raw data


Automatic and sleep expert data quality check

Raw data (binaries and .edf)

Sleep endpoints (e.g. TST, WASO, N1, N2, N3, REM sleep, SOL, nb and duration of awakenings)

Heart rate

Breathing rate and snoring

Perceived sleep quality (e.g. Likert scales and questionnaires)


Access to secured platform for compliance and data quality assessments

Integrated data management

Industry-audited SOPs and policies

Site training and patient documentation

With strong implementation of data control, data transfer and data management standards according to GCPs.
Records compliant with 21cfr11

Our clinical validation

Latest validation in top peer-reviewed journal in Sleep Science SLEEP

Recently published (Arnal et al. 2020), a peer-reviewed study showed that the Dreem headband achieve a level of analysis as accurate as the PSG for measurement, and experts for sleep staging analysis.

The EEG signal quality is similar to a PSG
Dreem headband & algorithms have a similar accuracy to sleep experts scoring on PSG
Our publications

Superior solution for at-home sleep monitoring

More than 200 academic institutions and industrial partners globally

IDEA-FAST IMI Innovative Medicines Initiative, Europe

Identifying digital endpoints to assess fatigue, sleep and activities in daily living.

Trials@Home IMI Innovative Medicines Initiative, Europe

Reshape clinical trial design, conduct and operations, by developing and piloting standards.

University of Cambridge, UK

Decoding the subjective experience of meditative states from daily EEG recordings.

Washington University St Louis Hospital, USA

Postoperative delirium linked with cognitive and EEG markers.

Cardiff University, UK

Optimizing auditory closed-loop stimulation of slow waves.

Biomedical research center of the armed force, France

Sleep recording in various protocols including subjects with sleep debt.

Human Brain Project, France

European SlowDyn Consortium (FLAGERA) on Slow Wave Dynamics.

University of Paris Sorbonne Cité, France

Optimisation of slow wave sleep by non-invasive techniques.

Contact us

Thank you ! Our team will contact you shortly.

The personal data collected through this document shall be processed automatically by Dreem for the processing of the service. Some of the answers are not mandatory, except the identified mandatory data and are intended for Dreem or its partners within the limits of the needs of the service. Personal data will be stored for the duration of the business relationship. You may request to access, rectify, or delete your data, as well as set specific instructions regarding their fate after your death. You also have the right to request the receipt of your personal data in a structured, commonly used and machine-readable format. To exercise your rights, please contact us at the following address:


Headband use
Data access

1. I would like to start a study using the headband, who should I contact?

If you want to start a study using the headband, please contact:

2. What is the regulatory status of the headband?

The Dreem 2 headband is FDA-registered as a class II medical Device. The Dreem headband also has a consumer CE marking.

3. What information can I submit to my institutional review board/local ethic committee?

We encourage you to share the Dreem general guide to your institution. Upon request, we can provide documentation on data security/data transfer.

4. How can I edit a quote or order devices?

Please use the following link to edit and submit quotations:

5. What are the authorized payment methods?

You can pay via paypal or bank transfer.

6. Why is the research headband more expensive than the consumer headband?

The research headband offers additional services compared to the consumer headband: access to raw data, algorithms. We also provide support, data management services, documentation.

7. What are the differences between Dreem 1 and Dreem 2?

Dreem 2 is more comfortable, with flexible lateral branches, and a set of 3 three adjusters for better fit. Dreem 1 comes in only one size (but with an elastic band at the back so fits most head sizes).

8. Is the headband suitable for children?

The only blocking point would be fit. The Dreem 2 headband is designed to fit head perimeters between 530-610mm (20,86”-24,01”). To ensure good signal quality, the headband must be properly adjusted, the tighter it is, the better the signal quality. For pediatric studies, it is therefore not the age of the child which needs to be taken into account but rather head size. While the headband can fit adolescents well, it may vary from one child to another in younger populations (under 11s).

9. Do you have an API?

We do not have a public or private API for the moment.

10. I would like to run a study with auditory closed-loop stimulation

Dreem can be used to send auditory closed-loop stimulation on the up-phase of SO during N3 with the following settings: Since Dreem does not have an API, it is not possible to adjust how auditory closed-loop simulation is delivered at your hand.

1. How can I manage Dreem user accounts?

The creation of a Dreem administrator account will allow you to manage Dreem user accounts.

2. Can I synchronize the headband with another device?

Resynchronizing several devices is not a straightforward process, as each device has its own errors in terms of sampling. When Dreem records sleep, it uses its internal clock that samples at approximately 250Hz with a non- linear error of + or - 3Hz through the nights. Therefore, if you want to perfectly align the Dreem device’s EEG traces with a PSG for instance, you will need to go through a resynchronization process. This resynchronization process involves updating the Dreem firmware into a specific one and running an algorithm for resynchronizing the data and rerunning the algorithm. The specific firmware enables us to have an ubuntu timestamp associated with each point of measure to enable resynchronization. The firmware can be pushed to you very easily. On your side, you will just need to charge the headband in a place where the WiFi was previously set-up. However, please be aware that this firmware currently deletes all sounds from the headband. For the resynchronization process, we can simply send you the code to be run on Python. Please contact us for further details.

3. What if my patients don't have WiFi or a smartphone?

It is possible to configure WiFi on the headband using a smartphone before giving it to your patients. They can then launch a recording using the touchpad located on the top arch of the headband. The headband can store up to 80 hours of recordings without any WiFi connection. However, the headband needs to be plugged in and connected to WiFi so that data can be transferred to servers and accessed on the "Dreem Viewer".

4. Can I use the same headband for several participants?

Yes, you can use the same headband for several participants. Each participant has to be attached to a user account, and each headband can be used for several user accounts. Please see cleaning recommendations in the dedicated section.

5. Can I enable/disable the active features of the headband (SIP, stimulations, etc)?

Yes, all active features are optional. In some cases, we can lock the features. Coming soon: A new research dedicated app will allow you to use Dreem without any active features.

6. How can I run a study with stim/sham situations, without the participant having access to info about deep sleep stimulation (on/off)?

You can simply turn the stimulations off/on on the app and ask your participant to launch the recording by using the touchpad.
If you want to know more about the touchpad functionalities, you can read this support page.

7. Can I skip the sleep assessment phase?

Yes. Once you have downloaded the app, let us know if you would like to skip this step and we’ll do it for you remotely. (The first 7 nights with the headband are dedicated to analyzing the user’s sleep. During this first step, the Relaxation Techniques and Pink Noise aren’t available. In the new Dreem Research app, the onboarding period will no longer exist.)

8. What do I need to use the headband?

A smartphone with the Dreem app and WiFi access are required to use the headband.
If you want to know more about smartphone compatibility, take a look at this support page.

9. Can I transfer my data with a cable if I don't have a WiFi connection?

Unfortunately not. The data is only transferable via WiFi.

10. Is it necessary to have WiFi access to upload the data?

Yes. However, the headband can store up to 8 nights before being overwritten.

11. Do I need WiFi to start my night?

No, you can start your night using the Dreem app on your phone or the headband’s touchpad (long touch). WiFi is useful in the morning for uploading data.
If you want to know more about the touchpad’s functionalities, you can read this support page.

12. Do I need the app to start my night?

No, you can start your night by using the headband’s touchpad (long touch): the night’s parameters will be the same as the last ones you set in the app.

13. Can I schedule the beginning of the night’s recording in advance?

No, the beginning of the night cannot be scheduled in advance or started automatically/remotely.

14. Can I set the night’s parameters for a participant?

Yes, parameters (active features) can be set in the app and the participant just has to start the night (via the app or touchpad).

15. If multiple individuals are wearing headbands, is there a way to link them all to one device controlled by the researcher, instead of each participant having the device linked to their personal phone?

We can create an administrator account for the researcher, who will be able to monitor all the headbands' data. You would just have to let us know which Dreem account (email) will be the administrator, and which Dreem accounts (email or name of headbands) we need to link.

16. Does calibration need to be done prior to each use?

No it does not. A live EEG section on the application can help the subject to verify that the headband is well positioned though.

17. What are the battery life and the charging time of the device?

The average battery life of both Dreem 1 and Dreem 2 is of ~12 hour with an average consumption of ~6.3% per hour. The charging time is 2h45min.

1. What is the sampling rate of the data files?

The EEG sampling frequency of the headband is 250Hz. The accelerometer and pulse sensor sampling frequencies are 50Hz.

2. Is it possible to check the quality of the signal?

You can check the signal quality by looking at the live EEG. If your subject or patient is relaxed with closed eyes, alpha rhythm should be visible. We cannot provide you with an impedance value.

3. What is the displayed channel on the live EEG in the app?

The EEG derivation displayed in the app is the one with the best signal quality.

4. What about the maximum level of sound in decibel, emitted during stimulation (as perceived by the bone conduction)?

It’s very hard to have a precise measure of the equivalent in decibel (dB) of the bone conduction as compared to a sound produced by a speaker. By using sensitivity tests, it seems that the volume we use is equivalent to a perceived 40dB sound. However, if you would like to maximize the effect, we can increase the volume.

1. How can I clean the headband?

70% isopropyl alcohol wipes can be used to clean the inside of the headband covered with TPU (hypoallergenic polymer) and the front sensors. The detachable textile strips (or "pads") can be cleaned by hand with soap and water. They are designed for 300 gentle wash cycles each.

2. What is the headband’s warranty?

Our warranty covers the Dreem headband for two years. Refurbished headbands are covered for 6 months.

1. What is the size of the recording after one night?

After one night, the raw data file of the recording (.h5 file) is around 100MB.

2. What's your policy in terms of data privacy?

Dreem follows GDPR rules. Please note that for your study, Dreem subjects' accounts will be created with dummy names, age, and gender. Only the principal investigator or authorized personnel will have access to the correspondence table that contains both the identity of the subjects and identifiers. Dreem won't have access to any personal data.
Upon request, data can be deleted at any time during the study. At the end of the study (or after a few months depending on the agreement), Dreem will delete all the recordings from its server.

3. How is data transferred and where is it stored?

Data is available in multiple formats, all of which are open and can be analyzed and/or processed with adequate tools. The unprocessed raw data is available as binary blobs. Once processed they are stored as HDF5 files and/or EDF.
Currently, recordings must go through our servers in order for them to be accessible. The storage pipeline is as follows: First, the recording is created and stored in the headband on its internal storage. Once the recording is over and the headband is plugged in and connected to WiFi, the recording is uploaded to our servers and deleted from the headband. The raw recordings are then accessed and processed by our internal services, making them available for download afterward.
The actual storage for these records is Amazon S3. For EU users, all our servers and storage capabilities are located in an AWS region located within the EU. Data access permissions are granted only to you and certain members of our team.

4. For how long can I hold data in the headband?

The headband can hold around 80 hours before overwriting the recorded data. That means you shall be able to recover all (or most of) the data, of 8 nights without WiFi (unuploaded data).

5. Can I upload the data to my phone and then synchronize them with the cloud after several days?

The headband has to be connected to WiFi to enable the server to process it, and unfortunately, you cannot upload the raw data to your phone.

6. What format are the recordings in?

As a researcher, our special offer provides you with the raw data. The format is basically HDF5, but we can generate the EDF files on demand.

7. Is it possible to store the data on local servers?

The data is accessible on our external online "Dreem Viewer", and you are encouraged to download and store it on your servers.

1. What is the "Dreem Viewer" for? Can I manipulate my data with it?

Please note that our "Dreem Viewer" tool only provides you with a way to access and download your raw physiological data in the following format: .tar.gz (binaries) .h5 format, .edf format and to access our automatic sleep staging. It’s not a scoring software, if you want to manipulate your data, you have to download them and use your own software.

2. Can I score the data by myself?

Yes. You can download your data in .edf and score it by yourself, using your own software.

3. Can I change the stimulation algorithm by myself?

No. Since Dreem does not have an API, it isn't possible to change the settings of the stimulation. Depending on the changes and the trials, some settings can be modified on our side, but these changes remain very rare and light.

4. Is it possible to customize the stimulation algorithm? (sleep-staging, pink noise stimulating, etc...)

No. Some rare and light settings can be modified on our side.

5. Can extra sensors be added on demand or is there a possibility to integrate them to the Dreem headband by ourselves?

Adding extra-sensors requires to going through a resynchronization procedure that is not straightforward. It is, therefore, usually difficult to integrate extra sensors.

6. What is the post process on filters?

The .edf files that are provided have the following filters: 0.4-18Hz and Notches. The raw (binary blobs) and .h5 files are not filtered.

7. Does the headband have a GPS?

No, the headband doesn’t have GPS. But as smartphones do, Dreem can obtain the localization information in the app (in order to know the timezone). This information is not saved.

8. Can I integrate my own sounds in the headband and play them during my recordings?

We do not have an API, so this is not possible.

9. Do you measure spO2?

The pulse sensor is placed against the forehead and not on the finger, the reflectivity is not comparable. Therefore, the pulse oximeter sensor embedded on the Dreem band can provide pulse measurement but not oxygen saturation.

10. Can we use the headband and make recordings continuously?

No, this is not possible because the battery of the headband has a lifespan of approximately 12 hours and it is impossible to make recordings when the headband is in charge. The only way to record continuously is to alternate between several headbands.

11. Is the data accessible in real time?

No, the data is not accessible in real time but at the end of each night, once the headband is plugged in and connected to the WiFi. The data needs to be transferred to our servers first. The only data accessible in real time is that of the live EEG but this data cannot be used for rigorous research, it is only an indicator allowing the user to determine if the electrodes are in place in real time.

1. How many clinical trials Dreem has been involved in?

The device has been used in 5 clinical trials so far:
NCT03725943 (France, n=31), NCT03657329 (US, n=67), NCT04262791 (US, n=56), NCT02956161 (France, n=24), NCT03953196 (Belgium, n=48)
The device has also been included in many academic research protocols (>50).

2. Have the algorithms for determining sleep stages been validated? Has the data been published?

Yes, the paper was recently published in the peer-reviewed journal 'Sleep'. Data is also available.
Ref: Arnal & al, 2020, The Dreem Headband compared to Polysomnography for EEG Signal Acquisition and Sleep Staging, Sleep
DOI: 10.1093/sleep/zsaa097