InsomniaNCT05438017
Performance Evaluation of the Dreem 3 System for Sleep Assessment in Patients With Insomnia
A study testing Dreem 3 System vs PSG in people with Insomnia, run by Dreem at 2 sites in 2 countries.
Trial summary
The objective of the clinical investigation is to assess the performance of the Dreem 3 System for sleep assessment compared to a FDA-cleared PSG assessment and human sleep expert scoring in a population experiencing insomnia symptoms. Read more about this study
- Who is it for?
- Ages 22 to 70 yearsHealthy volunteers can take part
- Conditions the study is for
- Insomnia
- What is being tested?
- Dreem 3 System vs PSG
- Type of treatment
- Medical device
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 41 participants
- Where
- 2 sitesin 2 countries
- Study dates
- 21 Apr 2022to 8 Jul 2022
- 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 22 to 70 years
- All sexes
- Healthy volunteers accepted
- Adult, Older adult
Who may be able to join
- Subjects must be ≥ 22 and ≤ 70 years old inclusive.
- Able to read, understand and sign an informed consent form.
- Subjects with stable disease or/and taking stable medications for at least 2 months can be included under Principal Investigator or Sub-Investigator discretion
- Self-reported insomnia symptoms (by means of a questionnaire completed by the participant before their visit to the sleep lab) as defined by International Classification of Sleep Disorders, third edition (ICSD-3), confirmed by a clinician.
Who cannot join
- Female subjects who are pregnant, or breastfeeding.
- Subject under 22 and above 70 years old inclusive.
- Not able to read, understand and sign an informed consent form
- Subjects with BMI ≥ 40
- Taking medications that induce somnolence or wakefulness, or that can interfere with sleep recording:
- If the subject is taking OTC medications that can induce somnolence or wakefulness, he/she must not take it the day of the measurement.
Show all 11Show fewer
- Prescription only drugs that induce somnolence or wakefulness must be stopped one week before, as PI or Sub-I discretion and/or review with subject's physician.
- Subjects previously diagnosed with Obstructive Sleep Apnea (OSA), REM Sleep Disorder, Narcolepsy, Hypersomnia, or significant difficulty breathing due to underlying condition(s), or subjects diagnosed with Central Nervous System (CNS) disease.
- Subjects that suffer from an unstable disease
- Any incidental finding on the Polysomnography reference system, happening during the study recording, that interferes with eligibility (probable moderate/severe undiagnosed OSA)
- Subjects who may experience fitting difficulties with the headband, including people with head circumference < 53cm, or a hairstyle impeding the sensor placement (tight braids, hair extension, dreadlocks…) as determined by the investigator.
Trial locations and contacts
2 sites in 2 countries.
2 sites in 2 countries
About this study
Official title: Assessment of the Performance of the Dreem 3 System for EEG Sleep Monitoring in the Lab Setting
The objective of the clinical investigation is to assess the performance of the Dreem 3 System for sleep assessment compared to a FDA-cleared PSG assessment and human sleep expert scoring in a population experiencing insomnia symptoms.
Read the detailed description
Subjects enrolled in the study will come to the sleep laboratory around 8 pm. Their involvement in the protocol will only require them to be equipped by the technician with Dreem 3 in addition to the PSG reference system. This involves the technician placing all the PSG electrodes on the subject's head as per normal practice, and then positioning the Dreem 3 headband so that both devices can operate simultaneously. The subject will be allowed to go to his/her room and do quiet activities (reading, film watching, chatting) prior to sleeping. At the end of the night, the technician will remove the Dreem 3 headband and the PSG.
A technical quality control will be performed on the collected data in accordance with the standard operating procedures, as defined in the study protocol. Recordings that do not meet the quality control criteria will be excluded from further analysis.
Subjects will receive the PSG report at the end of the study.
- Conditions
- Insomnia
- Being tested
- Dreem 3 System vs PSG
- Keywords
- Dreem, Insomnia symptoms, Sleep, Polysomnography, Performance, EEG, Sleep monitoring
- Medical subject headings
- Sleep Initiation and Maintenance Disorders
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Dreem 3 System vs PSGDevice
Dreem 3 System to be worn by each participant while undergoing in-lab sleep study with PSG.
| Study group | Role | What they receive |
|---|---|---|
| Dreem + PSG | Experimental | Not described Receives: Device: Dreem 3 System vs PSG |
What is being measured
The primary outcome is the main question the study is designed to answer.
Performance of the automatic sleep stage scoring of the Dreem 3 System compared to the consensus of 3 independent certified sleep scorers realized on the polysomnography signal.
Measured: Day 1
Secondary outcomes (10)
TST (Total Sleep Time)
Total time (in minutes) the subject spends asleep (TST) as automatically determined by the Dreem 3 System compared to the TST determined by the consensus of 3 certified sleep scorers' scoring of the subject's PSG record from the same night.
Measured: Day 1
SE (Sleep Efficiency)
Sleep efficiency (%) as automatically determined by the Dreem 3 System compared to the sleep efficiency determined by the consensus of 3 certified sleep scorers' scoring of the subject's PSG record from the same night.
Measured: Day 1
SOL (Sleep Onset Latency)
Sleep Onset Latency (in minutes) as automatically determined by the Dreem 3 System compared to the sleep onset latency determined by the consensus of 3 certified sleep scorers's scoring of the subject's PSG record from the same night.
Measured: Day 1
LPS (Latency to Persistent Sleep)
Latency to Persistent Sleep (in minutes) as automatically determined by the Dreem 3 System compared to the latency to persistent sleep determined by the consensus of 3 certified sleep scorers' scoring of the subject's PSG record from the same night.
Measured: Day 1
WASO (Wake After Sleep Onset)
Total time (in minutes) the subject spends awake from sleep onset to final epoch of sleep (WASO) as automatically determined by the Dreem 3 System compared to the WASO determined by the consensus of 3 certified sleep scorers' scoring of the subject's PSG record from the same night.
Measured: Day 1
Total time spent in N2 sleep stage
Total time (in minutes) the subject spends in AASM N2 sleep stage as automatically determined by the Dreem 3 System compared to the N2 time determined by the consensus of 3 certified sleep scorers' scoring of the subject's PSG record from the same night.
Measured: Day 1
Total time spent in N3 sleep stage
Total time (in minutes) the subject spends in AASM N3 sleep stage as automatically determined by the Dreem 3 System compared to the N3 time determined by the consensus of 3 certified sleep scorers' scoring of the subject's PSG record from the same night.
Measured: Day 1
Total time spent in REM sleep stage
Total time (in minutes) the subject spends in AASM REM sleep stage as automatically determined by the Dreem 3 System compared to the REM time determined by the consensus of 3 certified sleep scorers' scoring of the subject's PSG record from the same night.
Measured: Day 1
Total time spent in N1 sleep stage
Total time (in minutes) the subject spends in AASM N1 sleep stage as automatically determined by the Dreem 3 System compared to the N1 time determined by the consensus of 3 certified sleep scorers' scoring of the subject's PSG record from the same night.
Measured: Day 1
Respiratory Rate
Respiratory rate for each 30 second epoch (in cycles per minute) computed by the accelerometer of the Dreem device compared to the respiratory rate computed by the PSG sensor.
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 posted29 Jun 2022
- Study start21 Apr 2022
- Primary completion8 Jul 2022
- Study completion8 Jul 2022
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (1)Papers the sponsor has linked to this study.
- Other trials for InsomniaStudies 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
- Other
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Enrolment
- 41 participants (actual)
Sponsor and investigators
- Lead sponsor
- Dreem
- Sponsor type
- Industry (pharma, biotech, devices)
- Responsible party
- Sponsor
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT05438017
- Sponsor's protocol ID
- OCTAVE 3
- Status last verified
- Jul 2022
- First submitted
- 24 Jun 2022
- Last updated
- 29 Jul 2022
- Results posted
- No
- FDA-regulated drug
- No
- FDA-regulated device
- Yes
- Individual data sharing
- No
Publications
Savietto SF, Guillot A, Harris M, Pathmanathan J, Chan AM, Westover MB, Hill D, Bertaina-Anglade V, Viardot G, Arnal P, Donoghue J. Multicenter evaluation of the Waveband system for automated sleep assessment in patients with insomnia symptoms. Sleep. 2026 Jul 13;49(7):zsag069. doi: 10.1093/sleep/zsag069.
PubMed 41903179
Study at a glance
From the registry record, last updated by the sponsor on 29 Jul 2022. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Assessment of the Performance of the Dreem 3 System for EEG Sleep Monitoring in the Lab Setting
- ClinicalTrials.gov ID
- NCT05438017
- Acronym / sponsor ID
- OCTAVE 3
- Conditions
- Insomnia
- Keywords
- Dreem, Insomnia symptoms, Sleep, Polysomnography, Performance, EEG, Sleep monitoring
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 41 participants (actual)
- Lead sponsor
- DreemIndustry (pharma, biotech, devices)
- Study start
- 21 Apr 2022 (actual)
- Primary completion
- 8 Jul 2022 (actual)
- Study completion
- 8 Jul 2022 (actual)
- First posted
- 29 Jun 2022 (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.
The objective of the clinical investigation is to assess the performance of the Dreem 3 System for sleep assessment compared to a FDA-cleared PSG assessment and human sleep expert scoring in a population experiencing insomnia symptoms.
Detailed description
Subjects enrolled in the study will come to the sleep laboratory around 8 pm. Their involvement in the protocol will only require them to be equipped by the technician with Dreem 3 in addition to the PSG reference system. This involves the technician placing all the PSG electrodes on the subject's head as per normal practice, and then positioning the Dreem 3 headband so that both devices can operate simultaneously. The subject will be allowed to go to his/her room and do quiet activities (reading, film watching, chatting) prior to sleeping. At the end of the night, the technician will remove the Dreem 3 headband and the PSG.
A technical quality control will be performed on the collected data in accordance with the standard operating procedures, as defined in the study protocol. Recordings that do not meet the quality control criteria will be excluded from further analysis.
Subjects will receive the PSG report at the end of the study.
Study design
- Primary purpose
- Other
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| Dreem + PSG | Experimental | Device: Dreem 3 System vs PSG |
Who may qualify
- Ages
- 22 to 70 years
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (4 listed)
- Subjects must be ≥ 22 and ≤ 70 years old inclusive.
- Able to read, understand and sign an informed consent form.
- Subjects with stable disease or/and taking stable medications for at least 2 months can be included under Principal Investigator or Sub-Investigator discretion
- Self-reported insomnia symptoms (by means of a questionnaire completed by the participant before their visit to the sleep lab) as defined by International Classification of Sleep Disorders, third edition (ICSD-3), confirmed by a clinician.
Key exclusion criteria (11 listed)
- Female subjects who are pregnant, or breastfeeding.
- Subject under 22 and above 70 years old inclusive.
- Not able to read, understand and sign an informed consent form
- Subjects with BMI ≥ 40
- Taking medications that induce somnolence or wakefulness, or that can interfere with sleep recording:
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 |
|---|---|---|
| Dreem 3 System vs PSGDreem 3 System to be worn by each participant while undergoing in-lab sleep study with PSG. | Device | Dreem + PSG |
Primary outcome
Performance of the automatic sleep stage scoring of the Dreem 3 System compared to the consensus of 3 independent certified sleep scorers realized on the polysomnography signal.
Time frame: Day 1
10 secondary outcomes
TST (Total Sleep Time)
Time frame: Day 1
SE (Sleep Efficiency)
Time frame: Day 1
SOL (Sleep Onset Latency)
Time frame: Day 1
LPS (Latency to Persistent Sleep)
Time frame: Day 1
WASO (Wake After Sleep Onset)
Time frame: Day 1
Total time spent in N2 sleep stage
Time frame: Day 1
Total time spent in N3 sleep stage
Time frame: Day 1
Total time spent in REM sleep stage
Time frame: Day 1
Total time spent in N1 sleep stage
Time frame: Day 1
Respiratory Rate
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 29 Jul 2022.
- Derived from this study: PubMed 41903179Savietto SF, Guillot A, Harris M, Pathmanathan J, Chan AM, Westover MB, Hill D, Bertaina-Anglade V, Viardot G, Arnal P, Donoghue J. Multicenter evaluation of the Waveband system for automated sleep assessment in patients with insomnia symptoms. Sleep. 2026 Jul 13;49(7):zsag069. doi: 10.1093/sleep/zsag069.
- Individual participant dataSharing planned: No
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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.
The record lists no contact. Use the official record to reach the sponsor.
2 sites in 2 countries: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Dreem 3 System vs PSG in people with Insomnia, run by Dreem at 2 sites in 2 countries.
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 4 inclusion and 11 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 29 Jul 2022. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 2 sites in United States, 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?
Performance of the automatic sleep stage scoring of the Dreem 3 System compared to the consensus of 3 independent certified sleep scorers realized on the polysomnography signal. (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 NCT05438017, 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 29 Jul 2022.