Insomnia, SecondaryNCT05611099
Robustness and Usability of the Dreem 3 System for at Home Sleep Monitoring in an Insomnia Population.
A study testing Dreem 3 System vs WatchPAT One and Usability Questionnaire in people with Insomnia, Secondary and Sleep Disturbance, run by Dreem at 1 site in United States.
Trial summary
There is an unmet medical need for monitoring sleep for multiple nights in a patient's home, without the inconvenience of traveling and staying overnight in a medical center, and without the need for a technician to set up a polysomnography (PSG) device at the patient's home. Read more about this study
- Who is it for?
- Ages 22 to 70 yearsHealthy volunteers can take part
- Conditions the study is for
- Insomnia, Secondary, Sleep Disturbance, Sleep
- What is being tested?
- Dreem 3 System vs WatchPAT One and Usability Questionnaire
- Type of treatment
- Medical device
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 15 participants
- Where
- 1 siteUnited States
- Study dates
- 15 Aug 2022to 5 Nov 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, including:
- 8 subjects under 55 years old.
- 7 subjects over 55 years old.
- Subjects who are under the care of a sleep clinician for experiencing insomnia symptoms.
- Subjects have wifi connection at their home.
- Subjects have a smartphone where they can install the Alfin App.
- Subjects agree to not having abnormal drugs or alcohol consumption 24 hours before the start of the measurement, and during the 3 days of measurement.
- Able to read, understand and sign an informed consent form.
Who cannot join
- Under 22 and above 70 years old inclusive.
- BMI ≥ 40.
- Obstructive sleep apnea diagnosis with ongoing CPAP therapy.
- Abnormal drugs or alcohol use during the measurement part of the study.
- Head circumference < 53 cm or device fitting issues as determined during training.
- Not able to read, understand and sign an informed consent form.
Trial locations and contacts
1 site in 1 country.
About this study
Official title: Assessment of the Stability, Robustness and Usability of the Dreem 3 System for EEG Sleep Monitoring in the Home Setting, in an Insomnia Population.
There is an unmet medical need for monitoring sleep for multiple nights in a patient's home, without the inconvenience of traveling and staying overnight in a medical center, and without the need for a technician to set up a polysomnography (PSG) device at the patient's home. Several disorders, and particularly sleep disorders, are associated with insomnia symptoms, and longitudinal sleep assessment may support a better understanding and management of these patients, who currently seldom access sleep lab PSG.
On one hand, this study aims at demonstrating whether the final device's user interface supports safe and effective use when being used at home over multiple nights.
On the other, the study aims at confirming that stable and consistent data are measured in the device's actual use, for the records to be clinically usable in daily practice.
- Being tested
- Dreem 3 System vs WatchPAT One, Usability Questionnaire
- Keywords
- Polysomnography, Sleep assessment, Dreem, EEG, dry EEG, Accuracy
- Medical subject headings
- Sleep Initiation and Maintenance Disorders, Parasomnias
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Dreem 3 System vs WatchPAT OneDevice
Dreem 3 System and WatchPAT One will be worn simultaneously during 3 nights by each study participant, in order to compare the TST automatically outputted by both devices.
Usability QuestionnaireOther
After having undergone the 3 nights of measurement, an end of Study Questionnaire will be performed on a separate day to obtain Usability feedback from participants who have undergone simultaneous recordings with the Dreem 3 + WatchPAT devices.
| Study group | Role | What they receive |
|---|---|---|
| Dreem + WatchPAT One | Experimental | Single arm of 15 subjects wearing simultaneously the Dreem 3 + WatchPAT One devices for 3 nights, and then undergoing an end of study usability questionnaire. Receives: Device: Dreem 3 System vs WatchPAT One; Other: Usability Questionnaire |
What is being measured
The primary outcome is the main question the study is designed to answer.
TST Correlation
Pearson's Correlation between the total time (in minutes) the subject spends asleep (TST) as automatically determined by the Dreem 3S compared to the TST automatically determined by the WatchPAT One (WP1) device on the same night.
Measured: 3 nights
Dreem 3 System usability
As determined by the System Usability Scale. The System Usability Scale establishes a score (the SUS score), between 0 and 100. A score of 68 indicates average performance of a system. A score > 68 indicated the system's usability is above average.
Measured: 1 day
Secondary outcomes (1)
ΔTST Correlation
Pearson's correlation on Dreem 3S and WP1 intra-subject, inter-nights TST differences.
Measured: 3 nights
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted9 Nov 2022
- Study start15 Aug 2022
- Primary completion31 Oct 2022
- Study completion5 Nov 2022
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Insomnia, SecondaryStudies 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
- 15 participants (actual)
Sponsor and investigators
- Lead sponsor
- Dreem
- Sponsor type
- Industry (pharma, biotech, devices)
- Responsible party
- Sponsor
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT05611099
- Sponsor's protocol ID
- LIVIE-1
- Status last verified
- Nov 2022
- First submitted
- 1 Nov 2022
- Last updated
- 28 Nov 2022
- Results posted
- No
- FDA-regulated drug
- No
- FDA-regulated device
- Yes
- Individual data sharing
- No
Study at a glance
From the registry record, last updated by the sponsor on 28 Nov 2022. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Assessment of the Stability, Robustness and Usability of the Dreem 3 System for EEG Sleep Monitoring in the Home Setting, in an Insomnia Population.
- ClinicalTrials.gov ID
- NCT05611099
- Acronym / sponsor ID
- LIVIE-1
- Keywords
- Polysomnography, Sleep assessment, Dreem, EEG, dry EEG, Accuracy
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 15 participants (actual)
- Lead sponsor
- DreemIndustry (pharma, biotech, devices)
- Study start
- 15 Aug 2022 (actual)
- Primary completion
- 31 Oct 2022 (actual)
- Study completion
- 5 Nov 2022 (actual)
- First posted
- 9 Nov 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.
There is an unmet medical need for monitoring sleep for multiple nights in a patient's home, without the inconvenience of traveling and staying overnight in a medical center, and without the need for a technician to set up a polysomnography (PSG) device at the patient's home. Several disorders, and particularly sleep disorders, are associated with insomnia symptoms, and longitudinal sleep assessment may support a better understanding and management of these patients, who currently seldom access sleep lab PSG.
On one hand, this study aims at demonstrating whether the final device's user interface supports safe and effective use when being used at home over multiple nights.
On the other, the study aims at confirming that stable and consistent data are measured in the device's actual use, for the records to be clinically usable in daily practice.
Study design
- Primary purpose
- Other
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| Dreem + WatchPAT One | Experimental | Device: Dreem 3 System vs WatchPAT One, Other: Usability QuestionnaireSingle arm of 15 subjects wearing simultaneously the Dreem 3 + WatchPAT One devices for 3 nights, and then undergoing an end of study usability questionnaire. |
Who may qualify
- Ages
- 22 to 70 years
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (8 listed)
- Subjects must be ≥ 22 and ≤ 70 years old inclusive, including:
- Subjects who are under the care of a sleep clinician for experiencing insomnia symptoms.
- Subjects have wifi connection at their home.
- Subjects have a smartphone where they can install the Alfin App.
- Subjects agree to not having abnormal drugs or alcohol consumption 24 hours before the start of the measurement, and during the 3 days of measurement.
Key exclusion criteria (6 listed)
- Under 22 and above 70 years old inclusive.
- BMI ≥ 40.
- Obstructive sleep apnea diagnosis with ongoing CPAP therapy.
- Abnormal drugs or alcohol use during the measurement part of the study.
- Head circumference < 53 cm or device fitting issues as determined during training.
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 WatchPAT OneDreem 3 System and WatchPAT One will be worn simultaneously during 3 nights by each study participant, in order to compare the TST automatically outputted by both devices. | Device | Dreem + WatchPAT One |
| Usability QuestionnaireAfter having undergone the 3 nights of measurement, an end of Study Questionnaire will be performed on a separate day to obtain Usability feedback from participants who have undergone simultaneous recordings with the Dreem 3 + WatchPAT devices. | Other | Dreem + WatchPAT One |
Primary outcome
TST Correlation
Time frame: 3 nights
Pearson's Correlation between the total time (in minutes) the subject spends asleep (TST) as automatically determined by the Dreem 3S compared to the TST automatically determined by the WatchPAT One (WP1) device on the same night.
Dreem 3 System usability
Time frame: 1 day
As determined by the System Usability Scale. The System Usability Scale establishes a score (the SUS score), between 0 and 100. A score of 68 indicates average performance of a system. A score > 68 indicated the system's usability is above average.
1 secondary outcome
ΔTST Correlation
Time frame: 3 nights
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 2022.
- 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.
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 3 System vs WatchPAT One and Usability Questionnaire in people with Insomnia, Secondary and Sleep Disturbance, 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 8 inclusion and 6 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 2022. 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?
TST Correlation (time frame: 3 nights). The study lists 2 primary outcomes in all. 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 2022.