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Behavioural Intervention

DREEM2 Device for Sleep Improvement (SBS Trial)

N/A
Recruiting
Led By Rebecca Robillard, PhD
Research Sponsored by University of Ottawa
Eligibility Criteria Checklist
Specific guidelines that determine who can or cannot participate in a clinical trial
Must have
Between 25 and 45 years old
Be between 18 and 65 years old
Must not have
Brain injury with loss of consciousness for over 5 minutes
Taking stimulant medications including, but not limited to, Adderall, Concerta, Ritalin, Desoxyn, Dexedrine, Dextrostat, Ephedrine, Phentermine, Procentra, Vyvanse, and Selegline
Timeline
Screening 3 weeks
Treatment Varies
Follow Up 2 weeks
Awards & highlights

Summary

This trial is testing a new way to look at sleep problems, by monitoring people's brain waves, heart rate, and body temperature. They will also look at how well people sleep with and without auditory stimulation.

Who is the study for?
This trial is for healthy sleepers and those with insomnia, aged 25-45, without significant medical conditions or hearing loss. Participants should not have a history of brain injury, substance abuse, recent shift work or travel across time zones. They must not be on certain medications including stimulants and should have stable mental health medication doses if applicable.
What is being tested?
The study tests the DREEM2 device's effect on deep sleep by comparing it to a placebo in a double-blind setup. Over five weeks at home plus potential lab visits, participants' sleep patterns are monitored using EEG headbands to assess changes in brain waves, heart rate, temperature, well-being, fatigue and cognitive function.
What are the potential side effects?
While specific side effects are not detailed for this type of non-invasive intervention like DREEM2 auditory stimulation during sleep; discomfort from wearing the headband or disturbances due to sounds might occur.

Eligibility Criteria

Inclusion Criteria

You may be eligible if you check “Yes” for the criteria below
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I am between 25 and 45 years old.

Exclusion Criteria

You may be eligible for the trial if you check “No” for criteria below:
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I have had a brain injury where I was unconscious for more than 5 minutes.
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I am currently taking stimulant medications such as Adderall or Ritalin.

Timeline

Screening ~ 3 weeks
Treatment ~ Varies
Follow Up ~2 weeks
This trial's timeline: 3 weeks for screening, Varies for treatment, and 2 weeks for reporting.

Treatment Details

Study Objectives

Study objectives can provide a clearer picture of what you can expect from a treatment.
Primary study objectives
Post-stimulation slow oscillations amplitude
Post-stimulation spectral power in the slow oscillations and delta frequency ranges
Secondary study objectives
Change in Depression symptoms
Change in PTSD symptoms
Change in mean sleep efficiency
+8 more

Trial Design

2Treatment groups
Experimental Treatment
Placebo Group
Group I: Auditory StimulationExperimental Treatment1 Intervention
In the active experimental condition, participants will complete 1 week of slow oscillation (SO) stimulation with the EEG headband monitor (DREEM2, Dreem, Paris, France) in the form of auditory stimuli (100ms pink noise pulses, i.e., below the waking threshold as established in prior work) sent on the ascending phase of the SO during N3 sleep.
Group II: ShamPlacebo Group1 Intervention
In the sham condition, participants will wear the EEG headband monitor (DREEM2, Dreem, Paris, France) for 1 week, but the sound stimulation feature will be deactivated.

Find a Location

Who is running the clinical trial?

University of OttawaLead Sponsor
213 Previous Clinical Trials
268,162 Total Patients Enrolled
Rebecca Robillard, PhDPrincipal InvestigatorUniversity of Ottawa Institute of Mental Health Research, affiliated to The Royal

Media Library

DREEM2 (Behavioural Intervention) Clinical Trial Eligibility Overview. Trial Name: NCT05024578 — N/A
Placebo Research Study Groups: Sham, Auditory Stimulation
Placebo Clinical Trial 2023: DREEM2 Highlights & Side Effects. Trial Name: NCT05024578 — N/A
DREEM2 (Behavioural Intervention) 2023 Treatment Timeline for Medical Study. Trial Name: NCT05024578 — N/A
~36 spots leftby Sep 2025
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