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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

Timeline

Screening 3 weeks

Treatment Varies

Follow Up 2 weeks

Awards & highlights

SBS Trial 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.Check my eligibility

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.See study design

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.

SBS Trial Eligibility Criteria

Inclusion Criteria

You may be eligible if you check “Yes” for the criteria below

Select...

I am between 25 and 45 years old.

SBS Trial Timeline

Screening ~ 3 weeks3 visits

Treatment ~ Varies

Follow Up ~ 2 weeks

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

Outcome measures can provide a clearer picture of what you can expect from a treatment.

Primary outcome measures

Post-stimulation slow oscillations amplitude

Post-stimulation spectral power in the slow oscillations and delta frequency ranges

Secondary outcome measures

Change in Depression symptoms

Change in PTSD symptoms

Change in mean sleep efficiency

+8 more

SBS 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.

0 / 1Eligibility criteria met

Find a Location

Who is running the clinical trial?

University of OttawaLead Sponsor

207 Previous Clinical Trials

267,031 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

Frequently Asked Questions

These questions and answers are submitted by anonymous patients, and have not been verified by our internal team.

Is the cut-off age for inclusion in this research project set at 80 years or younger?

"This clinical trial has established a limited age range for patient enrolment, with the minimum being 25 years old and the maximum being 45."

Answered by AI

To what extent is this experiment being undertaken by individuals?

"Affirmative. According to the details on clinicaltrials.gov, this research endeavour is currently looking for volunteers. The posting of the trial was initially made on August 12th 2022 and it has been kept up-to-date since then with a final update being published on that same day. One medical centre needs to recruit 110 participants in total for this investigation."

Answered by AI

What is the ultimate goal of this research endeavor?

"The primary purpose of this one-week trial is to assess the amplitude of post-stimulation slow oscillations. Other outcomes will measure changes in objective memory consolidation, night-to-night variability of sleep efficiency, and correctly timed sound stimulations expressed as a percentage."

Answered by AI

Could I possibly qualify for participation in this trial?

"This clinical trial requires 110 individuals aged between 25 and 45 who currently receive placebos. Furthermore, participants must satisfy the following conditions: a PHQ-9 score below 10 coupled with no current diagnosis of bipolar disorder or psychosis confirmed by the M.I.N.I., Primary Care PTSD Screen (PC-PTSD) score lower than 3 plus a positive current diagnosis of major depressive disorder or persistent depressive disorder verified via the Patient Health Questionnaire (PHQ-9), as well as being free from any Sleep Disorders Symptoms Checklist-25 symptoms excluding insomnia in certain cases and displaying minimal SCI scores above 3 on all items."

Answered by AI

Are there openings in this clinical experiment currently available?

"Affirmative. Per clinicaltrials.gov, this trial is searching for applicants - it was first posted on August 12th 2022 and most recently updated the same day. This study requires 110 participants to be enrolled at a single site."

Answered by AI

Recent research and studies

clinicaltrials.govStudy

Stimulating Brain Waves During Deep Sleep

Rébecca Robillard 2022. "Stimulating Brain Waves During Deep Sleep". ClinicalTrials.gov. https://clinicaltrials.gov/ct2/show/NCT05024578.

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