Auditory Stimulation for Placebo

Phase-Based Progress Estimates
1
Effectiveness
1
Safety
Sleep Research Unit, University of Ottawa Institute of Mental Health Research at the Royal, Ottawa, CanadaPlacebo+1 MoreDREEM2 - Device
Eligibility
25 - 45
All Sexes
What conditions do you have?
Select

Study 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.

Eligible Conditions
  • Experimental
  • Placebo

Treatment Effectiveness

Study Objectives

2 Primary · 12 Secondary · Reporting Duration: 2 weeks

Week 1
Correctly timed sound stimulations
Post-stimulation slow oscillations amplitude
Post-stimulation spectral power in the slow oscillations and delta frequency ranges
2 nights
Concordance for the detection of N3 sleep
2 weeks
Change in Depression symptoms
Change in PTSD symptoms
Change in mean sleep efficiency
Change in night-to-night variability of sleep efficiency
Change in objective cognitive performance
Change in objective memory consolidation
Change in subjective cognitive performance
Change in subjective fatigue
Change in subjective insomnia symptoms
Change in the proportion of N3 sleep

Trial Safety

Trial Design

2 Treatment Groups

Auditory Stimulation
1 of 2
Sham
1 of 2

Experimental Treatment

Non-Treatment Group

110 Total Participants · 2 Treatment Groups

Primary Treatment: Auditory Stimulation · Has Placebo Group · N/A

Auditory Stimulation
Device
Experimental Group · 1 Intervention: DREEM2 · Intervention Types: Device
Sham
Device
ShamComparator Group · 1 Intervention: Placebo · Intervention Types: Device

Trial Logistics

Trial Timeline

Screening: ~3 weeks
Treatment: Varies
Reporting: 2 weeks

Who is running the clinical trial?

University of OttawaLead Sponsor
183 Previous Clinical Trials
253,880 Total Patients Enrolled
Rebecca Robillard, PhDPrincipal InvestigatorUniversity of Ottawa Institute of Mental Health Research, affiliated to The Royal

Eligibility Criteria

Age 25 - 45 · All Participants · 6 Total Inclusion Criteria

Mark “Yes” if the following statements are true for you:
You must be between 25 and 45 years old.
You do not have any sleep-related symptoms, except for insomnia if you are part of the insomnia group.

Frequently Asked Questions

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." - Anonymous Online Contributor

Unverified Answer

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." - Anonymous Online Contributor

Unverified Answer

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." - Anonymous Online Contributor

Unverified Answer

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." - Anonymous Online Contributor

Unverified Answer

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." - Anonymous Online Contributor

Unverified Answer
Please Note: These questions and answers are submitted by anonymous patients, and have not been verified by our internal team.