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Stimulating Brain Waves During Deep Sleep

NCT05024578 · Status: UNKNOWN · Phase: NA · Type: INTERVENTIONAL · Enrollment: 110

Last updated 2022-08-16

No results posted yet for this study

Summary

This study aims to better delineate profiles of insomnia subtypes in people with and without depression or PTSD across simultaneous EEG, heart rate, and body temperature monitoring over multiple days in the natural sleeping environment. Using ambulatory EEG headbands, we also aim to compare the influence of auditory stimulation on slow waves and related objective and subjective sleep measures, as well as mental well-being, daytime fatigue, and cognitive performance in healthy sleepers and people with symptoms of insomnia (with and without psychiatric comorbidities). This is a double-blind randomized control trial. The overall protocol includes a web-based screening interview and home-based data collection spanning over 5 weeks. A subset of participants will be invited for in-lab monitoring via 3 overnight visits.

Conditions

  • Placebo
  • Experimental

Interventions

DEVICE

DREEM2

Closed-loop EEG monitoring and auditory stimulation in which 100ms pulses of pink noise are delivered on the ascending phase of slow oscillations during N3 sleep.

DEVICE

Placebo

EEG monitoring with the same headband as in the DREEM2 intervention, but without any sound stimulation.

Sponsors & Collaborators

  • University of Ottawa

    lead OTHER

Principal Investigators

  • Rebecca Robillard, PhD · University of Ottawa Institute of Mental Health Research, affiliated to The Royal

Study Design

Allocation
RANDOMIZED
Purpose
OTHER
Masking
QUADRUPLE
Model
CROSSOVER

Eligibility

Min Age
25 Years
Max Age
45 Years
Sex
ALL
Healthy Volunteers
Yes

Timeline & Regulatory

Start
2022-08-12
Primary Completion
2024-08-31
Completion
2024-09-30
FDA Device
Yes

Countries

  • Canada

Study Locations

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Read the full study record

This page highlights key information. For complete eligibility criteria, study locations, investigator contacts, and the full protocol, visit the original record on ClinicalTrials.gov.

View NCT05024578 on ClinicalTrials.gov