Stimulating Brain Waves During Deep Sleep

NCT05024578 | Unknown FDA Device

• 1 other identifier: 2021023
• Study Type: interventional
• Target: 110
• Locations: 1 country
• Sites: 1

Brief 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

Outcome Measures

Primary Outcomes (2)

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

  Mean spectral power in the 0.5-1Hz and 1-4Hz frequency bands in the 4 seconds following each sound stimulation (or sham stimulation) that was correctly delivered in the ascending phase of a slow oscillation (averaged across the 7 days of the intervention week).

  1 week (Active experimental condition)

• Post-stimulation slow oscillations amplitude

  Mean amplitude of slow oscillations in the 4 seconds following each sound stimulation (or sham stimulation) that was correctly delivered in the ascending phase of a slow oscillation (averaged across the 7 days of the intervention week).

  1 week (Active experimental condition)

Secondary Outcomes (11)

• Correctly timed sound stimulations

  1 week (Active experimental condition)

• Change in night-to-night variability of sleep efficiency

  2 weeks

• Change in mean sleep efficiency

  2 weeks

• Change in the proportion of N3 sleep

  2 weeks

• Change in subjective insomnia symptoms

  2 weeks

Study Arms (2)

Sham

SHAM COMPARATOR

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.

Device: Placebo

Auditory Stimulation

EXPERIMENTAL

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.

Device: DREEM2

Interventions

DREEM2 DEVICE

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.

Auditory Stimulation

Placebo DEVICE

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

Sham

Eligibility Criteria

• Age: 25 Years - 45 Years
• Sex: all
• Healthy Volunteers: Yes
• Age Groups: Adult (18-64)

You may qualify if:

• Between 25 and 45 years old;
• Asymptomatic on the Sleep Disorders Symptoms Checklist-25 (except for insomnia in the insomnia groups)
• Asymptomatic on the SCI (i.e. score \>3 on all items)
• Patient Health Questionnaire (PHQ-9) score \< 10
• Primary Care PTSD Screen (PC-PTSD) score \< 3
• No current diagnosis of mental disorder confirmed by the M.I.N.I.
• Symptomatic on the SCI (i.e. score above \<3 on specific combination of items (see 64))
• Patient Health Questionnaire (PHQ-9) score \< 10
• Primary Care PTSD Screen (PC-PTSD) score \< 3
• No current diagnosis of mental disorder confirmed by the M.I.N.I.
• Symptomatic on the SCI (i.e. score above \<3 on specific combination of items (see 64))
• Current diagnosis of PTSD confirmed by the PC- PTSD Screen (score \> 3) and the PTSD scale of the M.I.N.I.)
• No current diagnosis of bipolar disorder or psychotic disorder confirmed by the M.I.N.I.
• Symptomatic on the SCI (i.e. score above \<3 on specific combination of items (see 64))
• Current diagnosis of major depressive disorder or persistent depressive disorder confirmed by the Patient Health Questionnaire (PHQ-9) score \> 10 and the MDE scale of the M.I.N.I.;

You may not qualify if:

• Brain injury with loss of consciousness for over 5 minutes.
• Self-reported hearing loss
• Self-reported substance use disorder or \> monthly use of illicit drugs reported on item-2 of the WHO-ASSIST
• Body mass index \> 45;
• Shift work or rotating shifts within 1 month of study entry;
• Recent travel to a difference time zone;
• Any clinically significant cardiopulmonary, gastrointestinal, pancreatic, hepatic, renal, hematologic, endocrine, neurological (including seizure disorder), urogenital, or sleep disorder (other than insomnia);
• Not passing the COVID-19 screening;
• Taking any psychotropic medications p.r.n. (If taking any antidepressant or sleep medications, needs to be on a stable dose for at least 1 month prior to study start).
• Taking stimulant medications including, but not limited to, Adderall, Concerta, Ritalin, Desoxyn, Dexedrine, Dextrostat, Ephedrine, Phentermine, Procentra, Vyvanse, and Selegline;
• Insufficient English/French skills to provide informed consent, understand study instructions, or fill out questionnaires;
• Individuals with mini-braids, dreadlocks, hair extension or natural afro-hair (as this can alter the EEG headband recording).

Sponsors & Collaborators

• University of Ottawa: lead

Study Sites (1)

Sleep Research Unit, University of Ottawa Institute of Mental Health Research at the Royal

Ottawa, Ontario, K1Z7K4, Canada

RECRUITING

Study Officials

• Rebecca Robillard, PhD

  University of Ottawa Institute of Mental Health Research, affiliated to The Royal

  PRINCIPAL INVESTIGATOR

Central Study Contacts

Rebecca Robillard, PhD

CONTACT

(613) 722-6521; rebecca.robillard@uottawa.ca

Higginson Caitlin, MSc

CONTACT

(613) 722-6521; Caitlin.Higginson@theroyal.ca

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: QUADRUPLE
• Who Masked: PARTICIPANT, CARE PROVIDER, INVESTIGATOR, OUTCOMES ASSESSOR
• Purpose: OTHER
• Intervention Model: CROSSOVER
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Assistant Professor

Study Record Dates

• First Submitted: August 1, 2021
• First Posted: August 27, 2021
• Study Start: August 12, 2022
• Primary Completion: August 31, 2024
• Study Completion: September 30, 2024
• Last Updated: August 16, 2022

Record last verified: 2022-08

Locations

CA (1)