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Pilot Study: Investigating Mood Changes After Slow-wave Enhancement | Clinical Trials | Clareo Health

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Pilot Study: Investigating Mood Changes After Slow-wave Enhancement

NCT05146427•University of Pennsylvania

Summary

The aim of this pilot project proposal is to test the hypothesis that decreased sleep slow-wave activity (SWA) observed in individuals with major depressive disorder (MDD) is related to mood dysfunction, and that manipulating SWA may serve to improve mood by normalizing SWA regulation. The investigators propose to enhance SWA during nighttime sleep in a group of 20 antidepressant-free males and females age 25-50 with varying degrees of impairment in mood. Each participant will undergo one baseline night of sleep in the laboratory and then will sleep with the SmartSleep Headband nightly for two weeks in their own home. For one week, slow-wave sleep will be enhanced. On the alternate week, sleep will not be changed. Following the two weeks of sleeping with the device, participants will then spend another night in the sleep laboratory to assess changes in sleep. Mood will be assessed by self-report and clinician-administered scales following the baseline night of sleep, virtually after the first experimental week, and at the conclusion of the study.

Eligibility

Age

25 - 50 years

Sex

ALL

Healthy Volunteers

Inclusion Criteria

•1. Age 25-50 years.
•2. Primary language is English.
•3. Normal cognition.
•4. Normal (or corrected-to-normal) vision and hearing.
•5. Current depression.
•6. Stable, normally-timed sleep-wake cycle as determined by interview, 1-week daily sleep log, and 1-week wrist actigraphic evidence, and defined by:
•1. Habitual nocturnal sleep duration between 6h and 9h.
•2. Habitual bedtime between 9pm-12am.
•3. No evidence of habitual napping.

Exclusion Criteria

•1. Current or prior medical condition that could interfere with collection or interpretation of data, based on medical history.
•2. History of stroke, epilepsy, brain scarring, or head injury causing unconsciousness.
•3. Independent/Intrinsic sleep disorder other than insomnia based on history or polysomnogram.
•4. Recent use of psychoactive medications or medication thought to impact sleep or CNS function, as determined by investigators (e.g. SSRIs, benzodiazepines, glutamate modulators, gabapentin).
•5. History of or current psychiatric conditions that increase study risk or grossly impair CNS function (e.g., current anorexia or bulimia, history of substance dependence or current substance abuse, lifetime history of psychosis).
•6. Lifetime history of electroconvulsive therapy.
•7. Pregnancy as determined by self-report.
•8. Travel beyond 2 time zones in the 2 months before study.
•9. Unwillingness to refrain from using alcohol or caffeine during the study.

Key Dates

Start Date

January 1, 2025

Primary Completion Date

June 30, 2025

Completion Date

October 1, 2025

Last Updated

February 3, 2025

Conditions

Depressive Disorder, MajorDepressionDepression, UnipolarDepressive Disorder

Interventions

Slow-wave enhancement

DEVICE

Sham device

DEVICE

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Data Source & Attribution

This clinical trial information is sourced from ClinicalTrials.gov, a service of the U.S. National Institutes of Health.

ClinicalTrials.gov last update: February 3, 2025Data synced to Clareo: March 29, 2026

Modifications: This data has been reformatted for display purposes. Eligibility criteria have been parsed into inclusion/exclusion sections. Location data has been geocoded to enable distance-based search. For the authoritative and most current information, please visit ClinicalTrials.gov.

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Pilot Study: Investigating Mood Changes After Slow-wave Enhancement

Inclusion Criteria

Exclusion Criteria

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