Pilot Study: Investigating Mood Changes After Slow-wave Enhancement

Study Overview
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Brief Summary
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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.

Official Title
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Pilot Study: Investigating Mood Changes After Slow-wave Enhancement

Conditions
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Depressive Disorder, Major, Depression, Depression, Unipolar, Depressive Disorder

Intervention / Treatment
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* Device: Slow-wave enhancement
* Device: Sham device


Participation Criteria
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Eligibility Criteria
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Inclusion Criteria: Age 25-50 years. Primary language is English. Normal cognition. Normal (or corrected-to-normal) vision and hearing. Current depression. Stable, normally-timed sleep-wake cycle as determined by interview, 1-week daily sleep log, and 1-week wrist actigraphic evidence, and defined by: Habitual nocturnal sleep duration between 6h and 9h. Habitual bedtime between 9pm-12am. No evidence of habitual napping. Exclusion Criteria: Current or prior medical condition that could interfere with collection or interpretation of data, based on medical history. History of stroke, epilepsy, brain scarring, or head injury causing unconsciousness. Independent/Intrinsic sleep disorder other than insomnia based on history or polysomnogram. 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). 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). Lifetime history of electroconvulsive therapy. Pregnancy as determined by self-report. Travel beyond 2 time zones in the 2 months before study. Unwillingness to refrain from using alcohol or caffeine during the study.

Ages Eligible for Study
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Minimum Age: 25 Years
Maximum Age: 50 Years

Sexes Eligible for Study
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All

Accepts Healthy Volunteers
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No

Study Plan
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How is the study designed?
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Design Details

Primary Purpose: Basic Science
Allocation: Randomized
Intervention Model: Crossover Assignment
Interventional Model Description: All participants will be randomized to active or sham enhancement for one week. For the second week, they will then receive the alternate condition.
Masking: Single


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Experimental: Active Slow-wave enhancement<br>Participants will wear the Philips SmartSleep Deep Sleep Headband which will play auditory tones to selectively enhance slow-wave activity. | Device: Slow-wave enhancement<br>* A headband that measures slow-wave activity during sleep and uses auditory stimulation to enhance slow waves using closed-loop auditory stimulation.<br>|
| Sham Comparator: Sham Slow-wave enhancement<br>Participants will wear the Philips SmartSleep Deep Sleep Headband which will not be programmed to enhance slow-wave activity | Device: Sham device<br>* A headband that measures slow-wave activity during sleep but has no auditory stimulation.<br>|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Change from baseline in Quick Inventory of Depressive Symptoms | Depression severity measure, score ranges from 0-27, higher scores indicate worse depressive symptoms | daily, up to 14 days | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Change from baseline in Visual Analog Scale - Mood | measure of positive and negative mood, scores range from 0 to 100, higher scores indicate worse depressive symptoms | daily, up to 14 days | 
| Change from baseline in Profile of Mood States | measure of total mood disturbance, scores range from 0 to 28, higher scores indicate worse depressive symptoms | daily, up to 14 days | 
| Change from baseline in Positive and Negative Affect Schedule | measure of positive and negative affect, scores range from 10 to 50, higher scores indicate worse depressive symptoms | daily, up to 14 days |