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Equipment for slow wave enhancement is no longer available
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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.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Active Slow-wave enhancement | Experimental | Participants will wear the Philips SmartSleep Deep Sleep Headband which will play auditory tones to selectively enhance slow-wave activity. |
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| Sham Slow-wave enhancement | Sham Comparator | Participants will wear the Philips SmartSleep Deep Sleep Headband which will not be programmed to enhance slow-wave activity |
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| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Slow-wave enhancement | Device | A headband that measures slow-wave activity during sleep and uses auditory stimulation to enhance slow waves using closed-loop auditory stimulation. |
| 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 |
| 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 |
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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:
Exclusion Criteria:
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| ID | Term |
|---|---|
| D003865 | Depressive Disorder, Major |
| D003863 | Depression |
| D003866 | Depressive Disorder |
| ID | Term |
|---|---|
| D019964 | Mood Disorders |
| D001523 | Mental Disorders |
| D001526 | Behavioral Symptoms |
| D001519 | Behavior |
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All participants will be randomized to active or sham enhancement for one week. For the second week, they will then receive the alternate condition.
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| Sham device | Device | A headband that measures slow-wave activity during sleep but has no auditory stimulation. |
|
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 |