Pilot Study: Investigating Mood Changes After Slow-wave Enhancement (SWE)

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.

Study Overview

• Status: Withdrawn
• Conditions: Depressive Disorder; Depression; Depressive Disorder, Major; Depression, Unipolar
• Intervention / Treatment: Device: Slow-wave enhancement; Device: Sham device

• Study Type: Interventional
• Phase: Not Applicable

Contacts and Locations

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 25 years to 50 years (Adult)
• Accepts Healthy Volunteers: No

Description

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.

Study Plan

How is the study designed?

Design Details

• Primary Purpose: Basic Science
• Allocation: Randomized
• Interventional Model: Crossover Assignment
• Masking: Single

Number of Arms

2

Arms and Interventions

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

What is the study measuring?

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

Collaborators and Investigators

• Sponsor: University of Pennsylvania

Study record dates

Study Major Dates

• Study Start (Estimated): January 1, 2025
• Primary Completion (Estimated): June 30, 2025
• Study Completion (Estimated): October 1, 2025

Study Registration Dates

• First Submitted: November 11, 2021
• First Submitted That Met QC Criteria: November 23, 2021
• First Posted (Actual): December 6, 2021

Study Record Updates

• Last Update Posted (Actual): March 25, 2025
• Last Update Submitted That Met QC Criteria: January 30, 2025
• Last Verified: January 1, 2025

More Information

Terms related to this study

• Additional Relevant MeSH Terms: Mental Disorders; Behavioral Symptoms; Mood Disorders; Depression; Depressive Disorder; Depressive Disorder, Major
• Other Study ID Numbers: 844797

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: NO

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: No