Pilot Study: Investigating Mood Changes After Slow-wave Enhancement

Depression Clinical Trial

— SWE  

Official title:

Pilot Study: Investigating Mood Changes After Slow-wave Enhancement

Clinical Trial Details — Status: Not yet recruiting

Administrative data

• NCT number: NCT05146427
• Other study ID #: 844797
• Status: Not yet recruiting
• Phase: N/A
• Start date: January 1, 2025
• Est. completion date: October 1, 2025

Study information

• Verified date: February 2024
• Source: University of Pennsylvania
• Contact: Jennifer Goldschmied, PhD
• Phone: 3473068202
• Email: jrgolds2[@]pennmedicine.upenn.edu
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial 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.

Recruitment information / eligibility

• Status: Not yet recruiting
• Enrollment: 20
• Est. completion date: October 1, 2025
• Est. primary completion date: June 30, 2025
• Accepts healthy volunteers: No
• Gender: All
• Age group: 25 Years to 50 Years

Eligibility

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.

Related Conditions & MeSH terms

• Depression
• Depression, Unipolar
• Depressive Disorder
• Depressive Disorder, Major

Intervention

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 device
A headband that measures slow-wave activity during sleep but has no auditory stimulation.

Locations

Country	Name	City	State
n/a

Sponsors (1)

Lead Sponsor	Collaborator
University of Pennsylvania

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	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	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
Secondary	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
Secondary	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