NCT05146427

Pilot Study: Investigating Mood Changes After Slow-wave Enhancement

• Status: Withdrawn
• Phase: N/A
• Study type: Interventional
• Enrollment: 0 (actual)
• Sponsor: University of Pennsylvania · Academic / Other
• Sex: All
• Age: 25 Years – 50 Years
• Healthy volunteers: Not accepted

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.

Conditions

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

Interventions

Type	Name	Description
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.
DEVICE	Sham device	A headband that measures slow-wave activity during sleep but has no auditory stimulation.

Timeline

• Start date: 2025-01-01
• Primary completion: 2025-06-30
• Completion: 2025-10-01
• First posted: 2021-12-06
• Last updated: 2025-02-03