Pilot Study: Investigating Mood Changes After Slow-wave Enhancement

NCT05146427 | Withdrawn

• 1 other identifier: 844797
• Study Type: interventional
• Target: N/A
• Locations: 0 countries
• Sites: N/A

Brief 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

Outcome Measures

Primary Outcomes (1)

• 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 Outcomes (3)

• Change from baseline in Visual Analog Scale - Mood

  daily, up to 14 days

• Change from baseline in Profile of Mood States

  daily, up to 14 days

• Change from baseline in Positive and Negative Affect Schedule

  daily, up to 14 days

Study Arms (2)

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.

Device: Slow-wave enhancement

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

Device: Sham device

Interventions

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.

Active Slow-wave enhancement

Sham device DEVICE

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

Sham Slow-wave enhancement

Eligibility Criteria

• Age: 25 Years - 50 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64)

You may qualify if:

• 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.

You may not qualify if:

• 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.

Sponsors & Collaborators

• University of Pennsylvania: lead

MeSH Terms

Conditions

Depressive Disorder, Major; Depression; Depressive Disorder

Condition Hierarchy (Ancestors)

Mood Disorders; Mental Disorders; Behavioral Symptoms; Behavior

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: SINGLE
• Who Masked: PARTICIPANT
• Purpose: BASIC SCIENCE
• Intervention Model: CROSSOVER
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Associate Professor

Model Details: All participants will be randomized to active or sham enhancement for one week. For the second week, they will then receive the alternate condition.

Study Record Dates

• First Submitted: November 11, 2021
• First Posted: December 6, 2021
• Study Start: January 1, 2025
• Primary Completion: June 30, 2025
• Study Completion: October 1, 2025
• Last Updated: February 3, 2025

Record last verified: 2025-01

Data Sharing

• IPD Sharing: Will not share