Pilot Study: Investigating Mood Changes After Slow-wave Enhancement

NCT ID: NCT05146427

Last Updated: 2025-02-03

Basic Information

• Recruitment Status: WITHDRAWN
• Clinical Phase: NA
• Study Classification: INTERVENTIONAL
• Study Start Date: 2025-01-01
• Study Completion Date: 2025-10-01

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

Study Design

• Allocation Method: RANDOMIZED
• Intervention Model: CROSSOVER
• Primary Study Purpose: BASIC_SCIENCE
• Blinding Strategy: SINGLE

Study Groups

Active Slow-wave enhancement

Participants will wear the Philips SmartSleep Deep Sleep Headband which will play auditory tones to selectively enhance slow-wave activity.

Group Type: EXPERIMENTAL

Slow-wave enhancement

Intervention Type: DEVICE

A headband that measures slow-wave activity during sleep and uses auditory stimulation to enhance slow waves using closed-loop auditory stimulation.

Sham Slow-wave enhancement

Participants will wear the Philips SmartSleep Deep Sleep Headband which will not be programmed to enhance slow-wave activity

Group Type: SHAM_COMPARATOR

Sham device

Intervention Type: DEVICE

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

Interventions

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.

Intervention Type: DEVICE

Sham device

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

Intervention Type: DEVICE

Eligibility Criteria

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.

• Minimum Eligible Age: 25 Years
• Maximum Eligible Age: 50 Years
• Eligible Sex: ALL
• Accepts Healthy Volunteers: No

Sponsors

University of Pennsylvania

OTHER

Sponsor Role: lead

Responsible Party

Philip Gehrman

Associate Professor

Responsibility Role: PRINCIPAL_INVESTIGATOR

Other Identifiers

844797

Identifier Type: -

Identifier Source: org_study_id