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

Primary Purpose

Depressive Disorder, Major, Depression, Depression, Unipolar

Status

Not yet recruiting

Phase

Not Applicable

Locations

Study Type

Interventional

Intervention

Slow-wave enhancement

Sham device

About this trial

This is an interventional basic science trial for Depressive Disorder, Major

Eligibility Criteria

25 Years - 50 Years (Adult)All SexesDoes not accept healthy volunteers

Inclusion Criteria:

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:
1. Habitual nocturnal sleep duration between 6h and 9h.
2. Habitual bedtime between 9pm-12am.
3. No evidence of habitual napping.

Exclusion Criteria:

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.

Sites / Locations

Arms of the Study

Arm 1

Arm 2

Arm Type

Experimental

Sham Comparator

Arm Label

Active Slow-wave enhancement

Sham Slow-wave enhancement

Arm Description

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

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

Outcomes

Primary Outcome Measures

Change from baseline in Quick Inventory of Depressive Symptoms

Depression severity measure, score ranges from 0-27, higher scores indicate worse depressive symptoms

Secondary Outcome Measures

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

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

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

Full Information

NCT ID

NCT05146427

First Posted

November 11, 2021

Last Updated

July 7, 2023

Sponsor

University of Pennsylvania

1. Study Identification

Unique Protocol Identification Number

NCT05146427

Brief Title

Pilot Study: Investigating Mood Changes After Slow-wave Enhancement

Acronym

SWE

Official Title

Pilot Study: Investigating Mood Changes After Slow-wave Enhancement

Study Type

Interventional

2. Study Status

Record Verification Date

July 2023

Overall Recruitment Status

Not yet recruiting

Study Start Date

October 1, 2023 (Anticipated)

Primary Completion Date

June 30, 2024 (Anticipated)

Study Completion Date

October 1, 2024 (Anticipated)

3. Sponsor/Collaborators

Responsible Party, by Official Title

Principal Investigator

Name of the Sponsor

University of Pennsylvania

4. Oversight

Studies a U.S. FDA-regulated Drug Product

Studies a U.S. FDA-regulated Device Product

Data Monitoring Committee

5. Study Description

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.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study

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

7. Study Design

Primary Purpose

Basic Science

Study Phase

Not Applicable

Interventional Study Model

Crossover Assignment

Model Description

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

Masking

Participant

Allocation

Randomized

Enrollment

20 (Anticipated)

8. Arms, Groups, and Interventions

Arm Title

Active Slow-wave enhancement

Arm Type

Experimental

Arm Description

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

Arm Title

Sham Slow-wave enhancement

Arm Type

Sham Comparator

Arm Description

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

Intervention Type

Device

Intervention Name(s)

Slow-wave enhancement

Intervention Description

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

Intervention Name(s)

Sham device

Intervention Description

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

Primary Outcome Measure Information:

Title

Change from baseline in Quick Inventory of Depressive Symptoms

Description

Depression severity measure, score ranges from 0-27, higher scores indicate worse depressive symptoms

Time Frame

daily, up to 14 days

Secondary Outcome Measure Information:

Title

Change from baseline in Visual Analog Scale - Mood

Description

measure of positive and negative mood, scores range from 0 to 100, higher scores indicate worse depressive symptoms

Time Frame

daily, up to 14 days

Title

Change from baseline in Profile of Mood States

Description

measure of total mood disturbance, scores range from 0 to 28, higher scores indicate worse depressive symptoms

Time Frame

daily, up to 14 days

Title

Change from baseline in Positive and Negative Affect Schedule

Description

measure of positive and negative affect, scores range from 10 to 50, higher scores indicate worse depressive symptoms

Time Frame

daily, up to 14 days

10. Eligibility

Sex

All

Minimum Age & Unit of Time

25 Years

Maximum Age & Unit of Time

50 Years

Accepts Healthy Volunteers

Eligibility Criteria

Inclusion Criteria: 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. Exclusion Criteria: 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.

Central Contact Person:

First Name & Middle Initial & Last Name or Official Title & Degree

Jennifer Goldschmied, PhD

Phone

3473068202

jrgolds2@pennmedicine.upenn.edu

First Name & Middle Initial & Last Name or Official Title & Degree

Philip Gehrman, PhD

Phone

2157463578

gehrman@upenn.edu

12. IPD Sharing Statement

Plan to Share IPD

Learn more about this trial

Pilot Study: Investigating Mood Changes After Slow-wave Enhancement

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