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
Sponsored by
About this trial
This is an interventional basic science trial for Depressive Disorder, Major
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.
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
No
Studies a U.S. FDA-regulated Device Product
No
Data Monitoring Committee
No
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
No
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
Email
jrgolds2@pennmedicine.upenn.edu
First Name & Middle Initial & Last Name or Official Title & Degree
Philip Gehrman, PhD
Phone
2157463578
Email
gehrman@upenn.edu
12. IPD Sharing Statement
Plan to Share IPD
No
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Pilot Study: Investigating Mood Changes After Slow-wave Enhancement
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