Depressive Disorder, MajorSWENCT05146427
Pilot Study: Investigating Mood Changes After Slow-wave Enhancement
A study testing Slow-wave enhancement in people with Depressive Disorder, Major and Depression, run by University of Pennsylvania.
Trial 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. Read more about this study
- Who is it for?
- Ages 25 to 50 years
- Conditions the study is for
- Depressive Disorder, Major, Depression, Depression, Unipolar
- What is being tested?
- Slow-wave enhancement
- Type of treatment
- Medical device
- Could I receive a placebo?
- Yes, some participants may receive a placebo
- How many people
- 0 participants
- Where
- No sites listed yet
- Study dates
- 1 Jan 2025to 1 Oct 2025
- Phase
- Interventional
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 25 to 50 years
- All sexes
- No healthy volunteers
- Adult
Who may be able to join
- 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:
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- Habitual nocturnal sleep duration between 6h and 9h.
- Habitual bedtime between 9pm-12am.
- No evidence of habitual napping.
Who cannot join
- 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.
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- 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.
About this study
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.
- Being tested
- Slow-wave enhancement, Sham device
- Medical subject headings
- Depressive Disorder, Major, Depression, Depressive Disorder
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Slow-wave enhancementDevice
A headband that measures slow-wave activity during sleep and uses auditory stimulation to enhance slow waves using closed-loop auditory stimulation.
Sham deviceDevice
A headband that measures slow-wave activity during sleep but has no auditory stimulation.
| Study group | Role | What they receive |
|---|---|---|
| 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. Receives: 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 Receives: Device: Sham device |
What is being measured
The primary outcome is the main question the study is designed to answer.
Change from baseline in Quick Inventory of Depressive Symptoms
Depression severity measure, score ranges from 0-27, higher scores indicate worse depressive symptoms
Measured: daily, up to 14 days
Secondary outcomes (3)
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
Measured: daily, up to 14 days
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
Measured: daily, up to 14 days
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
Measured: daily, up to 14 days
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted6 Dec 2021
- Study start1 Jan 2025 (estimated)
- Primary completion30 Jun 2025 (estimated)
- Study completion1 Oct 2025 (estimated)
Why it stopped: Equipment for slow wave enhancement is no longer available
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Depressive Disorder, MajorStudies of the same condition, open and under way.
- More trials run by University of PennsylvaniaThe sponsor's other registered studies.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Basic science
- Allocation
- Randomised
- Intervention model
- Crossover
- 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
- Single blind
- Who is masked
- Participant
- Enrolment
- 0 participants (actual)
Sponsor and investigators
- Lead sponsor
- University of Pennsylvania
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Philip Gehrman, University of Pennsylvania
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT05146427
- Sponsor's protocol ID
- 844797
- Acronym
- SWE
- Status last verified
- Jan 2025
- First submitted
- 11 Nov 2021
- Last updated
- 3 Feb 2025
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Study at a glance
From the registry record, last updated by the sponsor on 3 Feb 2025. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Pilot Study: Investigating Mood Changes After Slow-wave Enhancement
- ClinicalTrials.gov ID
- NCT05146427
- Acronym / sponsor ID
- SWE / 844797
- Study type
- Interventional
- Recruitment status
- WithdrawnReason stopped: Equipment for slow wave enhancement is no longer available
- Enrolment
- 0 participants (actual)
- Lead sponsor
- University of PennsylvaniaUniversity, hospital or other
- Study start
- 1 Jan 2025 (estimated)
- Primary completion
- 30 Jun 2025 (estimated)
- Study completion
- 1 Oct 2025 (estimated)
- First posted
- 6 Dec 2021 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
Study design
- Primary purpose
- Basic science
- Allocation
- Randomised
- Intervention model
- Crossover
- Masking
- Single blind (participant)
- Number of arms
- 2
- 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.
| Arm | Type | Receives |
|---|---|---|
| Active Slow-wave enhancement | Experimental | Device: Slow-wave enhancementParticipants will wear the Philips SmartSleep Deep Sleep Headband which will play auditory tones to selectively enhance slow-wave activity. |
| Sham Slow-wave enhancement | Sham comparator | Device: Sham deviceParticipants will wear the Philips SmartSleep Deep Sleep Headband which will not be programmed to enhance slow-wave activity |
Who may qualify
- Ages
- 25 to 50 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult
Key inclusion criteria (9 listed)
- Age 25-50 years.
- Primary language is English.
- Normal cognition.
- Normal (or corrected-to-normal) vision and hearing.
- Current depression.
Key exclusion criteria (9 listed)
- 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).
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Slow-wave enhancementA headband that measures slow-wave activity during sleep and uses auditory stimulation to enhance slow waves using closed-loop auditory stimulation. | Device | Active Slow-wave enhancement |
| Sham deviceA headband that measures slow-wave activity during sleep but has no auditory stimulation. | Device | Sham Slow-wave enhancement |
Primary outcome
Change from baseline in Quick Inventory of Depressive Symptoms
Time frame: daily, up to 14 days
Depression severity measure, score ranges from 0-27, higher scores indicate worse depressive symptoms
3 secondary outcomes
Change from baseline in Visual Analog Scale - Mood
Time frame: daily, up to 14 days
Change from baseline in Profile of Mood States
Time frame: daily, up to 14 days
Change from baseline in Positive and Negative Affect Schedule
Time frame: daily, up to 14 days
Results and safety
The study was withdrawn before enrolling participants, so there are no results.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 3 Feb 2025.
- Individual participant dataSharing planned: No
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
The record lists no contact. Use the official record to reach the sponsor.
Questions about this trial
What is this clinical trial studying?
A study testing Slow-wave enhancement in people with Depressive Disorder, Major and Depression, run by University of Pennsylvania.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 9 inclusion and 9 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: withdrawn, as of the sponsor's last update on 3 Feb 2025. Status can change between updates, so confirm with the study contact before making plans.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. Some participants in this study may receive a placebo. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
The study was withdrawn before enrolling participants, so there are no results.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Change from baseline in Quick Inventory of Depressive Symptoms (time frame: daily, up to 14 days). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 3 Feb 2025.