Major Depressive DisorderNCT01719315
Neurophysiologic Correlates of Hypersomnia
An observational study of Major Depressive Disorder and Primary Hypersomnia, run by University of Wisconsin, Madison at 1 site in United States.
Trial summary
The goal of this project is to examine the neurophysiology of hypersomnia during sleep and wakefulness, to identify biomarkers for excessive sleepiness in neuropsychiatric disorders, and pilot acoustical slow wave induction during sleep in patients with hypersomnolence, to determine if this decreases daytime… Read more about this study
- Who is it for?
- Ages 18 to 60 yearsHealthy volunteers can take part
- Conditions the study is for
- Major Depressive Disorder, Primary Hypersomnia, Bipolar Disorder
- What is being tested?
- Acoustical slow wave induction
- How many people
- 76 participants
- Where
- 1 siteUnited States
- Study dates
- Nov 2012to Jun 2018
- Phase
- Observational
- 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 18 to 60 years
- All sexes
- Healthy volunteers accepted
- Adult
Study population: Subjects will be recruited from the greater Madison, WI area. Hypersomnolent subject groups (n=30 in each group) may include unipolar MDD with hypersomnolence, primary hypersomnia (idiopathic hypersomnia), bipolar disorder with hypersomnolence, and narcolepsy. Non-hypersomnolent comparison groups (n=30 in each group) will include: MDD without hypersomnolence, bipolar disorder without hypersomnolence, primary insomnia, and healthy controls.
Who may be able to join
- Meet Diagnostic and Statistical Manual edition IV criteria for neuropsychiatric disorders enumerated in study population description
Who cannot join
- Exclusionary criteria for all subjects will include: evidence of a clinically significant sleep disorder that would cause hypersomnolence (e.g. moderate to severe obstructive sleep apnea, restless legs syndrome, shift-work sleep disorder), history of significant head trauma or loss of consciousness > 30 minutes; current smoking of more than 15 cigarettes per day; >3 caffeinated beverages per day; significant neurologic or medical illness; active drug/alcohol abuse/dependence (within 6 months of enrollment), women who are pregnant, <6 months post-partum, nursing or planning to become pregnant during the study; left-handedness (due to effects on sleep topography); and imminent risk for self-harm or suicide.
Trial locations and contacts
1 site in 1 country.
United States1 site
University of Wisconsin-Madison, Department of Psychiatry
Madison, Wisconsin, 53719
About this study
Official title: Neurophysiologic Correlates of Hypersomnia: a High Density EEG Investigation
The goal of this project is to examine the neurophysiology of hypersomnia during sleep and wakefulness, to identify biomarkers for excessive sleepiness in neuropsychiatric disorders, and pilot acoustical slow wave induction during sleep in patients with hypersomnolence, to determine if this decreases daytime sleepiness in these patients. The primary study hypotheses are that individuals with hypersomnolence will have reduced slow wave activity (SWA) during sleep and increased waking theta/alpha activity during wake in specific brain regions. A secondary hypothesis is that acoustical slow wave induction in hypersomnolent patients will increase SWA during sleep, reduce theta/alpha activity during wake, and improve subjective sleepiness.
- Conditions
- Major Depressive Disorder, Primary Hypersomnia, Bipolar Disorder, Narcolepsy, Primary Insomnia
- Being tested
- Acoustical slow wave induction
- Medical subject headings
- Depressive Disorder, Major, Idiopathic Hypersomnia, Bipolar Disorder, Narcolepsy, Sleep Initiation and Maintenance Disorders
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Acoustical slow wave inductionOther
Brief tones (50 millisecond duration) at a frequency of 0.8 and 2 Hz, a rate that approximates the natural cellular oscillations of cortical neurons during sleep, will be played in blocks of 15-20 during non-rapid eye movement (NREM) sleep. Blocks of active acoustic slow wave induction will be followed by blocks of equal duration without induction, in order to make comparisons between stimulation periods (ON) and no stimulation periods (OFF). Tone intensity will be manually adjusted so as to be above an individual participant's auditory threshold during waking, but still quiet enough as not to awaken the subject from sleep. Sham slow wave induction will consist of auditory tones played prior to sleep, and during sleep of insufficient timing and intensity to alter slow wave activity.
| Study group | Role | What they receive |
|---|---|---|
| MDD with Hypersomnia | Participants with Major Depressive Disorder and co-morbid hypersomnia Receives: Other: Acoustical slow wave induction | |
| MDD without hypersomnia | Participants with Major Depressive Disorder but without co-morbid hypersomnia | |
| BPAD with hypersomnia | Participants with Bipolar Affective Disorder and co-morbid hypersomnia Receives: Other: Acoustical slow wave induction | |
| BPAD without hypersomnia | Participants with Bipolar Affective Disorder without co-morbid hypersomnia | |
| Primary Hypersomnia | Patients with primary hypersomnia (idiopathic hypersomnia) Receives: Other: Acoustical slow wave induction | |
| Primary Insomnia | Patients with primary insomnia | |
| Narcolepsy | Subjects with narcolepsy Receives: Other: Acoustical slow wave induction | |
| Healthy Controls | healthy participants |
What is being measured
The primary outcome is the main question the study is designed to answer.
Nocturnal Slow Wave Activity
EEG recordings during sleep will be analyzed to assess slow wave activity in the 1-4.5Hz range.
Measured: Individual nights of sleep recorded within an average of 4 weeks of enrollment
Secondary outcomes (1)
Waking theta/alpha activity
Waking EEG activity across the 1-12Hz range will be analyzed.
Measured: Individual days of waking EEG will be recorded within an average of 4 weeks of enrollment
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted1 Nov 2012 (estimated)
- Study startNov 2012
- Primary completionJun 2018
- Study completionJun 2018
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Major Depressive DisorderStudies of the same condition, open and under way.
- 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
- Observational
- Observational model
- Case-control
- Time perspective
- Prospective
- Enrolment
- 76 participants (actual)
Sponsor and investigators
- Lead sponsor
- University of Wisconsin, Madison
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor
- Investigators
- David T Plante, Principal investigator, University of Wisconsin, Madison
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT01719315
- Sponsor's protocol ID
- 2012-0201
- Status last verified
- Dec 2018
- First submitted
- 24 Oct 2012
- Last updated
- 24 Dec 2018
- Results posted
- No
- Data monitoring committee
- No
Study at a glance
From the registry record, last updated by the sponsor on 24 Dec 2018. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Neurophysiologic Correlates of Hypersomnia: a High Density EEG Investigation
- ClinicalTrials.gov ID
- NCT01719315
- Acronym / sponsor ID
- 2012-0201
- Conditions
- Major Depressive Disorder, Primary Hypersomnia, Bipolar Disorder, Narcolepsy, Primary Insomnia
- Study type
- Observational
- Recruitment status
- Completed
- Enrolment
- 76 participants (actual)
- Lead sponsor
- University of Wisconsin, MadisonUniversity, hospital or other
- Study start
- Nov 2012 (actual)
- Primary completion
- Jun 2018 (actual)
- Study completion
- Jun 2018 (actual)
- First posted
- 1 Nov 2012 (estimated)
- 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 goal of this project is to examine the neurophysiology of hypersomnia during sleep and wakefulness, to identify biomarkers for excessive sleepiness in neuropsychiatric disorders, and pilot acoustical slow wave induction during sleep in patients with hypersomnolence, to determine if this decreases daytime sleepiness in these patients. The primary study hypotheses are that individuals with hypersomnolence will have reduced slow wave activity (SWA) during sleep and increased waking theta/alpha activity during wake in specific brain regions. A secondary hypothesis is that acoustical slow wave induction in hypersomnolent patients will increase SWA during sleep, reduce theta/alpha activity during wake, and improve subjective sleepiness.
Study design
- Observational model
- Case-control
- Time perspective
- Prospective
- Number of arms
- 8
| Arm | Type | Receives |
|---|---|---|
| MDD with Hypersomnia | – | Other: Acoustical slow wave inductionParticipants with Major Depressive Disorder and co-morbid hypersomnia |
| MDD without hypersomnia | – | –Participants with Major Depressive Disorder but without co-morbid hypersomnia |
| BPAD with hypersomnia | – | Other: Acoustical slow wave inductionParticipants with Bipolar Affective Disorder and co-morbid hypersomnia |
| BPAD without hypersomnia | – | –Participants with Bipolar Affective Disorder without co-morbid hypersomnia |
| Primary Hypersomnia | – | Other: Acoustical slow wave inductionPatients with primary hypersomnia (idiopathic hypersomnia) |
| Primary Insomnia | – | –Patients with primary insomnia |
| Narcolepsy | – | Other: Acoustical slow wave inductionSubjects with narcolepsy |
| Healthy Controls | – | –healthy participants |
Who may qualify
- Ages
- 18 to 60 years
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Adult
- Study population
- Subjects will be recruited from the greater Madison, WI area. Hypersomnolent subject groups (n=30 in each group) may include unipolar MDD with hypersomnolence, primary hypersomnia (idiopathic hypersomnia), bipolar disorder with hypersomnolence, and narcolepsy. Non-hypersomnolent comparison groups (n=30 in each group) will include: MDD without hypersomnolence, bipolar disorder without hypersomnolence, primary insomnia, and healthy controls.
Key inclusion criteria (1 listed)
- Meet Diagnostic and Statistical Manual edition IV criteria for neuropsychiatric disorders enumerated in study population description
Key exclusion criteria (1 listed)
- Exclusionary criteria for all subjects will include: evidence of a clinically significant sleep disorder that would cause hypersomnolence (e.g. moderate to severe obstructive sleep apnea, restless legs syndrome, shift-work sleep disorder), history of significant head trauma or loss of consciousness > 30 minutes; current smoking of more than 15 cigarettes per day; >3 caffeinated beverages per day; significant neurologic or medical illness; active drug/alcohol abuse/dependence (within 6 months of enrollment), women who are pregnant, <6 months post-partum, nursing or planning to become pregnant during the study; left-handedness (due to effects on sleep topography); and imminent risk for self-harm or suicide.
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 |
|---|---|---|
| Acoustical slow wave inductionBrief tones (50 millisecond duration) at a frequency of 0.8 and 2 Hz, a rate that approximates the natural cellular oscillations of cortical neurons during sleep, will be played in blocks of 15-20 during non-rapid eye movement (NREM) sleep. Blocks of active acoustic slow wave induction will be followed by blocks of equal duration without induction, in order to make comparisons between stimulation periods (ON) and no stimulation periods (OFF). Tone intensity will be manually adjusted so as to be above an individual participant's auditory threshold during waking, but still quiet enough as not to awaken the subject from sleep. Sham slow wave induction will consist of auditory tones played prior to sleep, and during sleep of insufficient timing and intensity to alter slow wave activity. | Other | BPAD with hypersomnia, MDD with Hypersomnia, Narcolepsy, Primary Hypersomnia |
Primary outcome
Nocturnal Slow Wave Activity
Time frame: Individual nights of sleep recorded within an average of 4 weeks of enrollment
EEG recordings during sleep will be analyzed to assess slow wave activity in the 1-4.5Hz range.
1 secondary outcome
Waking theta/alpha activity
Time frame: Individual days of waking EEG will be recorded within an average of 4 weeks of enrollment
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 24 Dec 2018.
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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.
David T Plante principal investigator
University of Wisconsin, Madison
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
An observational study of Major Depressive Disorder and Primary Hypersomnia, run by University of Wisconsin, Madison at 1 site in United States.
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 1 inclusion and 1 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: finished, as of the sponsor's last update on 24 Dec 2018. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in United States. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. 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 is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
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?
Nocturnal Slow Wave Activity (time frame: Individual nights of sleep recorded within an average of 4 weeks of enrollment). 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 24 Dec 2018.