HypersomniaNCT05850676
Disentangling the Role of Depression in Hypersomnia
An observational study of Hypersomnia, run by University of Pennsylvania at 1 site in United States.
Trial summary
Individuals who have disorders of hypersomnolence (excessive sleepiness) often report symptoms of depression. The goal of this study is to further understand of the relationship between depression and hypersomnia by examining mood-relevant domains of slow wave sleep and reward function. Read more about this study
- Who is it for?
- Ages 21 to 55 years
- Conditions the study is for
- Hypersomnia
- What is being tested?
- Sleep study
- How many people
- 54 participants
- Where
- 1 siteUnited States
- Study dates
- 1 Aug 2023to 3 Aug 2026
- 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 21 to 55 years
- All sexes
- No healthy volunteers
- Adult
Study population: Adults with Idiopathic Hypersomnia or Hypersomnia Associated with a Psychiatry Disorder
Who may be able to join
- Males and females between the age of 21 and 55
- Meet DSM5 criteria for Idiopathic Hypersomnia or Hypersomnia Associated with a Psychiatry Disorder
- Ability to read and speak English
Who cannot join
- Unable or unwilling to provide informed consent
- Untreated obstructive sleep apnea (apnea-hypopnea index /= 15 events/hr)
- Meeting diagnostic criteria for narcolepsy
- A clinically unstable medical condition as defined by a new diagnosis or change in medical management in the previous 2 months (e.g., pneumonia, thyroid disease, ventricular arrhythmias, cirrhosis, surgery, or recently diagnosed cancer) because these changes could impact daytime hypersomnia and confound results
- Substance abuse/dependence, delirium, dementia, amnestic disorder, schizophrenia, and other psychotic disorders
- Prominent current suicidal or homicidal ideation.
- Unable to perform tests due to inability to communicate verbally, inability to read and write; less than a 5th grade reading level; visal, hearing, or cognitive impairment (e.g. previous head injury)
- Use of medications or OTC products that might impact sleep
Trial locations and contacts
1 site in 1 country.
United States1 site
The University of Pennsylvania
Philadelphia, Pennsylvania, 19104
About this study
Individuals who have disorders of hypersomnolence (excessive sleepiness) often report symptoms of depression. The goal of this study is to further understand of the relationship between depression and hypersomnia by examining mood-relevant domains of slow wave sleep and reward function.
Read the detailed description
There are often challenges in the diagnosis of Idiopathic Hypersomnia (IH) in patients with comorbid psychiatric disorders, mood disorders in particular, who often report symptoms including excessive sleep duration and daytime somnolence. Further, 15-25% of patients with IH report significant depressive symptoms. When comparing these patients groups, studies have not found significant differences in depression scores, indicating the severity of depression cannot be reliably used to support diagnostic distinctions. These findings present significant challenges to the differential diagnosis of IH vs. Hypersomnia Associated with a Psychiatric Disorder (HAPD). Indeed, the diagnostic criteria of IH and HAPD overlap considerably, leaving clinicians to make the often challenging distinction of whether hypersomnia symptoms are temporally related to the course of the psychiatric disorder(s).
The difficulty in differentiating IH from HAPD has largely focused on subjective sleepiness, but some studies have utilized objective measures of sleepiness, in particular the MSLT, to compare these groups. Vgontzas and colleagues found that IH was associated with faster sleep onset on daytime nap opportunities compared to HAPD. Further, a systematic review and meta-analysis found that subjective hypersomnolence in patients with mood disorders was not associated with faster sleep latency on the MSLT compared to normative values, although there was significant heterogeneity. This discrepancy between subjective and objective hypersomnia can logically be explained by the presence of depressive symptoms. Depression is associated with cognitive distortions that lead individuals to interpret events from a more negative perspective, which leads to greater reporting of physical symptoms including pain and fatigue. An in-depth investigation of depression in patients with IH and HAPD may shed light on fundamental differences between these groups and improve diagnostic accuracy.
In understanding the relationship between depression and subjective hypersomnia it will be critical to look beyond subjective depressive symptoms because there will be de facto associations found due to the common use of self-report methods. Studies need to assess the neurobiological domains that underlie depression, both to utilize more objective methods and to understand the actual mechanisms driving these associations. A logical target in this regard would be the reward system, which is activated by any pleasurable stimuli and directs motivation to seek out these stimuli. Reward function is disrupted in individuals with depression, leading to two core features of anhedonia, i.e reduced capacity to experience pleasure and low motivation during waking hours. More specifically, patients with MDD demonstrate deficits in areas of reward function, namely reduced effort for rewards, discounting of monetary rewards, and impairments in reward learning. It also seems totoo reasonable to expect that reward dysfunction is also related to the experience of hypersomnia, although this has not been previously investigated. Interestingly, investigations have recently begun to examine the ways in which sleep disturbance may independently affect reward processes. Poor sleep at night can contribute to impaired reward function the next day.
A second depression-related system to investigate would be the sleep/wake system. Depression is known to be associated with abnormalities in sleep, in particular in slow wave sleep, the most restorative type of sleep. More specifically, the quantity of slow waves during sleep can be quantified as slow wave activity (SWA), with greater SWA associated with greater perceptions of feeling rested the next day. Depression is associated reduced SWA, which is thought the reflect deficient neuroplasticity. Patients with depression and hypersomnia have been found to exhibit reduced SWA compared to those without hypersomnia, suggesting a potential deficit in the restorative quality of sleep in these individuals. This suggests that the SWA deficiencies may be specifically related to subjective hypersomnia in depression. No studies have examined SWA dynamics in IH.
The overarching hypothesis is that greater severity of subjective, but not objective, hypersomnia in patients with IH and HAPD is related to a combination of disruption in slow wave sleep dynamics at night and deficits in reward processes. Demonstration of these effects could improve understanding of the nature of subjective vs. objective hypersomnia and lead to improve the differential diagnosis of hypersomnia disorders.
- Conditions
- Hypersomnia
- Being tested
- Sleep study
- Medical subject headings
- Disorders of Excessive Somnolence
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Sleep studyDiagnostic test
Participants will spend two nights in the Penn Sleep Center
| Study group | Role | What they receive |
|---|---|---|
| Idiopathic Hypersomnia | Men and women with a current diagnosis of Idiopathic Hypersomnia Receives: Diagnostic Test: Sleep study | |
| Hypersomnia Associated with a Psychiatric Disorder | Men and women with a current diagnosis of Hypersomnia Associated with a Psychiatric Disorder Receives: Diagnostic Test: Sleep study |
What is being measured
The primary outcome is the main question the study is designed to answer.
Depression severity
Scores on the Hamilton Depression Inventory. Scores range from 0 to 52, with higher scores indiated more severe symptoms of depression.
Measured: One time at baseline
Secondary outcomes (1)
Sleep slow wave activity
EEG activity in the delta frequency range during sleep
Measured: one night
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted9 May 2023
- Study start1 Aug 2023
- Primary completion3 Aug 2026
- Study completion3 Aug 2026
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for HypersomniaStudies 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
- Observational
- Observational model
- Cohort
- Time perspective
- Prospective
- Enrolment
- 54 participants (actual)
Sponsor and investigators
- Lead sponsor
- University of Pennsylvania
- Sponsor type
- University, hospital or other
- Collaborators
- Jazz Pharmaceuticals
- Responsible party
- Sponsor
- Investigators
- Philip Gehrman, PhD, Principal investigator, University of Pennsylvania
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT05850676
- Sponsor's protocol ID
- 853172
- Status last verified
- Aug 2026
- First submitted
- 28 Apr 2023
- Last updated
- 6 Aug 2026
- 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 6 Aug 2026. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Disentangling the Role of Depression in Hypersomnia
- ClinicalTrials.gov ID
- NCT05850676
- Acronym / sponsor ID
- 853172
- Conditions
- Hypersomnia
- Study type
- Observational
- Recruitment status
- Completed
- Enrolment
- 54 participants (actual)
- Lead sponsor
- University of PennsylvaniaUniversity, hospital or other
- Collaborators
- Jazz Pharmaceuticals
- Study start
- 1 Aug 2023 (actual)
- Primary completion
- 3 Aug 2026 (actual)
- Study completion
- 3 Aug 2026 (actual)
- First posted
- 9 May 2023 (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.
Individuals who have disorders of hypersomnolence (excessive sleepiness) often report symptoms of depression. The goal of this study is to further understand of the relationship between depression and hypersomnia by examining mood-relevant domains of slow wave sleep and reward function.
Detailed description
There are often challenges in the diagnosis of Idiopathic Hypersomnia (IH) in patients with comorbid psychiatric disorders, mood disorders in particular, who often report symptoms including excessive sleep duration and daytime somnolence. Further, 15-25% of patients with IH report significant depressive symptoms. When comparing these patients groups, studies have not found significant differences in depression scores, indicating the severity of depression cannot be reliably used to support diagnostic distinctions. These findings present significant challenges to the differential diagnosis of IH vs. Hypersomnia Associated with a Psychiatric Disorder (HAPD). Indeed, the diagnostic criteria of IH and HAPD overlap considerably, leaving clinicians to make the often challenging distinction of whether hypersomnia symptoms are temporally related to the course of the psychiatric disorder(s).
The difficulty in differentiating IH from HAPD has largely focused on subjective sleepiness, but some studies have utilized objective measures of sleepiness, in particular the MSLT, to compare these groups. Vgontzas and colleagues found that IH was associated with faster sleep onset on daytime nap opportunities compared to HAPD. Further, a systematic review and meta-analysis found that subjective hypersomnolence in patients with mood disorders was not associated with faster sleep latency on the MSLT compared to normative values, although there was significant heterogeneity. This discrepancy between subjective and objective hypersomnia can logically be explained by the presence of depressive symptoms. Depression is associated with cognitive distortions that lead individuals to interpret events from a more negative perspective, which leads to greater reporting of physical symptoms including pain and fatigue. An in-depth investigation of depression in patients with IH and HAPD may shed light on fundamental differences between these groups and improve diagnostic accuracy.
In understanding the relationship between depression and subjective hypersomnia it will be critical to look beyond subjective depressive symptoms because there will be de facto associations found due to the common use of self-report methods. Studies need to assess the neurobiological domains that underlie depression, both to utilize more objective methods and to understand the actual mechanisms driving these associations. A logical target in this regard would be the reward system, which is activated by any pleasurable stimuli and directs motivation to seek out these stimuli. Reward function is disrupted in individuals with depression, leading to two core features of anhedonia, i.e reduced capacity to experience pleasure and low motivation during waking hours. More specifically, patients with MDD demonstrate deficits in areas of reward function, namely reduced effort for rewards, discounting of monetary rewards, and impairments in reward learning. It also seems totoo reasonable to expect that reward dysfunction is also related to the experience of hypersomnia, although this has not been previously investigated. Interestingly, investigations have recently begun to examine the ways in which sleep disturbance may independently affect reward processes. Poor sleep at night can contribute to impaired reward function the next day.
A second depression-related system to investigate would be the sleep/wake system. Depression is known to be associated with abnormalities in sleep, in particular in slow wave sleep, the most restorative type of sleep. More specifically, the quantity of slow waves during sleep can be quantified as slow wave activity (SWA), with greater SWA associated with greater perceptions of feeling rested the next day. Depression is associated reduced SWA, which is thought the reflect deficient neuroplasticity. Patients with depression and hypersomnia have been found to exhibit reduced SWA compared to those without hypersomnia, suggesting a potential deficit in the restorative quality of sleep in these individuals. This suggests that the SWA deficiencies may be specifically related to subjective hypersomnia in depression. No studies have examined SWA dynamics in IH.
The overarching hypothesis is that greater severity of subjective, but not objective, hypersomnia in patients with IH and HAPD is related to a combination of disruption in slow wave sleep dynamics at night and deficits in reward processes. Demonstration of these effects could improve understanding of the nature of subjective vs. objective hypersomnia and lead to improve the differential diagnosis of hypersomnia disorders.
Study design
- Observational model
- Cohort
- Time perspective
- Prospective
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Idiopathic Hypersomnia | – | Diagnostic Test: Sleep studyMen and women with a current diagnosis of Idiopathic Hypersomnia |
| Hypersomnia Associated with a Psychiatric Disorder | – | Diagnostic Test: Sleep studyMen and women with a current diagnosis of Hypersomnia Associated with a Psychiatric Disorder |
Who may qualify
- Ages
- 21 to 55 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult
- Study population
- Adults with Idiopathic Hypersomnia or Hypersomnia Associated with a Psychiatry Disorder
Key inclusion criteria (3 listed)
- Males and females between the age of 21 and 55
- Meet DSM5 criteria for Idiopathic Hypersomnia or Hypersomnia Associated with a Psychiatry Disorder
- Ability to read and speak English
Key exclusion criteria (8 listed)
- Unable or unwilling to provide informed consent
- Untreated obstructive sleep apnea (apnea-hypopnea index /= 15 events/hr)
- Meeting diagnostic criteria for narcolepsy
- A clinically unstable medical condition as defined by a new diagnosis or change in medical management in the previous 2 months (e.g., pneumonia, thyroid disease, ventricular arrhythmias, cirrhosis, surgery, or recently diagnosed cancer) because these changes could impact daytime hypersomnia and confound results
- Substance abuse/dependence, delirium, dementia, amnestic disorder, schizophrenia, and other psychotic disorders
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 |
|---|---|---|
| Sleep studyParticipants will spend two nights in the Penn Sleep Center | Diagnostic test | Hypersomnia Associated with a Psychiatric Disorder, Idiopathic Hypersomnia |
Primary outcome
Depression severity
Time frame: One time at baseline
Scores on the Hamilton Depression Inventory. Scores range from 0 to 52, with higher scores indiated more severe symptoms of depression.
1 secondary outcome
Sleep slow wave activity
Time frame: one night
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 6 Aug 2026.
- 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.
Philip Gehrman, PhD principal investigator
University of Pennsylvania
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 Hypersomnia, run by University of Pennsylvania 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 3 inclusion and 8 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 6 Aug 2026. 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?
Depression severity (time frame: One time at baseline). 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 6 Aug 2026.