NCT05850676 · University of Pennsylvania
Disentangling the Role of Depression in Hypersomnia
What this study is about
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.
View original scientific description
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.
Interventions
DIAGNOSTIC_TEST
Sleep study
Participants will spend two nights in the Penn Sleep Center
Primary outcome measures
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.
Who can participate
This study lists these criteria on ClinicalTrials.gov. A study coordinator reviews eligibility during screening — this page does not determine whether you qualify.
Inclusion criteria
- 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
Exclusion criteria
- 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
Where
- Philadelphia, Pennsylvania
Collaborators
Jazz Pharmaceuticals
Related conditions & keywords
Frequently asked questions
What is a clinical trial?
A clinical trial is a research study that tests new medical treatments, drugs, devices, or procedures to determine their safety and effectiveness. Trials are carefully designed and monitored to protect participants while advancing medical knowledge.
Is it safe to participate?
Clinical trials follow strict safety guidelines and ethical standards. Trials must be reviewed and approved, and participants are closely monitored by medical professionals throughout the study. You can withdraw at any time if you choose.
Will I be compensated?
Many clinical trials offer compensation for your time, travel expenses, and inconvenience. The specific compensation varies by study and will be discussed during the screening process. All study-related medical care is typically provided at no cost to participants.
Will I receive a placebo instead of treatment?
When effective treatment exists, participants typically receive either the standard treatment plus the study intervention, or the standard treatment plus placebo. You would not be denied effective care. Placebos are primarily used when no proven treatment is available, or in addition to standard care. Your trial consent form will clearly explain what treatments you may receive.
Can I leave a trial if I change my mind?
Absolutely. Participation in clinical trials is completely voluntary. You have the right to withdraw from the study at any time, for any reason, without penalty or loss of benefits to which you are otherwise entitled.
How long does a clinical trial last?
Trial duration varies widely depending on the study design and purpose. Some trials last just a few weeks, while others may continue for months or years. The study coordinator will provide specific timeline information during your screening call.
Data: ClinicalTrials.gov · synced Jul 16, 2025 · Source of record for eligibility and locations