Disentangling the Role of Depression in Hypersomnia

NCT05850676 | Recruiting

• 1 other identifier: 853172
• Study Type: observational
• Target: 45
• Locations: 1 country
• Sites: 1

Brief 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.

Conditions

Hypersomnia

Outcome Measures

Primary Outcomes (1)

• Depression severity

  Scores on the Hamilton Depression Inventory. Scores range from 0 to 52, with higher scores indiated more severe symptoms of depression.

  One time at baseline

Secondary Outcomes (1)

• Sleep slow wave activity

  one night

Study Arms (2)

Idiopathic Hypersomnia

Men and women with a current diagnosis of Idiopathic Hypersomnia

Diagnostic Test: Sleep study

Hypersomnia Associated with a Psychiatric Disorder

Men and women with a current diagnosis of Hypersomnia Associated with a Psychiatric Disorder

Diagnostic Test: Sleep study

Interventions

Sleep study DIAGNOSTIC_TEST

Participants will spend two nights in the Penn Sleep Center

Hypersomnia Associated with a Psychiatric Disorder; Idiopathic Hypersomnia

Eligibility Criteria

• Age: 21 Years - 55 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64)
• Sampling Method: Probability Sample

Study Population

Adults with Idiopathic Hypersomnia or Hypersomnia Associated with a Psychiatry Disorder

You may qualify if:

• 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

You may not qualify if:

• 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

Sponsors & Collaborators

• University of Pennsylvania: lead
• Jazz Pharmaceuticals: collaborator

Study Sites (1)

The University of Pennsylvania

Philadelphia, Pennsylvania, 19104, United States

RECRUITING

MeSH Terms

Conditions

Disorders of Excessive Somnolence

Interventions

Polysomnography

Condition Hierarchy (Ancestors)

Sleep Disorders, Intrinsic; Dyssomnias; Sleep Wake Disorders; Nervous System Diseases; Mental Disorders

Intervention Hierarchy (Ancestors)

Monitoring, Physiologic; Diagnostic Techniques and Procedures; Diagnosis

Study Officials

• Philip Gehrman, PhD

  University of Pennsylvania

  PRINCIPAL INVESTIGATOR

Central Study Contacts

Nayeli Nunez-Cruz

CONTACT

215-746-3067; Nayeli.NunezCruz@Pennmedicine.upenn.edu

Study Design

• Study Type: observational
• Observational Model: COHORT
• Time Perspective: PROSPECTIVE
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: April 28, 2023
• First Posted: May 9, 2023
• Study Start: August 1, 2023
• Primary Completion (Estimated): May 30, 2026
• Study Completion (Estimated): June 30, 2026
• Last Updated: July 16, 2025

Record last verified: 2025-07

Data Sharing

• IPD Sharing: Will not share

Locations

US (1)