Chronic Insomnia and CSF Markers of Dementia

The longstanding view has been that insomnia, and other forms of sleep disturbance, emerge as a consequence of dementia and are the result of progressive neuronal damage. However, there is growing evidence that the direction of causation may go both ways, with sleep disturbance potentially increasing vulnerability to dementia. Longitudinal studies have found that sleep disturbance often precedes and increases risk for dementia by several years.The purpose of this study is to examine the relationship between chronic insomnia and dementia biomarkers and orexin levels found in cerebrospinal fluid (CSF). Fifteen adults age 30-50 with chronic insomnia and age- and gender-matched good sleepers will undergo overnight polysomnography and CSF sampling in the morning.

Study Overview

• Status: Completed
• Conditions: Insomnia Chronic
• Intervention / Treatment: Other: lumbar puncture

• Study Type: Observational
• Enrollment (Actual): 30

Contacts and Locations

Study Locations

• United States
  • Pennsylvania
    • Philadelphia, Pennsylvania, United States, 19104
      • University of Pennsylvania

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 30 years to 50 years (Adult)
• Accepts Healthy Volunteers: N/A

• Sampling Method: Probability Sample

Study Population

Adults with chronic insomnia and matched good sleepers

Description

Inclusion Criteria:

• Age 30-50
• Men and women
• To be included in the insomnia group, subjects must meet the following DSM5 Diagnostic Criteria for insomnia disorder: dissatisfaction with sleep quantity or quality (difficulty initiating or maintaining sleep, or waking up too early) despite adequate opportunity for sleep; sleep disturbance causes clinical significant distress or impairment in functioning; present at least 3 times per week for at least 3 months; sleep disturbance is not better explained by a medical or psychiatric condition or based on the effects of a substance

Exclusion Criteria:

• Diagnosis or evidence of sleep disorders other than insomnia as determined by the screening questionnaires and clinical history
• Women who have been pregnant or lactating within the past six months
• Non-fluency in spoken or written English
• Current or past month shiftwork defined as working during the evening or night shift
• Current use of medications or OTC products that impact sleep
• Evidence of neurological abnormalities that could include the risks associated with lumbar puncture (e.g.papilledema, mass lesion, Chiari malformation).

Study Plan

How is the study designed?

Design Details

• Observational Models: Case-Control
• Time Perspectives: Cross-Sectional

Number of groups / cohorts

2

Cohorts and Interventions

Group / Cohort	Intervention / Treatment
Individuals with insomnia; Men and women with chronic insomnia (>5 years duration)	Other: lumbar puncture; Subjects will have a lumbar puncture to collect cerebrospinal fluid collection
Good sleepers; Men and women with a longstanding pattern of good sleep	Other: lumbar puncture; Subjects will have a lumbar puncture to collect cerebrospinal fluid collection

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
CSF markers related to dementia	CSF levels of the proteins tau and beta amyloid	one morning

Secondary Outcome Measures

Outcome Measure	Measure Description	Time Frame
CSF levels of orexin	Orexin is a chemical in the brain related to sleep regulation	one morning

Collaborators and Investigators

• Sponsor: University of Pennsylvania
• Collaborators: Merck Sharp & Dohme LLC
• Investigators: Principal Investigator: Philip Gehrman, PhD, University of Pennsylvania

Study record dates

Study Major Dates

• Study Start (Actual): January 1, 2019
• Primary Completion (Actual): October 31, 2023
• Study Completion (Actual): October 31, 2023

Study Registration Dates

• First Submitted: July 15, 2019
• First Submitted That Met QC Criteria: July 15, 2019
• First Posted (Actual): July 18, 2019

Study Record Updates

• Last Update Posted (Estimated): December 1, 2023
• Last Update Submitted That Met QC Criteria: November 30, 2023
• Last Verified: November 1, 2023

More Information

Terms related to this study

• Additional Relevant MeSH Terms: Mental Disorders; Brain Diseases; Central Nervous System Diseases; Nervous System Diseases; Sleep Disorders, Intrinsic; Dyssomnias; Sleep Wake Disorders; Neurocognitive Disorders; Sleep Initiation and Maintenance Disorders; Dementia
• Other Study ID Numbers: 829221

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: NO

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: No