Chronic Insomnia and CSF Markers of Dementia

NCT ID: NCT04024020

Last Updated: 2025-01-23

Basic Information

• Recruitment Status: COMPLETED
• Total Enrollment: 30 participants
• Study Classification: OBSERVATIONAL
• Study Start Date: 2019-01-01
• Study Completion Date: 2023-10-31

Brief Summary

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.

Conditions

Insomnia Chronic

Study Design

• Observational Model Type: CASE_CONTROL
• Study Time Perspective: CROSS_SECTIONAL

Study Groups

Individuals with insomnia

Men and women with chronic insomnia (\>5 years duration)

lumbar puncture

Intervention Type: OTHER

Subjects will have a lumbar puncture to collect cerebrospinal fluid collection

Good sleepers

Men and women with a longstanding pattern of good sleep

lumbar puncture

Intervention Type: OTHER

Subjects will have a lumbar puncture to collect cerebrospinal fluid collection

Interventions

lumbar puncture

Subjects will have a lumbar puncture to collect cerebrospinal fluid collection

Intervention Type: OTHER

Eligibility Criteria

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).

• Minimum Eligible Age: 30 Years
• Maximum Eligible Age: 50 Years
• Eligible Sex: ALL
• Accepts Healthy Volunteers: No

Sponsors

Merck Sharp & Dohme LLC

INDUSTRY

Sponsor Role: collaborator

University of Pennsylvania

OTHER

Sponsor Role: lead

Responsible Party

Responsibility Role: SPONSOR

Principal Investigators

Philip Gehrman, PhD

Role: PRINCIPAL_INVESTIGATOR

University of Pennsylvania

Locations

University of Pennsylvania

Philadelphia, Pennsylvania, United States

Countries

United States

Provided Documents

Document Type: Study Protocol and Statistical Analysis Plan

View Document

Other Identifiers

829221

Identifier Type: -

Identifier Source: org_study_id