Chronic Insomnia and CSF Markers of Dementia

NCT04024020 | Completed Results

• 1 other identifier: 829221
• Study Type: observational
• Target: 30
• Locations: 1 country
• Sites: 1

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

Outcome Measures

Primary Outcomes (1)

• CSF Markers Related to Dementia

  CSF levels of the proteins Abeta40 and Abeta42

  one morning

Secondary Outcomes (1)

• CSF Levels of Orexin

  one morning

Study Arms (2)

Individuals with insomnia

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

Other: lumbar puncture

Good sleepers

Men and women with a longstanding pattern of good sleep

Other: lumbar puncture

Interventions

lumbar puncture OTHER

Subjects will have a lumbar puncture to collect cerebrospinal fluid collection

Good sleepers; Individuals with insomnia

Eligibility Criteria

• Age: 30 Years - 50 Years
• Sex: all
• Age Groups: Adult (18-64)
• Sampling Method: Probability Sample

Study Population

Adults with chronic insomnia and matched good sleepers

You may qualify if:

• 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

You may not qualify if:

• 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).

Sponsors & Collaborators

• University of Pennsylvania: lead
• Merck Sharp & Dohme LLC: collaborator

Study Sites (1)

University of Pennsylvania

Philadelphia, Pennsylvania, 19104, United States

Location

MeSH Terms

Conditions

Sleep Initiation and Maintenance Disorders

Interventions

Spinal Puncture

Condition Hierarchy (Ancestors)

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

Intervention Hierarchy (Ancestors)

Biopsy; Specimen Handling; Clinical Laboratory Techniques; Diagnostic Techniques and Procedures; Diagnosis; Diagnostic Techniques, Neurological; Punctures; Therapeutics; Surgical Procedures, Operative; Investigative Techniques

Limitations and Caveats

The participants in this study had relatively mild insomnia, so it is not known whether the same pattern would be found for more severe cases. The size of this study is also relatively small so larger studies are needed to have more conclusive results.

Results Point of Contact

• Title: Philip Gehrman
• Organization: University of Pennsylvania

philip.gehrman@pennmedicine.upenn.edu

2157463578

Study Officials

• Philip Gehrman, PhD

  University of Pennsylvania

  PRINCIPAL INVESTIGATOR

Publication Agreements

• PI is Sponsor Employee: Yes

Study Design

• Study Type: observational
• Observational Model: CASE CONTROL
• Time Perspective: CROSS SECTIONAL
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: July 15, 2019
• First Posted: July 18, 2019
• Study Start: January 1, 2019
• Primary Completion: October 31, 2023
• Study Completion: October 31, 2023
• Last Updated: January 23, 2025
• Results First Posted: January 23, 2025

Record last verified: 2024-12

Data Sharing

• IPD Sharing: Will not share

Locations

US (1)