Chronic Insomnia and CSF Markers of Dementia

Insomnia Chronic Clinical Trial

Official title:

Chronic Insomnia and CSF Markers of Dementia

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT04024020
• Other study ID #: 829221
• Status: Completed
• Start date: January 1, 2019
• Est. completion date: October 31, 2023

Study information

• Verified date: November 2023
• Source: University of Pennsylvania
• Contact: n/a
• Is FDA regulated: No
• Study type: Observational

Clinical Trial 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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 30
• Est. completion date: October 31, 2023
• Est. primary completion date: October 31, 2023
• Gender: All
• Age group: 30 Years to 50 Years

Eligibility

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).

Related Conditions & MeSH terms

• Dementia
• Insomnia Chronic
• Sleep Initiation and Maintenance Disorders

Intervention

Other:
• lumbar puncture
Subjects will have a lumbar puncture to collect cerebrospinal fluid collection

Locations

Country	Name	City	State
United States	University of Pennsylvania	Philadelphia	Pennsylvania

Sponsors (2)

Lead Sponsor	Collaborator
University of Pennsylvania	Merck Sharp & Dohme LLC

Country where clinical trial is conducted

United States, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	CSF markers related to dementia	CSF levels of the proteins tau and beta amyloid	one morning
Secondary	CSF levels of orexin	Orexin is a chemical in the brain related to sleep regulation	one morning