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Chronic Insomnia and CSF Markers of Dementia - Effects of Treatment

Chronic Insomnia and CSF Markers of Dementia - Effects of Treatment

Status
Completed
Phases
NA
Study type
Interventional
Source
ClinicalTrials.gov
Registry ID
NCT04073992
Enrollment
9
Registered
2019-08-29
Start date
2019-09-01
Completion date
2022-12-30
Last updated
2023-01-17

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Insomnia Chronic

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 whether treatment of insomnia with cognitive behavioral therapy (CBT-I) is associated with a decrease in dementia biomarkers found in cerebrospinal fluid (CSF). Fifteen adults age 30-50 with chronic insomnia will undergo overnight polysomnography and CSF sampling in the morning. This will be followed by 8 weeks of treatment with CBT-I and then repeat CSF sampling.

Interventions

BEHAVIORALcognitive behavioral treatment of insomnia

A behavioral modification program consisting of 8 clinic sessions focused on sleep hygiene, stimulus control, sleep restriction, and cognitive restructuring.

Sponsors

University of Pennsylvania
Lead SponsorOTHER

Study design

Allocation
NA
Intervention model
SINGLE_GROUP
Primary purpose
TREATMENT
Masking
NONE

Eligibility

Sex/Gender
ALL
Age
30 Years to 50 Years
Healthy volunteers
No

Inclusion criteria

* Age 30-50 * Men and women * Meet DSM5 Diagnostic Criteria for insomnia disorder

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).

Design outcomes

Primary

MeasureTime frameDescription
CSF markers related to dementia8 weeksCSF levels of the proteins tau and beta amyloid

Countries

United States

Outcome results

None listed

Source: ClinicalTrials.gov · Data processed: Feb 4, 2026