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Chronic Insomnia and CSF Markers of Dementia - Effects of Treatment

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University of Pennsylvania

Status

Completed

Conditions

Insomnia Chronic

Treatments

Behavioral: cognitive behavioral treatment of insomnia

Study type

Interventional

Funder types

Other

Identifiers

Details and patient eligibility

About

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.

Enrollment

9 patients

Sex

All

Ages

30 to 50 years old

Volunteers

No Healthy Volunteers

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).

Trial design

Primary purpose

Treatment

Allocation

N/A

Interventional model

Single Group Assignment

Masking

None (Open label)

9 participants in 1 patient group

Cognitive behavioral treatment of insomnia (CBT-I)
Experimental group
Description:
Eight weeks of cognitive behavioral treatment of insomnia.
Treatment:
Behavioral: cognitive behavioral treatment of insomnia

Trial contacts and locations

1

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Data sourced from clinicaltrials.gov

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