Chronic Insomnia and CSF Markers of Dementia - Effects of Treatment

January 13, 2023 updated by: University of Pennsylvania
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.

Study Overview

Status

Completed

Conditions

Intervention / Treatment

Study Type

Interventional

Enrollment (Actual)

9

Phase

  • Not Applicable

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

  • United States
    • Pennsylvania
      • Philadelphia, Pennsylvania, United States, 19104
        • University of Pennsylvania

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

30 years to 50 years (Adult)

Accepts Healthy Volunteers

No

Genders Eligible for Study

All

Description

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).

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: Treatment
  • Allocation: N/A
  • Interventional Model: Single Group Assignment
  • Masking: None (Open Label)

Arms and Interventions

Participant Group / Arm
Intervention / Treatment
Experimental: Cognitive behavioral treatment of insomnia (CBT-I)
Eight weeks of cognitive behavioral treatment of insomnia.
Behavioral: cognitive behavioral treatment of insomnia
A behavioral modification program consisting of 8 clinic sessions focused on sleep hygiene, stimulus control, sleep restriction, and cognitive restructuring.

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
CSF markers related to dementia
Time Frame: 8 weeks
CSF levels of the proteins tau and beta amyloid
8 weeks

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

University of Pennsylvania

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start (Actual)

September 1, 2019

Primary Completion (Actual)

November 30, 2022

Study Completion (Actual)

December 30, 2022

Study Registration Dates

First Submitted

August 27, 2019

First Submitted That Met QC Criteria

August 27, 2019

First Posted (Actual)

August 29, 2019

Study Record Updates

Last Update Posted (Estimate)

January 16, 2023

Last Update Submitted That Met QC Criteria

January 13, 2023

Last Verified

January 1, 2023

More Information

Terms related to this study

Additional Relevant MeSH Terms

Other Study ID Numbers

  • 833798

Plan for Individual participant data (IPD)

Plan to Share Individual Participant Data (IPD)?

No

Drug and device information, study documents

Studies a U.S. FDA-regulated drug product

No

Studies a U.S. FDA-regulated device product

No

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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