Chronic Insomnia and CSF Markers of Dementia - Effects of Treatment
Primary Purpose
Insomnia Chronic
Status
Completed
Phase
Not Applicable
Locations
United States
Study Type
Interventional
Intervention
cognitive behavioral treatment of insomnia
Sponsored by
About this trial
This is an interventional treatment trial for Insomnia Chronic
Eligibility Criteria
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).
Sites / Locations
- University of Pennsylvania
Arms of the Study
Arm 1
Arm Type
Experimental
Arm Label
Cognitive behavioral treatment of insomnia (CBT-I)
Arm Description
Eight weeks of cognitive behavioral treatment of insomnia.
Outcomes
Primary Outcome Measures
CSF markers related to dementia
CSF levels of the proteins tau and beta amyloid
Secondary Outcome Measures
Full Information
NCT ID
NCT04073992
First Posted
August 27, 2019
Last Updated
January 13, 2023
Sponsor
University of Pennsylvania
1. Study Identification
Unique Protocol Identification Number
NCT04073992
Brief Title
Chronic Insomnia and CSF Markers of Dementia - Effects of Treatment
Official Title
Chronic Insomnia and CSF Markers of Dementia - Effects of Treatment
Study Type
Interventional
2. Study Status
Record Verification Date
January 2023
Overall Recruitment Status
Completed
Study Start Date
September 1, 2019 (Actual)
Primary Completion Date
November 30, 2022 (Actual)
Study Completion Date
December 30, 2022 (Actual)
3. Sponsor/Collaborators
Responsible Party, by Official Title
Sponsor
Name of the Sponsor
University of Pennsylvania
4. Oversight
Studies a U.S. FDA-regulated Drug Product
No
Studies a U.S. FDA-regulated Device Product
No
Data Monitoring Committee
No
5. Study Description
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.
6. Conditions and Keywords
Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Insomnia Chronic
7. Study Design
Primary Purpose
Treatment
Study Phase
Not Applicable
Interventional Study Model
Single Group Assignment
Masking
None (Open Label)
Allocation
N/A
Enrollment
9 (Actual)
8. Arms, Groups, and Interventions
Arm Title
Cognitive behavioral treatment of insomnia (CBT-I)
Arm Type
Experimental
Arm Description
Eight weeks of cognitive behavioral treatment of insomnia.
Intervention Type
Behavioral
Intervention Name(s)
cognitive behavioral treatment of insomnia
Intervention Description
A behavioral modification program consisting of 8 clinic sessions focused on sleep hygiene, stimulus control, sleep restriction, and cognitive restructuring.
Primary Outcome Measure Information:
Title
CSF markers related to dementia
Description
CSF levels of the proteins tau and beta amyloid
Time Frame
8 weeks
10. Eligibility
Sex
All
Minimum Age & Unit of Time
30 Years
Maximum Age & Unit of Time
50 Years
Accepts Healthy Volunteers
No
Eligibility Criteria
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).
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Philip Gehrman, PhD
Organizational Affiliation
University of Pennsylvania
Official's Role
Principal Investigator
Facility Information:
Facility Name
University of Pennsylvania
City
Philadelphia
State/Province
Pennsylvania
ZIP/Postal Code
19104
Country
United States
12. IPD Sharing Statement
Plan to Share IPD
No
Learn more about this trial
Chronic Insomnia and CSF Markers of Dementia - Effects of Treatment
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