Chronic Insomnia and CSF Markers of Dementia - Effects of Treatment

Insomnia Chronic Clinical Trial

Official title:

Chronic Insomnia and CSF Markers of Dementia - Effects of Treatment

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT04073992
• Other study ID #: 833798
• Status: Completed
• Phase: N/A
• Start date: September 1, 2019
• Est. completion date: December 30, 2022

Study information

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

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 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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 9
• Est. completion date: December 30, 2022
• Est. primary completion date: November 30, 2022
• Accepts healthy volunteers: No
• Gender: All
• Age group: 30 Years to 50 Years

Eligibility

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).

Related Conditions & MeSH terms

• Dementia
• Insomnia Chronic
• Sleep Initiation and Maintenance Disorders

Intervention

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.

Locations

Country	Name	City	State
United States	University of Pennsylvania	Philadelphia	Pennsylvania

Sponsors (1)

Lead Sponsor	Collaborator
University of Pennsylvania

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	8 weeks