Chronic Insomnia and CSF Markers of Dementia - Effects of Treatment

NCT04073992 | Completed

• 1 other identifier: 833798
• Study Type: interventional
• Target: 9
• Locations: 1 country
• Sites: 1

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.

Conditions

Insomnia Chronic

Outcome Measures

Primary Outcomes (1)

• CSF markers related to dementia

  CSF levels of the proteins tau and beta amyloid

  8 weeks

Study Arms (1)

Cognitive behavioral treatment of insomnia (CBT-I)

EXPERIMENTAL

Eight weeks of cognitive behavioral treatment of insomnia.

Behavioral: cognitive behavioral treatment of insomnia

Interventions

cognitive behavioral treatment of insomnia BEHAVIORAL

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

Cognitive behavioral treatment of insomnia (CBT-I)

Eligibility Criteria

• Age: 30 Years - 50 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64)

You may qualify if:

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

You may not qualify if:

• 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).

Sponsors & Collaborators

• University of Pennsylvania: lead

Study Sites (1)

University of Pennsylvania

Philadelphia, Pennsylvania, 19104, United States

Location

MeSH Terms

Conditions

Sleep Initiation and Maintenance Disorders

Condition Hierarchy (Ancestors)

Sleep Disorders, Intrinsic; Dyssomnias; Sleep Wake Disorders; Nervous System Diseases; Mental Disorders

Study Officials

• Philip Gehrman, PhD

  University of Pennsylvania

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: NA
• Masking: NONE
• Purpose: TREATMENT
• Intervention Model: SINGLE GROUP
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: August 27, 2019
• First Posted: August 29, 2019
• Study Start: September 1, 2019
• Primary Completion: November 30, 2022
• Study Completion: December 30, 2022
• Last Updated: January 17, 2023

Record last verified: 2023-01

Data Sharing

• IPD Sharing: Will not share

Locations

US (1)