Chronic Insomnia and CSF Markers of Dementia - Effects of Treatment

Not Applicable

Completed

• Conditions: Insomnia Chronic
• Interventions: Behavioral: cognitive behavioral treatment of insomnia

• Registration Number: NCT04073992
• Lead Sponsor: University of Pennsylvania

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.

Detailed Description

Not available

Study Timeline

• Study First Submitted: 2019-08-27
• Study First Submitted QC: 2019-08-27
• Study First Posted: 2019-08-29
• Study Start: 2019-09-01
• Primary Completion: 2022-11-30
• Study Completion: 2022-12-30
• Status Verified: 2023-01
• Last Update Submitted: 2023-01-13
• Last Update Posted: 2023-01-17

Recruitment & Eligibility

• Status: COMPLETED
• Sex: All
• Target Recruitment: 9

Inclusion Criteria

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

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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).

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Study & Design

• Study Type: INTERVENTIONAL
• Study Design: SINGLE_GROUP

Arm && Interventions

Group	Intervention	Description
Cognitive behavioral treatment of insomnia (CBT-I)	cognitive behavioral treatment of insomnia	Eight weeks of cognitive behavioral treatment of insomnia.

Primary Outcome Measures

Name	Time	Method
CSF markers related to dementia	8 weeks	CSF levels of the proteins tau and beta amyloid

Trial Locations

Locations (1)

University of Pennsylvania; 🇺🇸 Philadelphia, Pennsylvania, United States