CClinicalTrials.gg
CompletedNCT04073992Updated Jan 17, 2023

Chronic Insomnia and CSF Markers of Dementia - Effects of Treatment

An interventional study of cognitive behavioral treatment of insomnia in Insomnia Chronic, sponsored by University of Pennsylvania. Completed at 1 site in United States. Open to participants aged 30 Years to 50 Years. Per ClinicalTrials.gov, last updated 2023-01-17.

Sponsored by University of Pennsylvania · Not applicable, Interventional, and Treatment

Phase
Not applicable
Study type
Interventional
Enrollment
9
Allocation
Not applicable
Ages
30 Years to 50 Years
Sex
All
01

Study 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.

02

Conditions studied

03

In context

Dementia

2,172 studies on the registry are indexed under Dementia; 541 are open to participants now.

This study's enrollment of 9 is below the median of 83 across 1,629 interventional studies indexed under Dementia.

Browse Dementia studies →

Lead sponsor

University of Pennsylvania is the lead sponsor of 1,635 studies on the registry; 239 are open to participants now.

Of its 154 completed or terminated interventional studies of FDA-regulated products, 104 (68%) have results posted.

Counted across the registry records on this site, refreshed daily.

04

Who can participate

Ages eligible
30 Years to 50 Years
Sexes eligible
All
Accepts healthy volunteers
No

Inclusion criteria

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

Exclusion criteria

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).
05

Study design

Phase
Not applicable
Primary purpose
Treatment
Allocation
Not applicable
Intervention model
Single group
Masking
None (open label)
Enrollment
9 participants (actual)

Study arms

  • Experimental
    Cognitive behavioral treatment of insomnia (CBT-I)

    Eight weeks of cognitive behavioral treatment of insomnia.

    Behavioral: cognitive behavioral treatment of insomnia

Interventions

  • Behavioralcognitive behavioral treatment of insomnia

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

06

What researchers measure

Primary outcomes

  1. CSF markers related to dementia

    CSF levels of the proteins tau and beta amyloid

    Time frame: 8 weeks

07

Study locations

1 site
  • University of Pennsylvania
    Philadelphia, Pennsylvania 19104, United States
08

References and documents

Individual participant data

Plan to share: No

No publications or documents are linked to this record.

09

Updates

Tracking since Sep 25, 2026
No changes since tracking began. The registry record was last updated on Jan 17, 2023, before this site started recording changes on Sep 25, 2026. Its history is on ClinicalTrials.gov ↗
10

Registry details

Key details

Study ID
NCT04073992
Lead sponsor
University of Pennsylvania
Responsible party
Sponsor
First posted
Aug 29, 2019
Start date
Sep 1, 2019
Primary completion
Nov 30, 2022
Completion
Dec 30, 2022
Last update
Jan 17, 2023

Study contacts

Philip Gehrman, PhD
principal investigator · University of Pennsylvania

Oversight

Data monitoring committee
No
FDA-regulated drug
No
FDA-regulated device
No
View the source record on ClinicalTrials.gov ↗

Not currently enrolling

This study is completed, as verified in Jan 2023. You cannot join it, but the record below documents what was studied.

Follow this study

Get an email when the registry record changes — status, dates, results — or when someone posts here.

Sign in to follow

Discussion

Questions and observations about this study, from anyone following it. Not medical advice, and not a channel to the study team — their contact details are on the registry record.

Sign in to join the discussion. Reading takes no account; posting does. You choose a display name, and a pseudonym is the default.

Nothing here yet. If you are running this trial, taking part in it, or weighing whether to, this is the place to say so.

Start the discussion