Status:

COMPLETED

Chronic Insomnia and CSF Markers of Dementia - Effects of Treatment

Lead Sponsor:

University of Pennsylvania

Conditions:

Insomnia Chronic

Eligibility:

All Genders

30-50 years

Phase:

NA

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 evi...

Eligibility Criteria

Inclusion

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

Exclusion

  • 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).

Key Trial Info

Start Date :

September 1 2019

Trial Type :

INTERVENTIONAL

Allocation :

ACTUAL

End Date :

December 30 2022

Estimated Enrollment :

9 Patients enrolled

Trial Details

Trial ID

NCT04073992

Start Date

September 1 2019

End Date

December 30 2022

Last Update

January 17 2023

Active Locations (1)

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1

University of Pennsylvania

Philadelphia, Pennsylvania, United States, 19104