Trial Outcomes & Findings for Chronic Insomnia and CSF Markers of Dementia (NCT NCT04024020)

NCT ID: NCT04024020

Last Updated: 2025-01-23

Results Overview

CSF levels of the proteins Abeta40 and Abeta42

• Recruitment status: COMPLETED
• Target enrollment: 30 participants
• Primary outcome timeframe: one morning
• Results posted on: 2025-01-23

Participant Flow

Participant milestones

Measure	Individuals With Insomnia Men and women with chronic insomnia (\>5 years duration) lumbar puncture: Subjects will have a lumbar puncture to collect cerebrospinal fluid collection	Good Sleepers Men and women with a longstanding pattern of good sleep lumbar puncture: Subjects will have a lumbar puncture to collect cerebrospinal fluid collection
Overall Study STARTED	15	15
Overall Study COMPLETED	13	13
Overall Study NOT COMPLETED	2	2

Reasons for withdrawal

Measure	Individuals With Insomnia Men and women with chronic insomnia (\>5 years duration) lumbar puncture: Subjects will have a lumbar puncture to collect cerebrospinal fluid collection	Good Sleepers Men and women with a longstanding pattern of good sleep lumbar puncture: Subjects will have a lumbar puncture to collect cerebrospinal fluid collection
Overall Study Withdrawal by Subject	2	2

Baseline Characteristics

Chronic Insomnia and CSF Markers of Dementia

Baseline characteristics by cohort

Measure	Individuals With Insomnia n=15 Participants Men and women with chronic insomnia (\>5 years duration) lumbar puncture: Subjects will have a lumbar puncture to collect cerebrospinal fluid collection	Good Sleepers n=15 Participants Men and women with a longstanding pattern of good sleep lumbar puncture: Subjects will have a lumbar puncture to collect cerebrospinal fluid collection	Total n=30 Participants Total of all reporting groups
Age, Continuous	43.0 years STANDARD_DEVIATION 9.1 • n=5 Participants	43.2 years STANDARD_DEVIATION 9.2 • n=7 Participants	43.1 years STANDARD_DEVIATION 9.2 • n=5 Participants
Sex: Female, Male Female	10 Participants n=5 Participants	10 Participants n=7 Participants	20 Participants n=5 Participants
Sex: Female, Male Male	5 Participants n=5 Participants	5 Participants n=7 Participants	10 Participants n=5 Participants
Race (NIH/OMB) American Indian or Alaska Native	0 Participants n=5 Participants	0 Participants n=7 Participants	0 Participants n=5 Participants
Race (NIH/OMB) Asian	1 Participants n=5 Participants	1 Participants n=7 Participants	2 Participants n=5 Participants
Race (NIH/OMB) Native Hawaiian or Other Pacific Islander	0 Participants n=5 Participants	0 Participants n=7 Participants	0 Participants n=5 Participants
Race (NIH/OMB) Black or African American	2 Participants n=5 Participants	6 Participants n=7 Participants	8 Participants n=5 Participants
Race (NIH/OMB) White	12 Participants n=5 Participants	8 Participants n=7 Participants	20 Participants n=5 Participants
Race (NIH/OMB) More than one race	0 Participants n=5 Participants	0 Participants n=7 Participants	0 Participants n=5 Participants
Race (NIH/OMB) Unknown or Not Reported	0 Participants n=5 Participants	0 Participants n=7 Participants	0 Participants n=5 Participants
Region of Enrollment United States	15 participants n=5 Participants	15 participants n=7 Participants	30 participants n=5 Participants
Insomnia Severity Index	16.5 units on a scale STANDARD_DEVIATION 4.3 • n=5 Participants	3.6 units on a scale STANDARD_DEVIATION 3.7 • n=7 Participants	10.1 units on a scale STANDARD_DEVIATION 4.0 • n=5 Participants

PRIMARY outcome

Timeframe: one morning

CSF levels of the proteins Abeta40 and Abeta42

Outcome measures

Measure	Individuals With Insomnia n=13 Participants Men and women with chronic insomnia (\>5 years duration) lumbar puncture: Subjects will have a lumbar puncture to collect cerebrospinal fluid collection	Good Sleepers n=13 Participants Men and women with a longstanding pattern of good sleep lumbar puncture: Subjects will have a lumbar puncture to collect cerebrospinal fluid collection
CSF Markers Related to Dementia Abeta40	4332.1 picograms per milliliter Standard Deviation 1250.5	4824.0 picograms per milliliter Standard Deviation 2336.0
CSF Markers Related to Dementia Abeta42	393.2 picograms per milliliter Standard Deviation 122.8	419.4 picograms per milliliter Standard Deviation 201.8

SECONDARY outcome

Timeframe: one morning

Orexin is a chemical in the brain related to sleep regulation

Outcome measures

Measure	Individuals With Insomnia n=13 Participants Men and women with chronic insomnia (\>5 years duration) lumbar puncture: Subjects will have a lumbar puncture to collect cerebrospinal fluid collection	Good Sleepers n=13 Participants Men and women with a longstanding pattern of good sleep lumbar puncture: Subjects will have a lumbar puncture to collect cerebrospinal fluid collection
CSF Levels of Orexin	215.5 picograms per milliliter Standard Deviation 11.9	214.5 picograms per milliliter Standard Deviation 28.2

Adverse Events

Individuals With Insomnia

Serious events: 0 serious events

Other events: 0 other events

Deaths: 0 deaths

Good Sleepers

Serious events: 0 serious events

Other events: 1 other events

Deaths: 0 deaths

Serious adverse events

Adverse event data not reported

Other adverse events

Measure	Individuals With Insomnia n=15 participants at risk Men and women with chronic insomnia (\>5 years duration) lumbar puncture: Subjects will have a lumbar puncture to collect cerebrospinal fluid collection	Good Sleepers n=15 participants at risk Men and women with a longstanding pattern of good sleep lumbar puncture: Subjects will have a lumbar puncture to collect cerebrospinal fluid collection
Nervous system disorders headache	0.00% 0/15 • up to 1 month	6.7% 1/15 • up to 1 month

Additional Information

Philip Gehrman

University of Pennsylvania

Phone: 2157463578

Email: philip.gehrman@pennmedicine.upenn.edu

Results disclosure agreements

• Principal investigator is a sponsor employee
• Publication restrictions are in place