Insomnia ChronicNCT04024020
Chronic Insomnia and CSF Markers of Dementia
An observational study of Insomnia Chronic, run by University of Pennsylvania at 1 site in United States.
Trial 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… Read more about this study
- Who is it for?
- Ages 30 to 50 years
- Conditions the study is for
- Insomnia Chronic
- What is being tested?
- lumbar puncture
- How many people
- 30 participants
- Where
- 1 siteUnited States
- Study dates
- 1 Jan 2019to 31 Oct 2023
- Phase
- Observational
- Are there results?
- Yes, posted in the registrySummary in the doctors' view
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 30 to 50 years
- All sexes
- Adult
Study population: Adults with chronic insomnia and matched good sleepers
Who may be able to join
- Age 30-50
- Men and women
- To be included in the insomnia group, subjects must meet the following DSM5 Diagnostic Criteria for insomnia disorder: dissatisfaction with sleep quantity or quality (difficulty initiating or maintaining sleep, or waking up too early) despite adequate opportunity for sleep; sleep disturbance causes clinical significant distress or impairment in functioning; present at least 3 times per week for at least 3 months; sleep disturbance is not better explained by a medical or psychiatric condition or based on the effects of a substance
Who cannot join
- 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).
Trial locations and contacts
1 site in 1 country.
United States1 site
University of Pennsylvania
Philadelphia, Pennsylvania, 19104
About this study
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 the relationship between chronic insomnia and dementia biomarkers and orexin levels found in cerebrospinal fluid (CSF). Fifteen adults age 30-50 with chronic insomnia and age- and gender-matched good sleepers will undergo overnight polysomnography and CSF sampling in the morning.
- Conditions
- Insomnia Chronic
- Being tested
- lumbar puncture
- Medical subject headings
- Sleep Initiation and Maintenance Disorders
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
lumbar punctureOther
Subjects will have a lumbar puncture to collect cerebrospinal fluid collection
| Study group | Role | What they receive |
|---|---|---|
| Individuals with insomnia | Men and women with chronic insomnia (>5 years duration) Receives: Other: lumbar puncture | |
| Good sleepers | Men and women with a longstanding pattern of good sleep Receives: Other: lumbar puncture |
What is being measured
The primary outcome is the main question the study is designed to answer.
CSF Markers Related to Dementia
CSF levels of the proteins Abeta40 and Abeta42
Measured: one morning
Secondary outcomes (1)
CSF Levels of Orexin
Orexin is a chemical in the brain related to sleep regulation
Measured: one morning
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted18 Jul 2019
- Study start1 Jan 2019
- Primary completion31 Oct 2023
- Study completion31 Oct 2023
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Posted resultsParticipant flow, outcome measures and adverse events reported by the sponsor.
- Other trials for Insomnia ChronicStudies of the same condition, open and under way.
- More trials run by University of PennsylvaniaThe sponsor's other registered studies.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Observational
- Observational model
- Case-control
- Time perspective
- Cross-sectional
- Enrolment
- 30 participants (actual)
Sponsor and investigators
- Lead sponsor
- University of Pennsylvania
- Sponsor type
- University, hospital or other
- Collaborators
- Merck Sharp & Dohme LLC
- Responsible party
- Sponsor
- Investigators
- Philip Gehrman, PhD, Principal investigator, University of Pennsylvania
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT04024020
- Sponsor's protocol ID
- 829221
- Status last verified
- Dec 2024
- First submitted
- 15 Jul 2019
- Last updated
- 23 Jan 2025
- Results posted
- Yes, on ClinicalTrials.gov
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Study at a glance
From the registry record, last updated by the sponsor on 23 Jan 2025. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Chronic Insomnia and CSF Markers of Dementia
- ClinicalTrials.gov ID
- NCT04024020
- Acronym / sponsor ID
- 829221
- Conditions
- Insomnia Chronic
- Study type
- Observational
- Recruitment status
- Completed
- Enrolment
- 30 participants (actual)
- Lead sponsor
- University of PennsylvaniaUniversity, hospital or other
- Collaborators
- Merck Sharp & Dohme LLC
- Study start
- 1 Jan 2019 (actual)
- Primary completion
- 31 Oct 2023 (actual)
- Study completion
- 31 Oct 2023 (actual)
- First posted
- 18 Jul 2019 (actual)
- Results
- Posted 23 Jan 2025
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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 the relationship between chronic insomnia and dementia biomarkers and orexin levels found in cerebrospinal fluid (CSF). Fifteen adults age 30-50 with chronic insomnia and age- and gender-matched good sleepers will undergo overnight polysomnography and CSF sampling in the morning.
Study design
- Observational model
- Case-control
- Time perspective
- Cross-sectional
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Individuals with insomnia | – | Other: lumbar punctureMen and women with chronic insomnia (>5 years duration) |
| Good sleepers | – | Other: lumbar punctureMen and women with a longstanding pattern of good sleep |
Who may qualify
- Ages
- 30 to 50 years
- Sex
- All
- Age groups
- Adult
- Study population
- Adults with chronic insomnia and matched good sleepers
Key inclusion criteria (3 listed)
- Age 30-50
- Men and women
- To be included in the insomnia group, subjects must meet the following DSM5 Diagnostic Criteria for insomnia disorder: dissatisfaction with sleep quantity or quality (difficulty initiating or maintaining sleep, or waking up too early) despite adequate opportunity for sleep; sleep disturbance causes clinical significant distress or impairment in functioning; present at least 3 times per week for at least 3 months; sleep disturbance is not better explained by a medical or psychiatric condition or based on the effects of a substance
Key exclusion criteria (6 listed)
- 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
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| lumbar punctureSubjects will have a lumbar puncture to collect cerebrospinal fluid collection | Other | Good sleepers, Individuals with insomnia |
Primary outcome
CSF Markers Related to Dementia
Time frame: one morning
CSF levels of the proteins Abeta40 and Abeta42
1 secondary outcome
CSF Levels of Orexin
Time frame: one morning
Results and safety
Loading the posted results from ClinicalTrials.gov…
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 23 Jan 2025.
- Posted resultsParticipant flow, baseline, all outcome measures and adverse events.
- Individual participant dataSharing planned: No
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Philip Gehrman, PhD principal investigator
University of Pennsylvania
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
An observational study of Insomnia Chronic, run by University of Pennsylvania at 1 site in United States.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 3 inclusion and 6 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 23 Jan 2025. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in United States. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
Yes. Results are posted in the registry (first posted 23 Jan 2025). A summary is in the For doctors view, and the full results are on ClinicalTrials.gov.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
CSF Markers Related to Dementia (time frame: one morning). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 23 Jan 2025.