Sleep DeprivationNCT06452459
Glymphatic MRI Study
An observational study of Sleep Deprivation, run by Oregon Health and Science University.
Trial summary
This study aims at identifying neuroimaging markers of glymphatic function in humans. Read more about this study
- Who is it for?
- Ages 18 to 89 years
- Conditions the study is for
- Sleep Deprivation
- What is being tested?
- No interventinon
- How many people
- 10 participants
- Where
- No sites listed yet
- Study dates
- 1 Jul 2024to 1 Jul 2028
- Phase
- Observational
- Are there results?
- Not yet: the study is under way
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 18 to 89 years
- All sexes
- Adult, Older adult
Study population: Healthy adults
Who may be able to join
- Ability to undergo MRI without anesthesia
- Calculated GFR greater or equal to 60 mL/min/1.73 m2
Who cannot join
- Inability to obtain consent
- Subject is incarcerated, pregnant, or lactating or suspects they may be pregnant
- Known allergic or hypersensitivity reactions to gadolinium
- Three or more drug allergies from separate drug classes
- Recent or expected beed for imaging with iodinated contrast
- Contraindications to MRI: claustrophobia, weight greater than maximum MRI scanner capacity, presence of metallic foreign body, or implanted devices not documented as MRI safe
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- History of neurosurgical procedure or cervical surgery
- Current use of anticoagulation medications
- Contraindication to lumbar puncture (creatinine or INR elevated above laboratory standard cutoffs)
About this study
Official title: Evaluation of Glymphatic Function With MRI
This study aims at identifying neuroimaging markers of glymphatic function in humans.
- Conditions
- Sleep Deprivation
- Being tested
- No interventinon
- Medical subject headings
- Sleep Deprivation
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
No interventinonOther
No intervention is anticipated. This is an observational study.
What is being measured
The primary outcome is the main question the study is designed to answer.
Contrast enhancement
Measurement of contrast intensity in brain parenchyma
Measured: 2 weeks
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted11 Jun 2024
- Study start1 Jul 2024 (estimated)
- Primary completion1 Jul 2027 (estimated)
- Study completion1 Jul 2028 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Sleep DeprivationStudies of the same condition, open and under way.
- 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
- Cohort
- Time perspective
- Cross-sectional
- Enrolment
- 10 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Oregon Health and Science University
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Juan Piantino, Oregon Health and Science University
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT06452459
- Sponsor's protocol ID
- IT Gadolinium Study
- Status last verified
- Jun 2024
- First submitted
- 5 Jun 2024
- Last updated
- 11 Jun 2024
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- Yes
- FDA-regulated device
- No
- Individual data sharing
- No
Study at a glance
From the registry record, last updated by the sponsor on 11 Jun 2024. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Evaluation of Glymphatic Function With MRI
- ClinicalTrials.gov ID
- NCT06452459
- Acronym / sponsor ID
- IT Gadolinium Study
- Conditions
- Sleep Deprivation
- Study type
- Observational
- Recruitment status
- Not yet recruiting
- Enrolment
- 10 participants (estimated)
- Lead sponsor
- Oregon Health and Science UniversityUniversity, hospital or other
- Study start
- 1 Jul 2024 (estimated)
- Primary completion
- 1 Jul 2027 (estimated)
- Study completion
- 1 Jul 2028 (estimated)
- First posted
- 11 Jun 2024 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
This study aims at identifying neuroimaging markers of glymphatic function in humans.
Study design
- Observational model
- Cohort
- Time perspective
- Cross-sectional
Who may qualify
- Ages
- 18 to 89 years
- Sex
- All
- Age groups
- Adult, Older adult
- Study population
- Healthy adults
Key inclusion criteria (2 listed)
- Ability to undergo MRI without anesthesia
- Calculated GFR greater or equal to 60 mL/min/1.73 m2
Key exclusion criteria (9 listed)
- Inability to obtain consent
- Subject is incarcerated, pregnant, or lactating or suspects they may be pregnant
- Known allergic or hypersensitivity reactions to gadolinium
- Three or more drug allergies from separate drug classes
- Recent or expected beed for imaging with iodinated contrast
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 |
|---|---|---|
| No interventinonNo intervention is anticipated. This is an observational study. | Other | – |
Primary outcome
Contrast enhancement
Time frame: 2 weeks
Measurement of contrast intensity in brain parenchyma
Results and safety
This study is still under way. Results are not available in the source record yet.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 11 Jun 2024.
- 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.
The record lists no contact. Use the official record to reach the sponsor.
Questions about this trial
What is this clinical trial studying?
An observational study of Sleep Deprivation, run by Oregon Health and Science University.
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 2 inclusion and 9 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: opening soon, as of the sponsor's last update on 11 Jun 2024. Status can change between updates, so confirm with the study contact before making plans.
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?
This study is still under way. Results are not available in the source record yet.
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?
Contrast enhancement (time frame: 2 weeks). 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 11 Jun 2024.