Sleep DisorderNCT03912571
Sleep Disordered Breathing and Alzheimer's Disease Biomarkers in Normal Aging and Mild Cognitive Impairment
An observational study of Sleep Disorder, run by NYU Langone Health at 1 site in United States.
Trial summary
The purpose of this study is to determine the sleep patterns of subjects with or without sleep disturbances (insomnia, sleep apnea) and compare these findings with their previous FDG/PIB PET, structural MRI and brain blood flow scams performed during their participation in the Following studies 'Alzheimer's Disease… Read more about this study
- Who is it for?
- Ages 55 to 90 years
- Conditions the study is for
- Sleep Disorder
- What is being tested?
- Structural 3T MRI, MRI Based Perfusion Imaging and VR-CO2 MRI Scans
- How many people
- 28 participants
- Where
- 1 siteUnited States
- Study dates
- 13 Nov 2011to Sep 2019
- Phase
- Observational
- Are there results?
- None posted in the registry
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 55 to 90 years
- All sexes
- No healthy volunteers
- Adult, Older adult
Study population: 80 cognitively healthy subjects (normal or MCI) previously enrolled in Alzheimer's Disease Core Center (ADCC) and CBH studies who have agreed to be contacted about future research studies will be asked to additionally participate in this study. The age range of the subjects will be of 55-90 years based on the incidence of dementia in middle age and elder adults.
Who may be able to join
- All subjects will have participated in prior CBH studies and have agreed to an FDG, PIB and MRI scans.
Who cannot join
- Diagnosis of sleep apnea and under treatment with a continuous positive airway pressure (CPAP) machine.
- Active depressive episode during the evaluation with a Geriatric Depression Scale score >7 and/or a Clinical Global Impression scale for depression score >4.
- Moderate Cognitive decline (GDS >3).
- Severe primary or secondary insomnia except insomnia due to SDB.
Trial locations and contacts
1 site in 1 country.
United States1 site
NYU Langone Medical Center
New York, New York, 10016
About this study
The purpose of this study is to determine the sleep patterns of subjects with or without sleep disturbances (insomnia, sleep apnea) and compare these findings with their previous FDG/PIB PET, structural MRI and brain blood flow scams performed during their participation in the Following studies 'Alzheimer's Disease Core Center (ADCC) Clinical Evaluation' (IRB: 2942), MRI Progression Markers of Cognitive Decline in the Elderly' (IRB:09-0586), or 'Imaging Neuro inflammation in Alzheimer's Disease with [11C] Arachidonic Acid (AA) and PET'(IRB: 10-00442).
- Conditions
- Sleep Disorder
- Being tested
- Structural 3T MRI, MRI Based Perfusion Imaging, VR-CO2 MRI Scans
- Medical subject headings
- Sleep Wake Disorders
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Structural 3T MRIDiagnostic test
measures of global and hippocampal atrophy)
MRI Based Perfusion ImagingDiagnostic test
brain blood flow
VR-CO2 MRI ScansDiagnostic test
reduced vaso reactivity to carbon dioxide
| Study group | Role | What they receive |
|---|---|---|
| Mild Cognitive Impairment (MCI) | Patients with clinical dementia rating of 0.5 or a global deterioration scale of 3. Receives: Diagnostic Test: Structural 3T MRI; Diagnostic Test: MRI Based Perfusion Imaging; Diagnostic Test: VR-CO2 MRI Scans | |
| Normal Cognition (NL) | Clinical Dementia Rating [CDR] of 0 or Global Deterioration Scale [GDS] of 1-2 Receives: Diagnostic Test: Structural 3T MRI; Diagnostic Test: MRI Based Perfusion Imaging; Diagnostic Test: VR-CO2 MRI Scans |
What is being measured
The primary outcome is the main question the study is designed to answer.
Decreased cerebral blood flow (CBF)
Measured by perfusion MRI
Measured: 1 Week
Measure of vasoreactivity to CO2 (VRCO2)
subjects will breath through a respiratory tube and CO2 will be meaured
Measured: 1 Week
Increase in cortical AB plaque burden
Measured by PIB PET
Measured: 1 Week
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted11 Apr 2019
- Study start13 Nov 2011
- Primary completionSep 2019
- Study completionSep 2019
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Sleep DisorderStudies of the same condition, open and under way.
- More trials run by NYU Langone HealthThe 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
- Cohort
- Time perspective
- Prospective
- Enrolment
- 28 participants (actual)
Sponsor and investigators
- Lead sponsor
- NYU Langone Health
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor
- Investigators
- Ricardo Osorio, MD, Principal investigator, NYU Langone Health
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT03912571
- Sponsor's protocol ID
- 12-00041
- Status last verified
- Sep 2021
- First submitted
- 9 Apr 2019
- Last updated
- 5 Sep 2021
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
Study at a glance
From the registry record, last updated by the sponsor on 5 Sep 2021. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Sleep Disordered Breathing and Alzheimer's Disease Biomarkers in Normal Aging and Mild Cognitive Impairment
- ClinicalTrials.gov ID
- NCT03912571
- Acronym / sponsor ID
- 12-00041
- Conditions
- Sleep Disorder
- Study type
- Observational
- Recruitment status
- Completed
- Enrolment
- 28 participants (actual)
- Lead sponsor
- NYU Langone HealthUniversity, hospital or other
- Study start
- 13 Nov 2011 (actual)
- Primary completion
- Sep 2019 (actual)
- Study completion
- Sep 2019 (actual)
- First posted
- 11 Apr 2019 (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.
The purpose of this study is to determine the sleep patterns of subjects with or without sleep disturbances (insomnia, sleep apnea) and compare these findings with their previous FDG/PIB PET, structural MRI and brain blood flow scams performed during their participation in the Following studies 'Alzheimer's Disease Core Center (ADCC) Clinical Evaluation' (IRB: 2942), MRI Progression Markers of Cognitive Decline in the Elderly' (IRB:09-0586), or 'Imaging Neuro inflammation in Alzheimer's Disease with [11C] Arachidonic Acid (AA) and PET'(IRB: 10-00442).
Study design
- Observational model
- Cohort
- Time perspective
- Prospective
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Mild Cognitive Impairment (MCI) | – | Diagnostic Test: Structural 3T MRI, Diagnostic Test: MRI Based Perfusion Imaging, Diagnostic Test: VR-CO2 MRI ScansPatients with clinical dementia rating of 0.5 or a global deterioration scale of 3. |
| Normal Cognition (NL) | – | Diagnostic Test: Structural 3T MRI, Diagnostic Test: MRI Based Perfusion Imaging, Diagnostic Test: VR-CO2 MRI ScansClinical Dementia Rating [CDR] of 0 or Global Deterioration Scale [GDS] of 1-2 |
Who may qualify
- Ages
- 55 to 90 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
- Study population
- 80 cognitively healthy subjects (normal or MCI) previously enrolled in Alzheimer's Disease Core Center (ADCC) and CBH studies who have agreed to be contacted about future research studies will be asked to additionally participate in this study. The age range of the subjects will be of 55-90 years based on the incidence of dementia in middle age and elder adults.
Key inclusion criteria (1 listed)
- All subjects will have participated in prior CBH studies and have agreed to an FDG, PIB and MRI scans.
Key exclusion criteria (4 listed)
- Diagnosis of sleep apnea and under treatment with a continuous positive airway pressure (CPAP) machine.
- Active depressive episode during the evaluation with a Geriatric Depression Scale score >7 and/or a Clinical Global Impression scale for depression score >4.
- Moderate Cognitive decline (GDS >3).
- Severe primary or secondary insomnia except insomnia due to SDB.
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 |
|---|---|---|
| Structural 3T MRImeasures of global and hippocampal atrophy) | Diagnostic test | Mild Cognitive Impairment (MCI), Normal Cognition (NL) |
| MRI Based Perfusion Imagingbrain blood flow | Diagnostic test | Mild Cognitive Impairment (MCI), Normal Cognition (NL) |
| VR-CO2 MRI Scansreduced vaso reactivity to carbon dioxide | Diagnostic test | Mild Cognitive Impairment (MCI), Normal Cognition (NL) |
Primary outcome
Decreased cerebral blood flow (CBF)
Time frame: 1 Week
Measured by perfusion MRI
Measure of vasoreactivity to CO2 (VRCO2)
Time frame: 1 Week
subjects will breath through a respiratory tube and CO2 will be meaured
Increase in cortical AB plaque burden
Time frame: 1 Week
Measured by PIB PET
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 5 Sep 2021.
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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.
Ricardo Osorio, MD principal investigator
NYU Langone Health
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 Sleep Disorder, run by NYU Langone Health 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 1 inclusion and 4 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 5 Sep 2021. 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?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
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?
Decreased cerebral blood flow (CBF) (time frame: 1 Week). The study lists 3 primary outcomes in all. 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 5 Sep 2021; AzTrials last refreshed its copy on 8 Nov 2026.