Alzheimer's DiseaseBEDTIMENCT02741505
Brain Sleep Deprivation MRI Effects (BEDTIME)
A study testing Actigraph in people with Alzheimer's Disease, run by NYU Langone Health at 1 site in United States.
Trial summary
The primary purpose of this study is to explore the underlying mechanisms that link sleep to Alzheimer's disease (AD), with special focus on the clearance of metabolites in the extracellular space of the brain during sleep. Read more about this study
- Who is it for?
- Ages 21 to 30 yearsHealthy volunteers can take part
- Conditions the study is for
- Alzheimer's Disease
- What is being tested?
- Actigraph
- Type of treatment
- Medical device
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 0 participants
- Where
- 1 siteUnited States
- Study dates
- Jun 2019to 1 Dec 2019
- Phase
- Interventional
- 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 21 to 30 years
- All sexes
- Healthy volunteers accepted
- Adult
Who may be able to join
- Age range 21-30
- Capable of giving informed consent
Who cannot join
- Diagnosis of any brain disease or brain damage including significant trauma, hydrocephalus, seizures, mental retardation or other serious neurological disorders (e.g. Parkinson's disease or other movement disorders). Persons with silent cortical infarcts will be excluded. White matter lesions will not be exclusions.
- History of major psychiatric illness (e.g., schizophrenia, bipolar or life long history of major depression)
- Conditions that alter normal sleep patterns: irregular sleep-wake rhythms (based on one week at home monitoring with actigraphy), moderate to severe periodic limb movement while you sleep (PLMS) or Obstructive Sleep Apnea (OSA).
- History of claustrophobia.
- BMI≥30
- Significant history of alcoholism or drug abuse.
Show all 10Show fewer
- Inability to avoid the use of alcohol or caffeine during the 48h before the MRI.
- Current pregnancy or intent to become pregnant during the period of study.
- Any electronic or ferromagnetic devices (e.g., pacemaker or surgical clips) that constitutes a hazard for MRI imaging.
- Any medications adversely affecting cognition, blood pressure, glucose metabolism, or sleep will result in exclusion.
Trial locations and contacts
1 site in 1 country.
United States1 site
New York University School of Medicine
New York, New York, 10016
About this study
Official title: Open Masking, Micro Motionlogger Actigraph, 3T Siemens MRI, Sleep Deprivation, Nocturnal PSG
The primary purpose of this study is to explore the underlying mechanisms that link sleep to Alzheimer's disease (AD), with special focus on the clearance of metabolites in the extracellular space of the brain during sleep. Subjects will wear an actigraph for 1 week to determine regular daytime activity and sleep patterns. Subjects will then undergo partial sleep deprivation followed by 4 hours of in-lab nocturnal polysomnography (NPSG). Participants will be be asked to stay awake and active all day after the partial sleep deprivation with a new actigraphy secured by a hospital band to assure participants remain awake. They will seep inside an MRI machine for 90 minutes on the following night during their usual bedtime (established by 1 week actigraphy study.) Morphologic imaging, flow imaging and diffusion kurtosis imaging (DKI) will be performed on a 3T Siemens scanner.
- Conditions
- Alzheimer's Disease
- Being tested
- Actigraph
- Keywords
- cerebrospinal fluid (CSF), sleep, Obstructive Sleep Apnea (OSA), Sleep Disordered Breathing (SDB), Period Limb Movement during Sleep (PLMS)
- Medical subject headings
- Alzheimer Disease, Sleep Apnea, Obstructive, Sleep Apnea Syndromes
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
ActigraphDevice
Participants will be asked to wear an actigraph
| Study group | Role | What they receive |
|---|---|---|
| Sleep Deprivation followed by Normal Sleep | Experimental | Subjects will be sleep deprived at the sleep laboratory. Receives: Device: Actigraph |
What is being measured
The primary outcome is the main question the study is designed to answer.
Measure of Interstitial Space Volume during sleep using MRI imaging
Data will be acquired using imaging sequences that comply with federal limits regarding radiofrequency energy deposition and gradient slew rates.
Measured: 6 Months
Secondary outcomes (1)
Changes in Cerebral Spinal Fluid volume measured by increases in the power of slow wave activity (SWA)
Data will be acquired using imaging sequences that comply with federal limits regarding radiofrequency energy deposition and gradient slew rates.
Measured: 6 Months
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted18 Apr 2016 (estimated)
- Study startJun 2019 (estimated)
- Primary completion1 Dec 2019
- Study completion1 Dec 2019
Why it stopped: Funding was not obtained
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Alzheimer's DiseaseStudies 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
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Diagnosis
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Enrolment
- 0 participants (actual)
Sponsor and investigators
- Lead sponsor
- NYU Langone Health
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor
- Investigators
- Ricardo Osorio Suarez, MD, Principal investigator, New York University Medical School
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT02741505
- Sponsor's protocol ID
- 15-00971
- Acronym
- BEDTIME
- Status last verified
- Jul 2020
- First submitted
- 13 Apr 2016
- Last updated
- 13 Jul 2020
- Results posted
- No
- Data monitoring committee
- Yes
- FDA-regulated drug
- No
- FDA-regulated device
- Yes
- Individual data sharing
- Yes: Individual participant data that underlie the results reported in this article, after deidentification (text, tables, figures, and appendices).
Study at a glance
From the registry record, last updated by the sponsor on 13 Jul 2020. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Open Masking, Micro Motionlogger Actigraph, 3T Siemens MRI, Sleep Deprivation, Nocturnal PSG
- ClinicalTrials.gov ID
- NCT02741505
- Acronym / sponsor ID
- BEDTIME / 15-00971
- Conditions
- Alzheimer's Disease
- Keywords
- cerebrospinal fluid (CSF), sleep, Obstructive Sleep Apnea (OSA), Sleep Disordered Breathing (SDB), Period Limb Movement during Sleep (PLMS)
- Study type
- Interventional
- Recruitment status
- WithdrawnReason stopped: Funding was not obtained
- Enrolment
- 0 participants (actual)
- Lead sponsor
- NYU Langone HealthUniversity, hospital or other
- Study start
- Jun 2019 (estimated)
- Primary completion
- 1 Dec 2019 (actual)
- Study completion
- 1 Dec 2019 (actual)
- First posted
- 18 Apr 2016 (estimated)
- 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 primary purpose of this study is to explore the underlying mechanisms that link sleep to Alzheimer's disease (AD), with special focus on the clearance of metabolites in the extracellular space of the brain during sleep. Subjects will wear an actigraph for 1 week to determine regular daytime activity and sleep patterns. Subjects will then undergo partial sleep deprivation followed by 4 hours of in-lab nocturnal polysomnography (NPSG). Participants will be be asked to stay awake and active all day after the partial sleep deprivation with a new actigraphy secured by a hospital band to assure participants remain awake. They will seep inside an MRI machine for 90 minutes on the following night during their usual bedtime (established by 1 week actigraphy study.) Morphologic imaging, flow imaging and diffusion kurtosis imaging (DKI) will be performed on a 3T Siemens scanner.
Study design
- Primary purpose
- Diagnosis
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| Sleep Deprivation followed by Normal Sleep | Experimental | Device: ActigraphSubjects will be sleep deprived at the sleep laboratory. |
Who may qualify
- Ages
- 21 to 30 years
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Adult
Key inclusion criteria (2 listed)
- Age range 21-30
- Capable of giving informed consent
Key exclusion criteria (10 listed)
- Diagnosis of any brain disease or brain damage including significant trauma, hydrocephalus, seizures, mental retardation or other serious neurological disorders (e.g. Parkinson's disease or other movement disorders). Persons with silent cortical infarcts will be excluded. White matter lesions will not be exclusions.
- History of major psychiatric illness (e.g., schizophrenia, bipolar or life long history of major depression)
- Conditions that alter normal sleep patterns: irregular sleep-wake rhythms (based on one week at home monitoring with actigraphy), moderate to severe periodic limb movement while you sleep (PLMS) or Obstructive Sleep Apnea (OSA).
- History of claustrophobia.
- BMI≥30
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 |
|---|---|---|
| ActigraphParticipants will be asked to wear an actigraph | Device | Sleep Deprivation followed by Normal Sleep |
Primary outcome
Measure of Interstitial Space Volume during sleep using MRI imaging
Time frame: 6 Months
Data will be acquired using imaging sequences that comply with federal limits regarding radiofrequency energy deposition and gradient slew rates.
1 secondary outcome
Changes in Cerebral Spinal Fluid volume measured by increases in the power of slow wave activity (SWA)
Time frame: 6 Months
Results and safety
The study was withdrawn before enrolling participants, so there are no results.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 13 Jul 2020.
- Individual participant dataSharing planned: Yes. Individual participant data that underlie the results reported in this article, after deidentification (text, tables, figures, and appendices).
Related trials for Alzheimer's Disease
Recruiting
The Effects of Successful OSA Treatment on Memory and AD Biomarkers in Older Adults Study
Obstructive Sleep Apnea, Cognitive Decline
Active, not recruiting
Promoting Physical Activity in Older Hispanic/Latino(a) Adults
Sedentary Behavior, Physical Inactivity
RecruitingPhase 2
Alzheimer's Tau Platform: Master Protocol
Preclinical Alzheimer's Disease, Alzheimer Disease
RecruitingObservational study
Amyloid PET Imaging in the Baltimore Longitudinal Study of Aging
Aging
Enrolling by invitationPhase 2
Alzheimer's Tau Platform: Regimen A - AADvac1
Preclinical Alzheimer's Disease, Prodromal Alzheimer's Disease
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 Suarez, MD principal investigator
New York University Medical School
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Actigraph in people with Alzheimer's Disease, 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 2 inclusion and 10 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: withdrawn, as of the sponsor's last update on 13 Jul 2020. 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 was withdrawn before enrolling participants, so there are no results.
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?
Measure of Interstitial Space Volume during sleep using MRI imaging (time frame: 6 Months). 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 13 Jul 2020; AzTrials last refreshed its copy on 27 Oct 2026.