Normal PhysiologyNCT02629107
Functional Magnetic Resonance Imaging Sleep Study With Auditory Stimuli
An observational study of Normal Physiology, run by National Institute of Neurological Disorders and Stroke (NINDS) at 1 site in United States.
Trial summary
Background: An electroencephalogram (EEG) measures the brain s electrical activity. EEG shows that the louder the sound needed to wake a person, the deeper the person s sleep. Researchers are using functional magnetic resonance imaging (fMRI) to study people during sleep so they can view brain activity in 3D. Read more about this study
- Who is it for?
- Ages 18 to 34 yearsHealthy volunteers can take part
- Conditions the study is for
- Normal Physiology
- How many people
- 2,378 participants
- Where
- 1 siteUnited States
- Study dates
- 14 Jan 2016to 31 Dec 2045
- 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 34 years
- All sexes
- Healthy volunteers accepted
- Adult
Study population: Volunteers will be recruited from the community and NIH employees.
Who may be able to join
- able to give informed consent;
- in good general heath;
- between the ages of 18 and 34 years;
- able to sleep on your back for several hours (with breaks).
Who cannot join
- have a medical condition like diabetes or uncontrolled hypertension;
- have a psychiatric or neurologic condition like depression or stroke;
- have ever had a seizure;
- have a sleep disorder like insomnia or sleep apnea;
- work night shifts;
- have metal in your body such as pacemakers, metal prostheses, or aneurysm clips that would make MRI scanning unsafe;
Show all 14Show fewer
- are pregnant or nursing;
- drink too much caffeine (6 or more cups of coffee per day or 10 or more cups of caffeinated soda per day);
- use too much alcohol (15 or more alcoholic beverages per week for men and 8 or more alcoholic beverages per week for women);
- use too much nicotine (nicotine use within 30 minutes of waking);
- are afraid of enclosed spaces;
- have known hearing problems;
- regularly use a prescription or over-the-counter drug to help you sleep or stay awake;
- are an employee, contractor, or volunteer of the Laboratory of Functional and Molecular Imaging in the National Institute of Neurological Disorders and Stroke.
Trial locations and contacts
1 site in 1 country. Contact the study team or a site near you to ask about taking part.
United States1 site, 1 recruiting
- Recruiting
National Institutes of Health Clinical Center
Bethesda, Maryland, 20892
About this study
Official title: An All-Night Functional Magnetic Resonance Imaging Sleep Study With Auditory Stimuli
Background:
An electroencephalogram (EEG) measures the brain s electrical activity. EEG shows that the louder the sound needed to wake a person, the deeper the person s sleep. Researchers are using functional magnetic resonance imaging (fMRI) to study people during sleep so they can view brain activity in 3D. But they still need to correlate fMRI with sound thresholds, like the EEG.
Read more
Objective:
To measure brain activity during sleep using fMRI and EEG.
Eligibility:
Healthy people ages 18 34 who can sleep on their back for several hours.
Design:
Participants will be screened online about their sleep and general health.
At a screening visit, participants will have:
Physical exam
Hearing exam
MRI scan. A strong magnetic field and radio waves take pictures of the brain. Participants will lie down on a bed that slides into the scanner, which is shaped like a cylinder.
Participants will wear an actigraph on their wrist that records their motor activity.
Participants will follow a 2-week routine. This includes regular in-to-bed and out-of-bed times and limits on alcohol, caffeine, and nicotine.
During the overnight visits, participants will have:
Female subjects will have a urine pregnancy test.
fMRI. A coil will be placed over the head. Participants will do tasks shown on a computer screen inside the scanner.
EEG. Small electrodes on the scalp will record brain waves while sleeping or doing a task in the scanner.
Participants will be asked to try to sleep while researchers collect fMRI and EEG data. Participants eyes will be monitored with a video camera. Headphones will deliver sounds to wake them up throughout the night.
...
Read the detailed description
Objective
Electroencephalography is generally considered the gold standard for defining sleep, but, in fact, sleep is a behavior and is defined by widely accepted behavioral characteristics like auditory arousal threshold. Electroencephalography merely became a surrogate for the behavioral definition when, in the first electroencephalographic sleep studies, researchers discovered a strong correlation between electroencephalographic slow waves and auditory arousal thresholds. With the advent of functional magnetic resonance imaging, one would expect the first sleep studies that used this new measure would have been designed to correlate it with auditory arousal threshold. However, these studies have never been conducted. This protocol will fill this gap in the literature. We hypothesize that undiscovered patterns of brain activity or functional connectivity exist during sleep and that an approach that defines sleep behaviorally will expose these patterns.
Study Population
The subject group in this study will be young, healthy individuals with excellent sleep health. Choosing this subject group will maximize the probability that subjects will sleep during all-night functional magnetic resonance imaging. Our target number of completers was 12 for the pilot study, was 43 for the main study, and is 85 for the normative study.
Design
After a one-week home-monitoring period that includes a regular in-to-bed and out-of-bed time, subjects will undergo two all-night functional magnetic resonance imaging sleep studies separated by a one-week washout period with continued home monitoring. The first night will serve as an adaptation night, which is known to reduce the sleep alterations that accompany sleeping in a laboratory environment. We will measure sleep depth behaviorally by arousing subjects with auditory stimuli that progressively increase in intensity. This procedure will be performed approximately eight times per night. The timing of the arousals will be distributed randomly across the night.
Data Generated
The data generated will be auditory arousal thresholds and the preceding brain activity and functional connectivity derived from functional magnetic resonance imaging.
- Conditions
- Normal Physiology
- Keywords
- Sleep, Functional Magnetic Resonance Imaging (fMRI), Electroencephalogram (EEG), Natural History
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
| Study group | Role | What they receive |
|---|---|---|
| Healthy Volunteers | Healthy volunteers, age 18-34. |
What is being measured
The primary outcome is the main question the study is designed to answer.
The data generated will be auditory arousal thresholds and the preceding brain activity and functional connectivity derived from fMRI
Auditory arousal thresholds will allow us to define sleep depth behaviorally.
Measured: This outcome will be measured during Overnight Visit 1 and 2.
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted14 Dec 2015 (estimated)
- Study start14 Jan 2016
- Primary completion31 Dec 2044 (estimated)
- Study completion31 Dec 2045 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (1)Papers the sponsor has linked to this study.
- Other trials for Normal PhysiologyStudies 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
- Prospective
- Enrolment
- 2,378 participants (estimated)
Sponsor and investigators
- Lead sponsor
- National Institute of Neurological Disorders and Stroke (NINDS)
- Sponsor type
- US National Institutes of Health
- Responsible party
- Sponsor
- Investigators
- Jeffrey H Duyn, Ph.D., Principal investigator, National Institute of Neurological Disorders and Stroke (NINDS)
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT02629107
- Sponsor's protocol ID
- 160031
- Other IDs
- 16-N-0031
- Status last verified
- 29 Jul 2026
- First submitted
- 10 Dec 2015
- Last updated
- 28 Aug 2026
- Results posted
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Publications
Moehlman TM, de Zwart JA, Chappel-Farley MG, Liu X, McClain IB, Chang C, Mandelkow H, Ozbay PS, Johnson NL, Bieber RE, Fernandez KA, King KA, Zalewski CK, Brewer CC, van Gelderen P, Duyn JH, Picchioni D. All-night functional magnetic resonance imaging sleep studies. J Neurosci Methods. 2019 Mar 15;316:83-98. doi: 10.1016/j.jneumeth.2018.09.019. Epub 2018 Sep 20.
PubMed 30243817
Study at a glance
From the registry record, last updated by the sponsor on 28 Aug 2026. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- An All-Night Functional Magnetic Resonance Imaging Sleep Study With Auditory Stimuli
- ClinicalTrials.gov ID
- NCT02629107
- Acronym / sponsor ID
- 160031
- Conditions
- Normal Physiology
- Keywords
- Sleep, Functional Magnetic Resonance Imaging (fMRI), Electroencephalogram (EEG), Natural History
- Study type
- Observational
- Recruitment status
- Recruiting
- Enrolment
- 2,378 participants (estimated)
- Lead sponsor
- National Institute of Neurological Disorders and Stroke (NINDS)US National Institutes of Health
- Study start
- 14 Jan 2016 (actual)
- Primary completion
- 31 Dec 2044 (estimated)
- Study completion
- 31 Dec 2045 (estimated)
- First posted
- 14 Dec 2015 (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.
Background:
An electroencephalogram (EEG) measures the brain s electrical activity. EEG shows that the louder the sound needed to wake a person, the deeper the person s sleep. Researchers are using functional magnetic resonance imaging (fMRI) to study people during sleep so they can view brain activity in 3D. But they still need to correlate fMRI with sound thresholds, like the EEG.
Objective:
To measure brain activity during sleep using fMRI and EEG.
Eligibility:
Healthy people ages 18 34 who can sleep on their back for several hours.
Design:
Participants will be screened online about their sleep and general health.
At a screening visit, participants will have:
Physical exam
Hearing exam
MRI scan. A strong magnetic field and radio waves take pictures of the brain. Participants will lie down on a bed that slides into the scanner, which is shaped like a cylinder.
Participants will wear an actigraph on their wrist that records their motor activity.
Participants will follow a 2-week routine. This includes regular in-to-bed and out-of-bed times and limits on alcohol, caffeine, and nicotine.
During the overnight visits, participants will have:
Female subjects will have a urine pregnancy test.
fMRI. A coil will be placed over the head. Participants will do tasks shown on a computer screen inside the scanner.
EEG. Small electrodes on the scalp will record brain waves while sleeping or doing a task in the scanner.
Participants will be asked to try to sleep while researchers collect fMRI and EEG data. Participants eyes will be monitored with a video camera. Headphones will deliver sounds to wake them up throughout the night.
...
Detailed description
Objective
Electroencephalography is generally considered the gold standard for defining sleep, but, in fact, sleep is a behavior and is defined by widely accepted behavioral characteristics like auditory arousal threshold. Electroencephalography merely became a surrogate for the behavioral definition when, in the first electroencephalographic sleep studies, researchers discovered a strong correlation between electroencephalographic slow waves and auditory arousal thresholds. With the advent of functional magnetic resonance imaging, one would expect the first sleep studies that used this new measure would have been designed to correlate it with auditory arousal threshold. However, these studies have never been conducted. This protocol will fill this gap in the literature. We hypothesize that undiscovered patterns of brain activity or functional connectivity exist during sleep and that an approach that defines sleep behaviorally will expose these patterns.
Study Population
The subject group in this study will be young, healthy individuals with excellent sleep health. Choosing this subject group will maximize the probability that subjects will sleep during all-night functional magnetic resonance imaging. Our target number of completers was 12 for the pilot study, was 43 for the main study, and is 85 for the normative study.
Design
After a one-week home-monitoring period that includes a regular in-to-bed and out-of-bed time, subjects will undergo two all-night functional magnetic resonance imaging sleep studies separated by a one-week washout period with continued home monitoring. The first night will serve as an adaptation night, which is known to reduce the sleep alterations that accompany sleeping in a laboratory environment. We will measure sleep depth behaviorally by arousing subjects with auditory stimuli that progressively increase in intensity. This procedure will be performed approximately eight times per night. The timing of the arousals will be distributed randomly across the night.
Data Generated
The data generated will be auditory arousal thresholds and the preceding brain activity and functional connectivity derived from functional magnetic resonance imaging.
Study design
- Observational model
- Cohort
- Time perspective
- Prospective
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| Healthy Volunteers | – | –Healthy volunteers, age 18-34. |
Who may qualify
- Ages
- 18 to 34 years
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Adult
- Study population
- Volunteers will be recruited from the community and NIH employees.
Key inclusion criteria (4 listed)
Key exclusion criteria (14 listed)
- have a medical condition like diabetes or uncontrolled hypertension;
- have a psychiatric or neurologic condition like depression or stroke;
- have ever had a seizure;
- have a sleep disorder like insomnia or sleep apnea;
- work night shifts;
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Primary outcome
The data generated will be auditory arousal thresholds and the preceding brain activity and functional connectivity derived from fMRI
Time frame: This outcome will be measured during Overnight Visit 1 and 2.
Auditory arousal thresholds will allow us to define sleep depth behaviorally.
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 28 Aug 2026.
- Derived from this study: PubMed 30243817Moehlman TM, de Zwart JA, Chappel-Farley MG, Liu X, McClain IB, Chang C, Mandelkow H, Ozbay PS, Johnson NL, Bieber RE, Fernandez KA, King KA, Zalewski CK, Brewer CC, van Gelderen P, Duyn JH, Picchioni D. All-night functional magnetic resonance imaging sleep studies. J Neurosci Methods. 2019 Mar 15;316:83-98. doi: 10.1016/j.jneumeth.2018.09.019. Epub 2018 Sep 20.
- NIH Clinical Center Detailed Web PageLink provided by the sponsor.
- 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.
Jeffrey H Duyn, Ph.D. principal investigator
National Institute of Neurological Disorders and Stroke (NINDS)
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 Normal Physiology, run by National Institute of Neurological Disorders and Stroke (NINDS) 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 4 inclusion and 14 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: looking for participants now, as of the sponsor's last update on 28 Aug 2026. 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?
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?
Contact Susan C Guttman ((301) 451-9912, fultons@mail.nih.gov), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
The data generated will be auditory arousal thresholds and the preceding brain activity and functional connectivity derived from fMRI (time frame: This outcome will be measured during Overnight Visit 1 and 2.). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT02629107, which also lists 1 linked publication.
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 28 Aug 2026.