Functional Magnetic Resonance Imaging Sleep Study With Auditory Stimuli

NCT02629107 | Recruiting

• 2 other identifiers: 16003116-N-0031
• Study Type: observational
• Target: 2,378
• Locations: 1 country
• Sites: 1

Brief 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. 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. ...

Conditions

Normal Physiology

Keywords

Sleep; Functional Magnetic Resonance Imaging (fMRI); Electroencephalogram (EEG); Natural History

Outcome Measures

Primary Outcomes (1)

• 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.

  This outcome will be measured during Overnight Visit 1 and 2.

Study Arms (1)

Healthy Volunteers

Healthy volunteers, age 18-34.

Eligibility Criteria

• Age: 18 Years - 34 Years
• Sex: all
• Healthy Volunteers: Yes
• Age Groups: Adult (18-64)
• Sampling Method: Non-Probability Sample

Study Population

Volunteers will be recruited from the community and NIH employees.

You may qualify if:

• 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).

You may not qualify if:

• 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;
• 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.

Sponsors & Collaborators

• National Institute of Neurological Disorders and Stroke (NINDS): lead

Study Sites (1)

National Institutes of Health Clinical Center

Bethesda, Maryland, 20892, United States

RECRUITING

Related Publications (1)

• 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.

  PMID: 30243817 DERIVED

Related Links

• NIH Clinical Center Detailed Web Page

Study Officials

• Jeffrey H Duyn, Ph.D.

  National Institute of Neurological Disorders and Stroke (NINDS)

  PRINCIPAL INVESTIGATOR

Central Study Contacts

Susan C Guttman

CONTACT

(301) 451-9912; fultons@mail.nih.gov

Jeffrey H Duyn, Ph.D.

CONTACT

(301) 594-7305; duynjeff@ninds.nih.gov

Study Design

• Study Type: observational
• Observational Model: COHORT
• Time Perspective: PROSPECTIVE
• Sponsor Type: NIH
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: December 10, 2015
• First Posted: December 14, 2015
• Study Start: January 14, 2016
• Primary Completion (Estimated): December 31, 2044
• Study Completion (Estimated): December 31, 2045
• Last Updated: April 24, 2026

Record last verified: 2026-02-10

Data Sharing

• IPD Sharing: Will not share

Locations

US (1)