Olfactory Decision-making and Deprived Sleep (ODDS)

This research study will use magnetic resonance imaging (MRI) and olfactory stimuli to better understand the connection between sleep deprivation, brain activity, and olfaction in humans.

Study Overview

• Status: Completed
• Conditions: Sleep Deprivation
• Intervention / Treatment: Behavioral: Sleep deprivation

• Study Type: Interventional
• Enrollment (Actual): 46
• Phase: Not Applicable

Contacts and Locations

Study Locations

• United States
  • Illinois
    • Chicago, Illinois, United States, 60611
      • Northwestern University

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 18 years and older (Adult, Older Adult)
• Accepts Healthy Volunteers: Yes
• Genders Eligible for Study: All

Description

Inclusion Criteria:

• At least 18 years old
• Fluent English speakers

Exclusion Criteria:

• History of neurological conditions (e.g., epilepsy, dementia, multiple sclerosis, brain tumors, etc.)
• History of psychiatric conditions (e.g., general anxiety disorder, depression, schizophrenia, obsessive-compulsive disorder, post-traumatic stress disorder, attention deficit hyperactivity disorder, alcoholism, etc.)
• Significant medical illnesses (e.g., cancer, meningitis, chronic obstructive pulmonary disease, cardiovascular disease, etc.)
• Cerebrovascular risk factors (e.g., hypertension, diabetes, elevated cholesterol, etc.)
• Use of psychoactive medications (e.g., barbiturates, benzodiazepines, chloral hydrate, haloperidol, lithium, carbamazepine, phenytoin, citalopram, escitalopram, fluoxetine, diazepam, etc.)
• Smell or taste dysfunction
• History of severe allergies requiring hospitalization for treatment
• History of severe asthma requiring hospitalization for treatment
• Habitual smoking
• History of eating disorders (e.g., anorexia nervosa, bulimia nervosa, binge-eating disorder, etc.)
• Dieting or fasting
• History of sleep disorders (e.g., obstructive sleep apnea, narcolepsy, insomnia, etc.) Magnetic implants (e.g., shunts or stents, aneurysm clips, surgical clips, cochlear implants, metal bone/joint pins, plates and screws, eyelid spring or wires, etc.)
• Electronic implants (e.g., implanted cardiac defibrillator, cardiac pacemaker, deep brain/spinal cord or nerve stimulator, internal electrodes/wires, medication infusion devices, etc.)
• History of metal working without proper eye protection, or injury with metal shrapnel or metal slivers
• Left-handedness
• Claustrophobia

Study Plan

How is the study designed?

Design Details

• Primary Purpose: Basic Science
• Allocation: Randomized
• Interventional Model: Crossover Assignment
• Masking: None (Open Label)

Number of Arms

2

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
Experimental: Fully slept first; Sleep deprived second; Participants will be fully slept during the first experimental visit and sleep deprived during the second experimental visit	Behavioral: Sleep deprivation; Fully slept: Sleep habitual amount (i.e., go to sleep at habitual bedtime and wake up at habitual wake time) Sleep deprived: Reduce sleep by 50% (i.e., go to sleep at habitual bedtime and wake up early)
Experimental: Sleep deprived first; Fully slept second; Participants will be sleep deprived during the first experimental visit and fully slept during the second experimental visit	Behavioral: Sleep deprivation; Fully slept: Sleep habitual amount (i.e., go to sleep at habitual bedtime and wake up at habitual wake time) Sleep deprived: Reduce sleep by 50% (i.e., go to sleep at habitual bedtime and wake up early)

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Behavior an olfactory perceptual decision-making task	Food-like perceptual responses to binary food-nonfood odor mixtures	Up to 24 hours after the intervention

Secondary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Resting-state functional magnetic resonance imaging	Resting-state activity determined by functional magnetic resonance imaging	Up to 24 hours after the intervention

Collaborators and Investigators

• Sponsor: Northwestern University
• Investigators: Principal Investigator: Thorsten Kahnt, PhD, Associate professor; Principal Investigator: Christina Zelano, PhD, Assistant Professor

Study record dates

Study Major Dates

• Study Start (Actual): January 14, 2021
• Primary Completion (Actual): May 19, 2022
• Study Completion (Actual): May 19, 2022

Study Registration Dates

• First Submitted: September 29, 2021
• First Submitted That Met QC Criteria: October 13, 2021
• First Posted (Actual): October 26, 2021

Study Record Updates

• Last Update Posted (Actual): July 13, 2022
• Last Update Submitted That Met QC Criteria: July 11, 2022
• Last Verified: July 1, 2022

More Information

Terms related to this study

• Additional Relevant MeSH Terms: Mental Disorders; Nervous System Diseases; Dyssomnias; Sleep Wake Disorders; Neurologic Manifestations; Sleep Deprivation
• Other Study ID Numbers: STU00215342

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: YES
• IPD Plan Description: Data underlying published results may be shared
• IPD Sharing Time Frame: Data may be shared upon publication
• IPD Sharing Access Criteria: Data can be obtained from the PI for non-profit purposes upon reasonable request

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: No