Olfactory Decision-making and Deprived Sleep (ODDS)
Primary Purpose
Sleep Deprivation
Status
Completed
Phase
Not Applicable
Locations
United States
Study Type
Interventional
Intervention
Sleep deprivation
Sponsored by
About this trial
This is an interventional basic science trial for Sleep Deprivation
Eligibility Criteria
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
Sites / Locations
- Northwestern University
Arms of the Study
Arm 1
Arm 2
Arm Type
Experimental
Experimental
Arm Label
Fully slept first; Sleep deprived second
Sleep deprived first; Fully slept second
Arm Description
Participants will be fully slept during the first experimental visit and sleep deprived during the second experimental visit
Participants will be sleep deprived during the first experimental visit and fully slept during the second experimental visit
Outcomes
Primary Outcome Measures
Behavior an olfactory perceptual decision-making task
Food-like perceptual responses to binary food-nonfood odor mixtures
Secondary Outcome Measures
Resting-state functional magnetic resonance imaging
Resting-state activity determined by functional magnetic resonance imaging
Full Information
NCT ID
NCT05093413
First Posted
September 29, 2021
Last Updated
July 11, 2022
Sponsor
Northwestern University
1. Study Identification
Unique Protocol Identification Number
NCT05093413
Brief Title
Olfactory Decision-making and Deprived Sleep
Acronym
ODDS
Official Title
Olfactory Decision-making and Deprived Sleep
Study Type
Interventional
2. Study Status
Record Verification Date
July 2022
Overall Recruitment Status
Completed
Study Start Date
January 14, 2021 (Actual)
Primary Completion Date
May 19, 2022 (Actual)
Study Completion Date
May 19, 2022 (Actual)
3. Sponsor/Collaborators
Responsible Party, by Official Title
Principal Investigator
Name of the Sponsor
Northwestern University
4. Oversight
Studies a U.S. FDA-regulated Drug Product
No
Studies a U.S. FDA-regulated Device Product
No
Data Monitoring Committee
No
5. Study Description
Brief Summary
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.
6. Conditions and Keywords
Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Sleep Deprivation
7. Study Design
Primary Purpose
Basic Science
Study Phase
Not Applicable
Interventional Study Model
Crossover Assignment
Masking
None (Open Label)
Allocation
Randomized
Enrollment
46 (Actual)
8. Arms, Groups, and Interventions
Arm Title
Fully slept first; Sleep deprived second
Arm Type
Experimental
Arm Description
Participants will be fully slept during the first experimental visit and sleep deprived during the second experimental visit
Arm Title
Sleep deprived first; Fully slept second
Arm Type
Experimental
Arm Description
Participants will be sleep deprived during the first experimental visit and fully slept during the second experimental visit
Intervention Type
Behavioral
Intervention Name(s)
Sleep deprivation
Intervention Description
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)
Primary Outcome Measure Information:
Title
Behavior an olfactory perceptual decision-making task
Description
Food-like perceptual responses to binary food-nonfood odor mixtures
Time Frame
Up to 24 hours after the intervention
Secondary Outcome Measure Information:
Title
Resting-state functional magnetic resonance imaging
Description
Resting-state activity determined by functional magnetic resonance imaging
Time Frame
Up to 24 hours after the intervention
10. Eligibility
Sex
All
Minimum Age & Unit of Time
18 Years
Accepts Healthy Volunteers
Accepts Healthy Volunteers
Eligibility Criteria
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
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Thorsten Kahnt, PhD
Organizational Affiliation
Associate Professor
Official's Role
Principal Investigator
First Name & Middle Initial & Last Name & Degree
Christina Zelano, PhD
Organizational Affiliation
Assistant Professor
Official's Role
Principal Investigator
Facility Information:
Facility Name
Northwestern University
City
Chicago
State/Province
Illinois
ZIP/Postal Code
60611
Country
United States
12. IPD Sharing Statement
Plan to Share IPD
Yes
IPD Sharing 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
Learn more about this trial
Olfactory Decision-making and Deprived Sleep
We'll reach out to this number within 24 hrs