ODDS: Olfactory Decision-making and Deprived Sleep

Sponsor

Northwestern University (Other)

Overall Status

Completed

CT.gov ID

NCT05093413

Collaborator

(none)

Enrollment

Location

Arms

16.1

Actual Duration (Months)

2.9

Patients Per Site Per Month

Study Details

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.

Condition or Disease	Intervention/Treatment	Phase
Sleep Deprivation	Behavioral: Sleep deprivation	N/A

Study Design

Study Type:

Interventional

Actual Enrollment :

46 participants

Allocation:

Randomized

Intervention Model:

Crossover Assignment

Masking:

None (Open Label)

Primary Purpose:

Basic Science

Official Title:

Olfactory Decision-making and Deprived Sleep

Actual Study Start Date :

Jan 14, 2021

Actual Primary Completion Date :

May 19, 2022

Actual Study Completion Date :

May 19, 2022

Arms and Interventions

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)

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

Outcome Measures

Primary Outcome Measures

Behavior an olfactory perceptual decision-making task [Up to 24 hours after the intervention]
Food-like perceptual responses to binary food-nonfood odor mixtures

Secondary Outcome Measures

Resting-state functional magnetic resonance imaging [Up to 24 hours after the intervention]
Resting-state activity determined by functional magnetic resonance imaging

Eligibility Criteria

Criteria

Ages Eligible for Study:

18 Years and Older

Sexes Eligible for Study:

All

Accepts Healthy Volunteers:

Yes

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

Contacts and Locations

Locations

	Site	City	State	Country	Postal Code
1	Northwestern University	Chicago	Illinois	United States	60611

Sponsors and Collaborators

Northwestern University

Investigators

Principal Investigator: Thorsten Kahnt, PhD, Associate Professor
Principal Investigator: Christina Zelano, PhD, Assistant Professor

Study Documents (Full-Text)

None provided.

More Information

Publications

None provided.

Responsible Party:

Christina Zelano, Principal Investigator, Northwestern University

ClinicalTrials.gov Identifier:

NCT05093413

Other Study ID Numbers:

STU00215342

First Posted:

Oct 26, 2021

Last Update Posted:

Jul 13, 2022

Last Verified:

Jul 1, 2022

Individual Participant Data (IPD) Sharing Statement:

Yes

Plan to Share IPD:

Yes

Studies a U.S. FDA-regulated Drug Product:

Studies a U.S. FDA-regulated Device Product:

Additional relevant MeSH terms:

Sleep Deprivation

Study Results

No Results Posted as of Jul 13, 2022