NCT05093413

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.

Trial Health

87
On Track

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
46

participants targeted

Target at P25-P50 for not_applicable

Timeline
Completed

Started Jan 2021

Geographic Reach
1 country

1 active site

Status
completed

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

Study Start

First participant enrolled

January 14, 2021

Completed
9 months until next milestone

First Submitted

Initial submission to the registry

September 29, 2021

Completed
27 days until next milestone

First Posted

Study publicly available on registry

October 26, 2021

Completed
7 months until next milestone

Primary Completion

Last participant's last visit for primary outcome

May 19, 2022

Completed
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

May 19, 2022

Completed
Last Updated

July 13, 2022

Status Verified

July 1, 2022

Enrollment Period

1.3 years

First QC Date

September 29, 2021

Last Update Submit

July 11, 2022

Conditions

Outcome Measures

Primary Outcomes (1)

  • 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 Outcomes (1)

  • Resting-state functional magnetic resonance imaging

    Up to 24 hours after the intervention

Study Arms (2)

Fully slept first; Sleep deprived second

EXPERIMENTAL

Participants will be fully slept during the first experimental visit and sleep deprived during the second experimental visit

Behavioral: Sleep deprivation

Sleep deprived first; Fully slept second

EXPERIMENTAL

Participants will be sleep deprived during the first experimental visit and fully slept during the second experimental visit

Behavioral: Sleep deprivation

Interventions

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)

Fully slept first; Sleep deprived secondSleep deprived first; Fully slept second

Eligibility Criteria

Age18 Years+
Sexall
Healthy VolunteersYes
Age GroupsAdult (18-64), Older Adult (65+)

You may qualify if:

  • At least 18 years old
  • Fluent English speakers

You may not qualify if:

  • 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
  • +1 more criteria

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Northwestern University

Chicago, Illinois, 60611, United States

Location

MeSH Terms

Conditions

Sleep Deprivation

Condition Hierarchy (Ancestors)

DyssomniasSleep Wake DisordersNervous System DiseasesNeurologic ManifestationsSigns and SymptomsPathological Conditions, Signs and SymptomsMental Disorders

Study Officials

  • Thorsten Kahnt, PhD

    Associate Professor

    PRINCIPAL INVESTIGATOR
  • Christina Zelano, PhD

    Assistant Professor

    PRINCIPAL INVESTIGATOR

Study Design

Study Type
interventional
Phase
not applicable
Allocation
RANDOMIZED
Masking
NONE
Purpose
BASIC SCIENCE
Intervention Model
CROSSOVER
Sponsor Type
OTHER
Responsible Party
PRINCIPAL INVESTIGATOR
PI Title
Principal Investigator

Study Record Dates

First Submitted

September 29, 2021

First Posted

October 26, 2021

Study Start

January 14, 2021

Primary Completion

May 19, 2022

Study Completion

May 19, 2022

Last Updated

July 13, 2022

Record last verified: 2022-07

Data Sharing

IPD Sharing
Will share

Data underlying published results may be shared

Time Frame
Data may be shared upon publication
Access Criteria
Data can be obtained from the PI for non-profit purposes upon reasonable request

Locations