NCT04179838

Brief Summary

This within-subject experiment uses one night of acute sleep restriction (4h) vs normal sleep (8h) to study state-dependent changes in olfactory processing. Odor-evoked blood oxygen level dependent (BOLD) responses will be measured in olfactory brain regions using functional magnetic resonance imaging (fMRI). Food intake will be measured at a buffet.

Trial Health

100
On Track

Trial Health Score

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

Enrollment
29

participants targeted

Target at below P25 for not_applicable

Timeline
Completed

Started Sep 2016

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

September 19, 2016

Completed
11 months until next milestone

Primary Completion

Last participant's last visit for primary outcome

August 15, 2017

Completed
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

August 15, 2017

Completed
2.3 years until next milestone

First Submitted

Initial submission to the registry

November 21, 2019

Completed
6 days until next milestone

First Posted

Study publicly available on registry

November 27, 2019

Completed
4 months until next milestone

Results Posted

Study results publicly available

March 25, 2020

Completed
Last Updated

March 25, 2020

Status Verified

March 1, 2020

Enrollment Period

11 months

First QC Date

November 21, 2019

Results QC Date

February 13, 2020

Last Update Submit

March 24, 2020

Conditions

Outcome Measures

Primary Outcomes (1)

  • Functional Magnetic Resonance Imaging (fMRI)-Based Decoding Accuracy of Food vs Non-food Odors in Piriform Cortex

    In the evening after the night of the "Sleep-Deprived" and the "Non-Sleep Deprived" intervention, odor-evoked brain responses were collected using fMRI. fMRI data was analyzed using searchlight-based support vector machines and leave-one-run-out cross-validation to decode information about food vs. non-food odors. For each participant, this resulted in two maps of decoding accuracy (% data points correctly classified as food or non-food odors), one map per intervention. The measure of interest was decoding accuracy extracted from the piriform cortex.

    A single time point, in the evening (~19 h) after both the night of the "Sleep-Deprived" and the "Non-Deprived" intervention.

Secondary Outcomes (6)

  • Energy-density of Consumed Food

    A single time point, in the evening (~20 h) after both the night of the "Sleep-Deprived" and the "Non-Deprived" intervention.

  • Ghrelin

    A single time point, in the evening (~19.5 h) after both the night of the "Sleep-Deprived" and the "Non-Deprived" intervention.

  • Leptin

    A single time point, in the evening (~19.5 h) after both the night of the "Sleep-Deprived" and the "Non-Deprived" intervention.

  • Total Calories of Consumed Food

    A single time point, in the evening (~20 h) after both the night of the "Sleep-Deprived" and the "Non-Deprived" intervention.

  • Insulin

    A single time point, in the evening (~19.5 h) after both the night of the "Sleep-Deprived" and the "Non-Deprived" intervention.

  • +1 more secondary outcomes

Study Arms (2)

Sleep-Deprived first, then Non-Sleep Deprived

EXPERIMENTAL

Participants will first be tested after 1 night with partial sleep deprivation (sleep-deprived, 4 h sleep). After a washout period of 4 weeks, they will be tested again after 1 night with normal sleep (non-sleep deprived, 8 h sleep).

Behavioral: Sleep-DeprivedBehavioral: Non-Sleep Deprived

Non-Sleep Deprived first, then Sleep-deprived

EXPERIMENTAL

Participants will first be tested after 1 night with normal sleep (non-sleep deprived, 8 h sleep). After a washout period of 4 weeks, they will be tested again after 1 night with partial sleep deprivation (sleep-deprived, 4 h sleep).

Behavioral: Sleep-DeprivedBehavioral: Non-Sleep Deprived

Interventions

Sleep-DeprivedBEHAVIORAL

Sleep for 4 hours at home.

Non-Sleep Deprived first, then Sleep-deprivedSleep-Deprived first, then Non-Sleep Deprived

Sleep for 8 hours at home.

Non-Sleep Deprived first, then Sleep-deprivedSleep-Deprived first, then Non-Sleep Deprived

Eligibility Criteria

Age18 Years - 40 Years
Sexall
Healthy VolunteersYes
Age GroupsAdult (18-64)

You may qualify if:

  • age between 18 and 40 years old
  • regular sleep schedule (average sleep duration of ≥7 h/night, habitual mid-sleep time 3-5 am \[deviation ≤2 h in daily mid-sleep time\], time in bed ≤9 h)
  • right-handed
  • fluent English speakers

You may not qualify if:

  • history of significant cerebrovascular disease including (but not limited to) epilepsy, stroke, multiple sclerosis, meningitis
  • body mass index (BMI) below 18.5 (underweight) or above 24.9 (overweight or obese)
  • history of sleep disorder
  • job with night shifts
  • history of major head trauma with sustained loss of consciousness
  • history of neurosurgery, ear-nose-throat (ENT) surgery, or cardiac surgery
  • history of cardiac pacemaker or neurostimulator implantation
  • history of significant medical illness including cardiovascular disease, diabetes, cancer, chronic obstructive pulmonary disease, severe asthma requiring hospitalization for treatment, renal insufficiency requiring dialysis, etc.
  • history of major psychiatric disorder including major affective disorder, obsessive-compulsive disorder, schizophrenia
  • claustrophobia
  • history of significant food or non-food allergy, including latex, detergents, soaps
  • presence of known smell, taste or ENT disorder
  • history of sinusitis or allergic rhinitis
  • history of alcoholism or consistent drug use
  • current smoking
  • +3 more criteria

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Related Publications (1)

  • Bhutani S, Howard JD, Reynolds R, Zee PC, Gottfried J, Kahnt T. Olfactory connectivity mediates sleep-dependent food choices in humans. Elife. 2019 Oct 8;8:e49053. doi: 10.7554/eLife.49053.

MeSH Terms

Conditions

Sleep Deprivation

Condition Hierarchy (Ancestors)

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

Results Point of Contact

Title
Thorsten Kahnt
Organization
Northwestern University

Study Officials

  • Thorsten Kahnt, PhD

    Northwestern University

    PRINCIPAL INVESTIGATOR

Publication Agreements

PI is Sponsor Employee
Yes

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
Assistant Professor

Study Record Dates

First Submitted

November 21, 2019

First Posted

November 27, 2019

Study Start

September 19, 2016

Primary Completion

August 15, 2017

Study Completion

August 15, 2017

Last Updated

March 25, 2020

Results First Posted

March 25, 2020

Record last verified: 2020-03

Data Sharing

IPD Sharing
Will share

All data that underlie results in a publication

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