Sleep DeprivationSDFCNCT04179838
Olfactory Contributions to Sleep-dependent Food Craving
A study testing Sleep-Deprived and Non-Sleep Deprived in people with Sleep Deprivation, run by Northwestern University.
Trial 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). Read more about this study
- Who is it for?
- Ages 18 to 40 yearsHealthy volunteers can take part
- Conditions the study is for
- Sleep Deprivation
- What is being tested?
- Sleep-Deprived and Non-Sleep Deprived
- Type of treatment
- Lifestyle or therapy programme
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 29 participants
- Where
- No sites listed yet
- Study dates
- 19 Sep 2016to 15 Aug 2017
- Phase
- Interventional
- Are there results?
- Yes, posted in the registrySummary in the doctors' view
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 to 40 years
- All sexes
- Healthy volunteers accepted
- Adult
Who may be able to join
- 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
Who cannot join
- 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
Show all 18Show fewer
- 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
- current use of medications that affect alertness (e.g. barbiturates, benzodiazepines, cannabinoids, chloral hydrate, haloperidol, lithium, carbamazepine, phenytoin, etc.)
- current pregnancy (or possible pregnancy)
- history of metal working, or injury with shrapnel or metal slivers
About this study
Official title: Olfactory Contributions to Sleep-dependent Food Craving and Calorie Intake
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.
Read the detailed description
This randomized within-subject sleep-deprivation protocol is designed to examine the effects of reduced sleep on neural processing of food odors in olfactory brain areas. Subjects will be healthy, normal-weight subjects (N=30) with comparable regular sleep patterns. They will be pseudorandomly assigned to first participate in either the sleep deprived (SD) or the non-deprived (ND) session, and then undergo a 7-day sleep stabilization phase during which subjects will maintain a regular sleep schedule of 8 h (within pre-determined range of 10:30 pm to 7:30 am). After sleep stabilization, subjects will either sleep normally (ND, 8h between 11pm and 7am), or sleep for only for 4h (SD, between 1am and 5am), at home. During the sleep stabilization phase and the night of sleep deprivation, sleep duration, as well as sleep and wakeup time will be recorded using actigraphy (ActiGraph, LLC, Pensacola, Florida). All subjects will participate in both sessions (SD and ND) with the two sessions being separated by 4 weeks. In the evening of the next day, olfactory fMRI will be conducted after dinner. Isocaloric meals will be provided during the 24h before fMRI and no beverages other than water will be permitted. After fMRI, subjects will have ad libitum access to high-caloric snacks in the form of an all-you-can-eat buffet.
During initial screening, subjects will rate the pleasantness of six food odors, including three high-caloric sweet odors (caramel, yellow cake, ginger bread) and three high-caloric savory odors (potato chips, pot roast, garlic butter). Based on each participant's ratings, two sweet and two savory odors that are matched in pleasantness will be selected. In addition, two non-food control odors (fir needle and celery seed) will be used. On the evening after the sleep manipulation, subjects will arrive at the imaging center at 5:15pm, and will consume an isocaloric dinner at 6pm before entering the scanner at 7pm. Neuroimaging will be performed on a Siemens PRISMA system with a 64 channel head/neck coil, using imaging sequences optimized for signal recovery in olfactory and orbitofrontal cortices. Subjects will participate in 4 runs of olfactory stimulation inside the scanner and BOLD responses will be acquired with high spatial (2 mm isotopic) and temporal resolution (2000 ms). On each trial, subjects will be visually cued to sniff, and an odor (food or non-food) or non-odorized air will be delivered. Subsequently, subjects will rate the pleasantness or the intensity of the odor (pseudo-randomized). Sniffing will be measured using an fMRI-compatible breathing belt and spirometer. A high-resolution anatomical image will be acquired for the purpose of spatial normalization and anatomical localization of the fMRI responses.
Upon arrival at the imaging center, a study study nurse will insert an intravenous sterile heparin-lock catheter in the left forearm vein and initiate blood sampling. Blood will be drawn every 30 min after arrival, resulting in 5 samples: before dinner, after dinner, before fMRI, during fMRI, and after fMRI.
At the completion of fMRI, participants will be provided with a buffet where they have ad libitum access to high-caloric food items (sweet [mini muffins, cinnamon buns, chocolate chip cookies, and doughnut holes] and savory high-calorie snacks [pizza bites, potato chips, hash browns, garlic bread]). Subjects will be instructed to consume as much food as they like. All food items will be weighed pre- and post-consumption, and the consumed calories will be calculated.
- Conditions
- Sleep Deprivation
- Being tested
- Sleep-Deprived, Non-Sleep Deprived
- Medical subject headings
- Sleep Deprivation
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Sleep-DeprivedBehavioural
Sleep for 4 hours at home.
Non-Sleep DeprivedBehavioural
Sleep for 8 hours at home.
| Study group | Role | What they receive |
|---|---|---|
| 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). Receives: Behavioral: Sleep-Deprived; Behavioral: 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). Receives: Behavioral: Sleep-Deprived; Behavioral: Non-Sleep Deprived |
What is being measured
The primary outcome is the main question the study is designed to answer.
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.
Measured: 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
Energy-density (kcal/g) of the food items consumed at the buffet provided after fMRI scanning in the evening after the night of the "Sleep-Deprived" and the "Non-Sleep Deprived" intervention.
Measured: A single time point, in the evening (~20 h) after both the night of the "Sleep-Deprived" and the "Non-Deprived" intervention.
Ghrelin
Ghrelin levels in blood samples (ng/mL) collected in the evening after the night of the "Sleep-Deprived" and the "Non-Sleep Deprived" intervention.
Measured: A single time point, in the evening (~19.5 h) after both the night of the "Sleep-Deprived" and the "Non-Deprived" intervention.
Leptin
Leptin levels in blood samples (ng/mL) collected in the evening after the night of the "Sleep-Deprived" and the "Non-Sleep Deprived" intervention.
Measured: 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
Total calories (kcal) of the food items consumed at the buffet provided after fMRI scanning in the evening after the night of the "Sleep-Deprived" and the "Non-Sleep Deprived" intervention.
Measured: A single time point, in the evening (~20 h) after both the night of the "Sleep-Deprived" and the "Non-Deprived" intervention.
Insulin
Insulin levels in blood samples (uU/mL) collected in the evening after the night of the "Sleep-Deprived" and the "Non-Sleep Deprived" intervention.
Measured: A single time point, in the evening (~19.5 h) after both the night of the "Sleep-Deprived" and the "Non-Deprived" intervention.
Cortisol
Cortisol levels in blood samples (ug/dl) collected in the evening after the night of the "Sleep-Deprived" and the "Non-Sleep Deprived" intervention.
Measured: A single time point, in the evening (~19.5 h) after both the night of the "Sleep-Deprived" and the "Non-Deprived" intervention.
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted27 Nov 2019
- Study start19 Sep 2016
- Primary completion15 Aug 2017
- Study completion15 Aug 2017
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Posted resultsParticipant flow, outcome measures and adverse events reported by the sponsor.
- Publications (1)Papers the sponsor has linked to this study.
- Other trials for Sleep DeprivationStudies of the same condition, open and under way.
- More trials run by Northwestern UniversityThe sponsor's other registered studies.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Basic science
- Allocation
- Randomised
- Intervention model
- Crossover
- Masking
- None (open label)
- Enrolment
- 29 participants (actual)
Sponsor and investigators
- Lead sponsor
- Northwestern University
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Thorsten Kahnt, Northwestern University
- Investigators
- Thorsten Kahnt, PhD, Principal investigator, Northwestern University
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT04179838
- Sponsor's protocol ID
- R21DK118503
- Acronym
- SDFC
- Status last verified
- Mar 2020
- First submitted
- 21 Nov 2019
- Last updated
- 25 Mar 2020
- Results posted
- Yes, on ClinicalTrials.gov
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- Yes: All data that underlie results in a publication
Publications
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.
PubMed 31591965
Study at a glance
From the registry record, last updated by the sponsor on 25 Mar 2020. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Olfactory Contributions to Sleep-dependent Food Craving and Calorie Intake
- ClinicalTrials.gov ID
- NCT04179838
- Acronym / sponsor ID
- SDFC / R21DK118503
- Conditions
- Sleep Deprivation
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 29 participants (actual)
- Lead sponsor
- Northwestern UniversityUniversity, hospital or other
- Study start
- 19 Sep 2016 (actual)
- Primary completion
- 15 Aug 2017 (actual)
- Study completion
- 15 Aug 2017 (actual)
- First posted
- 27 Nov 2019 (actual)
- Results
- Posted 25 Mar 2020
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
Detailed description
This randomized within-subject sleep-deprivation protocol is designed to examine the effects of reduced sleep on neural processing of food odors in olfactory brain areas. Subjects will be healthy, normal-weight subjects (N=30) with comparable regular sleep patterns. They will be pseudorandomly assigned to first participate in either the sleep deprived (SD) or the non-deprived (ND) session, and then undergo a 7-day sleep stabilization phase during which subjects will maintain a regular sleep schedule of 8 h (within pre-determined range of 10:30 pm to 7:30 am). After sleep stabilization, subjects will either sleep normally (ND, 8h between 11pm and 7am), or sleep for only for 4h (SD, between 1am and 5am), at home. During the sleep stabilization phase and the night of sleep deprivation, sleep duration, as well as sleep and wakeup time will be recorded using actigraphy (ActiGraph, LLC, Pensacola, Florida). All subjects will participate in both sessions (SD and ND) with the two sessions being separated by 4 weeks. In the evening of the next day, olfactory fMRI will be conducted after dinner. Isocaloric meals will be provided during the 24h before fMRI and no beverages other than water will be permitted. After fMRI, subjects will have ad libitum access to high-caloric snacks in the form of an all-you-can-eat buffet.
During initial screening, subjects will rate the pleasantness of six food odors, including three high-caloric sweet odors (caramel, yellow cake, ginger bread) and three high-caloric savory odors (potato chips, pot roast, garlic butter). Based on each participant's ratings, two sweet and two savory odors that are matched in pleasantness will be selected. In addition, two non-food control odors (fir needle and celery seed) will be used. On the evening after the sleep manipulation, subjects will arrive at the imaging center at 5:15pm, and will consume an isocaloric dinner at 6pm before entering the scanner at 7pm. Neuroimaging will be performed on a Siemens PRISMA system with a 64 channel head/neck coil, using imaging sequences optimized for signal recovery in olfactory and orbitofrontal cortices. Subjects will participate in 4 runs of olfactory stimulation inside the scanner and BOLD responses will be acquired with high spatial (2 mm isotopic) and temporal resolution (2000 ms). On each trial, subjects will be visually cued to sniff, and an odor (food or non-food) or non-odorized air will be delivered. Subsequently, subjects will rate the pleasantness or the intensity of the odor (pseudo-randomized). Sniffing will be measured using an fMRI-compatible breathing belt and spirometer. A high-resolution anatomical image will be acquired for the purpose of spatial normalization and anatomical localization of the fMRI responses.
Upon arrival at the imaging center, a study study nurse will insert an intravenous sterile heparin-lock catheter in the left forearm vein and initiate blood sampling. Blood will be drawn every 30 min after arrival, resulting in 5 samples: before dinner, after dinner, before fMRI, during fMRI, and after fMRI.
At the completion of fMRI, participants will be provided with a buffet where they have ad libitum access to high-caloric food items (sweet [mini muffins, cinnamon buns, chocolate chip cookies, and doughnut holes] and savory high-calorie snacks [pizza bites, potato chips, hash browns, garlic bread]). Subjects will be instructed to consume as much food as they like. All food items will be weighed pre- and post-consumption, and the consumed calories will be calculated.
Study design
- Primary purpose
- Basic science
- Allocation
- Randomised
- Intervention model
- Crossover
- Masking
- None (open label)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Sleep-Deprived first, then Non-Sleep Deprived | Experimental | Behavioral: Sleep-Deprived, Behavioral: Non-Sleep DeprivedParticipants 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). |
| Non-Sleep Deprived first, then Sleep-deprived | Experimental | Behavioral: Sleep-Deprived, Behavioral: Non-Sleep DeprivedParticipants 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). |
Who may qualify
- Ages
- 18 to 40 years
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Adult
Key inclusion criteria (4 listed)
- 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
Key exclusion criteria (18 listed)
- 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
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Sleep-DeprivedSleep for 4 hours at home. | Behavioural | Non-Sleep Deprived first, then Sleep-deprived, Sleep-Deprived first, then Non-Sleep Deprived |
| Non-Sleep DeprivedSleep for 8 hours at home. | Behavioural | Non-Sleep Deprived first, then Sleep-deprived, Sleep-Deprived first, then Non-Sleep Deprived |
Primary outcome
Functional Magnetic Resonance Imaging (fMRI)-Based Decoding Accuracy of Food vs Non-food Odors in Piriform Cortex
Time frame: A single time point, in the evening (~19 h) after both the night of the "Sleep-Deprived" and the "Non-Deprived" intervention.
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.
6 secondary outcomes
Energy-density of Consumed Food
Time frame: A single time point, in the evening (~20 h) after both the night of the "Sleep-Deprived" and the "Non-Deprived" intervention.
Ghrelin
Time frame: A single time point, in the evening (~19.5 h) after both the night of the "Sleep-Deprived" and the "Non-Deprived" intervention.
Leptin
Time frame: 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
Time frame: A single time point, in the evening (~20 h) after both the night of the "Sleep-Deprived" and the "Non-Deprived" intervention.
Insulin
Time frame: A single time point, in the evening (~19.5 h) after both the night of the "Sleep-Deprived" and the "Non-Deprived" intervention.
Cortisol
Time frame: A single time point, in the evening (~19.5 h) after both the night of the "Sleep-Deprived" and the "Non-Deprived" intervention.
Results and safety
Loading the posted results from ClinicalTrials.gov…
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 25 Mar 2020.
- Posted resultsParticipant flow, baseline, all outcome measures and adverse events.
- Results publication: PubMed 31591965Bhutani 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.
- Individual participant dataSharing planned: Yes. All data that underlie results in a publication
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Thorsten Kahnt, PhD principal investigator
Northwestern University
Questions about this trial
What is this clinical trial studying?
A study testing Sleep-Deprived and Non-Sleep Deprived in people with Sleep Deprivation, run by Northwestern University.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 4 inclusion and 18 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 25 Mar 2020. Status can change between updates, so confirm with the study contact before making plans.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
Yes. Results are posted in the registry (first posted 25 Mar 2020). A summary is in the For doctors view, and the full results are on ClinicalTrials.gov.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Functional Magnetic Resonance Imaging (fMRI)-Based Decoding Accuracy of Food vs Non-food Odors in Piriform Cortex (time frame: A single time point, in the evening (~19 h) after both the night of the "Sleep-Deprived" and the "Non-Deprived" intervention.). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT04179838, which also lists 1 linked publication.
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 25 Mar 2020.