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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.
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.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| 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). |
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| 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). |
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| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Sleep-Deprived | Behavioral | Sleep for 4 hours at home. |
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| Measure | Description | Time Frame |
|---|---|---|
| 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. |
| Measure | Description | Time Frame |
|---|---|---|
| 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. | A single time point, in the evening (~20 h) after both the night of the "Sleep-Deprived" and the "Non-Deprived" intervention. |
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Inclusion Criteria:
Exclusion Criteria:
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| Name | Affiliation | Role |
|---|---|---|
| Thorsten Kahnt, PhD | Northwestern University | Principal Investigator |
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| PubMed Identifier | Type | Citation | Retractions |
|---|---|---|---|
| 31591965 | Result | 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. |
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All data that underlie results in a publication
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Upon publication
Data can be obtained from the PI for non-profit purposes upon reasonable request.
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| ID | Title | Description |
|---|---|---|
| FG000 | Sleep-Deprived First, Then Non-Sleep Deprived | 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). |
| FG001 | Non-Sleep Deprived First, Then Sleep-deprived | 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). |
| Title | Milestones | Reasons Not Completed | ||||||||||||||||||
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
| First Intervention (1 Day) |
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| Washout (4 Weeks) |
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| Second Intervention (1 Day) |
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| ID | Title | Description |
|---|---|---|
| BG000 | Sleep-Deprived First, Then Non-Sleep Deprived | 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). |
| BG001 |
| Units | Counts |
|---|---|
| Participants |
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| Title | Description | Population Description | Parameter Type | Dispersion Type | Unit of Measure | Calculate Percentage | Denominator Units Selected | Denominators | Classes |
|---|---|---|---|---|---|---|---|---|---|
| Age, Continuous | Mean |
| Type | Title | Description | Population Description | Reporting Status | Anticipated Posting Date | Parameter Type | Dispersion Type | Unit of Measure | Calculate Percentage | Time Frame | Units Analyzed | Denominator Units Selected | Arm/Group Information | Denominators | Classes | Analyses | |||
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
| Primary | 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. | Posted | Mean | Standard Error | Percentage correctly classified | A single time point, in the evening (~19 h) after both the night of the "Sleep-Deprived" and the "Non-Deprived" intervention. |
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Day of Sleep-Deprived and Non-Sleep Deprived sessions, approximately 26 hours
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| ID | Title | Description | Deaths (Affected) | Deaths (At Risk) | Serious Events (Affected) | Serious Events (At Risk) | Other Events (Affected) | Other Events (At Risk) |
|---|---|---|---|---|---|---|---|---|
| EG000 | Sleep-Deprived | Participants who were sleep-deprived in either the first or the second phase of the study. |
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| Title | Organization | Phone | Extension | |
|---|---|---|---|---|
| Thorsten Kahnt | Northwestern University | 3125032896 | thorsten.kahnt@northwestern.edu |
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| Type | Includes Protocol | Includes SAP | Includes ICF | Document Label | Document Date | Document Uploaded Date | Document File Name |
|---|---|---|---|---|---|---|---|
| SAP | No | Yes | No | Statistical Analysis Plan | Mar 9, 2020 | Mar 9, 2020 | SAP_000.pdf |
| Prot | Yes | No | No | Study Protocol | Apr 22, 2019 | Mar 24, 2020 | Prot_001.pdf |
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| ID | Term |
|---|---|
| D012892 | Sleep Deprivation |
| ID | Term |
|---|---|
| D020920 | Dyssomnias |
| D012893 | Sleep Wake Disorders |
| D009422 | Nervous System Diseases |
| D009461 | Neurologic Manifestations |
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| Non-Sleep Deprived | Behavioral | Sleep for 8 hours at home. |
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| 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. | 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. | 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. | 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. | 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. | A single time point, in the evening (~19.5 h) after both the night of the "Sleep-Deprived" and the "Non-Deprived" intervention. |
| NOT COMPLETED |
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| NOT COMPLETED |
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| Non-Sleep Deprived First, Then Sleep-deprived |
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). |
| BG002 | Total | Total of all reporting groups |
| years |
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| Sex: Female, Male | Count of Participants | Participants |
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| Ethnicity (NIH/OMB) | Count of Participants | Participants |
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| Race (NIH/OMB) | Count of Participants | Participants |
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| Region of Enrollment | Number | participants |
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| OG001 | Non-Sleep Deprived | Participants who were non-sleep deprived in either the first or the second phase of the study. |
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| Secondary | 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. | Posted | Mean | Standard Error | kcal/g | A single time point, in the evening (~20 h) after both the night of the "Sleep-Deprived" and the "Non-Deprived" intervention. |
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| Secondary | 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. | Posted | Mean | Standard Error | ng/mL | A single time point, in the evening (~19.5 h) after both the night of the "Sleep-Deprived" and the "Non-Deprived" intervention. |
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| Secondary | 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. | Posted | Mean | Standard Error | ng/mL | A single time point, in the evening (~19.5 h) after both the night of the "Sleep-Deprived" and the "Non-Deprived" intervention. |
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| Secondary | 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. | Posted | Mean | Standard Error | kcal | A single time point, in the evening (~20 h) after both the night of the "Sleep-Deprived" and the "Non-Deprived" intervention. |
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| Secondary | 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. | Posted | Mean | Standard Error | uU/mL | A single time point, in the evening (~19.5 h) after both the night of the "Sleep-Deprived" and the "Non-Deprived" intervention. |
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| Secondary | 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. | Posted | Mean | Standard Error | ug/dl | A single time point, in the evening (~19.5 h) after both the night of the "Sleep-Deprived" and the "Non-Deprived" intervention. |
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| 0 |
| 29 |
| 0 |
| 29 |
| 0 |
| 29 |
| EG001 | Non-Sleep Deprived | Participants who were non-sleep deprived in either the first or the second phase of the study. | 0 | 29 | 0 | 29 | 0 | 29 |
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| D012816 |
| Signs and Symptoms |
| D013568 | Pathological Conditions, Signs and Symptoms |
| D001523 | Mental Disorders |