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| ID | Type | Description | Link |
|---|---|---|---|
| 1R01HL128226-01A1 | U.S. NIH Grant/Contract | View source |
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| Name | Class |
|---|---|
| NYU Langone Health | OTHER |
| National Heart, Lung, and Blood Institute (NHLBI) | NIH |
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The overall goal of this project is to look at the effects of long-term, sustained sleep restriction (SR) in adults, and assess the effects on mood and cognitive and physical performance.
Chronic Sleep Restriction (SR) is highly prevalent in today's modern society. Artificial light, portable electronic devices, and 24-h services have allowed individuals to remain active throughout the night, leading to reductions in sleep duration. SSD has been linked to obesity and our laboratory has been interested in establishing whether sleep could be a causal factor in the etiology of obesity. Given the increasing prevalence of obesity over the past 5 decades, coinciding with the marked reduction in sleep duration, further exploration into the role of sleep as a risk factor for obesity could provide additional ammunition in the fight to prevent further increases in the incidence of obesity.
This study will be a randomized, crossover, outpatient SR study with 2 phases of 6 weeks each, with a 6 week wash-out period between the phases. Sleep duration in each phase will be the participant's regular bed- and wake times during the habitual sleep (HS) phase and HS minus 1.5 hours in the SR phase. During the HS phase, participants will be asked to follow a fixed bedtime routine based on their screening sleep schedule. During the SR phase, participants will be asked to keep their habitual wake time constant but delay their bedtime to achieve a reduction of 1.5 hours in total sleep time.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Habitual Sleep (HS) | No Intervention | Participants will be asked to follow a fixed bedtime routine based on the participant's regular bed- and wake-times during the habitual sleep (HS) phase. | |
| Sleep Restriction (SR) | Experimental | Participants will be asked to keep their habitual wake time constant but delay their bedtime to achieve a reduction of 1.5 hours in total sleep time during the sleep restriction (SR) phase. |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Sleep Restriction (SR) | Behavioral | Participants will be asked to keep their habitual wake time constant but delay their bedtime to achieve a reduction of 1.5 hours in total sleep time. A delay in bedtimes was chosen rather than advancing wake-up time because it most closely reflects differences in sleep timing behavior between short and normal sleepers. |
| Measure | Description | Time Frame |
|---|---|---|
| Endpoint Fat Volume | Body composition (specifically fat volume) will be measured by MRI at baseline and endpoint. | Week 6 (endpoint) |
| Measure | Description | Time Frame |
|---|---|---|
| Energy Expenditure (EE) | EE is the amount of energy (or calories) that a person needs to carry out physical functions and will be assessed using Doubly Labeled Water (DLW), during the last 2 weeks of each sleep phase. | Measured over 14 days at the end of each phase (weeks 5 and 6; endpoint) |
| Physical Activity |
| Measure | Description | Time Frame |
|---|---|---|
| NIH Toolbox® | Working memory data were collected using the List Sorting Working Memory Test from the NIH Toolbox. Data were transformed into a t-score ranging from 0-100 where a higher t-score indicates better performance. T-score of 50 indicates the population mean with a standard deviation of 10. Data were collected at baseline and after 6 weeks on study intervention. Traditionally, a clinically relevant threshold for cognitive data is 1.5 standard deviations below the mean. For a t-score, this would mean that a score of 35 or lower suggests clinical relevance. |
Inclusion Criteria:
Exclusion Criteria:
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| Name | Affiliation | Role |
|---|---|---|
| Marie-Pierre St-Onge, PhD | Columbia University | Principal Investigator |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| New York Nutrition Obesity Research Center | New York | New York | 10032 | United States |
| PubMed Identifier | Type | Citation | Retractions |
|---|---|---|---|
| 20175398 | Background | Luckhaupt SE, Tak S, Calvert GM. The prevalence of short sleep duration by industry and occupation in the National Health Interview Survey. Sleep. 2010 Feb;33(2):149-59. doi: 10.1093/sleep/33.2.149. | |
| 16801930 | Background | Keith SW, Redden DT, Katzmarzyk PT, Boggiano MM, Hanlon EC, Benca RM, Ruden D, Pietrobelli A, Barger JL, Fontaine KR, Wang C, Aronne LJ, Wright SM, Baskin M, Dhurandhar NV, Lijoi MC, Grilo CM, DeLuca M, Westfall AO, Allison DB. Putative contributors to the secular increase in obesity: exploring the roads less traveled. Int J Obes (Lond). 2006 Nov;30(11):1585-94. doi: 10.1038/sj.ijo.0803326. Epub 2006 Jun 27. |
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De-identified data will be provided on request after discussion among parties.
After study completion and publication of main findings.
Contact PI for information
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| ID | Title | Description |
|---|---|---|
| FG000 | Adequate Sleep Followed by Sleep Restriction | Participants were randomized to continue adequate sleep in phase 1 and crossed over to sleep restriction condition in phase 2 |
| FG001 | Sleep Restriction Followed by Adequate Sleep | Participants were randomized to restrict sleep in phase 1 and crossed over to follow their habitual adequate sleep in phase 2 |
| Title | Milestones | Reasons Not Completed | ||||||||||||
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
| Overall Study |
|
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| ID | Title | Description |
|---|---|---|
| BG000 | Adequate Sleep Followed by Sleep Restriction | Participants were randomized to continue adequate sleep in phase 1 and crossed over to sleep restriction condition in phase 2 |
| BG001 | Sleep Restriction Followed by Adequate Sleep |
| Units | Counts |
|---|---|
| Participants |
|
| 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 | Endpoint Fat Volume | Body composition (specifically fat volume) will be measured by MRI at baseline and endpoint. | Data were available from 38 women who underwent MRI scanning for body composition assessment. | Posted | Mean | Standard Deviation | Liter | Week 6 (endpoint) |
|
Throughout participation in the study (from time accrued to end of phase 2); approximately 16-20 weeks for most participants.
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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 | Habitual Sleep (HS) | Participants will be asked to follow a fixed bedtime routine based on the participant's regular bed- and wake-times during the habitual sleep (HS) phase. |
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| Title | Organization | Phone | Extension | |
|---|---|---|---|---|
| Marie-Pierre St-Onge | Columbia University Irving Medical Center | 212-305-9379 | ms2554@cumc.columbia.edu |
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| Type | Includes Protocol | Includes SAP | Includes ICF | Document Label | Document Date | Document Uploaded Date | Document File Name |
|---|---|---|---|---|---|---|---|
| Prot_SAP | Yes | Yes | No | Study Protocol and Statistical Analysis Plan | Feb 5, 2024 | Mar 28, 2024 | Prot_SAP_000.pdf |
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| ID | Term |
|---|---|
| D009765 | Obesity |
| D001835 | Body Weight |
| ID | Term |
|---|---|
| D050177 | Overweight |
| D044343 | Overnutrition |
| D009748 | Nutrition Disorders |
| D009750 | Nutritional and Metabolic Diseases |
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|
Time spent in moderate-to-vigorous physical activity. |
| Average over 6 weeks (measured daily) |
| Ghrelin | Average post-baseline values | 6 weeks |
| Regional Brain Activation in Response to Food Stimuli | The primary aim of this outcome was to investigate brain activation in response to food stimuli after a six-week period of Adequate Sleep (AS) or mild Sleep Restriction (SR). To achieve this, the investigators contrasted neuronal responses to food and non-food stimuli at two time points (baseline and six weeks post-intervention/control). This contrast allowed the investigators to calculate the number of voxels activated during the view of food stimuli compared to the number of voxels activated during the view of non-food stimuli (food - non-food) under each condition (AS or SR). Regional brain activation is reported as the total number of voxels activated on the group contrast images (combination of all analyzed participants) of the neuronal response to food stimuli compared to non-food stimuli. For this analysis, voxels were considered activated if they survived Gaussian Random Field theory correction with a 2-tailed p < 0.001 threshold when creating the group contrast images. | Week 6 |
| Sedentary Behavior | Time spent in sedentary physical activity. | Average over 6 weeks (measured daily) |
| Leptin | Average post-baseline values | 6 weeks |
| Glucagon-like Peptide 1 | Average post-baseline values | 6 weeks |
| Orexin | Average post-baseline values | 6 weeks |
| Neuropeptide Y | Average post-baseline values | 6 weeks |
| Week 6 (endpoint) |
| Neuro-behavioral Measures | Episodic verbal learning and memory were collected using the Modified Rey Auditory Verbal Learning Test (ModRey). The primary variable of interest for this test is the number of correctly recalled words across three learning trials from List A consisting of 20 words in each trial. The total score range across three trials is 0-60. A higher score indicates better performance. | Week 6 (endpoint) |
| Immune Function | CD8+ T-cells from samples collected late in the day (non-fasted) | Week 5 (endpoint) |
| Immune Markers | Classical monocytes measured from samples collected late in the day (non-fasted) | Week 5 (endpoint) |
| Distance Walked | Distance walked over a 6-minute walk test | Week 5 |
| 32700156 | Background | Zuraikat FM, Makarem N, Redline S, Aggarwal B, Jelic S, St-Onge MP. Sleep Regularity and Cardiometabolic Heath: Is Variability in Sleep Patterns a Risk Factor for Excess Adiposity and Glycemic Dysregulation? Curr Diab Rep. 2020 Jul 23;20(8):38. doi: 10.1007/s11892-020-01324-w. |
| 32086595 | Background | Makarem N, Zuraikat FM, Aggarwal B, Jelic S, St-Onge MP. Variability in Sleep Patterns: an Emerging Risk Factor for Hypertension. Curr Hypertens Rep. 2020 Feb 21;22(2):19. doi: 10.1007/s11906-020-1025-9. |
| 31416797 | Result | Smith I, Salazar I, RoyChoudhury A, St-Onge MP. Sleep restriction and testosterone concentrations in young healthy males: randomized controlled studies of acute and chronic short sleep. Sleep Health. 2019 Dec;5(6):580-586. doi: 10.1016/j.sleh.2019.07.003. Epub 2019 Aug 12. |
| 31383241 | Result | St-Onge MP, Campbell A, Salazar I, Pizinger T, Liao M, Aggarwal B. Information on Bedtimes and Wake Times Improves the Relation Between Self-Reported and Objective Assessments of Sleep in Adults. J Clin Sleep Med. 2019 Jul 15;15(7):1031-1036. doi: 10.5664/jcsm.7888. |
| 33807690 | Result | Barragan R, Zuraikat FM, Tam V, Scaccia S, Cochran J, Li S, Cheng B, St-Onge MP. Actigraphy-Derived Sleep Is Associated with Eating Behavior Characteristics. Nutrients. 2021 Mar 5;13(3):852. doi: 10.3390/nu13030852. |
| 38342031 | Result | Benasi G, Cheng B, Aggarwal B, St-Onge MP. The effects of sustained mild sleep restriction on stress and distress among healthy adults: Findings from two randomized crossover studies. Sleep Med. 2024 Mar;115:83-87. doi: 10.1016/j.sleep.2024.02.001. Epub 2024 Feb 2. |
| 38233280 | Result | Zimmerman ME, Benasi G, Hale C, Yeung LK, Cochran J, Brickman AM, St-Onge MP. The effects of insufficient sleep and adequate sleep on cognitive function in healthy adults. Sleep Health. 2024 Apr;10(2):229-236. doi: 10.1016/j.sleh.2023.11.011. Epub 2024 Jan 16. |
| 38104943 | Result | Li XY, Yoncheva Y, Yan CG, Castellanos FX, St-Onge MP. Chronic Mild Sleep Restriction Does Not Lead to Marked Neuronal Alterations Compared With Maintained Adequate Sleep in Adults. J Nutr. 2024 Feb;154(2):446-454. doi: 10.1016/j.tjnut.2023.12.016. Epub 2023 Dec 16. |
| 37815115 | Result | Barragan R, Zuraikat FM, Cheng B, Scaccia SE, Cochran J, Aggarwal B, Jelic S, St-Onge MP. Paradoxical Effects of Prolonged Insufficient Sleep on Lipid Profile: A Pooled Analysis of 2 Randomized Trials. J Am Heart Assoc. 2023 Oct 17;12(20):e032078. doi: 10.1161/JAHA.123.032078. Epub 2023 Oct 10. |
| 37409467 | Result | Barragan R, Zuraikat FM, Tam V, RoyChoudhury A, St-Onge MP. Changes in eating patterns in response to chronic insufficient sleep and their associations with diet quality: a randomized trial. J Clin Sleep Med. 2023 Nov 1;19(11):1867-1875. doi: 10.5664/jcsm.10696. |
| 36129517 | Result | McAlpine CS, Kiss MG, Zuraikat FM, Cheek D, Schiroli G, Amatullah H, Huynh P, Bhatti MZ, Wong LP, Yates AG, Poller WC, Mindur JE, Chan CT, Janssen H, Downey J, Singh S, Sadreyev RI, Nahrendorf M, Jeffrey KL, Scadden DT, Naxerova K, St-Onge MP, Swirski FK. Sleep exerts lasting effects on hematopoietic stem cell function and diversity. J Exp Med. 2022 Nov 7;219(11):e20220081. doi: 10.1084/jem.20220081. Epub 2022 Sep 21. |
| 42407080 | Derived | Zuraikat FM, Scaccia SE, Cochran JA, Cheng B, Diaz KM, Creasy SA, Melanson EL, Shen W, Aggarwal B, Jelic S, St-Onge MP. Prolonged Short Sleep and Its Effect on Body Weight and Composition : A Pooled Analysis of Randomized Trials. Ann Intern Med. 2026 Jul 7. doi: 10.7326/ANNALS-25-01660. Online ahead of print. |
| 39488926 | Derived | Petrov ME, Zuraikat FM, Cheng B, Aggarwal B, Jelic S, Laferrere B, St-Onge MP. Impact of sleep restriction on biomarkers of thyroid function: Two pooled randomized trials. Sleep Med. 2024 Dec;124:606-612. doi: 10.1016/j.sleep.2024.10.035. Epub 2024 Oct 30. |
Participants were randomized to restrict sleep in phase 1 and crossed over to follow their habitual adequate sleep in phase 2
| BG002 | Total | Total of all reporting groups |
| years |
|
| Sex: Female, Male | Count of Participants | Participants |
|
| Ethnicity (NIH/OMB) | Count of Participants | Participants |
|
| Race (NIH/OMB) | Count of Participants | Participants |
|
| Region of Enrollment | Number | participants |
|
| Body fat volume by MRI | MRI data were not obtained in one participant at baseline of phase 1 for sleep restriction | Mean | Standard Deviation | Liter |
|
| Sedentary Behavior | Mean | Standard Deviation | minutes/day |
|
| Physical Activity | Data were not available for 5 participants. | Mean | Standard Deviation | minutes/day |
|
| Ghrelin | Blood samples were not available at baseline for 1 participant who started phase 1 in adequate sleep condition and 2 participants who started phase 1 in sleep restriction condition | Mean | Standard Deviation | pg/mL |
|
| Leptin | Blood samples were not available at baseline for 1 participant who started phase 1 in adequate sleep condition and 1 participant who started phase 1 in sleep restriction condition | Mean | Standard Deviation | ng/mL |
|
| Glucagon-like peptide 1 | Blood samples were not available at baseline for 1 participant who started phase 1 in adequate sleep condition and 1 participant who started phase 1 in sleep restriction condition | Mean | Standard Deviation | pM |
|
| Orexin | Assay was run on a sub-set of participants | Mean | Standard Deviation | ng/mL |
|
| Neuropeptide Y | Assay was run on a subset of participants | Mean | Standard Deviation | ng/mL |
|
|
|
| Secondary | Energy Expenditure (EE) | EE is the amount of energy (or calories) that a person needs to carry out physical functions and will be assessed using Doubly Labeled Water (DLW), during the last 2 weeks of each sleep phase. | Posted | Mean | Standard Deviation | kcal/d | Measured over 14 days at the end of each phase (weeks 5 and 6; endpoint) |
|
|
|
| Secondary | Physical Activity | Time spent in moderate-to-vigorous physical activity. | Posted | Mean | Standard Deviation | minutes/day | Average over 6 weeks (measured daily) |
|
|
|
| Secondary | Ghrelin | Average post-baseline values | Posted | Mean | Standard Deviation | pg/mL | 6 weeks |
|
|
|
| Secondary | Regional Brain Activation in Response to Food Stimuli | The primary aim of this outcome was to investigate brain activation in response to food stimuli after a six-week period of Adequate Sleep (AS) or mild Sleep Restriction (SR). To achieve this, the investigators contrasted neuronal responses to food and non-food stimuli at two time points (baseline and six weeks post-intervention/control). This contrast allowed the investigators to calculate the number of voxels activated during the view of food stimuli compared to the number of voxels activated during the view of non-food stimuli (food - non-food) under each condition (AS or SR). Regional brain activation is reported as the total number of voxels activated on the group contrast images (combination of all analyzed participants) of the neuronal response to food stimuli compared to non-food stimuli. For this analysis, voxels were considered activated if they survived Gaussian Random Field theory correction with a 2-tailed p < 0.001 threshold when creating the group contrast images. | fMRI data was collected from 26 participants. | Posted | Number | Activated Voxels | Week 6 |
|
|
|
| Secondary | Sedentary Behavior | Time spent in sedentary physical activity. | Posted | Mean | Standard Deviation | minutes/day | Average over 6 weeks (measured daily) |
|
|
|
| Secondary | Leptin | Average post-baseline values | Posted | Mean | Standard Deviation | ng/mL | 6 weeks |
|
|
|
| Secondary | Glucagon-like Peptide 1 | Average post-baseline values | Posted | Mean | Standard Deviation | pM | 6 weeks |
|
|
|
| Secondary | Orexin | Average post-baseline values | Assays were run on a sub-set of participants. | Posted | Mean | Standard Deviation | ng/mL | 6 weeks |
|
|
|
| Secondary | Neuropeptide Y | Average post-baseline values | Assay run on a sub-set of participants | Posted | Mean | Standard Deviation | ng/mL | 6 weeks |
|
|
|
| Other Pre-specified | NIH Toolbox® | Working memory data were collected using the List Sorting Working Memory Test from the NIH Toolbox. Data were transformed into a t-score ranging from 0-100 where a higher t-score indicates better performance. T-score of 50 indicates the population mean with a standard deviation of 10. Data were collected at baseline and after 6 weeks on study intervention. Traditionally, a clinically relevant threshold for cognitive data is 1.5 standard deviations below the mean. For a t-score, this would mean that a score of 35 or lower suggests clinical relevance. | Posted | Mean | Standard Deviation | T-score | Week 6 (endpoint) |
|
|
|
| Other Pre-specified | Neuro-behavioral Measures | Episodic verbal learning and memory were collected using the Modified Rey Auditory Verbal Learning Test (ModRey). The primary variable of interest for this test is the number of correctly recalled words across three learning trials from List A consisting of 20 words in each trial. The total score range across three trials is 0-60. A higher score indicates better performance. | Posted | Mean | Standard Deviation | score | Week 6 (endpoint) |
|
|
|
| Other Pre-specified | Immune Function | CD8+ T-cells from samples collected late in the day (non-fasted) | Posted | Mean | Standard Deviation | cells/mL | Week 5 (endpoint) |
|
|
|
| Other Pre-specified | Immune Markers | Classical monocytes measured from samples collected late in the day (non-fasted) | Posted | Mean | Standard Deviation | cells/mL | Week 5 (endpoint) |
|
|
|
| Other Pre-specified | Distance Walked | Distance walked over a 6-minute walk test | Posted | Mean | Standard Deviation | meters | Week 5 |
|
|
|
| 0 |
| 42 |
| 0 |
| 42 |
| 0 |
| 42 |
| EG001 | Sleep Restriction (SR) | Participants will be asked to keep their habitual wake time constant but delay their bedtime to achieve a reduction of 1.5 hours in total sleep time during the sleep restriction (SR) phase. Sleep Restriction (SR): Participants will be asked to keep their habitual wake time constant but delay their bedtime to achieve a reduction of 1.5 hours in total sleep time. A delay in bedtimes was chosen rather than advancing wake-up time because it most closely reflects differences in sleep timing behavior between short and normal sleepers. | 0 | 39 | 0 | 39 | 0 | 39 |
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| D012816 |
| Signs and Symptoms |
| D013568 | Pathological Conditions, Signs and Symptoms |
| Unknown or Not Reported |
|
| Native Hawaiian or Other Pacific Islander |
|
| Black or African American |
|
| White |
|
| More than one race |
|
| Unknown or Not Reported |
|