Clinical trial NCT02960776: Impact of Sleep Restriction on Performance in Adults
Official title: Effect of Long Term Sleep Restriction on Energy Balance
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: Sleep
Obesity
Sleep Restriction
Keywords: Body Weight
Habitual sleep
Lead sponsor: Columbia University
Sponsor class: OTHER
Collaborators: name: NYU Langone Health
name: National Heart, Lung, and Blood Institute (NHLBI)
First posted: 2016-11-10
Enrollment: 45
Sex: ALL
Minimum age (years): 20
Maximum age (years): 75
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: yes
Allocation: RANDOMIZED
Intervention model: CROSSOVER
Primary purpose: PREVENTION

Brief summary: 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.

Detailed description: 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.

Eligibility criteria: Inclusion Criteria:

* BMI 25-29.9 kg/m2
* Have at least one obese parent
* Habitually sleep 7-9 hours a night
* Free of any current and past sleep and psychiatric disorders, including eating disorders, diabetes or Cardiovascular disease (CVD) (i.e., normal scores on: Pittsburgh Quality of Sleep Questionnaire Epworth Sleepiness Scale, Berlin Questionnaire, Sleep Disorders Inventory Questionnaire, Beck Depression Inventory, Composite Scale of Morningness/Eveningness, Three Factor Eating Questionnaire)
* All racial/ethnic groups

Exclusion Criteria:

* Smokers (any cigarettes or ex-smoker \< 3 years)
* Neurological, medical or psychiatric disorder
* Diabetics
* Eating and/or sleep disorders
* Contraindications for MRI scanning
* Travel across time zones within 4 weeks
* History of drug and alcohol abuse
* Shift worker (or rotating shift worker)
* Caffeine intake \> 300 mg/d
* Heavy equipment operators
* Commercial long-distance drivers

Primary outcomes:
measure: Endpoint Fat Volume
timeFrame: Week 6 (endpoint)
Secondary outcomes:
measure: Energy Expenditure (EE)
timeFrame: Measured over 14 days at the end of each phase (weeks 5 and 6; endpoint)
measure: Physical Activity
timeFrame: Average over 6 weeks (measured daily)
measure: Ghrelin
timeFrame: 6 weeks
measure: Regional Brain Activation in Response to Food Stimuli
timeFrame: Week 6
measure: Sedentary Behavior
timeFrame: Average over 6 weeks (measured daily)
measure: Leptin
timeFrame: 6 weeks
measure: Glucagon-like Peptide 1
timeFrame: 6 weeks
measure: Orexin
timeFrame: 6 weeks
measure: Neuropeptide Y
timeFrame: 6 weeks
Other outcomes:
measure: NIH Toolbox®
timeFrame: Week 6 (endpoint)
measure: Neuro-behavioral Measures
timeFrame: Week 6 (endpoint)
measure: Immune Function
timeFrame: Week 5 (endpoint)
measure: Immune Markers
timeFrame: Week 5 (endpoint)
measure: Distance Walked
timeFrame: Week 5
Locations:
city: New York
country: United States
facility: New York Nutrition Obesity Research Center
state: New York
Study officials:
affiliation: Columbia University
name: Marie-Pierre St-Onge, PhD
role: PRINCIPAL_INVESTIGATOR
References:
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citation: 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.
citation: 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.
citation: 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.
citation: 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.
citation: 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.
citation: 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.
citation: 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.
citation: 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.
citation: 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.
citation: 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.
citation: 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.
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