Impact of Sleep Restriction on Performance in Adults

Obesity Clinical Trial

Official title:

Effect of Long Term Sleep Restriction on Energy Balance

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT02960776
• Other study ID #: AAAQ7746
• Secondary ID: 1R01HL128226-01A
• Status: Completed
• Phase: N/A
• Start date: November 1, 2016
• Est. completion date: December 14, 2022

Study information

• Verified date: March 2024
• Source: Columbia University
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial 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.

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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 45
• Est. completion date: December 14, 2022
• Est. primary completion date: December 14, 2022
• Accepts healthy volunteers: Accepts Healthy Volunteers
• Gender: All
• Age group: 20 Years to 75 Years

Eligibility

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

Related Conditions & MeSH terms

• Obesity
• Sleep
• Sleep Restriction

Intervention

Behavioral:
• 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.

Locations

Country	Name	City	State
United States	New York Nutrition Obesity Research Center	New York	New York

Sponsors (3)

Lead Sponsor	Collaborator
Columbia University	National Heart, Lung, and Blood Institute (NHLBI), NYU Langone Health

Country where clinical trial is conducted

United States, 

References & Publications (13)

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 — View 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 — View 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. — View 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 2 — View 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. — View 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 2 — View Citation

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. — View 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. — View Citation

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. — View 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. — View 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 — View 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 Jan 16:S2352-7218(23)00293-0. doi: 10.1016/j.sleh.2023.11.011. O — View 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. — View Citation

* Note: There are 13 references in all — Click here to view all references

Outcome

Type	Measure	Description	Time frame	Safety issue
Other	NIH Toolbox® for Assessment of Neurological and Behavioral Function (NIH Toolbox)	Measure cognitive, emotional, sensory, and motor functions, raw scores	Baseline, Week 6 (endpoint)
Other	Neuro-behavioral measures	ModRey memory task	Baseline, Week 6 (endpoint)
Other	Immune function	T-cell stimulation	Baseline, Week 6 (endpoint)
Other	Immune markers	White blood cell populations	Baseline, Week 6 (endpoint)
Other	Activity	6-minute walk test	Week 5
Primary	Change in Fat Mass	Body composition (specifically fat mass) will be measured by MRI at baseline and endpoint.	Baseline, Week 6 (endpoint)
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.	Weeks 5 and 6 (endpoint)
Secondary	Physical activity	Time spent in sedentary, light, moderate, and moderate-to-vigoroud physical activity.	6 weeks (measured daily)
Secondary	Appetite-regulating hormones	Ghrelin, leptin, glucagon-like peptide 1, orexin, NPY	Baseline, Week 6 (endpoint)
Secondary	Neuronal activity	Neuronal activity at rest and in response to food stimuli	Week 6