Clinical Trials Logo

Clinical Trial Details — Status: Completed

Administrative data

NCT number NCT02960776
Other study ID # AAAQ7746
Secondary ID 1R01HL128226-01A
Status Completed
Phase N/A
First received
Last updated
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
Health authority
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

Study Design


Related Conditions & MeSH terms


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 allClick 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
See also
  Status Clinical Trial Phase
Recruiting NCT04101669 - EndoBarrier System Pivotal Trial(Rev E v2) N/A
Recruiting NCT04243317 - Feasibility of a Sleep Improvement Intervention for Weight Loss and Its Maintenance in Sleep Impaired Obese Adults N/A
Terminated NCT03772886 - Reducing Cesarean Delivery Rate in Obese Patients Using the Peanut Ball N/A
Completed NCT03640442 - Modified Ramped Position for Intubation of Obese Females. N/A
Completed NCT04506996 - Monday-Focused Tailored Rapid Interactive Mobile Messaging for Weight Management 2 N/A
Recruiting NCT06019832 - Analysis of Stem and Non-Stem Tibial Component N/A
Active, not recruiting NCT05891834 - Study of INV-202 in Patients With Obesity and Metabolic Syndrome Phase 2
Active, not recruiting NCT05275959 - Beijing (Peking)---Myopia and Obesity Comorbidity Intervention (BMOCI) N/A
Recruiting NCT04575194 - Study of the Cardiometabolic Effects of Obesity Pharmacotherapy Phase 4
Completed NCT04513769 - Nutritious Eating With Soul at Rare Variety Cafe N/A
Withdrawn NCT03042897 - Exercise and Diet Intervention in Promoting Weight Loss in Obese Patients With Stage I Endometrial Cancer N/A
Completed NCT03644524 - Heat Therapy and Cardiometabolic Health in Obese Women N/A
Recruiting NCT05917873 - Metabolic Effects of Four-week Lactate-ketone Ester Supplementation N/A
Active, not recruiting NCT04353258 - Research Intervention to Support Healthy Eating and Exercise N/A
Completed NCT04507867 - Effect of a NSS to Reduce Complications in Patients With Covid-19 and Comorbidities in Stage III N/A
Recruiting NCT03227575 - Effects of Brisk Walking and Regular Intensity Exercise Interventions on Glycemic Control N/A
Completed NCT01870947 - Assisted Exercise in Obese Endometrial Cancer Patients N/A
Recruiting NCT06007404 - Understanding Metabolism and Inflammation Risks for Diabetes in Adolescents
Recruiting NCT05972564 - The Effect of SGLT2 Inhibition on Adipose Inflammation and Endothelial Function Phase 1/Phase 2
Recruiting NCT05371496 - Cardiac and Metabolic Effects of Semaglutide in Heart Failure With Preserved Ejection Fraction Phase 2