Effects of Sleep Deprivation on Blood Glucose, Food Cravings, and Affect in a Non-Diabetic: An N-of-1 Randomized Pilot Study
1.2. N-of-1 Design
1.3. Sleep Deprivation, Glucose, Cravings, and Affect
2. Materials and Methods
2.1. A Priori Hypotheses
2.2. Study Design
- Blood glucose (BG) level, a continuous variable, was measured in units of mg/dL every 15 min on average (SD = 8.6 s; median = 13.59 min, IQR = 19 s) using a continuous glucose monitoring (CGM) device.
- Craving was defined as an intense desire to consume a particular food or food type that is difficult to resist. The participant was asked whether they felt a craving for a particular food and would answer “yes” or “no”; if they had just eaten, they were to answer the question for craving felt before they ate.
- Participant affect was assessed using the Positive and Negative Affect Scale (PANAS) , a list of 20 feeling/emotion words that the participant rated on a 5-point scale (i.e., not at all, a little, moderately, quite a bit, extremely). Cravings were scheduled to be measured at the start (as a morning participant-initiated “pull” around 08:00 or as soon as the participant woke up), middle (midday until around 15:00), and end (evening around 20:00) of each 24-h study day. Affect was scheduled to be measured at the start and end of each 24-h study day.
- Sleep deprivation was defined as getting at most four hours of sleep in one night.
- Active treatment was defined as sleep deprivation on the first night preceding a three-day period, followed by a two-night sub-period for recovery to “wash out” the effects of sleep deprivation (i.e., the “washout sub-period”).
- Baseline treatment was defined as getting at least six hours of sleep per night on all three nights of a period, with the last two nights mimicking an active-treatment washout sub-period. The latter pseudo washout sub-periods were included to try to avoid any effects of assigning irregular treatment periods (e.g., stress over uncertainty in personal scheduling).
- Active-treatment periods were designated as treatment level “A”, while baseline-treatment periods were designated as “B”. We were interested in treatment effects during the first day of each period, defined as the sleep-deprivation effects during the 24-h day immediately following a night of sleep deprivation starting at 06:00. We called this first day the “effect sub-period”.
- Recovery was defined as getting at least 14 h of accumulated sleep during the washout sub-period, with at least six hours on one of the nights, in order to fully recover from sleep deprivation (i.e., for outcomes to return to average baseline levels). To try to minimize the effect of unassigned sleep deprivation carrying over into a subsequent period, it was important to enforce at least six hours of sleep per night on the recovery nights. For example, suppose we only require 14 h of total sleep during both recovery nights. If a participant split their recovery sub-period as 10 h the first night and 4 h the next, they would have been sleep deprived on the second washout night. We allowed for it to take at least two nights of at least six hours of sleep each to recover from sleep deprivation. Hence, this non-randomized night of sleep deprivation might affect the outcome during day 1 of the following period, thereby worsening the observed day-1 effects in that period.
2.3. Sleep Duration and Deprivation Monitored with Fitbit
2.4. Randomization Plan and Study Period
2.5. Statistical Analysis Plan
Conflicts of Interest
- Crawford, K.; Lingel, J.; Karppi, T. Our metrics, ourselves: A hundred years of self-tracking from the weight scale to the wrist wearable device. Eur. J. Cult. Stud. 2015, 18, 479–496. [Google Scholar] [CrossRef]
- Daza, E.J. Causal Analysis of Self-tracked Time Series Data Using a Counterfactual Framework for N-of-1 Trials. Methods Inf. Med. 2018, 57, e10–e21. [Google Scholar] [CrossRef] [PubMed][Green Version]
- Daza, E.J. Person as Population: A Longitudinal View of Single-Subject Causal Inference for Analyzing Self-Tracked Health Data. arXiv 2019, arXiv:1901.03423. [Google Scholar]
- Margolis, A.; Giuliano, C. Making the switch: From case studies to N-of-1 trials. Epilepsy Behav. Rep. 2019, 12, 100336. [Google Scholar] [CrossRef]
- Nikles, J.; Mitchell, G. (Eds.) The Essential Guide to N-of-1 Trials in Health; Springer: New York, NY, USA, 2015. [Google Scholar]
- Duan, N.; Kravitz, R.L.; Schmid, C.H. Single-patient (n-of-1) trials: A pragmatic clinical decision methodology for patient-centered comparative effectiveness research. J. Clin. Epidemiol. 2013, 66, S21–S28. [Google Scholar] [CrossRef][Green Version]
- Depner, C.M.; Stothard, E.R.; Wright, K.P. Metabolic Consequences of Sleep and Circadian Disorders. Curr. Diabetes Rep. 2014, 14, 507. [Google Scholar] [CrossRef]
- Guyatt, G.H. The n-of-1 Randomized Controlled Trial: Clinical Usefulness: Our Three-Year Experience. Ann. Intern. Med. 1990, 112, 293. [Google Scholar] [CrossRef]
- Guyatt, G.; Sackett, D.; Taylor, D.W.; Chong, J.; Roberts, R.; Pugsley, S. Determining optimal therapy--randomized trials in individual patients. N. Engl. J. Med. 1986, 314, 889–892. [Google Scholar] [CrossRef]
- Lillie, E.O.; Patay, B.; Diamant, J.; Issell, B.; Topol, E.J.; Schork, N.J. The n-of-1 clinical trial: The ultimate strategy for individualizing medicine? Pers. Med. 2011, 8, 161–173. [Google Scholar] [CrossRef][Green Version]
- Chen, C.; Haddad, D.; Selsky, J.; Hoffman, J.E.; Kravitz, R.L.; Estrin, D.E.; Sim, I. Making sense of mobile health data: An open architecture to improve individual- and population-level health. J. Med. Internet Res. 2012, 14, e112. [Google Scholar] [CrossRef]
- Vohra, S.; Shamseer, L.; Sampson, M.; Bukutu, C.; Schmid, C.H.; Tate, R.; Nikles, J.; Zucker, D.R.; Kravitz, R.; Guyatt, G.; et al. CONSORT extension for reporting N-of-1 trials (CENT) 2015 Statement. BMJ 2015, 350, h1738. [Google Scholar] [CrossRef] [PubMed][Green Version]
- Kravitz, R.; Duan, N.; Eslick, I.; Gabler, N.B.; Kaplan, H.C. Design and Implementation of N-of-1 Trials: A User’s Guide; Agency for Healthcare Research and Quality, US Department of Health and Human Services: Rockville, MD, USA, 2014.
- Carskadon, M.A.; Dement, W.C. Normal human sleep: An overview. Princ. Pract. Sleep Med. 2005, 4, 13–23. [Google Scholar]
- Watson, N.F.; Badr, M.S.; Belenky, G.; Bliwise, D.L.; Buxton, O.M.; Buysse, D.; Dinges, D.F.; Gangwisch, J.; Grandner, M.A.; Kushida, C.; et al. Recommended Amount of Sleep for a Healthy Adult: A Joint Consensus Statement of the American Academy of Sleep Medicine and Sleep Research Society. Sleep 2015, 38, 843–844. [Google Scholar] [PubMed]
- Spiegel, K.; Tasali, E.; Leproult, R.; Van Cauter, E. Effects of poor and short sleep on glucose metabolism and obesity risk. Nat. Rev. Endocrinol. 2009, 5, 253–261. [Google Scholar] [CrossRef]
- Schmid, S.M.; Hallschmid, M.; Schultes, B. The metabolic burden of sleep loss. Lancet Diabetes Endocrinol. 2015, 3, 52–62. [Google Scholar] [CrossRef]
- Donga, E.; van Dijk, M.; van Dijk, J.G.; Biermasz, N.R.; Lammers, G.-J.; van Kralingen, K.W.; Corssmit, E.P.M.; Romijn, J.A. A single night of partial sleep deprivation induces insulin resistance in multiple metabolic pathways in healthy subjects. J. Clin. Endocrinol. Metab. 2010, 95, 2963–2968. [Google Scholar] [CrossRef][Green Version]
- Nedeltcheva, A.V.; Kessler, L.; Imperial, J.; Penev, P.D. Exposure to Recurrent Sleep Restriction in the Setting of High Caloric Intake and Physical Inactivity Results in Increased Insulin Resistance and Reduced Glucose Tolerance. J. Clin. Endocrinol. Metab. 2009, 94, 3242–3250. [Google Scholar] [CrossRef][Green Version]
- Buxton, O.M.; Pavlova, M.; Reid, E.W.; Wang, W.; Simonson, D.C.; Adler, G.K. Sleep Restriction for 1 Week Reduces Insulin Sensitivity in Healthy Men. Diabetes 2010, 59, 2126–2133. [Google Scholar] [CrossRef][Green Version]
- Morselli, L.; Leproult, R.; Balbo, M.; Spiegel, K. Role of sleep duration in the regulation of glucose metabolism and appetite. Best Pract. Res. Clin. Endocrinol. Metab. 2010, 24, 687–702. [Google Scholar] [CrossRef][Green Version]
- Spaeth, A.M.; Dinges, D.F.; Goel, N. Effects of Experimental Sleep Restriction on Weight Gain, Caloric Intake, and Meal Timing in Healthy Adults. Sleep 2013, 36, 981–990. [Google Scholar] [CrossRef]
- Markwald, R.R.; Melanson, E.L.; Smith, M.R.; Higgins, J.; Perreault, L.; Eckel, R.H.; Wright, K.P. Impact of insufficient sleep on total daily energy expenditure, food intake, and weight gain. Proc. Natl. Acad. Sci. USA 2013, 110, 5695–5700. [Google Scholar] [CrossRef] [PubMed][Green Version]
- Baglioni, C.; Spiegelhalder, K.; Lombardo, C.; Riemann, D. Sleep and emotions: A focus on insomnia. Sleep Med. Rev. 2010, 14, 227–238. [Google Scholar] [CrossRef] [PubMed]
- Kahn-Greene, E.T.; Killgore, D.B.; Kamimori, G.H.; Balkin, T.J.; Killgore, W.D.S. The effects of sleep deprivation on symptoms of psychopathology in healthy adults. Sleep Med. 2007, 8, 215–221. [Google Scholar] [CrossRef] [PubMed]
- Sagaspe, P.; Sanchez-Ortuno, M.; Charles, A.; Taillard, J.; Valtat, C.; Bioulac, B.; Philip, P. Effects of sleep deprivation on Color-Word, Emotional, and Specific Stroop interference and on self-reported anxiety. Brain Cogn. 2006, 60, 76–87. [Google Scholar] [CrossRef] [PubMed]
- Physicians for Human Rights; Hashemian, F. Broken Laws, Broken Lives: Medical Evidence of Torture by US Personnel and Its Impact: A Report; Physicians for Human Rights: Boston, MA, USA, 2008. [Google Scholar]
- Franzen, P.L.; Siegle, G.J.; Buysse, D.J. Relationships between affect, vigilance, and sleepiness following sleep deprivation. J. Sleep Res. 2008, 17, 34–41. [Google Scholar] [CrossRef][Green Version]
- Watson, D.; Clark, L.A.; Tellegen, A. Development and validation of brief measures of positive and negative affect: The PANAS scales. J. Personal. Soc. Psychol. 1988, 54, 1063–1070. [Google Scholar] [CrossRef]
- De Zambotti, M.; Goldstone, A.; Claudatos, S.; Colrain, I.M.; Baker, F.C. A validation study of Fitbit Charge 2TM compared with polysomnography in adults. Chronobiol. Int. 2018, 35, 465–476. [Google Scholar] [CrossRef]
- Pengo, M.F.; Won, C.H.; Bourjeily, G. Sleep in Women across the Life Span. Chest 2018, 154, 196–206. [Google Scholar] [CrossRef]
- Reen, E.V.; Kiesner, J. Individual differences in self-reported difficulty sleeping across the menstrual cycle. Arch. Womens Ment. Health 2016, 19, 599–608. [Google Scholar] [CrossRef]
- Little, R.J.A.; Rubin, D.B. Statistical Analysis with Missing Data; John Wiley & Sons, Inc.: Hoboken, NJ, USA, 1986; ISBN 978-0-471-80254-9. [Google Scholar]
- Rubin, D.B. Inference and Missing Data. Biometrika 1976, 63, 581–592. [Google Scholar] [CrossRef]
© 2019 by the authors. Licensee MDPI, Basel, Switzerland. This article is an open access article distributed under the terms and conditions of the Creative Commons Attribution (CC BY) license (http://creativecommons.org/licenses/by/4.0/).
Daza, E.J.; Wac, K.; Oppezzo, M. Effects of Sleep Deprivation on Blood Glucose, Food Cravings, and Affect in a Non-Diabetic: An N-of-1 Randomized Pilot Study. Healthcare 2020, 8, 6. https://doi.org/10.3390/healthcare8010006
Daza EJ, Wac K, Oppezzo M. Effects of Sleep Deprivation on Blood Glucose, Food Cravings, and Affect in a Non-Diabetic: An N-of-1 Randomized Pilot Study. Healthcare. 2020; 8(1):6. https://doi.org/10.3390/healthcare8010006Chicago/Turabian Style
Daza, Eric Jay, Katarzyna Wac, and Marily Oppezzo. 2020. "Effects of Sleep Deprivation on Blood Glucose, Food Cravings, and Affect in a Non-Diabetic: An N-of-1 Randomized Pilot Study" Healthcare 8, no. 1: 6. https://doi.org/10.3390/healthcare8010006