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Study Title and Description

Insomnia, metabolic rate and sleep restoration.



Key Questions Addressed
1 For [population], is caffeine intake above [exposure dose], compared to intakes [exposure dose] or less, associated with adverse effects on behavior*?
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Primary Publication Information
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TitleData
Title Insomnia, metabolic rate and sleep restoration.
Author MH Bonnet,DL Arand,
Country
Year 2003
Numbers

Secondary Publication Information
There are currently no secondary publications defined for this study.


Extraction Form: Behavior - Design Details - INCLUDED Studies
Arms
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Design Details
Question... Follow Up Answer Follow-up Answer
Refid 12823640
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What outcome is being evaluated in this paper? Behavior
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What is the objective of the study (as reported by the authors)? We hypothesized that administration of caffeine at a rate of 400 mg three times per day (TID) to normal young adults with a history of moderate caffeine use would produce significant physiological activation. Treatment at this dose level for a week might allow for the development of symptoms similar to those seen in insomnia patients.
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Provide a general description of the methods as reported by the authors. Information should be extracted based on relevance to the SR (i.e., caffeine related methods) Twelve healthy 18–30-year-old male subjects, weighing between 140 and 200 pounds and without significant history of sleeping problems, shift work, or frequent naps [18] were included in the study. Potential subjects using more than 250 mg of caffeine equivalent per day were excluded. Subjects participating in this study had two baseline nights (with placebo administration) followed by 7 days of caffeine TID administration followed by two withdrawal nights (with placebo administration). In the morning, all subjects followed the same schedule of alternating MSLTs, metabolic observations, performance test blocks, meals and breaks during each day. All subjects received pills at morning awakening, 8 h later, and 15 h later (the times were approximately 08:00, 16:00 and 23:00 hours)
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How many outcome-specific endpoints are evaluated? 6
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What is the (or one of the) endpoint(s) evaluated? (Each endpoint listed separately) Sleep
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List additional health endpoints (separately). Anger
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List additional health endpoints (separately) Confusion
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Notes Sleep includes total sleep time, sleep latency, and sleep stages). Vigour was also assessed on the POMS.
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Clinical
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Physiological Physiological
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Other
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What is the study design? Controlled Trial
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Randomized or Non-Randomized? NCT
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What were the diagnostics or methods used to measure the outcome? Both
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Optional: Name of Method or short description Profile of Mood States used to measure all outcomes except sleep which was not specified but presumed to be measured using a polysomnogram.
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Caffeine (general) Caffeine (general)
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Coffee
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Chocolate
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Energy drinks
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Gum
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Medicine/Supplement
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Soda
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Tea
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Measured Measured
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Self-report
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Children
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Adolescents
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Adults Adults
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Pregnant Women
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What was the reference, comparison, or control group(s)? (e.g. high vs low consumption, number of cups, etc.) baseline (placebo, 0 mg caffeine) vs 1200 mg/day caffine; and their results post-experiment receiving placebo (withdrawal)
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What were the listed confounders or modifying factors as stated by the authors? (e.g. multi-variable components of models.  Copy from methods) N/A
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Provide a general description of results (as reported by the authors). The 12 subjects selected for this study were 20.6 ± 1.5 years of age, 170 ± 23 pounds, and consumed 86 ± 74 mg of caffeine per day prior to entry into the study. Significant group differences indicative of poor sleep were seen during caffeine administration. As expected, acute caffeine administration resulted in decreased total sleep time and increased sleep latency. Additionally, stage 2 and stage 4 sleep were significantly reduced whilst awakenings and brief arousals were increased. On the final caffeine administration night, the degree of sleep disturbance was decreased compared to the acute caffeine condition, but stage 4 sleep was still significantly reduced in comparison with baseline, and brief arousals were still significantly elevated. With an average sleep latency of 28 min and sleep efficiency below 90%, these young adults could still receive a tentative diagnosis of insomnia. The entire MMPI was administered before caffeine use and at the end of the caffeine administration. All the MMPI values remained characteristic of young adults, but there was movement towards increased pathology on all the clinical scales except MF, and the change was statistically significant for the psychasthenia (PT) (anxiety) scale. Data from the Profile of Mood States (POMS) suggested increasing dysphoria as caffeine administration progressed (see Table 4). Significant main effects for Condition were found for all six POMS scales. For the scales Vigour and Tension (anxiety) initial caffeine administration resulted in an immediate significant increase followed by a decrease as caffeine administration continued (significant for Vigour). Fatigue was significantly increased at the end of caffeine administration compared with placebo.
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Did the authors perform a dose-response analysis (or trend/related analysis)? No
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What were the authors's observations re: trend analysis?
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What were the author's conclusions? Subjects given caffeine had significant changes in the direction of chronic insomnia patients on MSLT, metabolic rate, negative moods and personality.
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What were the sources of funding? Supported by a Merit Review Grant from the Department of Veterans Affairs and the Sleep–Wake Disorders Research Institute
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What conflicts of interest were reported? No conflict of interest was declared.
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Does the exposure (dose) need to be standardized to the SR? No
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Provide calculations/conversions for the exposure based on the decision tree in the guide (for all endpoints/exposure levels of interest).
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List all the endpoint(s) followed by the dose (mg) which will be used in comparison to Nawrot.  Characterize value as LOAEL/NOAEL, etc. if possible.  Sleep - LOAEL = 1200 mg/day (decreased total sleep time and increased sleep latency and brief arousals during sleep) Fatigue - LOAEL = 1200 mg/day Tension-Anxiety - LOAEL = 1200 mg/day Depression - NOAEL = 1200 mg/day Anger - LOAEL = 1200 mg/day Confusion - NOAEL = 1200 mg/day
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Notes regarding selection/listing of endpoints and exposures/doses to be compared to Nawrot. single daily dose Subjects were given 400 mg caffeine three times a day for one week. Acute caffeine administration decreased total sleep time and increased sleep latency and brief arousals during sleep. Caffeine significantly affected all mood measures on the POMS. Anxiety increased in the early days of the protocol whereas fatigue increased towards the end. Depression and confusion was only significant during the withdrawal phase.
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What is the importance of the study with respect to the adverseness of the outcome? Critcal
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