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Study Title and Description

Insomnia symptoms in older adults: associated factors and gender differences.



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 symptoms in older adults: associated factors and gender differences.
Author I Jaussent,Y Dauvilliers,ML Ancelin,JF Dartigues,B Tavernier,J Touchon,K Ritchie,A Besset,
Country
Year 2011
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 20808113
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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)? The aim of this study was to examine the factors associated with insomnia in community-dwelling elderly as a function of the nature and number of insomnia symptoms (IS), e.g., difficulty with initiating sleep (DIS), difficulty with maintaining sleep (DMS), and early morning awakening (EMA).
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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) Subjects were recruited as part of a multisite cohort study of community-dwelling persons aged 65 years and older, randomly selected from the electoral rolls of three French cities (Bordeaux, Dijon, and Montpellier) between 1999 and 2001 (3C Study). A total of 9,294 subjects, 3,650 men and 5,644 women were included in the study. Data were collected during a face-to-face interview using a standardized questionnaire by trained psychologists or nurses. Sleep complaints were assessed by a self-report questionnaire, which evaluates the frequency (never, rarely, regularly, or frequently) of 1) having difficulty initiating sleep (DIS), 2) waking up several times during the night (DMS), and 3) waking up too early in the morning without being able to fall asleep again (EMA). IS was defined as reporting regularly or frequently at least one symptom (DIS, DMS, or EMA). Other information related to sleep was also recorded including taking medication for sleep problems and duration of use (in years) or reporting regularly or frequently being excessively sleepy during the day, having nightmares, or snoring loudly. A life style questionnaire was used to obtain information on current smoking status, alcohol intake, and consumption of coffee and tea. Results were presented as odds ratios and their 95% confidence intervals (CIs). In the subgroup of subjects reporting only one IS (isolated IS), multivariate logistic regressions were used for each IS to model the relationship between IS and associated variables at p <0.10. Significance level was set at p <0.05. The statistical analysis was carried out using SAS software (version 9.1).
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How many outcome-specific endpoints are evaluated? 1
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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).
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List additional health endpoints (separately)
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Notes Insomniac symptoms are defined as reporting at least one of the following symptoms regularly or frequently difficulty in initiating sleep, difficulty in maintaining sleep, or early morning awakening. DMS and EMA endpoints are reported for women only.
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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? Cross-sectional
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Randomized or Non-Randomized?
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What were the diagnostics or methods used to measure the outcome? Subjective
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Optional: Name of Method or short description self-report questionnaire
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Caffeine (general)
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Coffee 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
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Self-report 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.) ≤2 cups/day vs >2 cups/day
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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) Men and women were found to differ on most exposure variables. To examine separate patterns of risk, gender-stratified analyses were undertaken. Univariate logistic regressions were used to determine differences in sociodemographic and clinical characteristics between men and women. Associations between the outcome variable, i.e., number of IS (0, 1, 2, or 3), and sociodemographic and clinical variables were tested using a multinomial logistic regression model adjusting for all significant associations between sociodemographic, clinical variables at the univariate level with a p <0.10.
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Provide a general description of results (as reported by the authors). For both sexes, marital status, coffee intake, or type of menopause for women was not significantly associated with IS (data not shown). In women only, coffee drinking and Mediterranean diet were marginally protective for DMS, and no variables were significantly associated with EMA.
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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? Complaints of IS are common in the elderly general population, with more than 70% of men and women in our study reporting IS with a significantly higher prevalence in women than in men. Women more frequently experience two or three symptoms, whereas men more frequently complain of only one symptom. As insomnia is frequently determined by a cutoff point on a scale, this could explain why the prevalence rates are often reported to be higher in women. Factors associated with IS are very similar for men and women, including sleep medication, nightmares, sleepiness, chronic disease, and depression. However, in women, we observed that life style factors (adherence to a Mediterranean diet and moderate coffee and/or alcohol intake) may have a protective effect, suggesting possible behavioral modulation. The protective effects of HRT use and of high BMI also suggest a specific female predisposition, which may involve hormonal factors. The results of this study suggest possible intervention strategies for improving sleep quality in elderly persons with insomnia through intervention at the level of specific symptoms.
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What were the sources of funding? The Fondation pour la Recherche Medicale funded the preparation and first phase of the study. The 3C Study is also supported by the Caisse Nationale Maladie des Travailleurs Salaries, Direction Generale de la Sante, MGEN, Institut de la Longevite, Agence Francaise de Securite Sanitaire des Produits de Sante, the Regional Governments of Aquitaine, Bourgogne and Languedoc-Roussillon, and the Fondation de France, the Ministry of Research-Inserm Programme "Cohorts and collection of biological material." The Lille Genopole received an unconditional grant from Eisai. Part of this project is supported by a grant from the Agence Nationale de la Recherche (ANR project 07 LVIE 004).
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What conflicts of interest were reported? Authors did not report COI
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Does the exposure (dose) need to be standardized to the SR? Yes
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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). ≥2 cups/d = 95 mg caffeine x 2 = 190
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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.  NOAEL (men) ≥ 190 mg/d NOAEL (women) ≥ 190 mg/d (frequency of waking up several times during the night, or waking up too early)
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Notes regarding selection/listing of endpoints and exposures/doses to be compared to Nawrot. Sleep endpoint includes analyses of frequency of waking up several times during the night and waking up early without being able to go back to sleep.
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What is the importance of the study with respect to the adverseness of the outcome? Important
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