title: How are normal sleeping controls selected? A systematic review of cross-sectional insomnia studies and a standardized method to select healthy controls for sleep research.
abstract: There appears to be some inconsistency in how normal sleepers (controls) are selected and screened for participation in research studies for comparison with insomnia patients. The purpose of the current study is to assess and compare methods of identifying normal sleepers in insomnia studies, with reference to published standards. We systematically reviewed the literature on insomnia patients, which included control subjects. The resulting 37 articles were systematically reviewed with reference to the five criteria for normal sleep specified by Edinger et al. In summary, these criteria are as follows: evidence of sleep disruption, sleep scheduling, general health, substance/medication use, and other sleep disorders. We found sleep diaries, polysomnography (PSG), and clinical screening examinations to be widely used with both control subjects and insomnia participants. However, there are differences between research groups in the precise definitions applied to the components of normal sleep. We found that none of the reviewed studies applied all of the Edinger et al. criteria, and 16% met four criteria. In general, screening is applied most rigorously at the level of a clinical disorder, whether physical, psychiatric, or sleep. While the Edinger et al. criteria seem to be applied in some form by most researchers, there is scope to improve standards and definitions in this area. Ideally, different methods such as sleep diaries and questionnaires would be used concurrently with objective measures to ensure normal sleepers are identified, and descriptive information for control subjects would be reported. Here, we have devised working criteria and methods to be used for the assessment of normal sleepers. This would help clarify the nature of the control group, in contrast to insomnia subjects and other patient groups.
authors.affiliation: School of Psychology, University of Glasgow, Glasgow, UK. Electronic address: l.beattie.1@research.gla.ac.uk.
authors.forename: Louise
authors.initials: L
authors.lastname: Beattie
authors.affiliation: Nuffield Department of Clinical Neurosciences/Sleep & Circadian Neuroscience Institute, University of Oxford, Oxford, UK.
authors.forename: Colin A
authors.initials: CA
authors.lastname: Espie
authors.affiliation: School of Psychological Sciences, University of Manchester, Manchester, UK.
authors.forename: Simon D
authors.initials: SD
authors.lastname: Kyle
authors.affiliation: School of Psychology, University of Glasgow, Glasgow, UK.
authors.forename: Stephany M
authors.initials: SM
authors.lastname: Biello
mesh_terms: D016022:Case-Control Studies; D035061:Control Groups; D006801:Humans; D008403:Mass Screening / Q000592:standards; D018579:Patient Selection; D012016:Reference Values; D007319:Sleep Initiation and Maintenance Disorders / Q000175:diagnosis / Q000453:epidemiology*
keywords: Assessment; Good sleep; Insomnia; Methods; Normal sleepers; Screening