Short-term sleep laboratory studies with cinolazepam in situational insomnia induced by traffic noise. 1987

B Saletu, and G Kindshofer, and P Anderer, and J Grünberger
Department of Psychiatry, School of Medicine, University of Vienna, Austria.

In a double-blind, placebo-controlled sleep-laboratory study the short-term effects of cinolazepam--a recently introduced 1,4 benzodiazepine with a half-life of 9 h--on the all-night sleep, morning awakening and early morning behaviour were investigated in 20 young normal subjects, whose sleep was experimentally disturbed by nocturnal traffic noise. The latter was prerecorded on tape and reproduced by loud speakers throughout the night with a sound pressure level of 68-90 dB(A) (energy equivalent mean noise level LAeq: 79dB(A)). According to the parallel group design subjects received either a placebo or 40 mg cinolazepam. Specifically, they spent nine nights in the sleep laboratory: two adaptation nights, one baseline night on placebo, three drug or placebo nights, and three post-drug/placebo nights under traffic noise. Somnopolygraphic investigations were carried out between 22h30 and 06h00. The drug was given orally half an hour before bedtime. Each 30 sec epoch was scored according to the criteria of Rechtschaffen and Kales. In the morning the subjects were awakened by 1000 Hz tones which were increased in loudness in 10 dB steps in two minute intervals. A sleep self-rating scale for sleep and awakening quality was completed half an hour after the morning toilet. Thereafter noopsychic and thymopsychic variables were evaluated utilizing a psychometric test battery. Statistical analyses of objective sleep variables demonstrated a significant improvement of sleep maintenance after 40 mg cinolazepam as reflected by an increase of sleep efficiency, decrease of wake time (during total sleep period) and number of awakenings as compared with the placebo. Sleep architecture was only affected slightly: sleep stage S1 decreased, S2 increased, while S3, S4 and SREM (S rapid eye movement) remained unchanged. Subjective sleep quality improved significantly as well. In the mornings there were no hangover signs, neither in subjective nor in objective psychometric and psychophysiological variables. Finally, the study suggests that man can adapt subjectively to nocturnal traffic noise over one week, although the improvement of objective sleep variables over time did not reach the level of statistical significance.

UI MeSH Term Description Entries
D007319 Sleep Initiation and Maintenance Disorders Disorders characterized by impairment of the ability to initiate or maintain sleep. This may occur as a primary disorder or in association with another medical or psychiatric condition. Disorders of Initiating and Maintaining Sleep,Insomnia,Sleeplessness,Chronic Insomnia,DIMS (Disorders of Initiating and Maintaining Sleep),Early Awakening,Insomnia Disorder,Nonorganic Insomnia,Primary Insomnia,Psychophysiological Insomnia,Rebound Insomnia,Secondary Insomnia,Sleep Initiation Dysfunction,Transient Insomnia,Awakening, Early,Dysfunction, Sleep Initiation,Dysfunctions, Sleep Initiation,Insomnia Disorders,Insomnia, Chronic,Insomnia, Nonorganic,Insomnia, Primary,Insomnia, Psychophysiological,Insomnia, Rebound,Insomnia, Secondary,Insomnia, Transient,Insomnias,Sleep Initiation Dysfunctions
D008297 Male Males
D009622 Noise Any sound which is unwanted or interferes with HEARING other sounds. Noise Pollution,Noises,Pollution, Noise
D009624 Noise, Transportation Noise associated with transportation, particularly aircraft and automobiles. Noises, Transportation,Transportation Noise,Transportation Noises
D002986 Clinical Trials as Topic Works about pre-planned studies of the safety, efficacy, or optimum dosage schedule (if appropriate) of one or more diagnostic, therapeutic, or prophylactic drugs, devices, or techniques selected according to predetermined criteria of eligibility and observed for predefined evidence of favorable and unfavorable effects. This concept includes clinical trials conducted both in the U.S. and in other countries. Clinical Trial as Topic
D004311 Double-Blind Method A method of studying a drug or procedure in which both the subjects and investigators are kept unaware of who is actually getting which specific treatment. Double-Masked Study,Double-Blind Study,Double-Masked Method,Double Blind Method,Double Blind Study,Double Masked Method,Double Masked Study,Double-Blind Methods,Double-Blind Studies,Double-Masked Methods,Double-Masked Studies,Method, Double-Blind,Method, Double-Masked,Methods, Double-Blind,Methods, Double-Masked,Studies, Double-Blind,Studies, Double-Masked,Study, Double-Blind,Study, Double-Masked
D005260 Female Females
D006801 Humans Members of the species Homo sapiens. Homo sapiens,Man (Taxonomy),Human,Man, Modern,Modern Man
D000328 Adult A person having attained full growth or maturity. Adults are of 19 through 44 years of age. For a person between 19 and 24 years of age, YOUNG ADULT is available. Adults
D001569 Benzodiazepines A group of two-ring heterocyclic compounds consisting of a benzene ring fused to a diazepine ring. Benzodiazepine,Benzodiazepine Compounds

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