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The International Pharmaco-EEG Society (IPEG) presents guidelines summarising the requirements for the recording and computerised evaluation of pharmaco-sleep data in man. Over the past years, technical and data-processing methods have advanced steadily, thus enhancing data quality and expanding the palette of sleep assessment tools that can be used to investigate the activity of drugs on the central nervous system (CNS), determine the time course of effects and pharmacodynamic properties of novel therapeutics, hence enabling the study of the pharmacokinetic/pharmacodynamic relationship, and evaluate the CNS penetration or toxicity of compounds. However, despite the presence of robust guidelines on the scoring of polysomnography -recordings, a review of the literature reveals inconsistent -aspects in the operating procedures from one study to another. While this fact does not invalidate results, the lack of standardisation constitutes a regrettable shortcoming, especially in the context of drug development programmes. The present guidelines are intended to assist investigators, who are using pharmaco-sleep measures in clinical research, in an effort to provide clear and concise recommendations and thereby to standardise methodology and facilitate comparability of data across laboratories., (Copyright © 2013 S. Karger AG, Basel.)

Background: In 2007, the AASM Manual for the Scoring of Sleep and Associated Events was published by the American Academy of Sleep Medicine (AASM). Concerning the visual classification of sleep stages, these new rules are intended to replace the rules by Rechtschaffen and Kales (R&K)., Methods: We adapted the automatic R&K sleep scoring system Somnolyzer 24 × 7 to comply with the AASM rules and subsequently performed a validation study based on 72 polysomnographies from the Siesta database (56 healthy subjects, 16 patients, 38 females, 34 males, aged 21-86 years). Scorings according to the AASM rules were performed manually by experienced sleep scorers and semi-automatically by the AASM version of the Somnolyzer. Manual scorings and Somnolyzer reviews were performed independently by at least 2 out of 8 experts from 4 sleep centers., Results: In the quality control process, sleep experts corrected 4.8 and 3.7% of the automatically assigned epochs, resulting in a reliability between 2 Somnolyzer-assisted scorings of 99% (Cohen's kappa: 0.99). In contrast, the reliability between the 2 manual scorings was 82% (kappa: 0.76). The agreement between the 2 Somnolyzer-assisted and the 2 visual scorings was between 81% (kappa: 0.75) and 82% (kappa: 0.76)., Conclusion: The AASM version of the Somnolyzer revealed an agreement between semi-automated and human expert scoring comparable to that published for the R&K version with a validity comparable to that of human experts, but with a reliability close to 1, thereby reducing interrater variability as well as scoring time to a minimum., (Copyright © 2010 S. Karger AG, Basel.)

Interrater variability of sleep stage scorings has an essential impact not only on the reading of polysomnographic sleep studies (PSGs) for clinical trials but also on the evaluation of patients' sleep. With the introduction of a new standard for sleep stage scorings (AASM standard) there is a need for studies on interrater reliability (IRR). The SIESTA database resulting from an EU-funded project provides a large number of studies (n = 72; 56 healthy controls and 16 subjects with different sleep disorders, mean age +/- SD: 57.7 +/- 18.7, 34 females) for which scorings according to both standards (AASM and R&K) were done. Differences in IRR were analysed at two levels: (1) based on quantitative sleep parameter by means of intraclass correlations; and (2) based on an epoch-by-epoch comparison by means of Cohen's kappa and Fleiss' kappa. The overall agreement was for the AASM standard 82.0% (Cohen's kappa = 0.76) and for the R&K standard 80.6% (Cohen's kappa = 0.68). Agreements increased from R&K to AASM for all sleep stages, except N2. The results of this study underline that the modification of the scoring rules improve IRR as a result of the integration of occipital, central and frontal leads on the one hand, but decline IRR on the other hand specifically for N2, due to the new rule that cortical arousals with or without concurrent increase in submental electromyogram are critical events for the end of N2.

Study Objective: To investigate differences between visual sleep scoring according to the classification developed by Rechtschaffen and Kales (R&K, 1968) and scoring based on the new guidelines of the American Academy of Sleep Medicine (AASM, 2007)., Design: All-night polysomnographic recordings were scored visually according to the R&K and AASM rules by experienced sleep scorers. Descriptive data analysis was used to compare the resulting sleep parameters., Participants: Healthy subjects and patients (38 females and 34 males) aged between 21 and 86 years., Interventions: N/A., Measurement and Results: While sleep latency and REM latency, total sleep time, and sleep efficiency were not affected by the classification standard, the time (in minutes and in percent of total sleep time) spent in sleep stage 1 (S1/N1), stage 2 (S2/N2) and slow wave sleep (S3+S4/N3) differed significantly between the R&K and the AASM classification. While light and deep sleep increased (S1 vs. N1 [+10.6 min, (+2.8%)]: P<0.01; S3+S4 vs. N3 [+9.1 min (+2.4%)]: P<0.01), stage 2 sleep decreased significantly according to AASM rules (S2 vs. N2 [-20.5 min, (-4.9%)]: P<0.01). Moreover, wake after sleep onset was significantly prolonged by approximately 4 minutes (P<0.01) according to the AASM standard. Interestingly, the effects on stage REM were age-dependent (intercept at 20 years: -7.5 min; slope: 1.6 min for 10-year age increase). No effects of sex and diagnosis were observed., Conclusion: The study shows significant and age-dependent differences between sleep parameters derived from conventional visual sleep scorings on the basis of R&K rules and those based on the new AASM rules. Thus, new normative data have to be established for the AASM standard.

Background Studies on effects of radio frequency-electromagnetic fields (RF-EMF) on the macrostructure of sleep so far yielded inconsistent results. This study investigated whether possible effects of RF-EMF exposure differ between individuals. Objective In a double-blind, randomized, sham-controlled cross-over study possible effects of electromagnetic fields emitted by pulsed Global System for Mobile Communications (GSM) 900 and Wideband Code-Division Multiple Access (WCDMA)/Universal Mobile Telecommunications System (WCDMA/UMTS) devices on sleep were analysed. Methods Thirty healthy young men (range 18–30 years) were exposed three times per exposure condition while their sleep was recorded. Sleep was evaluated according to the American Academy of Sleep Medicine standard and eight basic sleep variables were considered. Results Data analyses at the individual level indicate that RF-EMF effects are observed in 90% of the individuals and that all sleep variables are affected in at least four subjects. While sleep of participants was affected in various numbers, combinations of sleep variables and in different directions, showing improvements but also deteriorations, the only consistent finding was an increase of stage R sleep under GSM 900 MHz exposure (9 of 30 subjects) as well as under WCDMA/UMTS exposure (10 of 30 subjects). Conclusions The results underline that sleep of individuals can be affected differently. The observations found here may indicate an underlying thermal mechanism of RF-EMF on human REM sleep. Nevertheless, the effect of an increase in stage R sleep in one third of the individuals does not necessarily indicate a disturbance of sleep. [ABSTRACT FROM AUTHOR]

Disrupted sleep is prevalent in both mood and thyroid disorders. Given the emerging use of thyroid hormones in the treatment of mood disorders, we investigated the effects of supraphysiological doses of levothyroxine (L-T4) on sleep. In an open-label design, 13 healthy subjects received up to 500 µg/day for an eight-week period. A baseline night was polysomnographically recorded (PSG) followed by PSG under the maximum tolerated dose of L-T4. All subjects developed hyperthyroxinemia. The heart rate and respiration rate increased significantly with treatment; a significant increase in body temperature was observed in men but not in women. Surprisingly, treatment with supraphysiological doses of L-T4 did not cause significant effects on sleep architecture. However, the increase in body movements and REM density was close to reaching statistical significance. Here, we report on the sleep data, thyroid hormone levels, and physiological parameters during sleep. We conclude that experimentally induced hyperthyroidism does not profoundly change the sleep structure in healthy individuals underlining the good tolerability of treatment with supraphysiological doses of L-T4 in patients with mood disorders. [ABSTRACT FROM AUTHOR]

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To date, the only standard for the classification of sleep-EEG recordings that has found worldwide acceptance are the rules published in 1968 by Rechtschaffen and Kales. Even though several attempts have been made to automate the classification process, so far no method has been published that has proven its validity in a study including a sufficiently large number of controls and patients of all adult age ranges. The present paper describes the development and optimization of an automatic classification system that is based on one central EEG channel, two EOG channels and one chin EMG channel. It adheres to the decision rules for visual scoring as closely as possible and includes a structured quality control procedure by a human expert. The final system (Somnolyzer 24 × 7™) consists of a raw data quality check, a feature extraction algorithm (density and intensity of sleep/wake-related patterns such as sleep spindles, delta waves, SEMs and REMs), a feature matrix plausibility check, a classifier designed as an expert system, a rule-based smoothing procedure for the start and the end of stages REM, and finally a statistical comparison to age- and sex-matched normal healthy controls (Siesta Spot Report™). The expert system considers different prior probabilities of stage changes depending on the preceding sleep stage, the occurrence of a movement arousal and the position of the epoch within the NREM/REM sleep cycles. Moreover, results obtained with and without using the chin EMG signal are combined. The Siesta polysomnographic database (590 recordings in both normal healthy subjects aged 20–95 years and patients suffering from organic or nonorganic sleep disorders) was split into two halves, which were randomly assigned to a training and a validation set, respectively. The final validation revealed an overall epoch-by-epoch agreement of 80% (Cohen’s kappa: 0.72) between the Somnolyzer 24 × 7 and the human expert scoring, as compared with an inter-rater reliability of 77% (Cohen’s kappa: 0.68) between two human experts scoring the same dataset. Two Somnolyzer 24 × 7 analyses (including a structured quality control by two human experts) revealed an inter-rater reliability close to 1 (Cohen’s kappa: 0.991), which confirmed that the variability induced by the quality control procedure, whereby approximately 1% of the epochs (in 9.5% of the recordings) are changed, can definitely be neglected. Thus, the validation study proved the high reliability and validity of the Somnolyzer 24 × 7 and demonstrated its applicability in clinical routine and sleep studies. Copyright © 2005 S. Karger AG, Basel [ABSTRACT FROM AUTHOR]

Presents a study which examined the inter-rater reliability of a computer-based visual sleep scoring system in a number of accredited sleep centers in Germany. Overview of the study population; Methodology; Results and discussion.

Background: The use of wireless telecommunication systems such as wireless fidelity (Wi-Fi)-enabled devices has steadily increased in recent years. There are persistent concerns that radiofrequency electromagnetic field (RF-EMF) exposure might affect health. Possible effects of RF-EMF exposure on human sleep were examined with regard to mobile phones and base stations, but not with regard to Wi-Fi exposure.Objectives: The present double-blind, sham-controlled, randomized, fully counterbalanced cross-over study addressed for the first time the question whether a whole night Wi-Fi exposure has an effect on sleep.Methods: Thirty-four healthy young male subjects (mean ± SD: 24.1 ± 2.9 years) spent five nights in the sleep laboratory. A screening and adaptation night was followed by two experimental nights. Each of the experimental nights was preceded by a baseline night. Sleep was evaluated at the subjective level by a questionnaire and at the objective level (macro- and microstructure) by polysomnography. Either 2.45 GHz Wi-Fi (max psSAR10g of 6.4 mW/kg) or sham signals were delivered by a newly developed head exposure facility.Results: Results showed no statistically significant acute effects of a whole-night Wi-Fi exposure on subjective sleep parameters as well as on parameters characterizing the macrostructure of sleep. Analyses of the microstructure of sleep revealed a reduction in global EEG power in the alpha frequency band (8.00-11.75 Hz) during NREM sleep under acute Wi-Fi exposure compared to sham.Discussion: The results of the present human experimental study are well in line with several other neurophysiological studies showing that acute RF-EMF exposure has no effect on the macrostructure of sleep. The slight physiological changes in EEG power observed under Wi-Fi exposure are neither reflected in the subjective assessment of sleep nor at the level of objective measurements. The present results are not indicative of a sleep disturbing effect of Wi-Fi exposure. [ABSTRACT FROM AUTHOR]

Results from human experimental studies investigating possible effects of radiofrequency electromagnetic fields (RF-EMF) on sleep are heterogeneous. So far, there is no study on possible sex-differences in RF-EMF effects. The present study aimed at analyzing differences in RF-EMF effects on the macrostructure of sleep between healthy elderly males and females. With a double-blind, randomized, sham-controlled cross-over design effects of two RF-EMF exposures (GSM900 and TETRA) on sleep were investigated in samples of 30 elderly healthy male and 30 healthy elderly female volunteers. Participants underwent each of the three exposure conditions on three occassions following an individually randomized order resulting in a total of nine study nights per participant. Exposure was delivered for 30 min prior to sleep and for the whole night (7.5 h) by a head worn antenna specifically designed for the projects. The peak spatial absorption rate averaged over time in head tissues (psSAR10g) was 6 W/kg for TETRA and 2 W/kg for GSM900. Thirty variables characterising the macrostructure of sleep and arousals as well as four subjective sleep variables were considered for statistical analyses. Multivariate analyses revealed that exposure to GSM900 and/or TETRA resulted in a significant reduction in arousals, a shorter latency to sleep stage N3, and a shorter self-reported time awake after sleep in both males and females. Exposure effects depending on sex (significant interactions) were observed. Latency to sleep stage R was shorter in females and tended to be longer in males under both exposures. Latency to stage N3 was shorter in females under TETRA exposure and almost not affected in males. The time awake within the sleep period under TETRA exposure was shorter in females and only slightly longer in males. Under GSM exposure, the self-rated total sleep time tended to be longer in females and to be shorter in males. Finally, the number of awakenings was lower only in females and tended to be higher in males under GSM exposure. With regard to RF-EMF effects on human sleep it seems that gender matters since GSM900 and TETRA led to significantly more exposure effects in females. Regardless of gender, none of the observed changes is indicative of a sleep disturbing effect of RF-EMF exposure. Observed effects might be mediated by skin related thermoregulatory mechanisms. • First paper to investigate gender specific RF-EMF effects in elderly subjects. • RF-EMF affects approximately 10% of the sleep variables directly. • RF-EMF affects approximately 12% of the sleep variables differently in men and women. • Women are more affected than men. • None of the observed effects is indicative of a disturbed sleep. [ABSTRACT FROM AUTHOR]