Somno-Art Software identifies pathology-induced changes in sleep parameters similarly to polysomnography.

Polysomnographic sleep architecture parameters are commonly used to diagnose or evaluate treatment of sleep disorders. Polysomnography (PSG) having practical constraints, the development of wearable devices and algorithms to monitor and stage sleep is rising. Beside pure validation studies, it is necessary for a clinician to ensure that the conclusions drawn with a new generation wearable sleep scoring device are consistent to the ones of gold standard PSG, leading to similar interpretation and diagnosis.

Performance of Somno-Art Software compared to polysomnography interscorer variability: A multi-center study.

The visual scoring of gold standard polysomnography (PSG) is known to present inter- and intra-scorer variability. Previously, Somno-Art Software, a cardiac based sleep scoring algorithm, has been validated in comparison to 2 expert visual PSG scorers. The goal of this research is to evaluate the performances of the algorithm against a pool of scorers.

Validation of Somno-Art Software, a novel approach of sleep staging, compared with polysomnography in disturbed sleep profiles.

Study Objectives: Integrated analysis of heart rate (electrocardiogram [ECG]) and body movements (actimetry) during sleep in healthy subjects have previously been shown to generate similar evaluation of sleep architecture and continuity with Somno-Art Software compared to polysomnography (PSG), the gold standard. However, the performance of this new approach of sleep staging has not yet been evaluated on patients with disturbed sleep.

Methods: Sleep staging from 458 sleep recordings from multiple studies comprising healthy and patient population (obstructive sleep apnea [OSA], insomnia, major depressive disorder [MDD]) was obtained from PSG visual scoring using the American Academy of Sleep Medicine rules and from Somno-Art Software analysis on synchronized ECG and actimetry.

Guidelines for the recording and evaluation of pharmaco-sleep studies in man: the International Pharmaco-EEG Society (IPEG).

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.

A new sublingual formulation of zolpidem for the treatment of sleep-onset insomnia.

Insomnia is a very frequent complaint that periodically or permanently affects up to 60% of the general population. Valuable therapeutic options rely on pharmacological and nonpharmacological management of insomnia complaints. Zolpidem is one of the most popular hypnotic drugs used to treat insomnia.

EEG spectral power density profiles during NREM sleep for gaboxadol and zolpidem in patients with primary insomnia.

There is significant interest in the functional significance and the therapeutic value of slow-wave sleep (SWS)-enhancing drugs. A prerequisite for studies of the functional differences is characterization of the electroencephalography (EEG) spectra following treatment in relevant patients. We evaluate for the first time gaboxadol and zolpidem treatments in insomniac patients using power spectra analysis.

Citalopram may reduce sympathoadrenal hyperactivity in elderly depressed patients: an open multicenter study in Belgium and Luxembourg.

Introduction: Through effects of catecholamines upon the heart, blood vessels and platelets, sympathoadrenal hyperactivity contributes to the development of cardiovascular diseases in elderly depressed patients. To assess the cardiovascular effect of Citalopram in elderly depressed patients, data from an open multicenter study in Belgium and Luxembourg, in which a total of 811 patients were evaluated, was retrospectively analysed. Although the aim of the study was to assess the efficacy and safety of Citalopram, blood pressure and heart rate were also monitored.

Pharmacokinetic profile of SKP-1041, a modified release formulation of zaleplon.

Objectives: Two investigations aimed to define the pharmacokinetic profile of a modified-release preparation of zaleplon (SKP-1041).

Methods: Protocol SOM001 was a 5-way crossover, double-blind, randomized trial comparing three novel modified-release formulations of zaleplon 15 mg (SKP-1041A, SKP-1041B, SKP-1041C) to placebo and immediate-release zaleplon 10 mg. Protocol SOM002 was a randomized, crossover, open-label trial to compare the pharmacokinetics of SKP-1041B after day and night administration.

Structured multiplicity and confirmatory statistical analyses in pharmacodynamic studies using the quantitative electroencephalogram.

Pharmacodynamic (PD) clinical studies are characterised by a high degree of multiplicity. This multiplicity is the result of the design of these studies that typically investigate effects of a number of biomarkers at various doses and multiple time points. Measurements are taken at many or all points of a "hyper-grid" that can be understood as the cross-product of a number of dimensions each of which has typically 3-30 discrete values.

Sublingual zolpidem in early onset of sleep compared to oral zolpidem: polysomnographic study in patients with primary insomnia.

Objective: To compare the hypnotic effects of a single dose of a sublingual formulation of zolpidem (Edluar*) 10 mg vs oral formulation (Ambien dagger ) 10 mg by polysomnography (PSG) in DSM-IV primary insomnia patients. Primary objective was to compare the two formulations on sleep induction, measured by latency to persistent sleep (LPS), sleep onset latency (SOL) and latency to stage 1 (ST1L).

Research And Methods: This was a randomized, double-blind, two-period, cross-over multi-centre study in which each period comprised two successive PSG recording nights.

Comorbidity of insomnia and depression.

During the last decade, several studies have shown that insomnia, rather than a symptom of depression, could be a medical condition on its own, showing high comorbidity with depression. Epidemiological research indicates that insomnia could lead to depression and/or that common causalities underlie the two disorders. Neurobiological and sleep EEG studies suggest that a heightened level of arousal may play a common role in both conditions and that signs of REM sleep disinhibition may appear in individuals prone to depression.

The effect of prolonged-release melatonin on sleep measures and psychomotor performance in elderly patients with insomnia.

Objectives of this study were to investigate the effects of prolonged-release melatonin 2 mg (PRM) on sleep and subsequent daytime psychomotor performance in patients aged > or =55 years with primary insomnia, as defined by fourth revision of the Diagnostic and Statistical Manual of Mental Disorders of the American Psychiatric Association. Patients (N = 40) were treated nightly single-blind with placebo (2 weeks), randomized double-blind to PRM or placebo (3 weeks) followed by withdrawal period (3 weeks). Sleep was assessed by polysomnography, all-night sleep electroencephalography spectral analysis and questionnaires.

Relationships between the number of ultradian cycles and key sleep variables in outpatients with major depressive disorder.

The regulation of the alternation between rapid eye movement sleep (REMS) and non-rapid eye movement sleep (NREMS) is still a matter of much debate. It is also an important topic for psychiatric research, since both sleep components show anomalies in Major Depressive Disorders (MDD) and related syndromes. In previous studies on healthy controls, we showed preferential links of the number of ultradian cycles with REMS-related variables rather than with NREMS-related variables.

Insomnia treatment assessment based on physiological data analysis.

For the purposes of insomnia treatment, pharmacotherapy is widely used, despite the possibility for the use of behavioural treatment of insomnia. Thus, the assessment and treatment of patients with insomnia needs further investigation. This work addresses insomnia treatment evaluation and medication side-effect assessment based on continuous physiological signals such as EEG and ECG monitoring and analysis.

A double-blind, placebo-controlled, randomized study evaluating the effect of paliperidone extended-release tablets on sleep architecture in patients with schizophrenia.

The effects of paliperidone extended-release on sleep architecture in patients with schizophrenia-related insomnia were evaluated in this multicenter, double-blind, randomized, placebo-controlled study. Patients received paliperidone extended-release 9 mg/day or matching placebo during the 14-day double-blind phase. Sleep architecture and sleep continuity were evaluated using polysomnograms.

Effect of short-term treatment with gaboxadol on sleep maintenance and initiation in patients with primary insomnia.

Study Objective: To perform an early evaluation of the efficacy and safety of gaboxadol in the treatment of primary insomnia.

Methods: 26 adults (18-65 years) with DSM-IV criteria for primary insomnia were randomly assigned gaboxadol (5 mg, 15 mg) or placebo in a double-blind, crossover study. After a 3-night polysomnographic (PSG) screen, treatment was administered 30 min before bedtime on 2 consecutive nights during 3 separate sessions including PSG.

Surrogate outcomes in neurology, psychiatry, and psychopharmacology.

A surrogate outcome can be defined as an outcome that can be observed sooner, at lower cost, or less invasively than the true outcome, and that enables valid inferences about the effect of intervention on the true outcome. There is increasing interest in the use of surrogate outcomes of treatment efficacy measurement in investigational drug trials. However, the significance of surrogate markers of treatment outcome in neurology and psychiatry has not yet been sufficiently demonstrated.

Effects of acamprosate on sleep during alcohol withdrawal: A double-blind placebo-controlled polysomnographic study in alcohol-dependent subjects.

Background: Sleep disturbances are frequently encountered in alcohol-dependent patients. Drugs improving sleep during abstinence from alcohol may play an important role in the recovery process.

Methods: In the present study, the effects of acamprosate, a drug successfully used in maintaining abstinence following alcohol withdrawal, were assessed by polysomnographic recordings.

Sleep disturbances, psychiatric disorders, and psychotropic drugs.

Brain neurotransmitter dysfunctions involved in the pathophysiological processes of psychiatric disorders are likely to be reflected by concomitant alterations in sleep continuity and architecture. Since the corrective effects of psychotropic drugs on dysfunctional neurotransmission systems can be evidenced through polysomnographic recordings, one may consider sleep as a kind of "window" on the neurobiology of psychiatric disorders. During the last 10 years, major breakthroughs in our understanding of sleep-wake mechanisms have provided some indications on how psychotropic drugs could influence the sleep-wake cycle.

Next-day residual effects of hypnotics in DSM-IV primary insomnia: a driving simulator study with simultaneous electroencephalogram monitoring.

Rationale: Most studies that investigated the next-day residual effects of hypnotic drugs on daytime driving performances were performed on healthy subjects and after a single drug administration.

Objectives: In the present study, we further examine whether the results of these studies could be generalised to insomniac patients and after repeated drug administration.

Method: Single and repeated (7 day) doses of zolpidem (10 mg), zopiclone (7.

Inverse association between Slow Wave Activity per cycle and the number of ultradian sleep cycles per night in healthy humans.

Objective: Comparisons of sleep Slow Wave Activity (SWA) during successive sleep cycles rely on the assumption that SWA in a given cycle is independent of the number of ultradian cycles present in a night. This assumption was evaluated here.

Methods: Twenty-six healthy controls with no medical, sleep or psychiatric disorders were selected among 84 candidates and their sleep was recorded at home across 2 consecutive nights after two habituation nights.

What is the clinical significance of periodic limb movements during sleep?

Unlabelled: To understand better the clinical impact of periodic limb movements during sleep (PLMS) we analysed data from 51 patients who, following an adaptation night, presented a PLMS index > 5 during two consecutive nocturnal polysomnographic recordings. In the morning following each recording patients completed a questionnaire including five visual analogic scales (VAS): (1) I did not sleep well/I slept very well. (2) I feel very sleepy/I do not feel sleepy at all.

Periodic limb movements and sleepiness in obstructive sleep apnea patients.

Background And Purpose: The aim of this study was to assess the possibility that periodic limb movements during sleep (PLMS) could play an additive role in the sleepiness associated with obstructive sleep apnea syndrome (OSAS) before treatment, or could account for residual sleepiness in successfully CPAP-treated patients.

Patients And Methods: In order to test this hypothesis, we compared objective sleepiness, assessed by the Multiple Sleep Latency Test (MSLT) and subjective sleep propensity, assessed by the Epworth Sleepiness Scale (ESS), in a clinical series of 57 patients consecutively diagnosed with OSAS (apnea/hypopnea index, 53.3+/-26.