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Biomedical subjects

Colin M Shapiro

Publications and source records attributed to Colin M Shapiro.

At least 19 recordsLinked to original sources

Sleepiness is not the inverse of alertness: evidence from four sleep disorder patient groups.

The constructs "sleepiness" and "alertness" are often assumed to be reciprocal states of consciousness. This distinction is of increasing concern in relation to psychomotor performance tasks such as driving. We developed two separate subjective scales of alertness to complement existing sleepiness scales. Subjective sleepiness and alertness were compared in four groups of sleep-disordered patients. In a 175-patient cohort [25 narcoleptics and 50 each with sleep apnea, insomnia and periodic leg movement disorder (PLMD)], the Epworth Sleepiness Scale (ESS) was used to measure sleepiness while the Toronto Hospital Alertness Test (THAT) and ZOGIM Alertness Scale (ZOGIM-A) were used to measure alertness. Significant differences existed for sleepiness scores, with narcoleptics scoring highest on the ESS, followed by sleep apnea, with similar ESS scores for insomnia and PLMD. By contrast, alertness scores on both the THAT and ZOGIM-A did not differ significantly between the four groups. Sleepiness scores show a correlation of close to nil to alertness scores for the combined sleep disorder patient cohort, with the exception of insomnia patients, where a modest but significant inverse relationship was noted between sleepiness and alertness. Subjective states of impaired alertness and excessive sleepiness are independent constructs in the evaluation of sleep-disordered patients. The specific primary sleep disorder diagnosis may play a relevant role in mitigating this interrelationship.

Adult↗

Psychomotor disturbance in depression: assessment using a driving simulator paradigm.

BACKGROUND: Psychomotor disturbance is an essential feature of Major Depressive Disorder (MDD) and has been associated with impaired functioning on cognitively demanding tasks. Given the psychomotor demands required to navigate a motor vehicle and the disastrous effects of motor vehicles accidents, patients with MDD present a population of clinical interest. The goal of this investigation was to examine the association between MDD and driving ability assessed within a simulated driving paradigm. METHODS: 18 outpatients currently meeting diagnostic criteria for MDD and 29 control participants completed four 30-min simulated driving trials at 10:00 am, 12:00 pm, 2:00 pm, and 4:00 pm. Participants also completed the Beck Depression Inventory (BDI) to assess for depression severity and the Epworth Sleepiness Scale (ESS) to assess for everyday sleepiness. RESULTS: After controlling for age and sleepiness, the depressed sample exhibited slower steering reaction times across trials (p<.05) and an increased number of crashes across trials (p<.05) when compared to controls. These differences were characterized by a medium effect size. No significant time-of-day effects were found. LIMITATIONS: MDD patients were free of anti-depressant medication and findings may not generalize to medicated populations. Also, a rural highway driving route was used which may not generalize well to urban driving settings. CONCLUSIONS: Patients with untreated MDD demonstrate impaired simulated driving performance. Further research into whether these findings translate into on-the-road impairment is important for public health and safety.

Accidents, Traffic↗

Simulator performance, microsleep episodes, and subjective sleepiness: normative data using convergent methodologies to assess driver drowsiness.

OBJECTIVE: Our objective was to examine a novel standardized assessment methodology of detecting impaired driving performance due to drowsiness in a normative cohort. METHODS: Thirty-one healthy subjects with no significant sleep, medical, and psychiatric pathology were assessed in a driving simulation paradigm. Thirty-minute simulations were repeated at two-hourly intervals (i.e., at 1000, 1200, 1400, and 1600 h). Convergent data sources included drivers' subjective ratings of sleepiness and alertness, electroencephalogram-verified microsleep (MS) episodes, and a variety of real-time driving simulator performance measures such as speed, lane tracking, reaction time (RT), and off-road events (crashes). RESULTS: Significant diurnal fluctuations were noted on objective measures of RT, velocity, tracking, and MS events, indicating the highest risk of impairment in the afternoon. By contrast, subjective ratings of sleepiness and alertness did not demonstrate significant circadian variation. The mean incidence of MS episodes and crash risk correlated highly (r = .748). CONCLUSIONS: This prospective study demonstrates the relevance of multiple convergent measures for comprehensive assessment. The divergence of subjective and objective assays of impairment implies that healthy individuals may not have full insights into neurophysiologically mediated performance deficits. These results will serve as normative comparators to patients presenting with daytime somnolence and may allow a more accurate prediction of potential crash risk than noninteractive daytime polysomnogram tests such as the mean sleep latency test or the maintenance of wakefulness test.

Accidents, Traffic↗

A new approach to the construct of alertness.

OBJECTIVE: There are no psychometric measures to evaluate the critical construct of alertness. We, therefore, developed two questionnaires to measure alertness, the Toronto Hospital Alertness Test (THAT) and the ZOGIM-A, and evaluated their psychometric properties. METHODS: We examined the correspondence between scores on the THAT and the ZOGIM-A in a sample of sleep clinic outpatients (n=96) with Maintenance of Wakefulness Test (MWT) results after an overnight sleep study, physiological sleep parameters, measures of subjective sleepiness, and two psychosocial variables (psychological well-being and emotional distress). Test-retest reliability was estimated based on responses from an independent sample of 295 sleep clinic outpatients who completed the instruments before and after an overnight sleep study. RESULTS: High values were observed for both the THAT (r(tt)=.79) and the ZOGIM-A (r(tt)=.70). Internal consistency reliability (coefficient alpha) was also high: .96 for THAT and .83 for ZOGIM-A. Although neither of the new scales correlated significantly with measures derived from the MWT or nocturnal physiological measures, the two alertness scales did correlate significantly and as hypothesized with subjective measures of sleepiness and other psychosocial measures. CONCLUSIONS: These results support the perspective that subjective alertness cannot be reduced to the absence of sleepiness and corroborate the psychometric adequacy of the THAT and the ZOGIM-A as unique indices of alertness that complement objective data obtained via MWT and physiological indices of sleep architecture.

Adolescent↗

Chronic insomnia in kidney transplant recipients.

BACKGROUND: Recent studies confirmed that sleep disorders have a significant impact on various aspects of health in patients at different stages of chronic kidney disease. At the same time, there is an almost complete lack of information on the prevalence and correlates of insomnia in kidney transplant recipients. METHODS: In a cross-sectional study, the Athens Insomnia Scale was used to assess the prevalence of insomnia in a large sample of kidney transplant recipients compared with wait-listed dialysis patients and also a matched group obtained from a nationally representative sample of the Hungarian population. RESULTS: The prevalence of insomnia was 15% in wait-listed patients, whereas it was only 8% in transplant recipients (P < 0.001), which, in turn, was not different from the prevalence of this sleep problem in the sample of the general population (8%). Prevalences of insomnia in the transplant group were 5%, 7%, and 14% for the groups with glomerular filtration rates (GFRs) greater than 60 mL/min (> 1.00 mL/s), 30 to 60 mL/min (0.50 to 1.00 mL/s), and less than 30 mL/min (< 0.5 mL/s), respectively (P < 0.01). However, estimated GFR was no longer associated significantly with insomnia in the transplant population after statistical adjustment for several covariates. In a multivariate model, insomnia was significantly and independently associated with treatment modality (transplantation versus wait listing), as well as the presence of depression, restless legs syndrome, and high risk for obstructive sleep apnea syndrome, and with self-reported comorbidity. CONCLUSION: The prevalence of insomnia was substantially less in the transplant group than in wait-listed dialysis patients and similar to that observed in the general population. Because this condition potentially is treatable, attention should be directed to the appropriate diagnosis and management of insomnia in the kidney transplant recipient population.

Chronic Disease↗

Fatigue and shift work.

Shift work is a ubiquitous phenomenon and its adverse effects on workers' physical and mental health have been documented. In the sleep literature, differentiating between the symptoms of fatigue and sleepiness, and developing appropriate objective and subjective measures, have become very important endeavors. From such research, fatigue and sleepiness have been shown to be distinct and independent phenomena. However, it is not known whether shift work differentially affects fatigue and sleepiness. In an attempt to answer this question, 489 workers from a major Ontario employer completed a series of subjective, self-report questionnaires, including the Fatigue Severity Scale (FSS) and the Epworth Sleepiness Scale. Workers were separated into four groups based on the frequency with which they are engaged in shift work (never, fewer than four times per month, 1-2 days per week, 3 days or more per week). The frequency of shift work was found to have a significant effect on subjective fatigue, but not on subjective sleepiness. Compared with the subjects who never had a shift schedule, those who worked in a shift for 3 days or more had significantly higher mean score of the FSS. In agreement with previous results, a low correlation was found between workers' subjective fatigue and sleepiness scores, providing further support for the concept of fatigue and sleepiness as distinct and independent phenomena. Future research should address the possibility of using the FSS as an indicator when the frequency of shift work has become high enough to adversely affect work performance or cause health problems.

Adult↗

Polysomnographic and symptomatological analyses of major depressive disorder patients treated with mirtazapine.

OBJECTIVE: This study aimed to characterize the effects of mirtazapine on polysomnographic sleep, especially slow wave sleep (SWS) and rapid eye movement (REM) sleep, as well as its effects on clinical symptoms in patients with major depressive disorder (MDD). METHOD: Sixteen MDD patients were treated with mirtazapine 30 mg taken 30 minutes before bedtime. Polysomnographic and subjective sleep, as well as other clinical data, were collected at baseline and on Days or Nights 2, 9, 16, 30, and 58 during treatment. We used repeated measures analysis of variance, including pairwise comparison, to analyze data statistically. RESULTS: Mirtazapine administration increased total SWS and the SWS in the first sleep cycle, but not SWS in the second sleep cycle. The medication increased REM latency and the duration of the first REM episode; it also decreased the number of REM episodes. Simultaneously, mirtazapine significantly reduced wake-after-sleep onset and scores on the Athens Insomnia Scale. After patients took the medication, scores on the Hamilton Depression Rating Scale-17 (HDRS-17) decreased rapidly and continuously. The changes on the Beck Depression Inventory-II were consistent with those on the HDRS-17. The medication has a tendency to increase weight. CONCLUSIONS: Mirtazapine significantly improved sleep quality, reversed sleep markers of depression, and reduced depressive symptoms in this group of MDD patients.

Adult↗

Ropinirole treatment for restless legs syndrome.

In this paper we discuss therapy with ropinirole (known as adartrel in the United Kingdom) in patients with restless legs syndrome. Restless legs syndrome is characterized by an urge to move the legs, uncomfortable sensations in the legs and worsening of these symptoms during rest with at least temporary relief brought on by activity. Current recommendations suggest dopaminergic therapy (levodopa or dopamine receptor agonists like ropinirole) as the first-line treatment for restless legs syndrome. Based on the results of randomized, placebo-controlled, double-blind trials, we conclude that ropinirole is effective in reducing symptoms of restless legs syndrome in the general population. Ropinirole has no serious or common side effects that would limit its use significantly. Rebound and augmentation problems are relatively rarely seen with ropinirole, although properly designed comparative trials are still needed to address this question. It must be noted, however, that most published studies with ropinirole compare this drug with placebo. Very few studies have compared ropinirole with other drugs (L-dopa, gabapentin, opioids, benzodiazepines, other dopaminergic agents and selegiline hydrochloride). No cost-effectiveness trial has been published yet. Treatment of restless legs syndrome with ropinirole shows it to be effective, well-tolerated and safe and it can be used in restless legs syndrome in general.

Adult↗

Distinguishing sleepiness and fatigue: focus on definition and measurement.

Sleepiness and fatigue are two interrelated, but distinct phenomena; observed in a number of psychiatric, medical and primary sleep disorders. Despite their different implications in terms of diagnosis and treatment, these two terms are often used interchangeably, or merged under the more general lay term of 'tired'. Sleepiness is multidimensional and has many causes (multidetermined) and distinguished from fatigue by a presumed impairment of the normal arousal mechanism. Despite its ubiquity, no clear consensus exits as yet as to what constitutes sleepiness. Definitions of sleepiness, to date, are at best operational definitions, conceptualized so as to produce specific assessment instruments. As a result, while a number of subjective and objective measurement tools have been developed to measure sleepiness, each only captures a limited aspect of an otherwise heterogeneous entity. Fatigue is an equally complex phenomenon, its nature captured by a number of conceptualizations and definitions. Measures of fatigue have remained subjective, with a 'gold standard' for its measurement remaining elusive. Despite a high prevalence and high degree of morbidity, fatigue has remained a relatively under appreciated symptom, from both a clinical and research point of view.

Disorders of Excessive Somnolence↗

Blocking low-wavelength light prevents nocturnal melatonin suppression with no adverse effect on performance during simulated shift work.

Decreases in melatonin production in human and animals are known to be caused by environmental lighting, especially short-wavelength lighting (between 470 and 525 nm). We investigated the novel hypothesis that the use of goggles with selective exclusion of all wavelengths less than 530 nm could prevent the suppression of melatonin in bright-light conditions during a simulated shift-work experiment. Salivary melatonin levels were measured under dim (<5 lux), bright (800 lux), and filtered (800 lux) light at hourly intervals between 2000 and 0800 h in 11 healthy young males and eight females (mean age, 24.7 +/- 4.6 yr). The measurements were performed during three nonconsecutive nights over a 2-wk period. Subjective sleepiness was measured by self-report scales, whereas objective performance was assessed with the Continuous Performance Test. All subjects demonstrated preserved melatonin levels in filtered light similar to their dim-light secretion profile. Unfiltered bright light drastically suppressed melatonin production. Normalization of endogenous melatonin production while wearing goggles did not impair measures of performance, subjective sleepiness, or alertness.

Adult↗

Sleep apnea, hypertension, and the effects of continuous positive airway pressure.

BACKGROUND: Sleep apnea is being studied as a risk factor for hypertension. This observational chart review was conducted to determine the long-term effects of continuous positive airway pressure (CPAP) treatment on blood pressure (BP) in a sample of sleep apnea patients from urban and rural populations. METHODS: This study was conducted using data from 180 clinical charts from 1995 to 2002. Patients were identified as hypertensive or normotensive by their initial BP values before they were diagnosed with sleep apnea and were also reviewed after the use of CPAP. RESULTS: Of the patients diagnosed with sleep apnea, 32% were found to have hypertension (mean systolic BP: 164.4 +/- 20.3 mmHg; mean diastolic BP: 96.9 +/- 5.3 mmHg). The average use of CPAP was 12.1 +/- 22.4 months. The hypertensive group showed a significant reduction in BP with CPAP use: systolic BP dropped by an average of 11.2 mmHg (P < .001) and diastolic BP dropped by an average of 5.9 mmHg (P < .001). CONCLUSIONS: Our results confirm that frequency of hypertension is increased among sleep apnea patients. The long-term use of CPAP in hypertensive patients with sleep apnea is associated with a significant decrease in BP to levels that considerably decrease cardiovascular risk.

Adult↗

What is the driving performance of ambulatory surgical patients after general anesthesia?

BACKGROUND: Ambulatory surgical patients are advised to refrain from driving for 24 h postoperatively. However, currently there is no strong evidence to show that driving skills and alertness have resumed in patients by 24 h after general anesthesia. The purpose of this study was to determine whether impaired driver alertness had been restored to normal by 2 and 24 h after general anesthesia in patients who underwent ambulatory surgery. METHODS: Twenty patients who underwent left knee arthroscopic surgery were studied. Their driving simulation performance, electroencephalographically verified parameters of sleepiness, subjective assessment of sleepiness, fatigue, alertness, and pain were measured preoperatively and 2 and 24 h postoperatively. The same measurements were performed in a matched control group of 20 healthy individuals. RESULTS: Preoperatively, patients had significantly higher attention lapses and lower alertness levels versus normal controls. Significantly impaired driving skills and alertness, including longer reaction time, higher occurrence of attention lapses, and microsleep intrusions, were found 2 h postoperatively versus preoperatively. No significantly differences were found in any driving performance parameters or electroencephalographically verified parameters 24 h postoperatively versus preoperatively. CONCLUSIONS: Patients showed lower alertness levels and impaired driving skills preoperatively and 2 h postoperatively. Based on driving simulation performance and subjective assessments, patients are safe to drive 24 h after general anesthesia.

Adjuvants, Anesthesia↗

Subjective fatigue and subjective sleepiness: two independent consequences of sleep disorders?

The objective of this investigation was to evaluate subjective fatigue versus subjective sleepiness as independent consequences of sleep disorders. Furthermore, we tried to explore how these symptoms relate to alertness, depressive symptoms and illness intrusiveness. In a prospective observational study, 283 sleep-disordered patients referred to a hospital-based sleep laboratory for various indications over a 1-year period were evaluated vis-à-vis fatigue and sleepiness. All patients completed five subjective questionnaires, underwent objective sleep recording and attended a clinical interview with a sleep specialist. The subjective questionnaires included the Epworth Sleepiness Scale, the Fatigue Severity Scale, the Toronto Hospital Alertness Test, the Illness Intrusiveness Rating Scale and the Center for Epidemiologic Studies-Depression Scale. Only 4% of the total sample was referred to the sleep clinic due to a complaint of excessive fatigue compared with 17% for excessive daytime sleepiness. However, during the assessment, 64% of referred patients reported pathological fatigue without overlap of sleepiness and only 4% reported pathological sleepiness without overlap of fatigue. Pearson's correlation analysis indicated a weak association (r=0.18) between subjective fatigue and sleepiness in the total sample. Analysis of variance testing showed strong association between those patients with prominent fatigue and depressive symptoms (P<0.01) and illness intrusiveness (P<0.001). The findings support the notion that subjective fatigue and sleepiness can be independent manifestations of sleep disorders. Furthermore, predominantly fatigued individuals with sleep disorders seem vulnerable to additional negative consequences due to possible interplay between amplified fatigue and psychological distress.

Adolescent↗

Validation of a short questionnaire in English and French for use in patients with persistent upper gastrointestinal symptoms despite proton pump inhibitor therapy: the PASS (Proton pump inhibitor Acid Suppression Symptom) test.

BACKGROUND: The management of persistent symptoms during acid suppression therapy in patients with gastroesophageal reflux disease or dyspepsia might be improved if patient-physician communication regarding the presence and character of these persistent symptoms were facilitated. AIM: To validate a short, simple questionnaire (the Proton pump inhibitor [PPI] Acid Suppression Symptom [PASS] test), in English and French, to identify patients with persistent acid-related symptoms during PPI therapy and document their response to a change in therapy. METHODS: Patients with persistent acid-related symptoms on PPI therapy were interviewed to produce a draft, five-item questionnaire; content validity was evaluated by focus groups comprising English- and French-speaking patients. Psychometric validity was subsequently evaluated in a multicentre, family practice-based study of English- and French-speaking patients with persistent acid-related upper gastrointestinal symptoms despite PPI therapy. The PASS test, Global Overall Symptom scale, Gastrointestinal Symptom Rating Scale (GSRS), Quality of Life in Reflux and Dyspepsia questionnaire and Reflux Disease Questionnaire were completed at baseline and repeated after one week while patients continued their original PPI therapy. All patients then received esomeprazole 40 mg once daily for four weeks, after which all questionnaires and an evaluation of overall treatment effect were completed. RESULTS: Content validity was established in 20 English- and 16 French-speaking patients. Psychometric validation in 158 English- and 113 French-speaking patients revealed good-to-excellent test-retest reliability coefficients: 0.76 for English; 0.68 for French. For construct validity, the PASS test showed moderate-to-high correlation with the GSRS scale (0.51 for English; 0.43 for French). After four weeks of therapy, the PASS test score fell to zero in 30% of English- and 33% of French-speaking patients, while the Global Overall Symptom score fell to one (no symptoms) in 32% of patients (English- and French-speaking); the PASS test demonstrated good responsiveness in comparison with the GSRS, Reflux Disease Questionnaire and Quality of Life in Reflux and Dyspepsia questionnaire. CONCLUSION: The five-item PASS test is a valid tool for the evaluation of persistent acid-related symptoms in patients receiving PPI therapy. It demonstrates good content validity, test-retest reliability, responsiveness and construct validity in both English and French forms. The PASS test is a simple, clinically applicable tool for the identification of patients with persistent acid-related symptoms during therapy and the assessment of their responses to a change in therapy.

Dyspepsia↗

The effects of nefazodone on women with seasonal affective disorder: clinical and polysomnographic analyses.

OBJECTIVE: To outline the clinical and polysomnographic changes induced by nefazodone in patients with seasonal affective disorder. METHODS: Twelve patients were enrolled, and 9 of them studied, in an open-label trial with objective and subjective measurements. The mean age of the studied patients was 45 (range 35-58) years. They met Diagnostic and Statistical Manual of Mental Disorders, fourth edition (DSM-IV), criteria for major depressive disorder and current major depressive episode with seasonal patterns. The patients' mean baseline score on the Seasonal Patterns Assessment Questionnaire (SPAQ) was 15.7 (standard deviation [SD] 5.3). The total nefazodone treatment period was 8 weeks, and the daily dosages were 100 mg in week 1, 200 mg in week 2, 300 mg in week 3, and up to 400 mg in weeks 4-8. Each patient received the 29-item version of the Hamilton Rating Scale for Depression (HAM-D), the Hamilton Rating Scale for Anxiety (HAM-A) and 2-night polysomnographic assessments on 3 occasions: before treatment (baseline, W0), at the end of week 4 (W4) and at the end of week 8 (W8). RESULTS: There were statistically significant improvements in depression, anxiety, sleep latency and sleep efficiency during the 8-week treatment protocol. Repeated-measures analysis of variance results indicated that nefazodone has a time-dependent effect on both HAM-D and HAM-A scores. After 8 weeks of nefazodone therapy, HAM-D scores decreased from 33.4 (SD 8.1) to 11.6 (SD 5.6) (F(2,14) = 13.68, p = 0.001) and HAM-A decreased from 26.6 (SD 7.0) to 11.5 (SD 11.1) (F(2,14) = 13.46, p = 0.001). The results of paired t tests show that, compared with baseline, HAM-D and HAM-A scores decreased at both W4 (p = 0.004 and p = 0.002, respectively) and W8 (p = 0.002 and p = 0.005, respectively). The time-dependent effects on stage 1 sleep (F(2,16) = 6.06, p = 0.011) and periodic leg movement index (F(2,16) = 4.31, p = 0.035) were also significant. The mean sleep latency of these patients decreased from 39.9 (SD 32.7) minutes at W0 to 16.6 (SD 15.3) minutes at W8 (p < 0.05). Sleep efficiency increased from 78.8% (SD 14.6%) at W0 to 91.5% (SD 5.5%) at W8 (p < 0.05). Stage 1 sleep decreased from 4.9% (SD 1.9%) at W0 to 3.4% (SD 2.6%) at W8 (p < 0.05). CONCLUSIONS: The results of this preliminary study indicate that nefazodone not only has favourable antidepressant and anxiolytic effects but also enhances sleep efficiency and sleep latency.

Adult↗