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Biomedical subjects

Thomas Roth

Publications and source records attributed to Thomas Roth.

At least 19 recordsLinked to original sources
PubMed2003

Ethanol and sleep loss: a "dose" comparison of impairing effects.

STUDY OBJECTIVES: Studies to assess the risks associated with sleep loss relative to the well-documented risks of alcohol are limited in number and design. This study compared the "dose"-related sedative, performance-impairing, and amnestic effects of sleep loss to those of ethanol ingestion. DESIGN: Mixed-design experiment with random assignment to a sleep loss (n=12) or ethanol (n=20) group, with each participant assessed under 4 conditions. PARTICIPANTS: Thirty-two healthy normal adult volunteers, aged 21 to 35 years. INTERVENTIONS: In sleep loss, participants had 8, 6, 4, and 0 hours time in bed, producing 0, 2, 4, and 8 hours of sleep loss. For ethanol, participants ingested 0.0 g/kg, 0.3 g/kg, 0.6 g/kg, and 0.9 g/kg ethanol from 8:30 AM to 9:00 AM after 8 hours of time in bed the previous night. Each participant received his or her 4 doses of ethanol or sleep loss in a Latin square design with 3 to 7 days between doses. MEASUREMENTS: All subjects completed the Multiple Sleep Latency Test (MSLT) at 9:30 AM, 11:30 AM, 1:30 PM, 3:30 PM, and 5:30 PM and a performance battery at 10:00 AM, 12:00 NOON, 2:00 PM, and 4:00 PM consisting of memory, psychomotor vigilance, and divided attention tests. RESULTS: Ethanol and sleep loss reduced the average daily sleep latency on the MSLT, both as a linear function of dose, with sleep loss in hours being 2.7 times more potent than ethanol in grams per kilogram. Ethanol and sleep loss also slowed reaction time on the psychomotor vigilance test in a linear dose-related function with the 2 being equipotent in their impairing effect. On the divided attention test, tracking deviations were increased by both ethanol and sleep loss in an equipotent and linear dose-related function. Memory recall was reduced in a linear dose-related function by both ethanol and sleep loss with ethanol being slightly more potent. Finally, sleep loss doses produced a linear decrease in self-rated quality of performance, while only at the highest ethanol dose was performance rated as poorer. CONCLUSIONS: At the studied doses, sleep loss was more potent than ethanol in its sedative effects but comparable in effects on psychomotor performance. Ethanol produced greater memory deficits, and subjects were less aware of their overall performance impairment.

Adult↗
PubMed2003

Sustained efficacy of eszopiclone over 6 months of nightly treatment: results of a randomized, double-blind, placebo-controlled study in adults with chronic insomnia.

STUDY OBJECTIVES: To determine the long-term efficacy of eszopiclone in patients with chronic insomnia. DESIGN: Randomized, double-blind, multicenter, placebo-controlled. SETTING: Out-patient, with monthly visits. PATIENTS: Aged 21 to 69 years meeting DSM IV criteria for primary insomnia and reporting less than 6.5 hours of sleep per night, and/or a sleep latency of more than 30 minutes each night for at least 1 month before screening. INTERVENTIONS: Eszopiclone 3 mg (n = 593) or placebo (n = 195), nightly for 6 months MEASUREMENTS AND RESULTS: Efficacy was evaluated weekly using an interactive voice-response system. Endpoints included sleep latency; total sleep time; number of awakenings; wake time after sleep onset; quality of sleep; and next-day ratings of ability to function, daytime alertness, and sense of physical well-being. At the first week and each month for the study duration, eszopiclone produced significant and sustained improvements in sleep latency, wake time after sleep onset, number of awakenings, number of nights awakened per week, total sleep time, and quality of sleep compared with placebo (P < or = 0.003). Monthly ratings of next-day function, alertness, and sense of physical well-being were also significantly better with the use of eszopiclone than with placebo (P < or = 0.002). There was no evidence of tolerance, and the most common adverse events were unpleasant taste and headache. CONCLUSIONS: Throughout 6 months, eszopiclone improved all of the components of insomnia as defined by DSM-IV, including patient ratings of daytime function. This placebo-controlled study of eszopiclone provides compelling evidence that long-term pharmacologic treatment of insomnia is efficacious.

Adult↗
PubMed2003

The pediatric daytime sleepiness scale (PDSS): sleep habits and school outcomes in middle-school children.

STUDY OBJECTIVES: To develop a measure of daytime sleepiness suitable for middle-school children and examine the relationship between daytime sleepiness and school-related outcomes. DESIGN: Self-report questionnaire. PARTICIPANTS: Four hundred fifty, 11- to 15-year-old students, from grades 6, 7, and 8 of a public middle school in Dayton, Ohio. MEASUREMENTS AND RESULTS: A pediatric daytime sleepiness questionnaire was developed using factor analysis of questions regarding sleep-related behaviors. Results of the sleepiness questionnaire were then compared across other variables, including daily sleep patterns, school achievement, mood, and extracurricular activities. RESULTS: Factor analysis on the 13 questions related to daytime sleepiness yielded 1 primary factor ("pediatric daytime sleepiness"; 32% of variance). Only items with factor loadings above .4 were included in the final sleepiness scale. Internal consistency (Chronbach's alpha) for the final 8-item scale was .80. Separate one-way analyses of variance and trend analyses were performed comparing pediatric daytime sleepiness scores at the 5 different levels of total sleep time and academic achievement. Participants who reported low school achievement, high rates of absenteeism, low school enjoyment, low total sleep time, and frequent illness reported significantly higher levels of daytime sleepiness compared to children with better school-related outcomes. CONCLUSIONS: The self-report scale developed in the present work is suitable for middle-school-age children and may be useful in future research given its ease of administration and robust psychometric properties. Daytime sleepiness is related to reduced educational achievement and other negative school-related outcomes.

Adolescent↗
PubMed2003

Sleep during titration predicts continuous positive airway pressure compliance.

STUDY OBJECTIVES: Poor compliance with continuous positive airway pressure (CPAP) has been identified as a significant obstacle in the treatment of obstructive sleep apnea. While previous studies have focused on diagnostic screening variables, side effects, health beliefs, and measures of disease severity, investigators have generally ignored sleep parameters assessed during CPAP titration as predictors of compliance. As the titration night represents patients' initial exposure to nocturnal CPAP treatment, we hypothesized that nocturnal polysomnographic (PSG) variables, representing improved sleep at this time, would predict higher subsequent compliance. DESIGN: Prospective analyses of a sequential case series were undertaken using nocturnal PSG variables during titration as early predictors of CPAP compliance. SETTING: Accredited sleep center. PATIENTS: Seventy-one patients with sleep apnea, aged 31-78 years, with a mean respiratory disturbance index of 62.0 +/- 32.2. INTERVENTIONS: N/A. MEASUREMENTS AND RESULTS: Compliance was calculated as mean hours per night of CPAP use over the initial follow-up period (mean 46.9 days). Standard PSG variables and subjective reports of sleep were used as predictive variables in multivariate analyses. Mean objective compliance was 5.04 hours per night +/- 2.59. Consistent with our hypothesis, the best predictor of compliance was change in sleep efficiency (SE) from diagnostic to titration night [F (1,66) = 17.31, p < .000 (r = .48)], indicating that patients whose sleep improved most on the titration night had the highest levels of compliance. This relationship was also significant after controlling for measures of disease severity obtained during the diagnostic testing night. Importantly, individuals whose sleep improved on the CPAP titration night had nightly compliance rates of approximately 2 hours greater than patients whose sleep did not improve during titration. CONCLUSIONS: The findings suggest that patients' initial experience with CPAP treatment and, in particular, the degree of improvement in sleep during CPAP titration may be crucial factors in determining their subsequent use of this treatment modality.

Adult↗
PubMed2003

Insomnia causes, consequences, and therapeutics: an overview.

There is growing interest in insomnia both from the perspective of recent advances in clinical management as well as research aimed at elucidating its pathophysiology. This theoretical overview of insomnia describes the negative impact, etiological considerations, and pharmacological and behavioral treatments for the disorder, with an emphasis on areas receiving increased research attention. Insomnia, the most prevalent sleep disorder, affects 10-15% of the general population. In population-based studies severe insomnia has been shown to last for a median of 4 years. In addition, insomnia has a significant negative impact on an individual's work, physical, and social performance as well as overall quality of life. Furthermore, the economic cost of insomnia related to lost productivity, work-related accidents, absenteeism, and health-care costs are enormous. There is increasing evidence linking the precipitation of insomnia to stress, and converging evidence from cognitive, endocrine, neurological, and behavioral domains provide clear evidence for hyper-arousal in insomnia. However, there remains no consensus regarding the specific etiological mechanisms of this disorder. Although the pathophysiology of primary insomnia remains an enigma, numerous treatments both pharmacological and behavioral have been developed and found to be efficacious in controlled studies. Despite the wide availability of pharmacological treatments and increased knowledge of behavioral interventions, the vast majority of individuals with insomnia do not appear to be receiving adequate treatment. The inadequate treatment of insomnia leads to several important and under-recognized consequences including subsequent development of psychiatric disease and increased substance use.

Aged↗
PubMed2003

Hypnotics: an update.

This update reviews recent developments and advances in the therapeutic and side-effect profile of the benzodiazepine receptor agonists (BZRAs), the generally accepted drug class of choice for the symptomatic treatment of insomnia. All the approved BZRAs, depending on their pharmacokinetic profile, improve and maintain sleep. The major recent advance is in the enhanced diversity of the pharmacokinetic profiles of these drugs, and thus in the flexibility available to the clinician in treatment strategy. Also, during the past decade the nature and significance of the side effects associated with the BZRAs and their determinants, dose and half-life, have been identified and clarified. The important remaining question is whether, and how, the efficacy and safety of the BZRAs change with chronic use.

Amnesia↗
PubMed2003

Insomnia: epidemiology, characteristics, and consequences.

Insomnia is a symptom of difficulty initiating and maintaining sleep or experiencing nonrefreshing sleep and is associated with daytime consequences. Although insomnia is typically secondary to a medical, psychiatric, circadian, or sleep disorder, it can also be a primary disorder. Primary insomnia is estimated to occur in 25% of all chronic insomnia patients. It is hypothesized to be a disorder of hyperarousal, which has been supported by research on the autonomic nervous system and hypothalamic-pituitary-adrenal axis function. Chronic insomnia is prevalent in 10% of the adult population. Age, sex, medical and psychiatric disease, and shift work all represent an increased risk of chronic insomnia. The morbidity of insomnia varies as a function of etiology. While transient insomnia produces sleepiness and impairment in psychomotor performance, chronic insomnia is associated with absenteeism, frequent accidents, memory impairment, and greater health care utilization. The most consistent impact of insomnia is a high risk of depression.

Age Distribution↗
PubMed2003

Assessment of sleepiness and unintended sleep in Parkinson's disease patients taking dopamine agonists.

OBJECTIVE: We sought to determine if patients with Parkinson's disease (PD), taking dopamine agonists (DAs) and reporting unintended sleep episodes (SEs), exhibit physiologically defined daytime sleepiness and can thus be differentiated from those taking DAs but not reporting SEs. METHODS: Twenty-four patients with abnormal Epworth Sleepiness Scale scores of >10 who were taking DAs were enrolled into one of two groups: those with SEs (SE+, n=16) and those without (SE-, n=8). Three consecutive days of testing included two nights of polysomnography followed by the Multiple Sleep Latency Test (MSLT). RESULTS: Overall frequency of pathological sleepiness (MSLT <5 min) was 42% (10/24). Mean levels of sleepiness, frequencies of pathological sleepiness, and naps with stage 2 or REM-sleep were similar between SE+ and SE- groups. Sleep tendency was similar in patients prescribed pergolide, ropinirole, and pramipexole combined with levodopa. Polysomnography testing revealed no significant differences between the groups in total sleep time, sleep efficiency, sleep architecture, or presence of restless legs syndrome or periodic leg movements. There was no relation between degree of nocturnal sleep disturbance and level of daytime sleepiness. CONCLUSIONS: The results of this study suggest SEs in PD patients occur upon a background of excessive daytime sleepiness and are unrelated to nocturnal sleep or use of a specific DA.

Circadian Rhythm↗
PubMed2002

Caffeine reversal of ethanol effects on the multiple sleep latency test, memory, and psychomotor performance.

Caffeine has been shown to reverse some of the performance-impairing effects of ethanol. However, it is not known whether this antagonistic effect of caffeine is mediated by a reduction in sleepiness. The present study assessed physiological alertness/sleepiness, memory, and psychomotor performance following the administration of placebo, ethanol, and caffeine+ethanol combinations. A total of 13 healthy individuals (21-35 years old) underwent four conditions presented in a Latin Square Design: placebo-placebo, ethanol (0.5 g/kg)-placebo, ethanol (0.5 g/kg)-caffeine 150 mg, and ethanol (0.5 g/kg)-caffeine 300-mg. The Multiple Sleep Latency Test (MSLT), psychomotor performance battery, memory test, and mood/sleepiness questionnaires were administered following each condition. The peak breadth ethanol concentration (BrEC) was 0.043+/-0.0197% and did not differ among the three caffeine treatments. As expected, ethanol reduced mean latency on the MSLT. The lowest caffeine dose reversed this effect and the highest dose increased mean latency (greater alertness) significantly beyond placebo levels. Ethanol also impaired psychomotor performance and memory. The 300-mg caffeine dose restored performance and memory measures to placebo levels. Although visual analog ratings of dizziness were increased by ethanol, they were not diminished by either caffeine dose. In conclusion, Low-dose caffeine prevented the sleepiness and performance impairment associated with a moderate dose of ethanol. Thus, caffeine, similar to other stimulants, can reverse the physiologically sedating effects of ethanol, although other negative effects remain.

Adult↗
PubMed2002

Nighttime versus daytime hypnotic self-administration.

RATIONALE AND OBJECTIVES: Previous studies have shown that insomniacs self-administer hypnotics at high nightly rates. This study assessed whether insomniacs' self-administration of hypnotics extended to the daytime. METHODS: Forty-four healthy men and women, 21-55 years old, with ( n=22) and without ( n=22) insomnia volunteered. They were randomized to one of two triazolam dose groups (0.125 or 0.25 mg) and their preference for placebo versus triazolam was assessed at night (2300 hours) and day (0900 hours) over 7 consecutive days in each phase. In both night and day phases of the study, subjects received triazolam or placebo in color-coded capsules on two sampling days or nights and then were forced to choose their preferred capsule on 5 subsequent days or nights. The order of day and night study phases and the placebo and triazolam sampling days was counterbalanced. In the night phase subjects went to bed from 2330 to 0730 hours and in the day phase they were tested for level of sleepiness-alertness at 1000, 1200, 1400, and 1600 hours by the multiple sleep latency test (MSLT) and mood and performance at 1100 and 1500 hours. RESULTS: More triazolam was chosen at night than during the day. No dose differences in preferences at night versus day or between insomniacs and normals were found. Insomniacs did not differ in their triazolam preferences between night and day, while the normals chose triazolam less frequently during the day. Among insomniacs, 40% chose triazolam on >3 of the 5 days. On both screening and placebo sampling days, those with a high (>60%) daytime triazolam preference had greater average daily sleep latencies on the MSLT than those with a low (<50%) daytime triazolam preference (i.e. with a placebo preference). In the triazolam preference group, triazolam reduced daily MSLT latencies to the level of the placebo preference group. CONCLUSIONS: This study shows that the minority of insomniacs who self-administer hypnotics during the day are physiologically aroused and the drug reduces their arousal suggesting that their daytime self-administration, like their night-time self-administration, is more consistent with therapy-seeking than drug-seeking behavior, at least for the short-term.

Adult↗
PubMed2002

Management of insomnia--the role of zaleplon.

CONTEXT: Insomnia is the most frequently reported sleep symptom, severely affecting up to 15% of the US population. The need to effectively treat this disorder is underscored by the significant adverse consequences on the productivity, safety, overall health, and quality of life of the affected individual. Pharmacologic intervention has traditionally involved the use of benzodiazepine receptor agonists (BzRAs), for which efficacy and general safety have been established. OBJECTIVE: The purpose of this paper is to examine the potentially unique role of zaleplon in the treatment of insomnia. DATA SOURCE: The clinical experience of the authors was critically applied to peer-reviewed published papers or abstracts regarding zaleplon, which were identified via MEDLINE (1995-September 2000). RESULTS: Adverse effects, usually related to residual sedation, impose limits on the use of older BzRAs and have prompted the development of new sleep medications with advantageous adverse event profiles. Zaleplon demonstrates a very rapid onset and offset of effect that permits symptomatic rather than prophylactic administration, resulting in comparable efficacy and reduced risk of the adverse effects associated with longer half-life agents. CONCLUSIONS: The characteristics of zaleplon may translate into distinct and significant clinical advances in the treatment of insomnia.

Acetamides↗
PubMed2002

Prevalence of restless legs syndrome and periodic limb movement disorder in the general population.

BACKGROUND: Periodic limb movement disorder (PLMD) and restless legs syndrome (RLS) are two sleep disorders characterized by abnormal leg movements and are responsible for deterioration in sleep quality. However, the prevalence of these disorders is not well known in the general population. This study aims to document the prevalence of RLS and PLMD in the general population and to identify factors associated with these conditions. METHODS: Cross-sectional studies were performed in the UK, Germany, Italy, Portugal and Spain. Overall, 18,980 subjects aged 15 to 100 years old representative of the general population of these five European countries underwent telephone interviews with the Sleep-EVAL system. A section of the questionnaire assessed leg symptoms during sleep. The diagnoses of PLMD and RLS were based on the minimal criteria provided by the International Classification of Sleep Disorders. RESULTS: The prevalence of PLMD was 3.9% and RLS was 5.5%. RLS and PLMD were higher in women than in men. The prevalence of RLS significantly increased with age. In multivariate models, being a woman, the presence of musculoskeletal disease, heart disease, obstructive sleep apnea syndrome, cataplexy, doing physical activities close to bedtime and the presence of a mental disorder were significantly associated with both disorders. Factors specific to PLMD were: being a shift or night worker, snoring, daily coffee intake, use of hypnotics and stress. Factors solely associated with RLS were: advanced age, obesity, hypertension, loud snoring, drinking at least three alcoholic beverages per day, smoking more than 20 cigarettes per day and use of SSRI. CONCLUSIONS: PLMD and RLS are prevalent in the general population. Both conditions are associated with several physical and mental disorders and may negatively impact sleep. Greater recognition of these sleep disorders is needed.

Adolescent↗
PubMed2002

Substance use for insomnia in Metropolitan Detroit.

OBJECTIVE: People with insomnia are not typically treated medically for their insomnia. Studies have reported approximately 30% of insomniacs self-medicate with alcohol or over-the-counter (OTC) medications. This study was done to identify determinants and risks of different insomnia therapeutics. METHODS: A random-digit-dial, computer-assisted survey of a representative sample of adults in Metropolitan Detroit, aged 18-65 years, is being conducted. A sample of all respondents over an 18-month period was collected (n=1324) with a 68% response rate. Exclusive past-year use of alcohol for sleep was reported by 10% (n=132), prescription medications by 8% (n=108), and OTC medications by 10% (n=135). Five percent used both alcohol and sleep medications. The three exclusive-use groups formed the comparison groups of the study. RESULTS: The prescription drug group used medications for more consecutive nights and for more total nights than the alcohol and OTC users. Alcohol users were predominantly male, while OTC and prescription drug users were predominantly female. Alcohol users were more likely to be single than the others, and prescription drug users were older than the others. Prescription drug users had more severe insomnia and had greater disability, neuroticism, and daytime fatigue than the others. In contrast, the alcohol users had greater daytime sleepiness than the others. CONCLUSIONS: In Metropolitan Detroit, insomniacs receiving medical treatment have more severe insomnia and greater disability than those who self-treat. However, while the insomnia of those self-treating is less severe, it is still associated with some risks.

Adolescent↗
PubMed2002

Disturbed sleep predicts hypnotic self-administration.

OBJECTIVES: To evaluative whether polysomnographically determined sleep variables in a large group of subjects reflecting a wide range of sleep disturbance would be predictive of the self-administration of capsules before sleep. METHODS: Sixty-four healthy men and women with and without insomnia (aged 21-55 years) were given an opportunity to self-administer placebo or triazolam (0.25 mg) capsules (single-choice method - available capsule or no capsule) before sleep in three separate studies. All qualified using the identical criteria based on a standard nocturnal polysomnogram. Screening sleep measures then were used to predict subsequent placebo and triazolam self-administration. RESULTS: The percent of placebo and triazolam choices did not differ between or within the three studies. Persons with persistent psychophysiologic insomnia self-administered more capsules than persons with sleep state misperception or normals, with the subject groups not differing in placebo vs. active drug preference. Screening polysomnographic measures predicted percent of capsule choices. The single best predictor was the ratio of minutes of stage 3-4 sleep to minutes of wake plus stage 1 sleep with R=0.44. The addition of % stage 3-4 sleep, wake before sleep and total sleep time increased R to 0.49. On morning mood ratings less ability to concentrate and greater fatigue (Profile of Mood States) predicted percent of capsule choices with R=0.36. CONCLUSIONS: These results show that the extent of sleep disturbance predicts the likelihood of self-administering a capsule before sleep regardless of whether it is placebo or active drug.

Journal Article↗
PubMed2002

A new questionnaire to detect sleep disorders.

OBJECTIVES: Sleep disorders remain largely undiagnosed in the general population. The current study assessed whether the Global Sleep Assessment Questionnaire (GSAQ) could: (1), distinguish between sleep disorders (including no sleep disorder); (2), be a reliable and valid sleep disorder screener; and (3), serve as a practical, user-friendly screening tool for primary care and sleep centers. METHODS: Two hundred and twelve adults from five sleep centers and two primary care clinics completed the GSAQ and received confirmed diagnoses from a sleep specialist. Of the 212 patients, 139 (65.6%) had at least one sleep disorder, 60 (28.3%) had two or more sleep disorders, and 13 (6.1%) had no confirmed sleep disorder. Ninety-one (43%) individuals completed the GSAQ a second time for reliability testing. Scores for each sleep disorder including, but not limited to, primary insomnia (I), insomnia associated with a mental disorder (IME), obstructive sleep apnea (OSA), periodic limb movement (PLM), and parasomnia (P) were computed. The sensitivity and specificity were estimated using comprehensive clinical diagnosis as the gold standard and mean domain scores as a cutpoint. RESULTS: The mean participant age was 45 years, 52% were female. Observed frequencies were: 36 (I), 14 (IME), 31 (OSA), 7 (PLM) and 4% (P). Test-retest reliability ranged from 0.51 to 0.92. Pearson correlation coefficients suggested that the GSAQ discriminated between diagnoses. The sensitivities and specificities were 79/57, 83/51, 93/58, 93/52, and 100/49 for I, IME, OSA, PLM, and P, respectively. CONCLUSIONS: Our findings suggest that the GSAQ can aid in recognizing sleep disorders. Future studies should focus on characterizing its predictive values in primary care settings.

Journal Article↗
PubMed2002

Tolerance to daytime sedative effects of H1 antihistamines.

Sedation is the principal side effect of first generation H1 antihistamines, and recent studies have suggested that this side effect should limit the clinical application of these drugs. The sedative effect also underlies the use of these first-generation drugs as nonprescriptive remedies for insomnia. In both cases, the potential for tolerance to the sedative effect of these drugs is an important issue for which there are few objective data. In the study reported here, 15 healthy men age 18 to 50 years received either diphenhydramine 50 mg or placebo twice a day for 4 days in a randomized, double-blind, crossover trial design. Dependent measures included objective and subjective assessments of sleepiness and computer-based tests of psychomotor performance. Both objective and subjective measures of sleepiness showed significantly higher levels on day 1 for diphenhydramine compared to placebo. By day 4, however, levels of sleepiness on diphenhydramine were indistinguishable from placebo. Similarly, diphenhydramine produced significant impairment of performance that was completely reversed by day 4. These data provide the first objective confirmation that tolerance develops to the sedative effect of a prototypical first-generation H1 antihistamine, diphenhydramine. On this dosing regimen, tolerance was complete by the end of 3 days of administration. While other antihistamines and dosing regimens may differ, these results suggest that tolerance to the sedation produced by these drugs develops with remarkable rapidity.

Adolescent↗