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PubMedDate not supplied

The effectiveness of diphenhydramine HCI in pediatric sleep disorders.

Fifty children with a variety of sleep disorders were studied in a placebo-controlled, double-blind clinical trial of diphenydramine elixir given in a dosage of 1.0 mg/kg at bedtime. Sleep records measuring latency time, number of awakenings, and duration of sleep were compiled by the patient's parent. A global assessment as to the severity of sleep disturbance and the therapeutic effect of the medication and placebo was made on a weekly basis. Diphenhydramine was significantly better than placebo in reducing sleep latency time and the number of awakenings per night, while sleep duration was marginally increased. There were no essential differences between diphenhydramine and placebo in the other study parameters, i.e., restlessness, nightmares, and difficulty awakening. Diphenhydramine was judged to be more effective than placebo on the weekly global assessment. The results indicate that diphenhydramine is a safe, effective bedtime sleep aid for pediatric patients.

Child↗

PubMed2000

Periodic limb movements in sleep: state-dependent excitability of the spinal flexor reflex.

OBJECTIVE: To test the hypothesis that periodic limb movements (PLMs) are related to spinal flexor reflexes (FRs), the authors compared the state-dependent changes in FR excitability in 10 patients with restless legs syndrome (RLS) and PLMs with those from matched controls. BACKGROUND: PLM is a disorder of motor control during sleep, frequently occurring in RLS. Clinically, PLMs resemble spinal FRs. METHODS: FRs were obtained by electrically stimulating the medial plantar nerve and recording from antagonist leg and thigh muscles bilaterally. RESULTS: Compared with controls, patients had significantly increased spinal cord excitability, as indicated by lower threshold and greater spatial spread of the FR, which was more prominent during sleep. Multiple late responses were seen during sleep in all patients and in some controls at higher threshold. The most prominent of these responses had a very long duration and a latency range of 250 to 800 msec, and because of its close temporal relationship to the FR stimulus, the authors considered it was a late, high-threshold component of the FR (FR3). The authors also found a similarity between the pattern of muscle recruitment and spatial spread of late components of the FR and those of spontaneous PLMs. CONCLUSIONS: The results support the hypothesis that PLMs in RLS and FRs share common spinal mechanisms and suggest that PLMs may result from enhanced spinal cord excitability in RLS patients. Because dopaminergic mechanisms are involved in spinal FR control, the results are consistent with the current view that RLS is a disorder of dopaminergic function.

Adult↗

PubMed2006

Ropinirole is effective in the long-term management of restless legs syndrome: a randomized controlled trial.

The objective of this study was to investigate the long-term efficacy of ropinirole in patients with restless legs syndrome (RLS) and to assess the potential for relapse after the discontinuation of active treatment. Patients with primary RLS (n = 202) received single-blind ropinirole for 24 weeks. Patients meeting treatment continuation criteria were randomized to double-blind treatment with ropinirole or placebo for a further 12 weeks. The primary efficacy variable was the proportion of patients relapsing during double-blind treatment. Additional efficacy measures included time to relapse, withdrawals due to lack of efficacy, improvement on the Clinical Global Impression-Improvement (CGI-I) scale, change in International Restless Legs Scale (IRLS) score during double-blind treatment, and changes in sleep and quality of life (QoL) parameters. Significantly fewer patients relapsed on ropinirole than on placebo (32.6% vs. 57.8%; P = 0.0156). Time to relapse was longer with ropinirole and more patients withdrew due to lack of efficacy with placebo. Patients showed improvements in IRLS and CGI-I scores, sleep and QoL parameters with single-blind ropinirole, which were better maintained when ropinirole was continued during the double-blind phase, but reduced with placebo. Ropinirole was well tolerated; adverse events were typical for dopamine agonists. Ropinirole was highly effective and well tolerated in the long-term management of RLS, with pharmacological effect over 36 weeks.

Adolescent↗

PubMed2001

Opioid and dopamine antagonist drug challenges in untreated restless legs syndrome patients.

Background: The restless legs syndrome (RLS) is a common sensomotor disorder associated with severe sleep disturbances. Symptoms clearly improve following treatment with dopaminergic or opioidergic agonists.Objective: To further elucidate the involvement of opioidergic and dopaminergic mechanisms in the pathophysiology of RLS, the effects of specific antagonists on motor (periodic leg movements) and subjective (sensory) RLS-symptoms during daytime were assessed.Methods: A modified suggested immobilization test was performed in eight drug-naive RLS-patients. An infusion of either naloxone, metoclopramide or placebo was administered. In addition, the hormonal levels of adrenocorticotropic hormone, cortisol, prolactin and growth hormone were determined, to elucidate a possible involvement of the hypothalamic-pituitary-adrenocortical (HPA) system in RLS.Results: RLS sensory or motor symptoms could not be provoked. Hormonal responses showed no abnormal profiles.Conclusions: Rather than a general alteration of the opioidergic/dopaminergic tone and an involvement of the HPA system, it is more likely that specific neuronal dopaminergic or opioidergic pathways are altered in the pathophysiology of RLS.

Journal Article↗

PubMed1975

The exerience of pain in depressed patients. A clinical and experimental study.

An experience of pain according to Merskey's definition was found in 24 out of 40 consecutive patients with depressive disorders. No age or sex differences were found between patients with and those without an experience of pain. In a comparison of ratings using the Cronholm-Ottosson depression rating scale, patients with an experience of pain were found to have a more severe type of depression, more psychic and vegetative anxiety, more motoric restlessness, more local tension, more thoughts of suicide, more hypochondriacal ideas, more sleep disturbances and a higher total depression score. On the other hand, no difference was found as regards depressive ideas, intellectual, conative or emotional inhibition or psychomotoric retardation. In the experimental part of the study, 30 patients -- 18 with an experience of pain -- were investigated with pain measures and visual averaged evoked responses. No differences were found in pain measures between patients with and those without an experience of pain. Out of 18 patients with an experience of pain, 15 were found to be augmenters as measured by visual averaged evoked responses. In the group of patients without pain only 4 out of 12 patients were augmenters.

Adjustment Disorders↗

PubMed1999

[Sedation in the terminal phase of life].

In 2 patients, a woman aged 38 years and a man aged 48 years, in the terminal phase of life due to metastasized+ malignancy, palliative care failed. They suffered seriously from pain, delirium, restlessness, nausea, and fear. Deep sedation was given to induce almost continuous sleep without the intention of causing death. After one and five quiet days respectively the patients died. Deep sedation is an option when palliative care fails to diminish serious suffering. Midazolam, given by continuous subcutaneous infusion is the drug of choice.

Adult↗

PubMed2006

Efficacy and tolerability of ropinirole in patients with restless legs syndrome and a baseline IRLS total score > or = 24 points--data from the ropinirole clinical trial programme.

OBJECTIVE: Results from one of the largest clinical trial programmes to date of a dopamine agonist in patients with primary restless legs syndrome (RLS) have demonstrated that ropinirole, 0.25-4.0 mg once daily 1-3 hours before bedtime, is associated with significant improvements in RLS symptoms, sleep parameters and quality-of-life measures, compared with placebo. Analyses were conducted in a subpopulation of patients with a baseline score on the International Restless Legs Scale (IRLS) of at least 24 points. RESEARCH DESIGN AND METHODS: Data was pooled from four, 12-week, pivotal studies: RESET PLM and TREAT RLS 1, 2 and US. MAIN OUTCOME MEASURES: Covariate analysis demonstrated that the magnitude of treatment difference between ropinirole and placebo for change in IRLS total score (a measure of RLS symptom severity) increased with increasing baseline IRLS total score. Mean treatment difference was > 3 points in patients with a baseline total score > or = 24. Among this population, ropinirole treatment was associated with significant reduction in RLS symptom severity compared with placebo, along with significant improvements in global symptoms and sleep measures. A treatment benefit was also observed for measures of quality of life. Ropinirole is well tolerated in this patient population. CONCLUSIONS: Patients with primary RLS and baseline IRLS total score > or = 24 gain clinically meaningful benefits from ropinirole treatment. As with the overall population in the ropinirole clinical trial programme, ropinirole was associated with improvements in RLS symptoms, global symptoms, sleep and quality of life and was well tolerated in patients with a baseline IRLS total score > or = 24.

Adult↗

PubMed2005

The neurophysiology of the alternating leg muscle activation (ALMA) during sleep: study of one patient before and after treatment with pramipexole.

BACKGROUND AND PURPOSES: To report the neurophysiological features of a patient with alternating leg muscle activation (ALMA) during sleep, a quickly alternating pattern of anterior tibialis activation which might represent transient facilitation of a spinal central pattern generator for locomotion, perhaps due to the serotonergic effects of antidepressant medication. PATIENT AND METHODS: A 33-year-old male patient with ALMA. The patient underwent a complete and detailed study of his neurophysiological parameters during sleep, before and after treatment with pramipexole. RESULTS: The treatment with pramipexole was followed by a significant reduction in the rate of occurrence of ALMA, in reported insomnia, and in daytime sleepiness. The ALMA generally were preceded by cyclic alternating pattern A phases and increased heart rate in most instances. Visual scoring and spectral analyses suggested that after pramipexole more intense arousal was required to trigger ALMA. CONCLUSION: The evident beneficial effect induced by the treatment with pramipexole indicates that the spinal networks involved in the generation of ALMA might also be under the inhibitory control of dopaminergic networks. We suggest that ALMA can be seen even in the absence of other factors such as antidepressant therapy, sleep apnea or periodic leg movements during sleep, and might be considered as an additional phenomenon influenced by sleep instability. Our patient seems to indicate also that treatment with dopamine agonists can be useful in such patients because the treatment can be followed by a good clinical response.

Adult↗

PubMedDate not supplied

Clinical, EEG, electromyographic and polysomnographic studies in restless legs syndrome caused by magnesium deficiency.

The present paper reports biochemical and neurophysiological investigations in ten cases with restless leg syndrome. Other neuropsychiatric affections and factors which could generate the symptomatology of restless legs syndrome were not included. The EEG recordings demonstrated evident reticular neuronal hypersynchrony generated by hyperpnoea (sinusoidal slow waves). The classical EEG investigations pointed out neuromuscular hyperexcitability, but some modifications of the functional parameters of the neuromuscular excitability and conductibility (signs of neuropathy) were also noticed. In all the cases, continuous 8-hour polysomnographic recordings and monitorization on infrared TV screen were performed. Investigations reported: important disorders of sleep organization, agitated sleep with frequent periods of nocturnal awakenings, increase of the durations and percentages of light slow-wave sleep (LSWS) and rapid and frequent changes of various stages of LSWS, a decrease of duration and percentage of DSWS, a decrease of duration and percentage of REM sleep (as in other parasomnias caused by magnesium deficiency) and nocturnal EEG anomalies (long discharges of sinusoidal slow waves, of sharp waves and of sharp slow waves appearing in the LSWS stages with the disappearance in the REM sleep).

Adult↗

PubMed2005

[Hyperactivity in preschoolers: a clinical description].

INTRODUCTION: Hyperactivity is a behavioural development disorder characterised by disruptive motor activity that prevents the individual from establishing adequate social ties and normal communication, which are an essential part of a child's overall development. It is an unspecific symptom of several neurocognitive disorders, the most frequent of which is attention deficit hyperactivity disorder (ADHD). PATIENTS AND METHODS: We present the results of two investigations. In the first, a case-control study, we conducted a comparative analysis of how the parents of 50 children diagnosed with ADHD remember the behaviour of their children during the first 12 months of their lives. The symptoms were separated into 3 clinical profiles (daytime irritability, eating disorders and sleep dysfunctions). Up to 33% of the families reported a history of at least one of these aspects. 41% of the children were described as being excessively restless, crying a lot or irritability, and being easily startled and very sensitive to noises, and 42.7% had difficulty in getting to sleep or displayed intermittent periods of sleep and woke up crying. For the second research project, which was to complement the previous one, we designed a survey which was answered by the parents of 78 patients diagnosed with ADHD. The questionnaire collected information about the first 5 years of life in 4 sections (28 items): behaviour up to the age of one year, psychomotor development, development of play, and the parents' general perception of their child (distracted-inattentive, impulsive, destructive, immature, negativist, oppositional, other). The Rasch mathematical model was used to obtain the clinical profile of the case mix. CONCLUSIONS: The clinical symptoms appear on a continuum throughout the early years of the child's life. The results of our experience allow us to develop a method of clinical examination focused on the evaluation of the individual's development, play, and communication and socialisation skills which can be used to approach the differential diagnosis of the hyperactive preschooler.

Attention Deficit Disorder with Hyperactivity↗

PubMed1996

Persistence of repetitive EEG arousals (K-alpha complexes) in RLS patients treated with L-DOPA.

Compared to normal control subjects, patients with primary restless legs syndrome (RLS) have an increased number of K-complexes, followed by bursts of electroencephalographic (EEG) alpha activity-together these are referred to as K-alpha complexes. In the present study, a large proportion of K-alpha complexes was found to be temporally associated with periodic leg movements in sleep. Because many K-alpha complexes precede the onset of movements, they cannot be considered secondary to the movements themselves. The persistence of K-alpha complexes after suppression of leg movements by means of L-DOPA further supports the hypothesis that these EEG events are a primary phenomenon. The results may have clinical implications because a large proportion of RLS patients complain of non-restorative sleep even after treatment with L-DOPA.

Adult↗

PubMed1996

The cyclic alternating pattern plays a gate-control on periodic limb movements during non-rapid eye movement sleep.

Periodic limb movements in sleep (PLMS) is a disorder characterized by a cyclic pattern of motor phenomena and EEG changes (mostly arousals), both recurring at approximately 20- to 40-s intervals. The periodicity of the PLMS phenomena recalls the physiological EEG arousal rhythm of non-rapid eye movement (NREM) sleep known as the cyclic alternating pattern (CAP). During CAP, arousals and arousal-equivalent features do not appear as isolated events but periodically intrude (phase A) between intervals of background EEG activity (phase B). Though the A phases can be expressed by a variety of EEG patterns, each with a different arousal impact on polygraphic parameters, overall CAP is a sequence of biphasic cycles reflecting a condition of unstable sleep. Twelve middle-aged PLMS subjects complaining of poor sleep were polygraphically compared with 12 age-matched and gender-matched healthy volunteers (controls). With respect to controls, the PLMS recordings showed an enhancement of the more powerful arousals and presented significantly increased amounts of CAP time (+45 min) and CAP rate (+15%). Of all the jerks detected in NREM sleep, 92% occurred in CAP, with the great majority of limb movements (96%) associated with phase A. Ninety-four percent of the nocturnal jerks coupled with phase A started jointly with the onset of the phase or when the latter had already begun. In particular, most of the myoclonic events (67%) occurred in the first 2.5 s of the A phase. The CAP cycles coupled with periodic movements were significantly longer than those without motor events (+6.4 s). Compared to the American Sleep Disorders Association's rules for scoring EEG arousals, the CAP framework offers a more extensive insight into PLMS. In effect, the present study indicates an entrainment of nocturnal myoclonus by means of CAP and sheds light on the complex interactions between arousal mechanisms and motor phenomena during sleep.

Adult↗

PubMed2002

Periodic limb movements in sleep: to treat or not to treat?

BACKGROUND: Approximately 50% of our patients with sleep disturbances have periodic limb movements in sleep (PLMS). We have found that a high PLMS index is not correlated with the severity of symptoms on the Epworth Sleepiness Scale or response to pharmacologic therapy for restless legs syndrome (RLS)/PLMS. We hypothesized that differences in rhythm of contraction, predominance of periodic leg movements (PLMs) in different sleep stages, or PLM interval might distinguish responders from nonresponders. METHODS: We analyzed the hypnograms of 20 consecutive patients with PLMS, noting the number of PLMs and the PLM intervals in different sleep stages, the PLMS index, and the percentage of PLMs that led to arousals. RESULTS: We distinguished two groups of patients. The 13 patients in group A had a PLM arousal percentage of 10.9+/-5% (mean+/-SD), compared with 41.9+/-9% for the seven patients in group B. Group B had a lower PLMS index. Group A showed little variance in PLM intervals and experienced more delta sleep. CONCLUSIONS: PLMS index was not correlated with arousals. A strict rhythm of contractions was associated with fewer arousals and better quality of sleep. This subgroup may not benefit substantially from specific RLS/PLMS therapy.

Journal Article↗

PubMed2000

Differences between men and women on the waiting list for coronary revascularization.

This study aims to examine the situation for patients on the waiting list for possible coronary revascularization in terms of waiting time, treatment and various aspects of well-being in relation to gender. Patients on the waiting list for coronary angiography, percutaneous transluminal coronary angioplasty or coronary artery bypass grafting in September 1990 were approached with a questionnaire dealing with various aspects as described above. Of the 831 patients who participated in the evaluation, 174 (21%) were women. Although age was similar for men and women, men had a higher prevalence of previous myocardial infarction and a lower prevalence of previous hypertension. In terms of medication, women were more frequently treated with diuretics and sedatives than men. Women reported a higher frequency than men with regard to the following symptoms: chest pain at rest and at night, dyspnoea when walking, tachycardia, tiredness, headache, dizziness and sweating. Women also suffered more frequently from difficulty going to sleep, difficulty waking up, repeated awakening and insomnia. Men, on the other hand, suffered more frequently from restlessness, inability to act and irritability. Among patients on the waiting list for possible coronary revascularization, women differed from men by being more frequently treated with diuretics, reporting a higher frequency of various cardiovascular symptoms including chest pain and dyspnoea and, furthermore, reporting more sleeping disorders. Gender differences were found but they were not consistent.

Adult↗

PubMed2006

Ropinirole: new indication. Restless legs: disproportionate adverse effects.

(1) The restless legs syndrome consists of unpleasant sensory and motor symptoms of varying intensity in the lower limbs. Symptoms occur at rest, seated or lying down, are more intense in the evening and at night, and are relieved by moving the limb. This syndrome does not cause serious physical complications. When sleep disturbances occur, non drug methods should be tried first. (2) Ropinirole is a dopaminergic agonist initially marketed for the treatment of Parkinson's disease. It is the first drug to be approved for restless legs syndrome in France. (3) Three double-blind randomised placebo-controlled trials with similar designs showed minimal differences on a composite rating scale. After 12 weeks of treatment, ropinirole led to an improvement of about 3 points on a 40-point scale compared with placebo. (4) A 12-week double-blind randomised controlled trial and including patients who had "responded" to ropinirole showed a lower relapse rate in the group that continued to use ropinirole (32.6%) instead of switching to placebo (57.8%). However, we do not know if this was because of continued drug efficacy or a rebound effect in the placebo group. (5) The adverse effects of ropinirole in patients with restless legs syndrome had already been observed in the treatment of Parkinson's disease, and included nausea, vomiting, drowsiness, a sudden urge to sleep, syncope, hypotension, and hallucinations. (6) An increase in the severity of restless legs symptoms, typically seen with levodopa, was not evaluated in clinical trials of ropinirole. Some cases have nevertheless been reported. They describe the appearance of symptoms increasingly early in the evening, then in the afternoon, or as a rebound effect in the morning or the latter part of the night. Their intensity increases and can affect other parts of the body. (7) In practice, ropinirole has a negative risk-benefit balance in restless legs syndrome, which is a minor health disorder.

Cost-Benefit Analysis↗

PubMed1998

Failure of physician documentation of sleep complaints in hospitalized patients.

Sleep disorders are acknowledged to be common but remain underrecognized by the medical community, often attributed to the failure to question patients about their sleep quality. We examined the prevalence of sleep complaints (insomnia or excessive daytime sleepiness) in a group of general medical patients by administering a questionnaire to hospitalized patients in a Veterans Affairs tertiary care medical center. A total of 222 consecutive adults (215 men, 60 +/- 14 years; body mass index, 24.8 +/- 5.6) completed the questionnaire. Of these, 105 patients (47%) had either insomnia, excessive daytime somnolence, or both; 63 (28%) had excessive daytime somnolence, which was severe in 27 (12%). Of 75 patients (34%) who had insomnia, a third were taking hypnotic medication. Forty patients (18%) had snoring, which was associated with excessive daytime somnolence in 36, whereas 46 patients (21%) had either restless legs or a combination of leg jerks and leg kicking or twitching during sleep, associated with a sleep complaint (insomnia in 32). The medical records were subsequently reviewed to assess the admitting physicians' recognition of these symptoms. No record included mention of any patient symptom related to sleep. We conclude that symptoms related to sleep, some of which may be clinically important, are common, and that none of these complaints appear to be recognized by the physicians of record.

Adult↗

PubMed2006

Sleep-wake habits and disorders in a series of 100 adult epilepsy patients--a prospective study.

The aim of the study was to assess sleep-wake habits and disorders and excessive daytime sleepiness (EDS) in an unselected outpatient epilepsy population. Sleep-wake habits and presence of sleep disorders were assessed by means of a clinical interview and a standard questionnaire in 100 consecutive patients with epilepsy and 90 controls. The questionnaire includes three validated instruments: the Epworth Sleepiness Scale (ESS) for EDS, SA-SDQ for sleep apnea (SA), and the Ullanlinna Narcolepsy Scale (UNS) for narcolepsy. Sleep complaints were reported by 30% of epilepsy patients compared to 10% of controls (p=0.001). The average total sleep time was similar in both groups. Insufficient sleep times were suspected in 24% of patients and 33% of controls. Sleep maintenance insomnia was more frequent in epilepsy patients (52% vs. 38%, p=0.06), whereas nightmares (6% vs. 16%, p=0.04) and bruxism (10% vs. 19%, p=0.07) were more frequent in controls. Sleep onset insomnia (34% vs. 28%), EDS (ESS >or=10, 19% vs. 14%), SA (9% vs. 3%), restless legs symptoms (RL-symptoms, 18% vs. 12%) and most parasomnias were similarly frequent in both groups. In a stepwise logistic regression model loud snoring and RL-symptoms were found to be the only independent predictors of EDS in epilepsy patients. In conclusion, sleep-wake habits and the frequency of most sleep disorders are similar in non-selected epilepsy patients as compared to controls. In epilepsy patients, EDS was predicted by a history of loud snoring and RL-symptoms but not by SA or epilepsy-related variables (including type of epilepsy, frequency of seizures, and number of antiepileptic drugs).

Adult↗

PubMed2005

Alcohol withdrawal as an underrated cause of agitated delirium and terminal restlessness in patients with advanced malignancy.

A significant number of patients with terminal cancer experience terminal restlessness or an agitated delirium in the final days of life. Multifactorial etiologies may contribute to agitation and restlessness for any one patient; alcohol withdrawal may be underrated as a contributing factor. The symptoms and signs of alcohol withdrawal--autonomic dysfunction, tremor, anxiety, sleep disturbances, insomnia, and abnormal vital signs--may continue for 6 to 12 months after the cessation of alcohol. We report four patients with terminal restlessness in whom we believe alcohol withdrawal to be a significant causal factor and a fifth patient who subsequently benefited from our team's increased awareness of this clinical problem. Formal assessment of alcohol withdrawal may be of more value in the palliative setting than using the currently accepted assessment instruments. Many of the medications utilized for the treatment of agitated delirium and terminal restlessness in the palliative care setting are effective therapies for alcohol withdrawal.

Adult↗