World Association of Sleep Medicine (WASM) 2016 standards for recording and scoring leg movements in polysomnograms developed by a joint task force from the International and the European Restless Legs Syndrome Study Groups (IRLSSG and EURLSSG).

This report presents the results of the work by a joint task force of the International and European Restless Legs Syndrome Study Groups and World Association of Sleep Medicine that revised and updated the current standards for recording and scoring leg movements (LM) in polysomnographic recordings (PSG). First, the background of the decisions made and the explanations of the new rules are reported and then specific standard rules are presented for recording, detecting, scoring and reporting LM activity in PSG. Each standard rule has been classified with a level of evidence. At the end of the paper, Appendix 1 provides algorithms to aid implementation of these new standards in software tools. There are two main changes introduced by these new rules: 1) Candidate LM (CLM), are any monolateral LM 0.5-10 s long or bilateral LM 0.5-15 s long; 2) periodic LM (PLM) are now defined by runs of at least four consecutive CLM with an intermovement interval ≥10 and ≤ 90 s without any CLM preceded by an interval <10 s interrupting the PLM series. There are also new options defining CLM associated with respiratory events. The PLM rate may now first be determined for all CLM not excluding any related to respiration (providing a consistent number across studies regardless of the rules used to define association with respiration) and, subsequently, the PLM rate should also be calculated without considering the respiratory related events. Finally, special considerations for pediatric studies are provided. The expert visual scoringof LM has only been altered by the new standards to require accepting all LM > 0.5 s regardless of duration, otherwise the technician scores the LM as for the old standards. There is a new criterion for the morphology of LM that applies only to computerized LM detection to better match expert visual detection. Available automatic scoring programs will incorporate all the new rules so that the new standards should reduce technician burden for scoring PLMS.

Adjunct armodafinil improves wakefulness and memory in obstructive sleep apnea/hypopnea syndrome.

OBJECTIVE: Armodafinil is the R-enantiomer of racemic modafinil and has a significantly longer half-life than the S-enantiomer. This study evaluated armodafinil 150 mg/day as an adjunct treatment for residual excessive sleepiness in patients with obstructive sleep apnea/hypopnea syndrome (OSA/HS) who were otherwise well controlled with nasal continuous positive airway pressure (nCPAP). We assessed the ability of armodafinil to improve wakefulness and cognition and reduce fatigue in this population. METHODS: In this 12-week, randomized, double-blind study, patients (n=259) received armodafinil (150 mg) or placebo once daily. Efficacy assessments at baseline and weeks 4, 8, and 12 included the Maintenance of Wakefulness Test (MWT), Clinical Global Impression of Change (CGI-C), Cognitive Drug Research battery, Epworth Sleepiness Scale, and Brief Fatigue Inventory. RESULTS: At final visit, mean (SD) MWT sleep latency increased from baseline by 2.3 (7.8) min with armodafinil and decreased by 1.3 (7.1) min in the placebo group (P=0.0003). Armodafinil improved clinical condition (CGI-C, 71% vs. 53% for armodafinil and placebo, respectively; P=0.0069). Armodafinil significantly improved episodic secondary memory (P=0.0102) and patient-estimated wakefulness (P<0.01) and reduced fatigue (P<0.05) compared with placebo. Armodafinil did not adversely affect nCPAP use. The most common adverse event associated with armodafinil was headache. Sleep macroarchitecture was not altered by armodafinil. CONCLUSION: Adjunct treatment with armodafinil significantly improved alertness, overall clinical condition, and long-term memory. Armodafinil also reduced fatigue and the impact of sleepiness on daily activities in patients with OSA/HS who have residual excessive sleepiness notwithstanding regular use of nCPAP. Armodafinil was well tolerated.

Practice parameters for the use of laser-assisted uvulopalatoplasty: an update for 2000.

Laser-assisted uvulopalatoplasty (LAUP) is an outpatient surgical procedure which is in use as a treatment for snoring. LAUP also has been used as a treatment for sleep-related breathing disorders, including obstructive sleep apnea. The Standards of Practice Committee of the American Academy of Sleep Medicine reviewed the available literature, and developed these practice parameters as a guide to the appropriate use of this surgery. Adequate controlled studies on the LAUP procedure for sleep-related breathing disorders were not found in peer-reviewed journals. This is consistent with findings in the original practice parameters on LAUP published in 1994. The following recommendations are based on the review of the literature: LAUP is not recommended for treatment of sleep-related breathing disorders. However, it does appear to be comparable to uvulopalatopharyngoplasty (UPPP) for treatment of snoring. Individuals who are candidates for LAUP as a treatment for snoring should undergo a polysomnographic or cardiorespiratory evaluation for sleep-related breathing disorders prior to LAUP and periodic postoperative evaluations for the development of same. Patients should be informed of the best available information of the risks, benefits, and complications of the procedure.

Practice parameters for the treatment of narcolepsy: an update for 2000.

Successful treatment of narcolepsy requires an accurate diagnosis to exclude patients with other sleep disorders, which have different treatments, and to avoid unnecessary complications of drug treatment. Treatment objectives should be tailored to individual circumstances. Modafinil, amphetamine, methamphetamine, dextroamphetamine, methylphenidate, selegiline, pemoline, tricyclic antidepressants, and fluoxetine are effective treatments for narcolepsy, but the quality of published clinical evidence supporting them varies. Scheduled naps can be beneficial to combat sleepiness, but naps seldom suffice as primary therapy. Regular follow up of patients with narcolepsy is necessary to educate patients and their families, monitor for complications of therapy and emergent of other sleep disorders, and help the patient adapt to the disease.

Long-term efficacy and safety of modafinil (PROVIGIL((R))) for the treatment of excessive daytime sleepiness associated with narcolepsy.

Objectives: To assess the long-term efficacy and safety of modafinil in patients with excessive daytime sleepiness (EDS) associated with narcolepsy.Background: Modafinil has been shown to be effective and well tolerated for treating EDS associated with narcolepsy in two large-scale, well-controlled, 9-week clinical trials.Methods: Four hundred and seventy eight adult patients with a diagnosis of narcolepsy who had completed one of two 9-week, double-blind, placebo-controlled, multicenter, clinical trials of modafinil were enrolled in two 40-week, open-label, extension studies. A flexible-dose regimen (i.e. 200, 300, or 400 mg daily) was followed in one study. In the second study, patients received 200 mg/day for 1 week, followed by 400 mg/day for 1 week. Investigators then prescribed either 200- or 400-mg doses for the duration of the study. Efficacy was evaluated using Clinical Global Impression of Change (CGI-C) scores, the Epworth Sleepiness Scale (ESS), and the 36-item Medical Outcomes Study health survey (SF-36). Adverse events were recorded. Data from the two studies were combined.Results: The majority of patients ( approximately 75%) received 400 mg of modafinil daily. Disease severity improved in >80% of patients throughout the 40-week study. At weeks 2, 8, 24, and 40, disease severity was 'much improved' or 'very much improved' in 49, 58, 59, and 58% of patients, respectively. The mean (+/-SEM) ESS score improved significantly from 16.5+/-0.2 at open-label baseline to 12.4+/-0.2 at week 2 and remained at that level through week 40 (P<0.001). Quality of life scores at weeks 4, 8, 24, and 40 were significantly improved versus open-label baseline scores for six of the eight SF-36 domains (P<0.001). The most common treatment-related adverse events were headache (13%), nervousness (8%), and nausea (5%). Most adverse events were mild to moderate in nature. A total of 341 patients (71%) completed the studies. Forty-three patients (9.0%) discontinued treatment because of adverse events.Conclusions: Modafinil is effective for the long-term treatment of EDS associated with narcolepsy and significantly improves perceptions of general health. Modafinil is well tolerated, with no evidence of tolerance developing during 40 weeks of treatment.

Tobacco withdrawal signs and symptoms among women with and without a history of depression.

A past history of depression is associated with a decreased likelihood of quitting smoking. Tobacco withdrawal may be a mechanism through which depression history impedes smoking cessation. This research examined the influence of depression history on unmedicated tobacco withdrawal signs (polysomnographic measures of sleep) and symptoms (self-reported urge, negative affect, hunger, and sleep) among women (N= 13). Depression history was associated with differential withdrawal-induced changes in several REM sleep parameters. Self-report and other polysomnography (sleep fragmentation, slow-wave sleep) measures displayed statistically significant withdrawal effects but did not discriminate between depression history groups. These results suggest that REM sleep parameters may be sensitive to differential tobacco withdrawal responses that are not readily apparent through self-reported symptoms.

Sleep latency on the maintenance of wakefulness test (MWT) for 530 patients with narcolepsy while free of psychoactive drugs.

OBJECTIVES: To compare maintenance of wakefulness test (MWT) data gathered at baseline in the course of two, multicenter studies on the therapeutic efficacy of modafinil with published MWT norms. METHODS: The MWT is a procedure that uses electrophysiological measures to determine the ability to remain awake while sitting in a quiet, darkened room. The test consists of 4 20 min trials conducted 4 times at 2 h intervals commencing 2 h after awakening from a night of sleep. MWT data were gathered at baseline in the course of two, multicenter studies on the therapeutic efficacy of modafinil. Subjects were 17-68 year old men (n = 239) and women (n = 291) diagnosed with narcolepsy according to the International Classification of Sleep Disorders (ICSD). All patients were free of psychoactive medication for a minimum of 14 days. RESULTS: Mean MWT sleep latency was 6.0 +/- 4.8 min. However, the mean for the first MWT trial was 7.0 min which was longer that the means for the following 3 trials (5.8, 5.6 and 5.7 min, respectively). The 4 distributions of the individual MWT trials were similar and adequately summarized by the distribution of the average MWT sleep latency. As a group, patients with narcolepsy were less able to remain awake than normals; only 8 of 530 (1.5%) patients were able to remain awake on 4 20 min MWT trials compared with 35 of 64 (54.7%) normals in another study. However, using a mean MWT sleep latency of 12 min (the 5th percentile for normals) as the lowest cut-point for normalcy, 15% of patients with narcolepsy appeared to have an unimpaired ability to remain awake. CONCLUSIONS: The diagnosis of narcolepsy did not always predict inability to remain awake on the MWT. Age, gender and the duration of illness did not predict ability to remain awake. Patients with severe cataplexy and other ancillary symptoms were least able to remain awake on MWT trials. Patients who used tobacco and caffeine moderately had the lowest MWT sleep latencies relative to patients with heavy and light use.

Evaluation of erectile dysfunction and sleep-related erections.

Significant advances in this past decade have improved our understanding of erectile physiology. A variety of tests are available for diagnosing impotence. SRE testing provides objective physiological information that is useful for indexing erectile capability and formulating a rational treatment plan. As such, SRE testing is a powerful noninvasive tool for assessing dysfunction. Nonetheless, in making a final diagnosis, the skillful clinician relies on more than one assessment parameter and on clinical acumen.

Androgen and sleep-related erections.

Sleep-related penile erections provide a unique opportunity to objectively study erectile physiology in man. Testosterone is one of several factors involved in normal sexual function and testosterone reduction can be achieved by administering luteinizing-hormone releasing-hormone agonists (LHRH-A). In this study, ten healthy, young adult males were administered LHRH-A or placebo for a 12-week period. Subjects taking LHRH-A had a marginally significant decline in sleep-related erection duration at week 4 and significant reductions at weeks 8 and 12. By contrast, no statistically reliable change was found for the number of erections over the course of study. Maximum circumference increase during sleep erections showed mixed results. These results indicate that, whereas androgen reduction adversely affects sleep-related erections, it does not eliminate them over a 12-week trial in healthy young adult men. Further study in a larger sample is needed. Nonetheless, these preliminary findings support androgen having an important role in sleep-related erections.

Sleep-related erections: absence of change following presleep sexual arousal.

We examined the effects of a brief period of sexual arousal before sleep on sleep-related erections (SREs) to add to our knowledge concerning those factors that affect SREs. Twelve subjects watched a 5 minute sexually explicit video before sleep. On other evenings they watched a dysphoric arousal video or a lecture (neutral) video. Sleep and SREs were recorded throughout the following night. Although the brief sexual arousal video produced a full or near full erection in all subjects, no significant effect on subsequent SREs occurred. We conclude that the control of SREs in young healthy subjects is insulated against the effect of a brief period of sexual arousal before sleep.

Sleep-related erectile activity.

Sleep-related erections occur in all healthy, potent men in close temporal association with REM sleep. These erections are naturally occurring and can be assessed quantitatively. The nocturnal tumescence cycle seems unaffected by behavioral factors. Furthermore, sleep-related erections are present across the life span with only a slight decline in older healthy people. Analogous phenomena are present in women. The function of sleep-related erections is not known; however, they clearly involve vascular, neurologic, and hormonal mechanisms. Sleep-related erection testing provides a physiologic, objective, diagnostically useful technique for evaluating erectile capacity. Laboratory-based studies with comprehensive polysomnography offer the most complete diagnostic picture of erectile function available. Nonlaboratory procedures require further validation. The sleep-related tumescence pattern contains a wealth of information about the physiology and pathophysiology of erection. The coordination between REM sleep and erection, the differential expansion at the penile base and upper shaft, and the rate of circumference increase and decrease are meaningful indicators for determining if erectile dysfunction exists. Sleep-related erection testing indexes the magnitude and nature of organic involvement and takes the differential diagnosis of impotence beyond a simplistic psychogenic-organic dichotomy.

CPAP machine performance and altitude.

UNLABELLED: STUDY RATIONALE AND OBJECTIVE: Sleep-disordered breathing is commonly treated with nasally applied continuous positive airway pressure (CPAP). Typically, pressures are titrated to pneumatically splint the airway to prevent its collapse in response to negative inspiratory pressure. This investigation was prompted by several patient complaints of sleep-related breathing difficulty associated with travel to high altitudes. CPAP devices create pressure with fan-generated airflow; therefore, CPAP performance should behave according to collective fan laws. MEASUREMENTS AND RESULTS: In the present study, we examined the effect of simulated altitude change on four commercially available CPAP machines. Machines were tested using anatomic airway mannequins in an altitude chamber. We made three simulated ascents to 12,000 feet with machines set at 5, 10, and 12 cm H2O sea level pressure equivalents. We measured pressure using water manometers at 2,000-foot increments during ascent and descent. Mask pressures varied systematically with changing altitude in three machines. One machine, equipped with a pressure regulation feature, maintained pressure within 1 mm H2O at all pressure and altitude combinations. CONCLUSIONS: Altitude significantly alters delivered pressure according to predictions made by the fan laws, unless a unit has pressure-compensating features. Clinicians should consider this factor when CPAP is prescribed for patients who live or travel to places located at significantly higher or lower elevations than the titration site.

Inhibition of steroid 5 alpha-reductase with finasteride: sleep-related erections, potency, and libido in healthy men.

To objectively measure the effects of a 5 alpha-reductase inhibitor on erectile function, we studied 20 sexually active men (aged 41-64 yr) during double blind, randomized administration of 5 mg/day finasteride (F) or placebo (P). Serum testosterone and dihydrotestosterone (DHT) were measured every 4 weeks. Sleep-related erections were assessed with comprehensive polysomnography for 2 nights before randomization (session 1) and at week 12 (session 2). Sexual function questionnaires were administered weekly. Serum DHT levels at week 0 were 1.47 +/- 0.11 and 1.16 +/- 0.27 nmol/L (P > 0.05) in the P and F groups, respectively. F group levels fell to 31% and 28% of control values at week 4 and 12. Penile tip peak tumescence time increased on second nights more in the P than the F group at 12 weeks, producing a session main effect (P < 0.02) and a group X session interaction (P < 0.05). No significant group X session interactions were found for any sleep erection measures in a best night analysis or for self-reported sexual activity. Thus, F did not consistently suppress sleep-related erections compared to P. F primarily inhibits type 2 5 alpha-reductase activity; however, type 1 5 alpha-reductase is the major enzyme in the central nervous system. Therefore, DHT involvement in the maintenance of libido and potency is not excluded. Nonetheless, these data support the feasibility of using a type 2 inhibitor to treat benign prostatic hyperplasia without impairing erectile function.

Issues in computerized polysomnography.

Reliable, properly tested, computerized systems for recording and scoring polysomnographic data would be welcome assistants in sleep laboratories. They potentially could save time, effort, paper, storage and cost. There exists, however, questions of competence and confidence. The nature and scope of published literature fails to convince many cautious sleep specialists that the cost-benefit ratio is favorable. Nonetheless, computerized systems for polysomnography are here to stay and are improving. Most of us represent past, present or future consumers of these products. The market will adjust to our level of knowledge and demands. We can adopt a variety of perspectives; however, the three basic modes of use should guide our thinking. For clarity, it is helpful to dissect 1) recording issues, 2) scoring issues and 3) monitoring issues from one another. Also, we should insist on greater statistical sophistication in testing trials. Manufacturers face a dilemma. Sleep disorders medicine has few true standards and many idiosyncratic practices. The expertise of consultants vary and manufacturers may be in no position to judge their collaborators. We desperately need guidelines to meet both manufacturers' and clinicians' expectations for testing and using computerized polysomnography.

Nocturnal penile tumescence in cigarette smokers with erectile dysfunction.

We examined the relationship between cigarette smoking and erectile physiology in 314 men with erectile dysfunction. All of the men studied were currently cigarette smokers. Evaluations included interviews, physical examinations, and polysomnographic assessment of sleep-related erections. Penile rigidity during nocturnal erection inversely correlated with the number of cigarettes smoked per day. Smoking was also associated with indices of impairment on autonomic function tests and some measures of penile blood pressure. The group of men who smoked the most (more than 40 cigarettes per day) had the fewest minutes of nocturnal tumescence and detumesced fastest. These data are discussed with respect to the results of studies performed in dogs that demonstrated smoking-related reduction in arterial flow and venous restriction. Our findings suggest that smoking may further compromise penile physiology in men experiencing difficulty in maintaining erections long enough for satisfactory intercourse.