Health, Medicine

A Two-Year Randomized Trial of Interventions to Decrease Stress Hormone Vasopressin Production in Patients with Meniere’s Disease—A Pilot Study

by Tadashi Kitahara, Hidehiko Okamoto, Munehisa Fukushima, Masaharu Sakagami, Taeko Ito, Akinori Yamashita, Ichiro Ota, Toshiaki Yamanaka

Meniere’s disease, a common inner ear condition, has an incidence of 15–50 per 100,000. Because mental/physical stress and subsequent increase in the stress hormone vasopressin supposedly trigger Meniere’s disease, we set a pilot study to seek new therapeutic interventions, namely management of vasopressin secretion, to treat this disease. We enrolled 297 definite Meniere’s patients from 2010 to 2012 in a randomized-controlled and open-label trial, assigning Group-I (control) traditional oral medication, Group-II abundant water intake, Group-III tympanic ventilation tubes and Group-IV sleeping in darkness. Two hundred sixty-three patients completed the planned 2-year-follow-up, which included assessment of vertigo, hearing, plasma vasopressin concentrations and changes in stress/psychological factors. At 2 years, vertigo was completely controlled in 54.3% of patients in Group-I, 81.4% in Group-II, 84.1% in Group-III, and 80.0% in Group-IV (statistically I Trial Registration: ClinicalTrials.gov NCT01099046

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Uncategorized

Silent Cerebral Small Vessel Disease in Restless Legs Syndrome

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Study Objectives:

Growing literature suggests that patients with restless legs syndrome (RLS) may be at increased risk for hypertension, heart disease, and stroke. Cerebral small vessel disease (SVD) is a known risk factor for clinical stroke. This study evaluated silent cerebral SVD by MRI in patients with RLS, in the absence of a history of previous clinical stroke or known stroke risk factors and taking into account disease duration.

Methods:

Fifty-three patients with RLS < 10 y were prospectively recruited along with 44 with RLS > 10 y and 74 normal controls. A magnetic resonance imaging study was obtained from all subjects and scans were analyzed for area and volume of SVD.

Results:

There was a significant increase in SVD area in the entire group of RLS patients compared to controls (P = 0.036); this was almost entirely driven by the group with RLS > 10 y. SVD area and volume were significantly increased in patients with RLS > 10 y with respect to both controls (P < 0.0001 and P < 0.0014, respectively) and RLS < 10 y (P < 0.00022 and P < 0.003, respectively). Age, duration of RLS, and the interaction of age and duration of RLS were independent predictors of SVD disease. Duration of RLS was an independent predictor of the burden of cerebral SVD (area P < 0.00012 and volume P < 0.0025), whereas sex and insomnia were not.

Conclusion:

RLS duration should be taken into account when analyzing the association between RLS and cerebrovascular disease; our data support the hypothesis that a long-lasting RLS and its accompanying periodic limb movements in sleep are a risk factor for silent SVD and perhaps for the development of clinical stroke.

Citation:

Ferri R, Cosentino FI, Moussouttas M, Lanuzza B, Aricò D, Bagai K, Wang L, McLaughlin B, Walters AS. Silent cerebral small vessel disease in restless legs syndrome. SLEEP 2016;39(7):1371–1377.

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Uncategorized

Effect of Oral JZP-110 (ADX-N05) on Wakefulness and Sleepiness in Adults with Narcolepsy: A Phase 2b Study

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Study Objectives:

To evaluate the efficacy and safety of oral JZP-110, a second-generation wake-promoting agent with dopaminergic and noradrenergic activity, for treatment of impaired wakefulness and excessive sleepiness in adults with narcolepsy.

Methods:

This was a phase 2b, randomized, double-blind, placebo-controlled, parallel-group trial conducted at 28 centers in the United States. Patients were adults with narcolepsy who had baseline scores ≥ 10 on the Epworth Sleepiness Scale (ESS) and baseline sleep latency ≤ 10 min on the Maintenance of Wakefulness Test (MWT). Patients received a daily placebo (n = 49) or JZP-110 (n = 44) 150 mg/day weeks 1–4 and 300 mg/day weeks 5–12. Primary efficacy endpoints were change from baseline in average MWT sleep latency, and the Clinical Global Impression-Change (CGI-C); secondary endpoints were change from baseline in ESS score and Patient Global Impression-Change.

Results:

Improvements were significantly greater with JZP-110 versus placebo on mean MWT sleep latency (4 w, 9.5 versus 1.4 min, P < 0.0001; 12 w, 12.8 versus 2.1 min, P < 0.0001), percentage of patients with CGI-C improvement (4 w, 80% versus 51%, P = 0.0066; 12 w, 86% versus 38%, P < 0.0001), and mean change in ESS (4 w, −5.6 versus −2.4, P = 0.0038; 12 w, −8.5 versus −2.5, P < 0.0001). Three JZP-110-treated patients (6.8%) discontinued due to adverse events (AEs). The most common AEs with JZP-110 versus placebo were insomnia (23% versus 8%), headache (16% versus 10%), nausea (14% versus 6%), diarrhea (11% versus 6%), decreased appetite (14% versus 0%), and anxiety (11% versus 0%).

Conclusions:

At doses of 150–300 mg/day, JZP-110 was well tolerated and significantly improved the ability to stay awake and subjective symptoms of excessive sleepiness in adults with narcolepsy.

Clinical Trials Registration:

Clinicaltrials.gov identifier NCT01681121.

Citation:

Ruoff C, Swick TJ, Doekel R, Emsellem HA, Feldman NT, Rosenberg R, Bream G, Khayrallah MA, Lu Y, Black J. Effect of oral JZP-110 (ADX-N05) on wakefulness and sleepiness in adults with narcolepsy: a phase 2b study. SLEEP 2016;39(7):1379–1387.

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Uncategorized

Psychosocial Profile and Quality of Life in Children With Type 1 Narcolepsy: A Case-Control Study

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Study Objectives:

To investigate behavioral aspects and quality of life in children and adolescents with type 1 narcolepsy (NT1).

Methods:

We performed a case-control study comparing 29 patients with NT1 versus sex- and age-matched patients with idiopathic epilepsy (n = 39) and healthy controls (n = 39). Behavior and quality of life were evaluated by self-administered questionnaires (Child Behavior Checklist, Pediatric Quality of Life Inventory). Patient groups were contrasted and scale results were correlated with clinical and polysomnographic parameters, and cerebrospinal fluid hypocretin-1 levels.

Results:

Young patients with NT1 showed increased internalizing problems associated with aggressive behavior. Emotional profile in patients with NT1 positively correlated with age at onset, diagnostic delay, and subjective sleepiness, whereas treatment and disease duration were associated with fewer behavioral problems (attention problems, aggressive behavior, and attention deficit/hyperactivity disorder). Psychosocial health domains of pediatric NT1 were worse than in healthy controls, whereas the physical health domains were comparable.

Conclusions:

Young NT1 patients show a discrete pattern of altered behavioral, thought, and mood profile in comparison with healthy controls and with idiopathic epilepsy patients thus suggesting a direct link with sleepiness. Further studies investigating behavior in patients with idiopathic hypersomnia or type 2 narcolepsy are needed to disentangle the role of REM sleep dysfunction and hypocretin deficiency in psychiatric disorders. Symptoms of withdrawal, depression, somatic complaints, thought problems, and aggressiveness were common, NT1 children perceived lower school competencies than healthy children, and their parents also reported worse psychosocial health. Our data suggest that early effective treatment and disease self-awareness should be promoted in NT1 children for their positive effect on behavior and psychosocial health.

Citation:

Rocca FL, Finotti E, Pizza F, Ingravallo F, Gatta M, Bruni O, Plazzi G. Psychosocial profile and quality of life in children with type 1 narcolepsy: a case-control study. SLEEP 2016;39(7):1389–1398.

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Uncategorized

The National Veteran Sleep Disorder Study: Descriptive Epidemiology and Secular Trends, 2000–2010

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Study Objectives:

A large proportion of individuals affected by sleep disorders are untreated and susceptible to accidents, injuries, long-term sequelae (e.g., risk of cardiovascular disease, cancer, psychiatric disorders), and increased mortality risk. Few studies have examined the scope and magnitude of sleep disorder diagnoses in the United States (US) or factors influencing them. Veterans are particularly vulnerable to factors that elicit or exacerbate sleep disorders.

Methods:

This serial cross-sectional study characterized secular trends in diagnosed sleep disorders among veterans seeking care in US Veterans Health Administration facilities over an eleven-year span (FY2000–2010, n = 9,786,778). Electronic medical records from the national Veterans Administration Informatics and Computing Infrastructure database were accessed. Cases were defined using diagnostic codes specified by the American Academy of Sleep Medicine. Age-adjusted annual prevalence was summarized by sex, race, combat exposure, body mass index, and comorbid diagnoses (cardiovascular disease, cancer, mental disorders).

Results:

Sleep apnea (47%) and insomnia (26%) were the most common diagnoses among patients with any sleep disorder. There was a six-fold relative increase in total sleep disorder prevalence over the study period. Posttraumatic stress disorder, which tripled over the same time period, was associated with the highest prevalence of sleep disorders (16%) among the comorbid conditions evaluated.

Conclusions:

The results indicate a growing need for integration of sleep disorder management with patient care and health care planning among US veterans.

Commentary:

A commentary on this article appears in this issue on page 1331.

Citation:

Alexander M, Ray MA, Hébert JR, Youngstedt SD, Zhang H, Steck SE, Bogan RK, Burch JB. The National Veteran Sleep Disorder Study: descriptive epidemiology and secular trends, 2000–2010. SLEEP 2016;39(7):1399–1410.

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Health, Medicine

Initial Stop Voicing in Bilingual Children With Cochlear Implants and Their Typically Developing Peers With Normal Hearing

Purpose

This study focuses on stop voicing differentiation in bilingual children with normal hearing (NH) and their bilingual peers with hearing loss who use cochlear implants (CIs).

Method

Twenty-two bilingual children participated in our study (11 with NH, M age = 5;1 [years;months], and 11 with CIs, M hearing age = 5;1). The groups were matched on hearing age and a range of demographic variables. Single-word picture elicitation was used with word-initial singleton stop consonants. Repeated measures analyses of variance with three within-subject factors (language, stop voicing, and stop place of articulation) and one between-subjects factor (NH vs. CI user) were conducted with voice onset time and percentage of prevoiced stops as dependent variables.

Results

Main effects were statistically significant for language, stop voicing, and stop place of articulation on both voice onset time and prevoicing. There were no significant main effects for NH versus CI groups. Both children with NH and with CIs differentiated stop voicing in their languages and by stop place of articulation. Stop voicing differentiation was commensurate across the groups of children with NH versus CIs.

Conclusions

Stop voicing differentiation is accomplished in a similar fashion by bilingual children with NH and CIs, and both groups differentiate stop voicing in a language-specific fashion.

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Health, Medicine

Augmenting College Students’ Study of Speech-Language Pathology Using Computer-Based Mini Quiz Games

Purpose

This study examined whether undergraduate college students’ immediate recall and longer-term retention of introductory voice disorder concepts improved by using mini quiz games (MQGs; interactive knowledge tests in game format) compared with (a) traditional study alone, (b) MQGs and traditional study together, or (c) a no-study control condition.

Method

Ninety-three college students participated in proctored sessions in which they were given a pretest, viewed an online lecture on introductory voice disorder concepts, and then engaged in either no intervention or interventions including traditional study, MQG play, or both MQG play and traditional study, followed by an immediate recall posttest and longer-term retention follow-up test.

Results

Analyses suggested that the effects of all interventions (traditional study, MQG play, and the combination of the 2) were equivalent and resulted in significantly greater improvements from pretest to immediate recall posttest performance than the control condition. In contrast, MQGs and MQGs with traditional study, but not traditional study alone, showed better results for long-term retention than no study.

Conclusion

Results provide preliminary support for the idea that there may be multiple effective learning modes, beyond traditional study, that enhance recall and retention of knowledge foundational to speech-language pathology clinical training and practice.

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