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Trials May 2024Persistent pain is a common yet debilitating complication after breast cancer surgery. Given the pervasive effects of this pain disorder on the patient and healthcare...
BACKGROUND
Persistent pain is a common yet debilitating complication after breast cancer surgery. Given the pervasive effects of this pain disorder on the patient and healthcare system, post-mastectomy pain syndrome (PMPS) is becoming a larger population health problem, especially as the prognosis and survivorship of breast cancer increases. Interventions that prevent persistent pain after breast surgery are needed to improve the quality of life of breast cancer survivors. An intraoperative intravenous lidocaine infusion has emerged as a potential intervention to decrease the incidence of PMPS. We aim to determine the definitive effects of this intervention in patients undergoing breast cancer surgery.
METHODS
PLAN will be a multicenter, parallel-group, blinded, 1:1 randomized, placebo-controlled trial of 1,602 patients undergoing breast cancer surgery. Adult patients scheduled for a lumpectomy or mastectomy will be randomized to receive an intravenous 2% lidocaine bolus of 1.5 mg/kg with induction of anesthesia, followed by a 2.0 mg/kg/h infusion until the end of surgery, or placebo solution (normal saline) at the same volume. The primary outcome will be the incidence of persistent pain at 3 months. Secondary outcomes include the incidence of pain and opioid consumption at 1 h, 1-3 days, and 12 months after surgery, as well as emotional, physical, and functional parameters, and cost-effectiveness.
DISCUSSION
This trial aims to provide definitive evidence on an intervention that could potentially prevent persistent pain after breast cancer surgery. If this trial is successful, lidocaine infusion would be integrated as standard of care in breast cancer management. This inexpensive, widely available, and easily administered intervention has the potential to reduce pain and suffering in an already afflicted patient population, decrease the substantial costs of chronic pain management, potentially decrease opioid use, and improve the quality of life in patients.
TRIAL REGISTRATION
This trial has been registered on clinicaltrials.gov (NCT04874038, Dr. James Khan. Date of registration: May 5, 2021).
Topics: Humans; Lidocaine; Breast Neoplasms; Female; Pain, Postoperative; Mastectomy; Anesthetics, Local; Infusions, Intravenous; Multicenter Studies as Topic; Randomized Controlled Trials as Topic; Treatment Outcome; Pain Measurement; Quality of Life; Chronic Pain; Mastectomy, Segmental; Time Factors; Analgesics, Opioid; Cost-Benefit Analysis
PubMed: 38773653
DOI: 10.1186/s13063-024-08151-4 -
Arquivos de Neuro-psiquiatria Jun 2024Narcolepsy is a primary disorder of the central nervous system resulting from genetic, environmental, and immunological interactions defined as excessive daytime...
Narcolepsy is a primary disorder of the central nervous system resulting from genetic, environmental, and immunological interactions defined as excessive daytime sleepiness plus cataplexy, hallucinations, sleep paralysis, and sleep fragmentation. The pathophysiology is not entirely known, but the interaction among genetic predisposition, environmental exposition, and immune component with consequent hypocretin-1 deficiency is the model to explain narcolepsy type I. The mechanism of narcolepsy type II is less understood. There is a delay of over ten years for the diagnosis of narcolepsy around the world. Patients with narcolepsy have many comorbidities with a negative impact on quality of life. The treatment of narcolepsy must contain an educational approach for the family, coworkers, and patients. Scheduled naps and sleep hygiene are essential to minimize the dose of medications. Much progress has been seen in the pharmacological treatment of narcolepsy with new stimulants, different presentations of oxybate, and recent studies with orexin agonists. Narcolepsy is a rare disease that needs to be more understood and highlighted to avoid delayed diagnosis and severe disabilities in patients.
Topics: Humans; Quality of Life; Narcolepsy; Cataplexy; Sleep; Neurology
PubMed: 38565187
DOI: 10.1055/s-0044-1779299 -
Frontiers in Psychiatry 2024Excessive daytime sleepiness (EDS) is a crucial symptom that diminishes the quality of life. The primary causes of EDS are central hypersomnia, including narcolepsy type...
INTRODUCTION
Excessive daytime sleepiness (EDS) is a crucial symptom that diminishes the quality of life. The primary causes of EDS are central hypersomnia, including narcolepsy type 1 (NT1), type 2 (NT2), and idiopathic hypersomnia (IH). EDS is often associated with other psychiatric disorders, particularly attention deficit hyperactivity disorder (ADHD). The Multiple Sleep Latency Test (MSLT) is the standard assessment tool for EDS. Although the MSLT yields numerous parameters, most are not employed in clinical practice. In this study, we leveraged novel MSLT parameters to discern central hypersomnia and ADHD presence. Our analysis focused on sleep latency variability and employed cluster analysis to identify unique temporal patterns.
METHODS
We examined the MSLT data from 333 patients; of these, 200 (aged 14-54, mean: 24.9 ± 8.1, years; 114 females) met the inclusion criteria comprising comprehensive data an Apnea-Hypopnea Index (AHI) below 5, and no prior diagnosis of sleep apnea syndrome. We employed a time-course cluster approach that specifically targeted sleep latency variability during the MSLT.
RESULTS
Considering both multiple clustering quality evaluations and the study's objectives, we identified 9 distinct clusters. Clusters 1 and 3 predominantly had MSLT-positive results; Cluster 2 was entirely MSLT-positive; Clusters 4, 5, 6, 8, and 9 were mainly MSLT-negative; and Cluster 7 had mixed results. The diagnosis of hypersomnia varied notably among Clusters 1, 2, 3, and 7, with Cluster 2 demonstrating a pronounced tendency towards NT1 and NT2 diagnoses (p < 0.005). However, no significant correlation was observed between ADHD diagnoses and specific sleep latency patterns in any cluster.
CONCLUSIONS
Our study highlights the value of time-course clustering in understanding sleep latency patterns of patients with central hypersomnia.
PubMed: 38544845
DOI: 10.3389/fpsyt.2024.1361140 -
BMJ Open Mar 2024To explore the relationship between physical activity over a 10-year period and current symptoms of insomnia, daytime sleepiness and estimated sleep duration in adults...
OBJECTIVES
To explore the relationship between physical activity over a 10-year period and current symptoms of insomnia, daytime sleepiness and estimated sleep duration in adults aged 39-67.
DESIGN
Population-based, multicentre cohort study.
SETTING
21 centres in nine European countries.
METHODS
Included were 4339 participants in the third follow-up to the European Community Respiratory Health Survey (ECRHS III), who answered questions on physical activity at baseline (ECRHS II) and questions on physical activity, insomnia symptoms, sleep duration and daytime sleepiness at 10-year follow-up (ECRHS III). Participants who reported that they exercised with a frequency of at least two or more times a week, for 1 hour/week or more, were classified as being physically active. Changes in activity status were categorised into four groups: persistently non-active; became inactive; became active; and persistently active.
MAIN OUTCOME MEASURES
Insomnia, sleep time and daytime sleepiness in relation to physical activity.
RESULTS
Altogether, 37% of participants were persistently non-active, 25% were persistently active, 20% became inactive and 18% became active from baseline to follow-up. Participants who were persistently active were less likely to report difficulties initiating sleep (OR 0.60, 95% CI 0.45-0.78), a short sleep duration of ≤6 hours/night (OR 0.71, 95% CI 0.59-0.85) and a long sleep of ≥9 hours/night (OR 0.53, 95% CI 0.33-0.84) than persistently non-active subjects after adjusting for age, sex, body mass index, smoking history and study centre. Daytime sleepiness and difficulties maintaining sleep were not related to physical activity status.
CONCLUSION
Physically active people have a lower risk of some insomnia symptoms and extreme sleep durations, both long and short.
Topics: Adult; Humans; Sleep Initiation and Maintenance Disorders; Sleep Duration; Cohort Studies; Disorders of Excessive Somnolence; Exercise
PubMed: 38531588
DOI: 10.1136/bmjopen-2022-067197 -
Actas Espanolas de Psiquiatria Feb 2024This is a narrative review of sleep disorders, especially chronic insomnia, as a primary diagnosis or as a comorbid diagnosis associated with different psychiatric and... (Review)
Review
This is a narrative review of sleep disorders, especially chronic insomnia, as a primary diagnosis or as a comorbid diagnosis associated with different psychiatric and organic diseases. The epidemiological evidence is reviewed, the diagnostic criteria most frequently used in clinical practice are examined, and a series of therapeutic recommendations for the correct treatment of this pathology is presented. Sleep disorders are very prevalent in the general population (one-third experiences difficulty with sleep initiation/maintenance at least once a week, and about 6-15% meet the criteria for insomnia disorders), but remain relatively poorly understood and frequently overlooked by healthcare professionals. Prevalence estimates of insomnia disorder vary between 5% and 20%. Sleep disorders co-exist with psychiatric and medical conditions with an interactive and bidirectional relationship. About 70-80% of psychiatric patients show some sleep disturbance and there is a correlation between the severity of the sleep disturbance and the severity of the psychopathology. Untreated sleep disorders increase the risk of cardiovascular events, cognitive impairment, motor vehicle accidents, obesity, diabetes, and efficiency and safety at work, leading to increased all-cause healthcare utilization and being a strong predictor of sick leave or disability pension and poor quality of life. Sleep disorders can cause drowsiness or excessive daytime sleepiness, which can lead to functional impairment in 15% of the general adult population. Sleep quality should be a routine target in the evaluation of patients with psychiatric and non-psychiatric diseases to ensure sleep health based on early diagnosis and adequate therapeutic approaches.
Topics: Adult; Humans; Sleep Initiation and Maintenance Disorders; Quality of Life; Sleep Wake Disorders; Disorders of Excessive Somnolence; Comorbidity
PubMed: 38454895
DOI: No ID Found -
Alzheimer's & Dementia : the Journal of... Apr 2024Little is known regarding quality of life (QoL) in dementia with Lewy bodies (DLB), particularly in advanced stages.
INTRODUCTION
Little is known regarding quality of life (QoL) in dementia with Lewy bodies (DLB), particularly in advanced stages.
METHODS
Dyads of individuals with moderate-advanced DLB and their primary caregivers were recruited from specialty clinics, advocacy organizations, and research registries. The study collected demographics, disease-related measures, and measures of patient/caregiver experiences.
RESULTS
The Quality of Life in Alzheimer's Disease (QoL-AD) was completed by the person with DLB and the caregiver (proxy) in 61 dyads; 85 dyads had only a proxy-completed QoL-AD. Patient- and proxy-reported scores were moderately correlated (r = 0.57, P < 0.0001). Worse patient-reported QoL correlated with daytime sleepiness, autonomic symptom burden, and behavioral symptoms. Proxy ratings correlated with dementia severity, daytime sleepiness, behavioral symptoms, dependence in activities of daily living, and caregiver experience measures.
DISCUSSION
Patient- and proxy-reported quality of life (QoL) should be assessed separately in advanced DLB. Some symptoms associated with QoL have available therapeutic options. Research is needed regarding strategies to optimally improve QoL in DLB.
HIGHLIGHTS
Patient and proxy quality of life (QoL) ratings had moderate correlation in advanced dementia with Lewy bodies. Daytime sleepiness affected patient- and proxy-reported QoL. Behavioral symptoms affected patient- and proxy-reported QoL. Autonomic symptom burden affected patient-reported QoL. Dementia severity, dependence, and caregiver experiences affected proxy ratings.
Topics: Humans; Quality of Life; Lewy Body Disease; Activities of Daily Living; Alzheimer Disease; Caregivers; Disorders of Excessive Somnolence
PubMed: 38400528
DOI: 10.1002/alz.13745 -
Brain and Behavior Jan 2024Existing research has confirmed the link between childhood trauma and poor sleep quality in adulthood. This study focused on the relationship between childhood trauma...
BACKGROUND AND OBJECTIVE
Existing research has confirmed the link between childhood trauma and poor sleep quality in adulthood. This study focused on the relationship between childhood trauma and hypersomnia specifically, which is understudied. Additionally, childhood maltreatment has been related to mentalizing deficits. The current study examined the role of mentalizing deficits as mediators between childhood trauma and hypersomnia.
METHOD
The study sample of this cross-sectional study consisted of 496 individuals, who participated in the online survey, which contained the following measures: Persian version of the Mini Sleep Questionnaire, Reflective Functioning Questionnaire (RFQ-8), and Childhood Trauma Questionnaire (CTQ).
RESULTS
The results from structural equation modeling indicated that emotional abuse positively predicts hypersomnia. Mediation analysis confirmed that hypo-mentalizing partially mediates the association between emotional abuse and hypersomnia.
CONCLUSION
The present study provides primary evidence that experiencing emotional abuse during childhood is associated with hypersomnia in adulthood. This association underlines the importance of prevention. The result from mediation analysis suggests addressing mentalizing impairments in patients with hypersomnia and a history of emotional abuse may be helpful.
Topics: Child; Humans; Mentalization; Cross-Sectional Studies; Adverse Childhood Experiences; Mediation Analysis; Child Abuse; Disorders of Excessive Somnolence; Psychological Tests; Self Report
PubMed: 38376014
DOI: 10.1002/brb3.3363 -
Trials Jan 2024Patients with mental disorders have a higher prevalence of sleep problems than the general population. Sleep problems may include insomnia, circadian rhythm disorders,...
The efficacy of a transdiagnostic sleep intervention for outpatients with sleep problems and depression, bipolar disorder, or attention deficit disorder: study protocol for a randomized controlled trial.
BACKGROUND
Patients with mental disorders have a higher prevalence of sleep problems than the general population. Sleep problems may include insomnia, circadian rhythm disorders, or hypersomnia. A transdiagnostic approach combining cognitive behavioral therapy for insomnia (CBT-I) with chronotherapy addressing a broad range of sleep problems has shown promising results in a limited number of studies. The aim of the study is to investigate the efficacy of a transdiagnostic sleep intervention for patients with sleep problems comorbid to bipolar disorder, unipolar depression, or attention deficit disorders. The primary hypothesis is that the intervention improves sleep quality compared with a control group. The secondary hypotheses are that the intervention increases subjective and objective sleep efficiency, reduces sleep onset latency, wake after sleep onset, number of awakenings, and severity of insomnia; and that it improves well-being, personal recovery, work ability, and consumption of sleep medication compared with a control group.
METHODS
The study is a randomized controlled trial enrolling 88 outpatients with bipolar disorder, major depression, or attention deficit disorder with symptoms of various sleep problems (insomnia, circadian rhythm disorders, or hypersomnia). Patients are allocated to either an intervention group receiving six sessions of transdiagnostic sleep treatment or to a control group receiving a single session of sleep hygiene education. Assessments are made at baseline, at week two, and after 6 weeks in both groups. Actigraphy is performed continuously throughout the 6-week study period for all patients. The primary outcome is changes in the subjective appraisal of sleep quality (Pittsburgh Sleep Quality Index). The secondary outcomes are changes in sleep efficiency, sleep onset latency, wake after sleep onset, number of nocturnal awakenings (based on actigraph and sleep diary data), changes in insomnia severity (Insomnia Severity Index), well-being (WHO-5 Well-Being Index), personal recovery (INSPIRE-O), work ability (Work Ability Index), and consumption of sleep medication (sleep-diaries).
DISCUSSION
The study was initiated in 2022 and the inclusion period will continue until mid-2024. The results may have implications for the development and implementation of additional treatment options for patients with mental disorders and comorbid sleep problems.
TRIAL REGISTRATION
ClinicalTrials.gov. NCT05406414. Registered on June 6, 2022.
Topics: Humans; Bipolar Disorder; Sleep Initiation and Maintenance Disorders; Attention Deficit Disorder with Hyperactivity; Outpatients; Sleep; Depressive Disorder, Major; Disorders of Excessive Somnolence; Chronobiology Disorders; Treatment Outcome; Randomized Controlled Trials as Topic
PubMed: 38229181
DOI: 10.1186/s13063-024-07903-6 -
Pharmacology Research & Perspectives Feb 2024Pitolisant, a novel histamine H3-receptor antagonist, holds significant promise for treating narcolepsy. However, a petition, which highlighted that pitolisant was...
Pitolisant, a novel histamine H3-receptor antagonist, holds significant promise for treating narcolepsy. However, a petition, which highlighted that pitolisant was associated with deaths during clinical trials, has propelled it into the spotlight of widespread societal attention on April 3, 2023. Till now, the clinical safety of pitolisant remains a heatedly debated topic. This study aimed to offer a comprehensive assessment of the safety profile of pitolisant in real-world clinical settings. Adverse event reports where pitolisant was the primary suspect drug were extracted from the FDA Adverse Event Reporting System database. The clinical characteristics and concomitant drugs of the pitolisant-associated adverse events were analyzed. The potential adverse event signals of pitolisant were explored using four disproportionality analysis methods. Furthermore, the difference in pitolisant-associated adverse event signals was investigated concerning sex, age, weight, and dose. A total of 526 reports and 1695 adverse events with pitolisant as the primary suspected drug were identified. The most significant adverse event signals were generally mild and of short duration. The concomitant drugs of pitolisant were highly intricate, mainly included drugs for treating narcolepsy as well as antidepressants. Seven new significant adverse event signals emerged. The safety profile of pitolisant exhibited no significant differences across age and dose groups, although slight variations were observed in relation to sex and weight. The findings from reports of death and life-threatening outcomes underscore the importance of enhanced monitoring for cardiac and respiratory adverse reactions when utilizing pitolisant. This study provided a broader understanding of the safety profile of pitolisant.
Topics: Humans; Pharmacovigilance; Retrospective Studies; Narcolepsy; Piperidines
PubMed: 38174838
DOI: 10.1002/prp2.1161 -
Frontiers in Psychiatry 2023Hypersomnia poses major challenges to treatment providers given the limitations of available treatment options. In this context, the application of non-invasive brain...
Single sessions of transcranial direct current stimulation and transcranial random noise stimulation exert no effect on sleepiness in patients with narcolepsy and idiopathic hypersomnia.
BACKGROUND
Hypersomnia poses major challenges to treatment providers given the limitations of available treatment options. In this context, the application of non-invasive brain stimulation techniques such as transcranial electrical stimulation (tES) may open up new avenues to effective treatment. Preliminary evidence suggests both acute and longer-lasting positive effects of transcranial direct current stimulation (tDCS) on vigilance and sleepiness in hypersomniac patients. Based on these findings, the present study sought to investigate short-term effects of single sessions of tDCS and transcranial random noise stimulation (tRNS) on sleepiness in persons suffering from hypersomnia.
METHODS
A sample of 29 patients suffering from narcolepsy or idiopathic hypersomnia (IH) was recruited from the Regensburg Sleep Disorder Center and underwent single sessions of tES (anodal tDCS, tRNS, sham) over the left and right dorsolateral prefrontal cortex on three consecutive days in a double-blind, sham-controlled, pseudorandomized crossover trial. The primary study endpoint was the mean reaction time measured by the Psychomotor Vigilance Task (PVT) before and directly after the daily tES sessions. Secondary endpoints were additional PVT outcome metrics as well as subjective outcome parameters (e.g., Karolinska Sleepiness Scale; KSS).
RESULTS
There were no significant treatment effects neither on objective (i.e., PVT) nor on subjective indicators of sleepiness.
CONCLUSION
We could not demonstrate any clinically relevant effects of single sessions of tDCS or tRNS on objective or subjective measures of sleepiness in patients with hypersomnia. However, we cannot exclude that repeated sessions of tES may affect vigilance or sleepiness in hypersomniac patients.
PubMed: 38146280
DOI: 10.3389/fpsyt.2023.1288976