Sleep Disturbances Research Articles

Achievement of No-to-minimal Itch and Sleep Improvement with Tapinarof Cream 1% Once Daily in Two Pivotal Phase 3 Trials in Adults and Children Down to 2 Years of Age with Atopic Dermatitis

Introduction: Itch frequently causes sleep disturbance in patients with atopic dermatitis (AD). The gold-standard Peak Pruritus Numerical Rating Scale (PP-NRS) improvement from baseline is 4 points; however, more stringent outcomes include achieving no-to-minimal itch (PP-NRS ≤1). Tapinarof cream 1% once daily (QD) demonstrated superior efficacy, including itch reduction, versus vehicle and was well tolerated in adults and children down to 2 years of age with AD in the ADORING 1 and 2 pivotal phase 3 trials. Here we present highly stringent itch outcomes and sleep improvement with tapinarof from these trials. Methods: In ADORING 1 and 2, patients with a Validated Investigator Global Assessment for Atopic Dermatitis™ score ≥3 (moderate or severe), Eczema Area and Severity Index score ≥6, and body surface area involvement of 5–35% were randomized to tapinarof cream or vehicle QD for 8 weeks. Stringent PP-NRS assessments were analyzed post hoc and included achieving no‑to‑minimal itch (PP-NRS ≤1) or PP-NRS score <2. Mean weekly PP-NRS scores were assessed on an 11-point scale (0 indicates “no itch” and 10 is “worst imaginable itch”). The Patient Oriented Eczema Measure (POEM) question 2 evaluated sleep disturbance on a 5-point scale (0 indicates “no days” and 4 is “every day”); outcomes were pooled and stratified by age. Results: 407 and 406 patients were randomized in ADORING 1 and 2. Mean baseline scores were similar across ADORING 1 and 2 treatment groups: PP-NRS, 6.7 and 6.8; pooled POEM sleep disturbance scores, 2.0 (aged ≥12 years) and 2.4 (<12 years), respectively. Statistically significant achievement of no-to-minimal itch (PP-NRS ≤1), PP-NRS <2, and improvement in sleep were achieved with tapinarof versus vehicle as early as Week 1, the first assessment, and continued through Week 8. Stringent itch outcomes were achieved with tapinarof versus vehicle at Week 8: no-to-minimal itch, 31.4% versus 17.4% (P=0.0072) and 33.0% versus 14.0% (P=0.0003); and PP-NRS <2, 48.1% versus 28.4% (P=0.0006) and 46.8% versus 19.6% (P<0.0001) in ADORING 1 and 2, respectively. Sleep scores improved with tapinarof versus vehicle at Week 8: –1.4 versus –0.8 (≥12 years); –1.7 versus –1.0 (<12 years; both P<0.0001). Conclusion: Tapinarof cream 1% QD demonstrated early, significant, and meaningful achievement of no-to-minimal itch and improvement of sleep in adults and children down to 2 years of age with AD.

Efficacy and safety of fezolinetant for moderate-severe vasomotor symptoms associated with menopause in individuals unsuitable for hormone therapy: phase 3b randomised controlled trial

Abstract Objectives To assess the efficacy and safety of the non-hormonal, neurokinin 3 receptor antagonist, fezolinetant, to treat moderate-severe vasomotor symptoms associated with menopause in individuals unsuitable for hormone therapy. Design Phase 3b randomised controlled trial. Setting 16 countries. Participants 453 individuals aged 40-65 years with moderate-severe vasomotor symptoms associated with menopause who were considered unsuitable candidates for hormone therapy (contraindicated, caution (based on medical history), stoppers (previous discontinuation of hormone therapy), or averse (informed choice not to use hormone therapy)) were randomised to receive fezolinetant (n=227) or placebo (n=226). Intervention Fezolinetant 45 mg or placebo once daily for 24 weeks. Main outcome measures The primary endpoint was mean change in daily frequency of moderate-severe vasomotor symptoms from baseline to week 24. Secondary endpoints were mean change in symptom severity, sleep disturbance using the Patient-Reported Outcome Measurement Information System Sleep Disturbance Short Form (PROMIS SD-SF) 8b total score, and safety. Results 370 (81.7%) participants completed the study (fezolinetant=195, placebo group=175). The safety and full analysis sets comprised 452 participants who received at least one dose of study drug. Mean age was 54.5 (standard deviation 4.7) years and most of the participants (435 (96.7%) were white and categorised as either hormone therapy averse (168 (37.2%)) or caution (165 (36.5%)). At week 24, fezolinetant significantly reduced the frequency (least squares mean difference –1.93, 95% confidence interval (CI) –2.64 to –1.22; P<0.001) and severity of vasomotor symptoms (–0.39, –0.57 to –0.21; P<0.001). At week 24, the fezolinetant group had a greater reduction in sleep disturbance (PROMIS SD-SF 8b total score) compared with placebo (–2.5, –3.9 to –1.1; P<0.001). Improvements over placebo were observed as early as week 1. Both groups showed similar incidences of treatment emergent adverse events (TEAEs, 147 (65.0%) in the fezolinetant group, 138 (61.1%) in the placebo group) and serious TEAEs (10 (4.4%) and 8 (3.5%), respectively). The most common TEAEs in the fezolinetant group were covid-19 (30 (13.3%)), headache (20 (8.8%)), and fatigue (13 (5.8%)). Conclusions Fezolinetant was efficacious and well tolerated over a six month period for treating moderate-severe vasomotor symptoms in individuals considered unsuitable for hormone therapy. These results highlight the utility of fezolinetant as an effective treatment option for those who have contraindications to or choose not to use hormone therapy. Trial registration ClinicalTrials.gov NCT05033886 ; EudraCT 2021-001685-38.

Health-related quality of life and symptom-specific functional impairment among patients treated with parenterally administered complement inhibitors for paroxysmal nocturnal hemoglobinuria

AbstractThis study describes the health-related quality of life (HRQoL) and symptom-specific functional impairment of patients with paroxysmal nocturnal hemoglobinuria (PNH) in a real-world setting. US-based adults with PNH treated with a parenterally administered complement inhibitor (PACI) for ≥ 6 months completed an online, cross-sectional, observational survey; a subset of patients also participated in semi-structured qualitative interviews. The survey included the PROMIS® 29 + 2 Profile v2.1 (PROMIS 29 + 2) to measure HRQoL. The FACIT-Fatigue, Neuro-QOL Item Bank v2.0 Cognitive Function Short Form, and PROMIS Item Bank v1.0 Dyspnea Functional Limitations 10a Short Form measured symptom-specific functional impairment. For each patient with PNH who completed the online survey, 3 age- and sex-matched adults from the general population (GP) also completed the survey. The HRQoL and functional impairment of the PNH sample were compared to that of the GP sample. The association between HRQoL/functional impairment and fatigue severity for the PNH sample was also investigated. Compared to the age- and sex-matched GP sample, patients treated with PACIs for PNH had significantly worse HRQoL and greater functional impairment for all measured domains (p < 0.05). Within the PNH sample, statistically significant associations (p < 0.05) were observed between fatigue severity and HRQoL/functional impairment for all outcomes except the PROMIS 29 + 2 Sleep Disturbance domain. Interview participants described fatigue-related impairments in their physical, social, and cognitive functioning. Despite receiving treatment for PNH, patients experienced deficits in HRQoL and functional impairment, suggesting that opportunities to improve patient-relevant outcomes through treatment should be identified.

Effects of morning versus afternoon surgery on peri‐operative disturbance of sleep–wake timing: An observational study

AbstractIntroductionThe circadian timing system regulates diurnal sleep–wake rhythm. Previously, we showed that, in patients undergoing elective surgery, sleep–wake timing is altered and post‐operative sleep quality is reduced. However, how the timing of the surgical procedure affects the disturbance and what other factors affect this disturbance remain unknown.MethodsSingle‐centre prospective observational study investigating the influence of surgery timing on post‐operative sleep in adult patients (≥18 years) undergoing elective surgery. Sleep–wake timing was measured from three nights before until seven nights after surgery with a daily sleeping log. Primary outcome was post‐operative midpoint of sleep shift between patients undergoing morning and afternoon surgeries. Secondary outcomes included factors affecting sleep timing disturbance and changes in subjective sleep quality.ResultsWe included 259 patients: 144 patients underwent morning procedures (08:00 h–12:00 h) and 115 underwent afternoon procedures (12:00 h–17:00 h). Both groups had significant phase advance of midpoint of sleep on the night after surgery when compared with three nights before surgery (mean − 00:41 h, 95% CI −00:27 h to −00:54 h, p < .001, for morning surgery and mean − 00:28 h, 95% CI −00:09 h to −00:46 h, p = .003, for afternoon surgery). However, there was no between‐group difference (mean − 00:13 h, 95% CI −00:35 h–00:09 h, p = .25). Reduction of sleep quality was also similar. Phase advance was larger for patients with an evening chronotype or with lower pre‐operative sleep quality. Decline of sleep quality after surgery was larger for patients with an evening chronotype, longer procedures or better pre‐operative sleep quality.ConclusionOur results suggest that the timing of surgery between 08:00 h and 17:00 h does not modulate the effect of anaesthesia and surgery on phase of the sleep–wake rhythm in patients undergoing elective surgery with a low pre‐operative risk of delirium.Editorial CommentTiming of surgery may impact post‐operative sleep. However, in this prospective cohort study of elective surgical patients, sleep–wake timing and post‐operative sleep quality did not differ between those undergoing morning versus afternoon surgery.

Sling Results in Better Sleep Quality and Less Anxiety Early After Arthroscopic Rotator Cuff Repair: A Randomized Single-Blinded Trial.

Sleep disturbance is commonly reported by patients wearing an abduction brace after arthroscopic rotator cuff repair (ARCR). Although a sling has been proven noninferior to an abduction brace for function and repair integrity, there is no evidence-based medical support for the advantage of the sling in improving sleep quality compared with a brace. This study aimed to compare the effects of a sling and an abduction brace on sleep quality and clinical outcomes after ARCR. It was hypothesized that immobilization in a sling would result in better sleep quality while not deteriorating clinical outcomes and bone-tendon healing compared with an abduction brace. Randomized controlled trial; Level of evidence, 1. A total of 142 consecutive patients with rotator cuff tears were randomly assigned to 2 groups: (1) the brace group, receiving abduction brace immobilization for 6 weeks, and (2) the sling group, receiving sling immobilization after ARCR for 6 weeks. The primary outcome was the Pittsburgh Sleep Quality Index at 6 weeks postoperatively. Secondary outcomes-American Shoulder and Elbow Surgeons score, Self-rating Anxiety Scale, pain, satisfaction, and tendon healing (using ultrasonography)-were evaluated until 1 year postoperatively. Complete outcome measurements were obtained for 131 patients. The Pittsburgh Sleep Quality Index at 6 weeks was 11.1 ± 2.7 for the brace group and 9.2 ± 2.3 for the sling group (P < .001), indicating a statistically significant advantage for the sling group. The sling group also reported significantly lower Self-rating Anxiety Scale, lower pain level, and higher satisfaction scores at 6 weeks. No significant difference was observed in outcome measures between groups at 1 year. The tendon healing rates (91% vs 88%, respectively) were comparable between the brace and sling groups within the first 1 year (risk ratio, 1.03 [95% CI, 0.92-1.16]; P = .59). The use of a sling resulted in better sleep quality, less anxiety, and higher satisfaction compared with an abduction brace in the first 6 weeks after ARCR; nevertheless, functional outcomes and repair integrity were similar at 1 year postoperatively between the 2 groups. These findings indicate that a sling is appropriate for the postoperative care of ARCR. However, caution should be used when interpreting these results because the clinical relevance of sling-related benefits warrants further investigation. ChiCTR2200059967 (Chinese Clinical Trial Registry).

Investigating the Comparative Effectiveness of Yoga and Relaxation Therapy on Restlessness, Fatigue and Difficulty Concentrating in Multiple Sclerosis Patients

Background: Multiple sclerosis (MS) is a long-term autoimmune disorder affecting the central nervous system, leading to reduced quality of life and impaired physical and psychological functions. Objectives: This study aims to examine the relative efficacy of yoga and relaxation therapy in improving sleep disturbances, fatigue, and cognitive impairment among individuals diagnosed with MS. Methods: This study employed a semi-experimental research design, including a pre-test, post-test, and follow-up over three months. The target population comprised all MS patients referred to the Iranian MS Association in Tehran between July and November 2023. Sixty participants were selected using purposive sampling and randomly assigned to research groups: Two yoga therapy groups with 17 participants each, a relaxation therapy group with 16 participants, and a control group with 18 participants. The yoga therapy group participated in twelve 90-minute sessions twice a week, while the control group received no intervention and was placed on a waiting list. Various tools, including the Multidimensional Fatigue Inventory (MFI), Cohen-Mansfield Agitation Inventory (CMAI-O), and a concentration skills questionnaire, were used to collect data. The data were analyzed using ANOVA, Bonferroni post hoc test, MANCOVA, and Kruskal-Wallis H tests with a significance level of 0.05, utilizing SPSS 27 software. Results: The study found a significant difference (P &lt; 0.001) in the restlessness factor in both the post-test and follow-up phases. Additionally, there was a significant difference (P &lt; 0.001) in the levels of physical fatigue, mental fatigue, decreased activity, and decreased motivation in both the post-test and follow-up phases, indicating significant changes in the fatigue factor among the research groups. However, there was no significant difference in the general fatigue component between the research groups. A significant difference (P &lt; 0.001) was also found in the concentration factor, particularly in the components of voluntary and involuntary concentration, during both the post-test and follow-up stages. Conclusions: The results of this study indicate that both yoga and relaxation therapy techniques significantly reduce restlessness, physical tiredness, mental fatigue, decreased activity, and decreased motivation. Furthermore, the findings validate that both yoga and relaxation therapy techniques effectively enhance voluntary and involuntary concentration.

Predictors of Methylphenidate response in children and adolescents with ADHD: the role of sleep disturbances.

Sleep Disturbances (SD) have been linked to children and adolescents with ADHD, impacting its progression and outcomes. Methylphenidate (MPH), a commonly used stimulant medication for ADHD treatment, has been observed to potentially influence SD as a side effect, while SD can in turn potentially affect the response to MPH. This study aimed to explore the potential role of SD on MPH response in children and adolescents with ADHD. At this aim, 43 children and adolescents with ADHD received a single dose of MPH and were assessed for attention before and after medication administration. As expected, the administration of MPH resulted in improved attention levels. Our data indicate that patients with higher SD experienced greater benefits from the medication, stabilizing Reaction Times Variability (VRTs). This suggests that SD might influence the response to MPH, with individuals exhibiting higher SD deriving more advantages from the treatment. In addition, we found that other factors, such as externalizing problems and IQ, interact with each other and with SD, influencing the response to stimulant medication. Early detection of SD, along with the study of cognitive and emotional-behavioral characteristics, could assist clinicians in predicting the effectiveness of MPH therapy in children and adolescents with ADHD. However, further research is necessary to gain a deeper understanding of the role of SD and other factors in the long-term effects of MPH.

Ruxolitinib Cream Monotherapy Improved Symptoms and Quality of Life in Adults and Adolescents with Mild-to-Moderate Atopic Dermatitis: Patient-Reported Outcomes from Two Phase III Studies.

Atopic dermatitis (AD) is associated with itch, skin pain, sleep disturbances, and diminished quality of life (QoL). Ruxolitinib (Janus kinase [JAK] 1/JAK2 inhibitor) cream demonstrated efficacy and safety in adults and adolescents with mild-to-moderate AD in two phase III studies (TRuE-AD1/TRuE-AD2). In TRuE-AD1/TRuE-AD2, significant improvements in itch were observed as early as 12 h following application of ruxolitinib cream. The aim of this paper was to assess additional patient-reported outcomes (PROs) in the vehicle-controlled (VC) and long-term safety (LTS) periods of TRuE-AD1/TRuE-AD2. In the TRuE-AD studies, patients aged ≥12 years with AD were randomized 2:2:1 to apply twice-daily 1.5% ruxolitinib cream, 0.75% ruxolitinib cream, or vehicle cream continuously for 8weeks (VC period). During the LTS period, patients applied the same ruxolitinib cream strength, but on an as-needed basis; patients who initially applied vehicle were re-randomized to apply 0.75% or 1.5% ruxolitinib cream. Pooled data from both study periods were analyzed. PRO assessments included symptoms (itch [Patient-Oriented Eczema Measure, POEM], skin pain [numerical rating scale], and sleep [POEM and Patient-Reported Outcomes Measurement Information System]) and assessments of disease-specific QoL (Dermatology Life Quality Index [DLQI] and the children's version [CDLQI]). A total of 1208 and 1031 patients from the VC and LTS periods, respectively, were included in the analysis. Significant improvements in skin pain were observed within 12h among patients who applied ruxolitinib cream versus vehicle; improvements continued throughout the VC period. Improvements in patient-reported symptoms (including sleep) were observed within 2 weeks (first assessment) of ruxolitinib cream application. At Week 2, significant improvements in symptom burden and overall QoL were observed with ruxolitinib cream (0.75%/1.5%) versus vehicle in POEM (-8.9/-9.8 vs -2.2; both p<0.0001), DLQI (mean changes from baseline, -5.8/-6.1 vs -1.2; both p<0.0001), and CDLQI (-4.3/-5.3 vs -1.3; both p<0.0001). Further symptom burden and QoL improvements were reported during the VC period and were maintained through the end of the LTS period (Week 52). Consistent with the previously reported itch response data, ruxolitinib cream improved skin pain within 12 h of application. Ruxolitinib cream improved patient-reported AD symptom burden and overall QoL by Week 2. Improvements continued or were maintained for 52 weeks. (Graphical abstract and plain language summary available). ClinicalTrials.gov identifiers, NCT03745638 and NCT03745651 (both studies were registered on November 19, 2018).

UK medical cannabis registry: A clinical outcome analysis of medical cannabis therapy in chronic pain patients with and without co-morbid sleep impairment.

Chronic pain (CP) affects 35.0%-51.3% of the UK population, with 67%-88% reporting sleep disturbances. Cannabis-based medicinal products (CBMPs) have shown therapeutic potential in managing CP. Evidence suggests poor sleep worsens pain perception; therefore, this study aimed to assess patient-reported outcome measures (PROMs) following CBMP treatment in CP patients with and without co-morbid sleep impairment. A prospective cohort study of CP patients from the UK Medical Cannabis Registry was conducted. Participants were separated by baseline single-item sleep quality scale (SQS) score into sleep impaired (SQS ≤3) and unimpaired (SQS ≥4) cohorts. The primary outcome assessed changes in PROMs from baseline to 1-, 3-, 6-, and 12-months. Participants completed the following: SQS, General Anxiety Disorder-7, EQ-5D-5L, Brief Pain Inventory (BPI), and Short-Form McGill Pain Questionnaire-2. Significance was defined as p < 0.050. 1139 participants met the inclusion criteria (sleep impaired: n = 517, 45.4%; sleep unimpaired: n = 622, 54.61%). The sleep impaired cohort showed improvements in all PROMs at each follow-up (p < 0.010). The sleep unimpaired cohort showed similar results (p < 0.050), except in SQS and ED-5Q-5L: self-care and anxiety/depression scores (p > 0.050). However, the sleep impaired cohort observed greater improvements in BPI pain severity (p < 0.050) and SQS (p < 0.001) than the sleep unimpaired cohort at all follow-ups. 2817 adverse events were self-reported between both cohorts (p = 0.197). These findings align with literature that shows associated improvements in pain outcomes following CBMP administration. Sleep impaired individuals were more likely to experience greater pain severity improvements. However, this was not confirmed on multivariate logistic regression analysis and instead may be confounded by baseline pain severity. Whilst these results show promise for the effects of CBMPs on CP, they must be examined within the limitations of the study design. These findings provide further evidence to support the design of subsequent randomized controlled trials to verify causality between CBMPs and pain outcomes.

Exploring the mental health of young people in households and schools in Gorongosa District, Center of Mozambique.

The mental health needs of young people in sub-Saharan African societies remain understudied. This study builds upon the everyday perspectives of young people in Gorongosa, a rural district in central Mozambique, to determine the frequency and severity of key mental health issues, identify significant risk and protective factors, and their associations with demographic factors and mental health predictors. This cross-sectional study gathered culturally and ecologically relevant variables, such as sociodemographic indicators and risk and protective factors. The Beck Depression Inventory-II (BDI-II), Self-Report Questionnaire (SRQ) and Nocturnal Intrusions after Traumatic Experiences Questionnaire (NITE) were used to determine the prevalence and severity of key mental health issues. A convenience sampling was used involving n = 794 young people of those (45.8%) were females and the mean age of all participants was 17.24 years (SD 2.9). To examine the results, univariate analysis, chi-square tests, binary logistic regression analyses and odds ratio were used. Risk factors were pervasive in households, communities, and schools. Mental health problems were commonly linked to severe depression (14.2%), anxiety-related disorders (39.3%), sleep disturbances (37.3%), and anxiety dreams (27.5%). Gender, age, and protective factors were associated with the frequency and severity of mental health outcomes, while living with both parents protected against the severity of anxiety-related disorders. Understanding the contextual mental health needs of young people in rural Mozambique is crucial for developing insights to craft and implement targeted public mental health interventions in resource-limited settings. Addressing mental health issues among young people necessitates a concentrated effort on understanding and managing the interplay of risks and protective factors within families, communities, and schools.

Metabolic Abnormality and Sleep Disturbance are Associated with Clinical Severity of Patients with Schizophrenia

Metabolic Abnormality and Sleep Disturbance are Associated with Clinical Severity of Patients with Schizophrenia

Sex-specific changes in sleep quality with aging: Insights from wearable device analysis.

Prior studies evaluating sleep quality have found that women often have better polysomnography-defined sleep quality than men, but women subjectively report a greater frequency of sleep disturbances. Although these studies can be partially attributed to study design, it is currently unclear what may be causing these discrepancies. In this study, we aim to identify potential differences in objectively assessed sleep quality between men and women with further emphasis on subgroup analysis based on age. We hypothesize that women's sleep worsens after menopause. Sleep quality was assessed by comparing the Sleep Quality Index, Arousal Index, sleep efficiency and apnea-hypopnea index, as provided by the SleepImage Ring@ 2.3.0, between men and women, with a sub-group analysis performed by age (18-40 years, 41-50 years, 51-60 years, 61-70 years, and > 70 years), run separately for women and men. In total, 1444 subjects (704 women and 740 men) with a mean age of 53.6 ± 14.71 years were enrolled in this analysis. In women, a significant drop in Sleep Quality Index was noted after age 51 years. Regression analysis demonstrated that age, Arousal Index, sleep efficiency and apnea-hypopnea index correlated significantly with Sleep Quality Index - with age, Arousal Index and apnea-hypopnea index negatively correlated, and sleep efficiency positively correlated. The highest correlation coefficient was obtained for Arousal Index in both women and men. In women, age older than 50 years was associated with a more rapid decrease of sleep quality than men, as defined by an increase in Arousal Index and apnea-hypopnea index with a concurrent decrease in Sleep Quality Index.

Preliminary Evidence of Sleep Improvements Following Psilocybin Administration, and their Involvement in Antidepressant Therapeutic Action.

Psilocybin is a rapidly-emerging treatment for depression, yet its impact on sleep is not well understood. We sought to explore the literature on sleep and psilocybin use, and explore the topic using our own primary data. Whilst clinical trials demonstrate large depressive symptom improvements, the impact of psilocybin on sleep quality or insomnia symptoms, has not been directly studied. Using our own preliminary-data we demonstrated that both depressive-symptoms and sleep-disturbances decreased significantly following psilocybin use, though sleep improvements were smaller compared to depressive symptoms. More severe sleep-disturbances at baseline were linked to lower probability of depression remission, underscoring a potential interaction between sleep and psilocybin's efficacy. Addressing sleep disturbances could enhance therapeutic outcomes in psilocybin-assisted therapy and could lead to more effective, personalized treatment-strategies. Future research should focus on populations with sleep disorders, and on examining causal-pathways of sleep physiology's impact on psilocybin efficacy.

The assessment of psychosocial distress in hospitalized cancer patients during radio-oncological treatment: a monocentric experience study.

This study investigated the prevalence and determinants of psychosocial distress among hospitalized patients undergoing radiotherapy to identify opportunities for interventions to enhance patient well-being. Between January 2021 and May 2023, 137 hospitalized patients received radiotherapy treatment at the Department of Radiation Oncology of the Fondazione A. Gemelli IRCCS were recruited. Participants completed a questionnaire comprising the Distress Thermometer (DT) and the Hospital Anxiety and Depression Scale (HADS). The study revealed a significant correlation among anxiety, depression, total HADS scores, and Distress Thermometer scores (p < 0.001). Female patients exhibited higher total HADS scores and anxiety levels compared to males (p < 0.004, p < 0.010, respectively). Sleep disturbances were associated with increased anxiety, depression, and overall distress (p < 0.05). Younger patients (< 65years old) demonstrated elevated anxiety and depression levels, while no significant depressive tendency was observed among older participants (> 65years old). These findings underscore the intricate interplay between demographic variables, psychological distress, and treatment-related symptoms among patients during radiotherapy treatments. The study highlights the critical necessity of promptly identifying and addressing psychosocial distress in this population. It suggests that implementing a psychological therapeutic approach, particularly one focused on support, could effectively deter the onset of depression, especially among younger patients. Future research should focus on longitudinal studies to explore distress trajectories and interventions' effectiveness in mitigating distress, with collaborative efforts to translate research findings into evidence-based clinical practice for improved patient care.

A Study to Determine Sleeplessness as a Potential Predisposing Factor for Myocardial Infarction

Background It is well-established that insufficient sleep is related to more than one acute and persistent illness and leads to elevated mortality and morbidity for cardiovascular illnesses. In recent years, there has been growing interest in sleep-associated investigations. Significant interest has currently been focused on the impacts of sleep deficiency and disturbance on various organs and how they modulate an increasing listing of disease processes. This study aims to bring awareness about the importance of sleep in Myocardial Infarction patients and makes it necessary to counsel patients to change their lifestyle which could help reduce the possible morbidity and mortality rates in the population.  Methodology A prospective observational study was conducted on 400 MI patients (males and females) aged between 20- 60 years who were enrolled in Sri Jayadeva Institute of Cardiovascular Science and Research Hospital from February 2021 to April 2021 to assess sleep duration and quality in MI patients using Pittsburgh Sleep Quality Index (PSQI) scoring scale and a self-designed patient profile form.  Results It was observed that males (77%) were more prone to cardiovascular conditions due to impaired sleep as compared to females (23%) with the baseline age of 50- 60 years (46.8%) at the highest risk. Patients who were married (98.8%) and had a habit or abstinence from smoking and drinking (61.3% and 76.5% respectively), staying in urban places (63.5%), and without any significant medical history were observed to have cardiovascular diseases attributed to their poor sleep practice. Daily wagers were often sleep-deprived due to physical and financial stress which can cause high morbidity rates in the population.  Conclusion The study suggests a positive correlation between sleep deprivation and myocardial injury. Patients with impaired sleep might be at moderate risk of poor cardiac prognosis followed by a subsequent attack of MI.

Prevalence and determinants of sleep disturbances among pregnant women: an Indian community-based cross-sectional study

Prevalence and determinants of sleep disturbances among pregnant women: an Indian community-based cross-sectional study

Assessment of psychometric properties of the Dari version of the Pittsburgh Sleep Quality Index (PSQI) among Afghans

Abstract Background Sleep helps in improving the functions of all systems of human body. Disturbance in sleep can cause immediate adverse effects on normal human physiologic functions. Main objective of this study was to explore the psychometric properties of the Dari version of the of Pittsburgh Sleep Quality Index (PSQI) among general adult population of Afghanistan. Methods This methodological study has been conducted during July to November 2023. Reliability and validity of PSQI were evaluated using Cronbach’s Alpha and confirmatory factor analysis, respectively. Pearson correlation analysis was conducted to assess the convergent validity of the components of PSQI, comparing results with those obtained from the DASS-21 subdomains. Results In this cross-sectional study, 965 Afghan adults were studied during five months of duration between July and November, 2023. Mean age of the study participants was 35.2 years. The prevalence of sleep disturbance was 44.6% (430/965). Among them, 59.3% (572/965) reported experiencing subjective sleep quality disturbances less than once a week, 36.2% (349/965) had sleep latency issues less than once a week, 17.6% (170/965) had sleep duration disruption once or twice a week, while 36.3% (350/965) had daytime dysfunction less than once a week. The Cronbach’s alpha coefficient for the seven-component scale was 0.677, indicating acceptable internal consistency. Substantial and statistically significant positive correlations were present among the component of PSQI subjective sleep quality and sleep latency, sleep duration, habitual sleep efficiency, sleep disturbances, use of sleeping medication, daytime dysfunction, DASS-Depression, DASS-Anxiety, and DASS-Stress. The overall PSQI exhibited favorable fit indices, supporting the proposed single-factor structure among adult Afghan population. Conclusion Prevalence of sleep disturbance was very high among adult population of Afghanistan. This study provided useful information that will help policy makers (such as ministry of public health as well as international donor agencies like WHO, USAID, and UNICEF) to design a better strategy to reduce the prevalence of sleep disturbance that affects health of the Afghan community at large.

Abstract 4136745: How do sleep quality and heart failure symptoms impact functional status among patients with heart failure?

Background: Patients with heart failure (HF) frequently experience poor sleep quality and multiple HF symptoms, both of which are linked to diminished functional status. Poor sleep quality can manifest as prolonged latency, short duration, low efficiency, or difficulty staying asleep. HF symptoms encompass different dimensions: presence, frequency, severity, and distress of HF symptoms. Different dimensions of sleep quality and HF symptoms may uniquely influence functional status, necessitating tailored interventions, yet how individual dimensions of sleep quality and HF symptoms impact functional status remains unexplored. Research Question: how do individual dimensions of sleep quality and HF symptoms impact functional status in patients with HF? Methods: We studied 197 adults with HF (male: 66%, age: 62±11 yrs). The Pittsburgh Sleep Quality Index was used to assess seven dimensions of sleep quality: subjective sleep quality, latency, duration, efficiency, sleep disturbances, use of sleeping medications, and daytime dysfunction over the last month. Four dimensions (i.e., presence, frequency, severity, distress) of 7 HF symptoms (e.g., shortness of breath, fatigue, swelling) were assessed using the Symptom Status Questionnaire-HF. Functional status was measured using the Duke Activity Status Index. Correlations and two multiple linear regression models (1 st model: 7 dimensions of sleep quality on functional status, and 2 nd model: 4 dimensions of HF symptoms on functional status) were conducted for data analysis. Results: Worse subjective sleep quality, longer latency, more sleep disturbances, use of sleeping medications, and higher levels of daytime dysfunction were correlated with poor functional status. All four dimensions of HF symptoms were negatively correlated with functional status. In the 1 st multiple linear regression model, more sleep disturbances (B=-3.91, p =.006) and higher daytime dysfunction (B=-5.70, p &lt;.001) were predictive of poor functional status (model R 2 =0.23, p &lt;.001). In the 2 nd multiple linear regression model, only higher frequency of HF symptoms (B=-.70, p =.022) predicted poor functional status (model R 2 =0.34, p &lt;.001). Conclusion: Increased sleep disturbances, daytime dysfunction, and frequency of HF symptoms were associated with poorer functional status in patients with HF. These findings underscore the importance of developing tailored interventions to address individual sleep problems and HF symptoms to improve functional status.

Therapeutic Potential of Melatonin: Multifaceted Applications in Muscle Health, Metabolic Disorders and Cardiovascular Disease

Melatonin, a hormone primarily synthesized by the pineal gland, is traditionally associated with the regulation of circadian rhythms. However, recent research has unveiled its broad spectrum of biological effects, positioning it as a valuable therapeutic agent in diverse health contexts. Known for its potent antioxidant and anti-inflammatory properties, melatonin plays a crucial role in maintaining homeostasis and protecting cellular integrity. This review explores melatonin’s therapeutic applications across multiple medical domains, including muscle health, metabolic disorders, chronic pain management, and cardiovascular health. In muscle health, melatonin facilitates muscle hypertrophy and regeneration by mitigating oxidative stress and enhancing the activity of satellite cells responsible for muscle repair. This action is particularly beneficial for individuals undergoing intense physical exertion, recovering from injuries, or combating age-related muscle. In metabolic disorders, such as type 2 diabetes, melatonin improves insulin sensitivity and reduces cellular oxidative damage, which supports beta-cell function and glucose regulation, potentially minimizing diabetes-related complications. Furthermore, in fibromyalgia - a condition marked by widespread pain and sleep disturbances - melatonin has demonstrated efficacy in alleviating pain and improving sleep quality, thus enhancing the overall quality of life for patients. In cardiovascular health, melatonin has shown promise in preventing and managing heart failure by reducing oxidative damage, modulating inflammatory pathways, and supporting endothelial function, which collectively contribute to improved cardiac health and reduced disease progression. This comprehensive review underscores melatonin’s emerging role as an integrative therapeutic agent in modern medicine.

The Bidirectional Relationship Between Sleep and Pain in Crohn's Disease: A Daily Diary Study.

Pain is common in Crohn's disease (CD) even after endoscopic healing is achieved. Depression, sleep disturbances, fatigue, and worry about pain impact the pain experience. There is a bidirectional relationship between sleep and pain, though it has received minimal attention in CD. Herein, we sought to comprehensively assess this relationship in CD using daily diaries. Patients with active symptoms of insomnia and CD were recruited as part of an ongoing clinical trial. Participants completed 14-day diaries on sleep patterns and CD symptoms. Temporal associations between sleep and pain were assessed using cross-lagged path analysis and controlled for age, sex, and menstrual cycle. Overall, 26 participants completed 14-day diaries. All assessed aspects of sleep continuity disturbance were associated with worse next-day abdominal pain (Ps < 0.01). When assessed microlongitudinally, sleep onset latency predicted next-day pain (P = 0.07) and vice versa (P = 0.03). Similarly, nightly awakenings predicted next day pain (P = 0.02) and vice versa (P = 0.04). Sleep efficiency (P = 0.003), sleep quality (P < 0.001), and total sleep time (P = 0.04) predicted next-day pain whereas models with pain as the predictor were not significant. Sleep continuity and abdominal pain are closely related, with sleep efficiency, total sleep time, and sleep quality potentially driving next-day abdominal pain. As interventions for pain in IBD are limited, it may be important to capitalize on the impact of sleep disturbances on pain to optimize overall wellbeing in people with CD.