338 How Much Improvement in the Insomnia Severity Index Is Associated With a Positive Impact of A Patient’s Insomnia Medication?

SLEEP ◽  
2021 ◽  
Vol 44 (Supplement_2) ◽  
pp. A135-A135
Author(s):  
William Lenderking ◽  
Yulia Savva ◽  
Isabelle Chabot ◽  
Genevieve Meier ◽  
Jane Yardley ◽  
...  
Keyword(s):  
Total Sleep Time ◽  
Severity Index ◽  
Sleep Time ◽  
Double Blind Study ◽  
Negative Effects ◽  
Double Blind ◽  
Insomnia Severity Index ◽  
Positive Effects ◽  
Falling Asleep ◽  
Insomnia Severity

Abstract Introduction In Phase 3 Study 304 (SUNRISE-1; NCT02783729) and Study 303 (SUNRISE-2; NCT02952820), lemborexant (LEM) provided significant benefit versus placebo on sleep diary-based sleep onset/maintenance outcomes over 1mo and 6mo, respectively, in subjects with insomnia disorder. Both studies included the Insomnia Severity Index (ISI) and the Patient Global Impression–Insomnia version (PGI-I). On the PGI-I scale, subjects assess positive, neutral or negative treatment impact on falling asleep, overall benefit on sleep, and total sleep time. Using an anchor-based approach, ratings were compared with mean changes in ISI scores from baseline to evaluate what would be considered a responder definition on the ISI. Methods Study 304 was a 1mo, randomized, double-blind, placebo- and active-controlled, parallel-group study in female (age ≥55y) and male (age ≥65y) subjects (n=1006); subjects received placebo, LEM 5mg, LEM 10mg, or zolpidem tartrate extended-release. Study 303 was a 12mo, randomized, double-blind study in subjects age ≥18y (n=950). Subjects received placebo, LEM 5mg, or LEM 10mg for 6mo. Data from both studies were pooled for the first month of treatment across all treatment groups. A modified ISI total score (ISI-ts) was used based on a confirmatory factor analysis that showed no incremental value to including Question 5 (How NOTICEABLE to others do you think your sleep problem is in terms of impairing the quality of your life?). Results The ‘Overall Sleep’ PGI-I item demonstrated that mean [SD] changes from baseline in ISI-ts decreased more in association with self-reported positive effects (−8.15 [4.98]) than for neutral (−3.59 [3.37]) or negative effects (−1.67 [2.91]) at Day 31/Month 1. For PGI-I Item ‘Time to Fall Asleep,’ mean (SD) changes from baseline in ISI-ts were −7.49 (5.10) for positive, −4.54 (4.13) for neutral, and −2.94 (4.04) for negative effects at Day 31/Month 1. For PGI-I Item ‘Total Sleep Time’ mean (SD) changes from baseline in ISI-ts were −8.15 (5.04) for positive, −3.74 (3.23) for neutral, and −2.40 (3.49) for negative effects at Day 31/Month 1. Conclusion Results of this anchor-based approach using the PGI-I suggest that the responder definition for ISI-ts, using the modified ISI, should be approximately −8 points. Support (if any) Eisai Inc.

scholarly journals EFEKTIFITAS PEMBERIAN TERAPI MUSIK KLASIK TERHADAP PENURUNAN GEJALA INSOMNIA PADA LANSIA

2020 ◽  
Vol 9 (1) ◽  
pp. 1095-1102
Author(s):  
Medina Reggyanti ◽  
Tantri Wenny Sitanggang
Keyword(s):  
Music Therapy ◽  
Classical Music ◽  
Severity Index ◽  
The Elderly ◽  
Wilcoxon Test ◽  
Control Group ◽  
Purposive Sampling ◽  
Insomnia Severity Index ◽  
Falling Asleep ◽  
Insomnia Severity

Insomnia adalah suatu keadaan dimana seseorang mengalami kesulitan tidur, terutama tidur malam hari. Insomnia sering terjadi pada Lansia akibat penurunan jumlah neuron. Di dunia diperkirakan 40-50% orang menderita insomnia, salah satu cara untuk mengatasinya adalah dengan terapi musik klasik.Penelitian bertujuan untuk menentukan efektifitas pemberian terapi musik klasik terhadap penurunan gejala insomnia pada Lansia di  Posbindu Dahlia dan Karang Mekar Puskesmas Pisangan tahun 2017.Penelitian ini menggunakan rancangan Quasi Eksperiment dengan menggunakan teknik purposive sampling. Sampel dalam penelitian ini adalah 60 responden dibagi ke dalam 2 kelompok, yaitu 30 responden kelompok kontrol dan 30 responden kelompok intervensi. Pengumpulan data menggunakan instrumen pengukuran insomnia yang berupa kuesioner Insomnia Severity Index (ISI). Data dianalisa menggunakan uji wilcoxon test.Hasil dari analisa univariat menunjukkan bahwa usia kelompok kontrol adalah 60-74 (86,7%), 75-90 (13,3%), sedangkan usia kelompok intervensi adalah 60-74 (83,3%), 75-90 (16,7%) dan jenis kelamin kelompok kontrol adalah 6,7% laki-laki, 93,3% perempuan dan kelompok intervensi adalah 20% laki-laki, 80% perempuan. Hasil dari analisa bivariat uji wilcoxon test, pretest pada kedua kelompok ɑ > 0.05 dan posttest pada kedua kelompok ɑ <0,05. Terapi musik klasik dibutuhkan untuk menurunkan gejala insomnia pada Lansia.Kata kunci : Lansia, Insomnia, Terapi music    ABSTRACT                                                                                                                                                         Insomnia is a condition where a person has difficulty falling asleep, especially at night. Insomnia often occurs in the elderly due to a decrease in the number of neurons. It is estimated there are 40-50% of people around the world suffering from insomnia, one way to overcome it is to do classical music therapy. Research aims to determine the effectiveness of classical music therapy to decreased symptoms of insomnia in elderly in Posbindu Dahlia and Karang Mekar Puskesmas Pisangan in 2017. This research uses Quasi Experiment using purposive sampling. Sample in this research there are 60 respondents divide into 2 groups, 30 in the experiment group and 30 in the control group, Data collection using measuing instruments insomnia in the form of Insomnia Severity Index (ISI) questionnaires. Data were analized using wixolcom test. The result of the univariate analysis showed that the age of the control group is 60-74(86,7%), 75-90(13,3%), experiment group 60-74 (83,3%), 75-90(16,7%) and gender of control group is6,7% man, 93,3% woman while in the experiment group is 20% man and 80% woman. The result of bivariat wilcoxon test, pretest in both group ɑ > 0.05 and the posttest ɑ < 0,05. Classical music therapy is needed to reduce symptoms of insomnia in the elderly. Ederly should learn more about how to cope with insomnia with classical music therapyKeywoard : Elderly, Insomnia, Music Therapy

scholarly journals Differential Effects of DHA- and EPA-Rich Oils on Sleep in Healthy Young Adults: A Randomized Controlled Trial

Nutrients ◽  
2021 ◽  
Vol 13 (1) ◽  
pp. 248
Author(s):  
Michael J. Patan ◽  
David O. Kennedy ◽  
Cathrine Husberg ◽  
Svein Olaf Hustvedt ◽  
Philip C. Calder ◽  
...  
Keyword(s):  
Sleep Quality ◽  
Controlled Trial ◽  
Sleep Time ◽  
Sleep Efficiency ◽  
Omega 3 ◽  
Double Blind ◽  
Differential Effects ◽  
Positive Effects ◽  
Time In Bed ◽  
Oily Fish

Emerging evidence suggests that adequate intake of omega-3 polyunsaturated fatty acids (n-3 PUFAs), which include docosahexaenoic acid (DHA) and eicosapentaenoic acid (EPA), might be associated with better sleep quality. N-3 PUFAs, which must be acquired from dietary sources, are typically consumed at suboptimal levels in Western diets. Therefore, the current placebo-controlled, double-blind, randomized trial, investigated the effects of an oil rich in either DHA or EPA on sleep quality in healthy adults who habitually consumed low amounts of oily fish. Eighty-four participants aged 25–49 years completed the 26-week intervention trial. Compared to placebo, improvements in actigraphy sleep efficiency (p = 0.030) and latency (p = 0.026) were observed following the DHA-rich oil. However, these participants also reported feeling less energetic compared to the placebo (p = 0.041), and less rested (p = 0.017), and there was a trend towards feeling less ready to perform (p = 0.075) than those given EPA-rich oil. A trend towards improved sleep efficiency was identified in the EPA-rich group compared to placebo (p = 0.087), along with a significant decrease in both total time in bed (p = 0.032) and total sleep time (p = 0.019) compared to the DHA-rich oil. No significant effects of either treatment were identified for urinary excretion of the major melatonin metabolite 6-sulfatoxymelatonin. This study was the first to demonstrate some positive effects of dietary supplementation with n-3 PUFAs in healthy adult normal sleepers, and provides novel evidence showing the differential effects of n-3 PUFA supplements rich in either DHA or EPA. Further investigation into the mechanisms underpinning these observations including the effects of n-3 PUFAs on sleep architecture are required.

scholarly journals Tasimelteon safely and effectively improves sleep in Smith–Magenis syndrome: a double-blind randomized trial followed by an open-label extension

2021 ◽  
Author(s):  
Christos M. Polymeropoulos ◽  
Justin Brooks ◽  
Emily L. Czeisler ◽  
Michaela A. Fisher ◽  
Mary M. Gibson ◽  
...  
Keyword(s):  
Sleep Quality ◽  
Crossover Study ◽  
Total Sleep Time ◽  
Sleep Time ◽  
Open Label ◽  
Double Blind ◽  
Open Label Study ◽  
Label Study ◽  
Sleep Complaints ◽  
Open Label Extension

Abstract Purpose To assess the efficacy of tasimelteon to improve sleep in Smith–Magenis syndrome (SMS). Methods A 9-week, double-blind, randomized, two-period crossover study was conducted at four US clinical centers. Genetically confirmed patients with SMS, aged 3 to 39, with sleep complaints participated in the study. Patients were assigned to treatment with tasimelteon or placebo in a 4-week crossover study with a 1-week washout between treatments. Eligible patients participated in an open-label study and were followed for >3 months. Results Improvement of sleep quality (DDSQ50) and total sleep time (DDTST50) on the worst 50% of nights were primary endpoints. Secondary measures included actigraphy and behavioral parameters. Over three years, 52 patients were screened, and 25 patients completed the randomized portion of the study. DDSQ50 significantly improved over placebo (0.4, p = 0.0139), and DDTST50 also improved (18.5 minutes, p = 0.0556). Average sleep quality (0.3, p = 0.0155) and actigraphy-based total sleep time (21.1 minutes, p = 0.0134) improved significantly, consistent with the primary outcomes. Patients treated for ≥90 days in the open-label study showed persistent efficacy. Adverse events were similar between placebo and tasimelteon. Conclusion Tasimelteon safely and effectively improved sleep in SMS.

scholarly journals Sleep Disturbances in Individuals Quarantined Due to SARS-CoV-2 Pandemic in Poland: A Mixed Methods Design Study

2021 ◽  
Vol 10 ◽  
pp. 216495612110207
Author(s):  
Sabina Krupa ◽  
Witt Paweł ◽  
Wioletta Mędrzycka-Dąbrowska ◽  
Agnieszka Lintowska ◽  
Dorota Ozga
Keyword(s):  
Mixed Methods ◽  
Sleep Disturbances ◽  
Acute Stress ◽  
Sleep Problems ◽  
Severity Index ◽  
Structured Interview ◽  
Mixed Methods Design ◽  
Design Study ◽  
Insomnia Severity Index ◽  
Insomnia Severity

Objectives The study aimed to assess sleep disturbances in patients subjected to home quarantine due to suspected SARS-CoV-2 infection. The study used a mixed methods design study as a research methodology. Methods A semi-structured interview and the scale for Insomnia Severity Index (ISI) were used to achieve the aim of the study. The survey was conducted from 16 to 20 April 2020 and 1 to 2 September 2020 in Poland, at the during of SARS-CoV-2 epidemic in this country. The data were coded and cross-processed. The (COREQ) checklist was followed. Results Interviews with patients and a thorough analysis of recordings revealed commonly used phrases in the following categories: “anxiety”, “ Am I going crazy?”, “Sleep problems”. 10 out of 11 respondents reported sleep disorders of varying severity according to the Insomnia Severity Index scale. Patients presented a fear related to the return to society and normal functioning after quarantine. Additionally, some study participants voiced concerns related to their mental health; some cases of hallucinations were reported. Conclusions Further global population studies should be conducted to analyse this phenomenon. Acute Stress Disorder should be understood as a threat to life and health of an isolated society in quarantine. Further research in this area should be promoted and the need for global guidelines for the entire population should be developed.

The Relationship Between Smartphone Use, Insomnia, Stress, and Anxiety Among University Students: A Cross-Sectional Study

2020 ◽  
pp. 105477382098316
Author(s):  
Nisreen Al Battashi ◽  
Omar Al Omari ◽  
Murad Sawalha ◽  
Safiya Al Maktoumi ◽  
Ahmed Alsuleitini ◽  
...  
Keyword(s):  
University Students ◽  
Severity Index ◽  
Depression Anxiety Stress Scale ◽  
Cross Sectional ◽  
Convenience Sample ◽  
Insomnia Severity Index ◽  
Stress Scale ◽  
Smartphone Use ◽  
The Relationship ◽  
Insomnia Severity

The rapid increase in the number of smartphone users has raised concern about the negative psychosocial and physical effects of this use. A descriptive cross-sectional design was conducted to investigate the relationship between smartphone use, anxiety and insomnia among university students. A convenience sample of 404 students from one public university completed questionnaires with items from the Smartphone Addiction Scale, the Depression Anxiety Stress Scale and the Insomnia Severity Index, with some demographic data. High smartphone addition scale score was significantly associated with higher anxiety and stress scores of the Depression Anxiety Stress scale, and higher insomnia severity index score. The findings support the importance of an intervention program to promote appropriate use of smartphones and to improve sleep and psychological symptoms such as stress and anxiety among university students.

scholarly journals Mapping of the Insomnia Severity Index and other sleep measures to EuroQol EQ-5D health state utilities

2011 ◽  
Vol 9 (1) ◽  
pp. 119 ◽  
Author(s):  
Ning Yan Gu ◽  
Marc F Botteman ◽  
Xiang Ji ◽  
Christopher F Bell ◽  
John A Carter ◽  
...  
Keyword(s):  
Severity Index ◽  
Health State ◽  
Insomnia Severity Index ◽  
Health State Utilities ◽  
Insomnia Severity

Unexpected Reduction in Migraine and Psychogenic Headaches Following rTMS Treatment for Major Depression: A Report of Two Cases

CNS Spectrums ◽  
2007 ◽  
Vol 12 (12) ◽  
pp. 921-925 ◽  
Author(s):  
John P. O'Reardon ◽  
Jeisson F. Fontecha ◽  
Mario A. Cristancho ◽  
Suzanne Newman
Keyword(s):  
Antidepressant Treatment ◽  
Repetitive Transcranial Magnetic Stimulation ◽  
Common Side Effect ◽  
Double Blind Study ◽  
Double Blind ◽  
Positive Effects ◽  
Diagnostic And Statistical Manual ◽  
Headache Pain ◽  
Psychogenic Headaches ◽  
Maintenance Intervention

ABSTRACTOur objective is to report a coincident reduction in headache pain in patients treated with repetitive transcranial magnetic stimulation (rTMS) for major depressive disorder (MDD). Two patients with a Diagnostic and Statistical Manual of Mental Disorders, Fourth Edition diagnosis of MDD, non-responsive to prior antidepressant treatment who were enrolled in a sham-controlled, double-blind study of rTMS for MDD. After the study, it was revealed that both were in the active-treatment arm. Both patients suffered from near daily headaches and kept logs of headache frequency and severity before, during, and after the study. Headache pain was significantly reduced under double-blind conditions with rTMS treatment, but returned to baseline following cessation of rTMS treatment. Ultimately, when receiving rTMS post-study as a maintenance intervention for MDD (~2 rTMS sessions/week), the positive effects on headache amelioration were sustained. Headache pain is frequently comorbid with mood disorders and has been reported as the most common side effect with rTMS. In these subjects, rTMS was, in fact, associated with relief of depressive symptoms and preexisting headache pain. This indicates that rTMS may be beneficial for both disorders in some patients.

Changes in sleep predict changes in depressive symptoms in depressed subjects receiving vortioxetine: An open-label clinical trial

2019 ◽  
Vol 33 (11) ◽  
pp. 1388-1394 ◽  
Author(s):  
Bing Cao ◽  
Caroline Park ◽  
Joshua D Rosenblat ◽  
Yan Chen ◽  
Michelle Iacobucci ◽  
...  
Keyword(s):  
Major Depressive Disorder ◽  
Depressive Disorder ◽  
Sleep Quality ◽  
Epworth Sleepiness Scale ◽  
Quality Index ◽  
Pittsburgh Sleep Quality Index ◽  
Severity Index ◽  
Major Depressive ◽  
Insomnia Severity Index ◽  
Insomnia Severity

Background Sleep disturbances are frequently reported in patients with major depressive disorder. We aimed to investigate the effects of vortioxetine on sleep quality and association between changes in sleep and treatment response. Methods: This study is a post-hoc analysis of a clinical trial that sought to evaluate the sensitivity to cognitive change of THINC-integrated tool in patients with major depressive disorder. In total, 92 patients (aged 18 to 65) meeting Diagnostic and Statistical Manual of Mental Disorders, Fifth Edition criteria for moderate or severe major depressive disorder and 54 healthy controls were included. All patients received open-label vortioxetine (10–20 mg/day, flexibly dosed) for 8 weeks. Herein, the primary outcomes of interest were changes in sleep, as measured by the Pittsburgh Sleep Quality Index, Epworth Sleepiness Scale and Insomnia Severity Index, between weeks 0, 2, and 8. The association between changes in sleep and depressive symptom severity was secondarily assessed. Results: We observed that sleep, as indicated by scores of Pittsburgh Sleep Quality Index, Epworth Sleepiness Scale and Insomnia Severity Index, was significantly poorer in patients with major depressive disorder compared to healthy controls at weeks 0, 2, and 8 ( p < 0.05). Among patients with major depressive disorder, we observed significant improvements on the Pittsburgh Sleep Quality Index, Epworth Sleepiness Scale and Insomnia Severity Index between weeks 0 and 8 ( p < 0.05). We observed a significant association between improvements on the Pittsburgh Sleep Quality Index, Epworth Sleepiness Scale, and Insomnia Severity Index and improvement of depressive symptoms. Conclusion: Improvement of depressive symptoms in major depressive disorder patients treated with vortioxetine was associated with significant improvements in sleep. Furthermore, improvements in sleep were predictive of antidepressant response and were linearly correlated with improvement in overall depressive symptom severity.

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