scholarly journals Isolating the role of time in bed restriction in the treatment of insomnia: a randomized, controlled, dismantling trial comparing sleep restriction therapy with time in bed regularization

SLEEP ◽  
2020 ◽  
Vol 43 (11) ◽  
Author(s):  
Leonie Franziska Maurer ◽  
Colin Alexander Espie ◽  
Ximena Omlin ◽  
Matthew James Reid ◽  
Rachel Sharman ◽  
...  

Abstract Study Objectives Sleep restriction therapy (SRT) is one of the most effective treatments for insomnia. Restriction of time in bed (TIB) is assumed to be the central mechanism through which SRT improves sleep consolidation and reduces insomnia symptoms. This hypothesis has never been directly tested. We designed a randomized, controlled, dismantling trial in order to isolate the role of TIB restriction in driving both clinical and polysomnographic sleep outcomes. Methods Participants aged 25–55 who met diagnostic criteria for insomnia disorder were block-randomized (1:1) to 4 weeks of SRT or time in bed regularization (TBR), a treatment that involves the prescription of a regular but not reduced TIB. The primary outcome was assessed with the insomnia severity index (ISI) at baseline, 4-, and 12-weeks post-randomization. Secondary outcomes included sleep continuity (assessed via polysomnography, actigraphy, and diary) and quality of life. We performed intention-to-treat analyses using linear mixed models. Results Fifty-six participants (39 females, mean age = 40.78 ± 9.08) were assigned to SRT (n = 27) or TBR (n = 29). Daily monitoring of sleep via diaries and actigraphy confirmed large group differences in TIB (d range = 1.63–1.98). At 4-weeks post-randomization, the adjusted mean difference for the ISI was −4.49 (d = −1.40) and −4.35 at 12 weeks (d = −1.36), indicating that the SRT group reported reduced insomnia severity relative to TBR. Robust treatment effects in favor of SRT were also found for objective and self-reported sleep continuity variables (d range = 0.40–0.92) and sleep-related quality of life (d = 1.29). Conclusions For the first time, we demonstrate that TIB restriction is superior to the regularization of TIB on its own. Our results underscore the centrality of the restriction component in reducing insomnia symptoms and consolidating sleep.

2021 ◽  
Author(s):  
Kathleen P. O'Hora ◽  
Raquel A. Osorno ◽  
Dena Sadeghi-Bahmani ◽  
Mateo Lopez ◽  
Allison Morehouse ◽  
...  

BACKGROUND The COVID-19 Pandemic led to drastic increases in the prevalence and severity of insomnia symptoms. These increases in insomnia complaints have been paralleled by significant decreases in well-being, including increased symptoms of depression, anxiety, and suicidality and decreased quality of life. However, the efficacy and impact of early treatment of insomnia symptoms on future sleep and well-being remains unknown. OBJECTIVE Here, we present the framework and protocol for a novel study that aims to investigate whether a brief telehealth insomnia intervention targeting new insomnia that developed during the pandemic prevents deterioration of well-being, including symptoms of insomnia, depression, anxiety, suicidality, and quality of life. METHODS The protocol details a two-arm randomized controlled trial to investigate the efficacy of a brief, telehealth-delivered, early treatment of insomnia and evaluate its potential to prevent a deterioration of well-being. Participants with clinically significant insomnia symptoms that began during the pandemic are randomized to either a treatment group or a 28-week waitlist control group. Treatment consists of 4 telehealth sessions of Cognitive Behavioral Therapy for Insomnia (CBT-I) delivered over 5 weeks. All participants will complete assessments of insomnia symptom severity, well-being, and daily habits checklist at baseline (week 0), and at weeks 1-6, 12, 28, and 56. RESULTS The trial began enrollment June 3, 2020 and closed enrollment June 17, 2021. As of October 2021, 49 participants have been randomized to either immediate treatment or a 28-week waitlist. 23 participants are still active in the protocol. CONCLUSIONS To our knowledge, this protocol would be represent the first study to test an early sleep intervention for improving insomnia that emerged during the COVID-19 Pandemic. The findings of this study could provide information about the utility of CBT-I for symptoms that emerge in the context of other stressors before they develop a chronic course and deepen understanding of the relationship between sleep and well-being. CLINICALTRIAL NCT04409743


2018 ◽  
Vol 2018 ◽  
pp. 1-7 ◽  
Author(s):  
Chuo-Yu Lee ◽  
Shih-Jung Cheng ◽  
Hui-Chi Lin ◽  
Yu-Lu Liao ◽  
Pei-Hao Chen

Dementia with Lewy bodies (DLB) is a complex, multisymptom disorder. When making decisions regarding the treatment of DLB, the patient’s quality of life (QoL) should always be the main consideration. To our knowledge, this is the first review article focusing on the QoL in DLB patients. We searched the PubMed database using the keywords “quality of life” and “dementia with Lewy bodies.” Previously, no specific instrument had been developed for assessing the QoL in DLB patients. Patients with DLB have a decreased QoL compared to patients with Alzheimer’s disease, which is reportedly caused by several factors including level of independence in instrumental activities of daily living, whether the patient is living with the caregiver, apathy, delusion, and dysautonomia. The direct effect of visual hallucination, sleep, and movement disorders on the QoL in DLB patients has not been previously studied. The role of cognitive function on the QoL is still controversial. In a randomized controlled study, memantine may improve the QoL in PDD or DLB patients. We concluded that it is important to develop a specific instrument to assess the QoL in DLB patients. Furthermore, there is an urgent need for large clinical trials to identify factors associated with the QoL and how they can be managed.


Author(s):  
Maurício Telles ◽  
Samara Jamile Mendes

A psoríase é uma doença cutânea comum, crônica e não transmissível, sem causa clara ou cura. O impacto negativo desta condição sobre as vidas das pessoas pode ser imenso. A psoríase afeta pessoas de todas as idades, e em todos os países. É importante levar em consideração alguns fatos, a psoríase afeta pessoas de todas as idades, e em todos os países. A prevalência relatada nos países varia entre 0,09% e 11,43%, o que torna a psoríase um problema global sério, com no mínimo 100 milhões de indivíduos afetados mundialmente. A psoríase apresenta uma evolução dos sintomas imprevisível, uma diversidade de gatilhos externos e comorbidades significativas, incluindo artrite, doenças cardiovasculares, síndrome metabólica, doença intestinal inflamatória e depressão. A OMS reconhece a psoríase como uma doença não transmissível (NCD) séria, destacando que muitas pessoas no mundo sofrem sem necessidade em virtude do diagnóstico incorreto ou tardio, de opções de tratamento inadequadas e do acesso insuficiente aos cuidados, e em virtude da estigmatização social, a psoríase causa um grande ônus físico, emocional e social. Há a necessidade de um debate central quando fala-se em psoríase: Para estes pacientes é de fato um ponto de extrema relevância, qualidade de vida é uma noção eminentemente humana, que tem sido aproximada ao grau de satisfação encontrado na vida familiar, amorosa, social e ambiental e à própria estética existencial. Pressupõe a capacidade de efetuar uma síntese cultural de todos os elementos que determinada sociedade considera seu padrão de conforto e bem-estar. O termo abrange muitos significados, que refletem conhecimentos, experiências e valores de indivíduos e coletividades que a ele se reportam em variadas épocas, espaços e histórias diferentes, sendo, portanto, uma construção social com a marca da relatividade cultural. Desde 2010 anos foram lançados tratamentos biológicos focados na Psoriase Moderada a Grave com o objetivo de maior eficácia e promoção de melhora na qualidade de vida dos pacientes. Maior eficácia quer dizer que as lesões dos pacientes serão eliminadas em maior proporção passando de uma escala PASI75 para PASI90, onde PASI significa Psoriasis Área and Severity Index (PASI). Os agentes biológicos são moléculas de natureza proteica, semelhantes a proteínas animais ou humanos, sendo susceptíveis à digestão no trato gastrointestinal. Apresentam tamanho molecular relativamente grande, sendo, por isso, administradas por via parenteral (subcutânea, intramuscular ou intravenosa) e não oral. São proteínas recombinantes, criadas por engenharia genética, que podem ser anticorpos monoclonais, proteínas de fusão ou citocinas humanas recombinantes. Revisar a literatura cientifica sobre o uso de medicamentos biológicos na qualidade de vida de pacientes com psoríase. O presente trabalho é uma revisão integrativa da literatura sobre os medicamentos biológicos para o tratamento da Psoríase moderada a grave e seus impactos na qualidade de vida destes pacientes. Foi realizada uma pesquisa exploratória a partir das bases de dados disponíveis na Biblioteca Virtual em Saúde Pública – BVS (Lilacs e Sistema Online de Busca e Análise de Literatura Médica – Medline). A definição de descritores para a busca foi realizada a partir da pergunta de pesquisa, permitindo a formulação das sintaxes para encontrar a literatura adequada para a revisão proposta. A pergunta de pesquisa utilizada para nortear esta revisão foi: O impacto da psoríase moderada a grave na qualidade de vida dos pacientes antes e depois do uso de medicamentos Biológicos? A busca bibliográfica foi realizada a partir da combinação dos descritores A composição sintática realizada do tema parte da compreensão de três eixos temáticos (descritores principais) identificados a partir da pergunta da pesquisa: Psoríase; Qualidade de Vida; Biológicos. As combinações foram realizadas com os sinônimos. psoríase: Psoríase Pustular de palmas e plantas dos pés, Pustulose Palmoplantar, Pustulose de palmas, plantas dos pés, Artrite Psoriásica, psoríase artropática, psoríase artropática. Para qualidade de vida: HRQOL, QVRS, Qualidade de Vida Relacionada à Saúde e o próprio termo Qualidade de vida. Para biológicos: Biofarmácos, drogas biológicas, medicamentos biológicos, produtos biológicos, produtos biofarmacêuticos, remédios biológicos e imunomodulador. Após estes achados realizou-se as combinações tanto na BVS quanto no PubMed e Scielo e foram compostas sintaxes com os operadores booleanos “OR” e “AND”. As possibilidades de síntese foram ordenadas. Sendo que nesta fase optou-se por incluir a base de dados Pubmed na busca e foi adicionado o filtro “Ensaios Clínicos Controlados” para um melhor direcionamento nas pesquisas. Sintaxes utilizadas: BVS: (tw:(psoriasis)) AND (tw:(quality of life)) AND (tw:(biologic)) + filtro – Ensaios Clínicos Controlados = 121 estudos (tw:(psoríase)) AND (tw:(qualidade de vida)) AND (tw:(biológico)) + Filtro – Ensaios clínicos controlados= 36 estudos. PubMed: ((psoriasis) AND (quality of life)) AND (biologic*) + filtro – Randomized controlled trials= 40 estudos (((psoriasis) AND (quality of life)) AND (biologic*)) AND (brazil) + Filtro – randomized controlled trials= 0. Scielo: (psoriasis) AND (quality of life) AND (biologic*) = 14 estudos; (psoríase) AND (qualidade de vida) AND (biológico) = 1 estudo. Chegou-se a 210 resultados identificados, sendo que 62 foram retirados por serem duplicados. Posteriormente será realizada a leitura de títulos e resumos, incluindo os artigos que correspondam a psoríase, qualidade de Vida e medicamentos biológicos e serão excluídos artigos de outras línguas que não inglês, espanhol e português, além de artigos que tratem apenas dos medicamentos.


Author(s):  
Samir El Sayed ◽  
Sarah Gomaa ◽  
Doaa Shokry ◽  
Ahmed Kabil ◽  
Ahmed Eissa

Abstract Background COVID-19 pandemic became a global health problem affecting the life of millions of people all over the world. The effects of this pandemic were not only on the physical and medical aspects but also on the psychological issues including anxiety disorders, depressive manifestations, sleep problems and others. Sleep disorders were very commonly reported during the novel Coronavirus-19 pandemic either in the acute phase of COVID-19 infection or after recovery. These sleep problems might have a drastic burden on the recovered patients’ life. This study aimed to investigate the sleep in the post-Coronavirus-19 period and if has an impact on the different items of patients’ quality of life. This cross-sectional observational study investigated the sleep problems in 500 patients in the post recovery period using Insomnia Severity Index and Pittsburgh sleep quality index (PSQI), their relation to this critical period and their impact on different domains of Quality of Life which was assessed by the SF36 Health Survey. Results Socio-demographic characteristics of 500 post-Coronavirus-19 patients were collected; the insomnia severity index and Pittsburgh sleep quality index evaluated the sleep pattern. The quality of life was investigated using Short Form 36 scale. The study revealed high scores of insomnia severity index (13.01 ± 4.9), Pittsburgh sleep quality index (15.37 ± 4.43), also high scores of different items of scale of quality of life in the studied group. Conclusion Post-COVID-19 sleep disturbances were commonly reported in the recovery period, also these sleep deficits had an impact on the physical and mental aspects of quality of life, so these sleep problems must be managed properly especially in this critical pandemic era.


BMJ Open ◽  
2020 ◽  
Vol 10 (3) ◽  
pp. e036248
Author(s):  
Simon D Kyle ◽  
Claire Madigan ◽  
Nargis Begum ◽  
Lucy Abel ◽  
Stephanie Armstrong ◽  
...  

IntroductionInsomnia is a prevalent sleep disorder that negatively affects quality of life. Multicomponent cognitive-behavioural therapy (CBT) is the recommended treatment but access remains limited, particularly in primary care. Sleep restriction therapy (SRT) is one of the principal active components of CBT and could be delivered by generalist staff in primary care. The aim of this randomised controlled trial is to establish whether nurse-delivered SRT for insomnia disorder is clinically and cost-effective compared with sleep hygiene advice.Methods and analysisIn the HABIT (Health-professional Administered Brief Insomnia Therapy) trial, 588 participants meeting criteria for insomnia disorder will be recruited from primary care in England and randomised (1:1) to either nurse-delivered SRT (plus sleep hygiene booklet) or sleep hygiene booklet on its own. SRT will be delivered over 4 weekly sessions; total therapy time is approximately 1 hour. Outcomes will be collected at baseline, 3, 6 and 12 months post-randomisation. The primary outcome is self-reported insomnia severity using the Insomnia Severity Index at 6 months. Secondary outcomes include health-related and sleep-related quality of life, depressive symptoms, use of prescribed sleep medication, diary and actigraphy-recorded sleep parameters, and work productivity. Analyses will be intention-to-treat. Moderation and mediation analyses will be conducted and a cost-utility analysis and process evaluation will be performed.Ethics and disseminationEthical approval was granted by the Yorkshire and the Humber - Bradford Leeds Research Ethics Committee (reference: 18/YH/0153). We will publish our primary findings in high-impact, peer-reviewed journals. There will be further outputs in relation to process evaluation and secondary analyses focussed on moderation and mediation. Trial results could make the case for the introduction of nurse-delivered sleep therapy in primary care, increasing access to evidence-based treatment for people with insomnia disorder.Trial registration numberISRCTN42499563


2019 ◽  
Author(s):  
Charlotte Angelhoff ◽  
Peter Johansson ◽  
Erland Svensson ◽  
Anna Lena Sundell

Abstract Background: To increase health and well-being in young children, it is important to acknowledge and promote the child’s sleep behaviour. However, there is a lack of brief, validated sleep screening instruments for children. The aim of this study was to present a Swedish version of the Pediatric Insomnia Severity Index (PISI), analyse the structure, test the validity and reliability of the instrument. Methods: The English version of the PISI was translated into Swedish, translated back into English, and agreed upon before use. Parents of healthy 3- to 10-year-old children filled out the Swedish version of the PISI and the generic health-related quality of life instrument KIDSCREEN-27 two times. Exploratory and confirmatory factor analyses for baseline and test-retest, structural equation modelling, and correlations between the PISI and KIDSCREEN-27 were performed Results: In total, 160 parents filled out baseline questionnaires (test), whereof 100 parents (63%) filled out the follow-up questionnaires (retest). Confirmative factor analysis of the PISI found two correlated factors: sleep onset problems (SOP) and sleep maintenance problems (SMP). The PISI had substantial construct and test-retest reliability. The PISI factors influenced all KIDSCREEN-27 dimensions. Conclusions: The Swedish version of the PISI is applicable for screening sleep problems and is a useful aid in dialogues with families about sleep. It is also relevant in research and for evaluation of treatment. Keywords: Child; Child, Preschool; Health Promotion; Sleep; Translations; Pediatrics; Validation Studies; Quality of Life


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