Active clinical trials for "Sleep Initiation and Maintenance Disorders"

Abstract Objectives: To explore the clinical effects of self-acupressure for treating insomnia delivered by a training course. Hypothesis: Subjects who have participated in the self-acupressure training course will have greater improvement in insomnia symptoms and daytime impairment than the sleep hygiene education control group at 4 and 8 weeks. Design and subjects: A pilot randomized controlled trial. Subjects with insomnia will be recruited from the community. 30 subjects will be randomized to self-acupressure and sleep hygiene education control groups in a 1: 1 ratio. Study instrument: Insomnia Severity Index (ISI) will be used to assess insomnia symptoms and daytime impairment. Interventions: Subjects in the self-acupressure group will attend two training sessions to learn self-acupressure and will practice self-acupressure every night for 4 weeks; subjects in the sleep hygiene education control group will receive two training sessions to learn sleep hygiene practice. Main outcome measures: The primary outcome measure is the ISI score. Other measures include sleep parameters using subjective sleep diary, Hospital Anxiety and Depression Scale, and SF-6D at 4 and 8 weeks. Acceptability and sustainability of self-acupressure will also be evaluated. Data Analysis: Differences in the questionnaire scores, subjective sleep parameters will be examined using a mixed-effects model.

Acupuncture is widely used for treatment of insomnia. The research hypothesis is that acupuncture may be more effective than sham acupuncture to treat insomnia during pregnancy. GAS is a randomized controlled trial with placebo acupuncture using the insomnia severity index (ISI) as the main outcome criterion.

Chronic insomnia affects more than 25% of cancer survivors, a rate double that of the general population. The Pan-Canadian sleep guideline for adults with cancer recommends Cognitive-Behavioral Therapy for Insomnia (CBT-I) as the best treatment. Major problems, however, are the lack of available CBT-I at cancer centers and the lack of information about possible side-effects of CBT-I. To address this issue, our study will evaluate the effectiveness and potential short-term side-effects of an online version of CBT-I. It is expected that when compared to cancer survivors who receive an online sleep education program, those who receive online CBT-I will experience improved sleep, mood, and quality of life, as well as reduced anxiety and fatigue.

Transcranial magnetic stimulation (TMS) is a non-invasive brain stimulation technique that has been approved as a treatment of depression in patients that have not responded to a trial of one antidepressant medication. The investigators hypothesize that low frequency TMS exerts inhibitory effect on hyper excitable cortical state in patients with chronic insomnia and therefore is therapeutic. The investigators want to compare the change in insomnia scores between baseline and end of treatment in an open label trial with bifrontal low frequency TMS stimulation in 20 patients with primary insomnia using daily stimulation of 3 weeks (15 week days).

There is evidence that CBT for insomnia (CBTi) is an effective treatment for sleep disturbance both as a primary problem and when co-morbid with other health problems, such as chronic pain. This study will investigate the effectiveness of CBTi as a treatment for tinnitus related insomnia. Tinnitus patients reporting clinically significant insomnia will be offered sleep-specific treatment. Six sessions of CBTi will be offered to one group of patients and 2 sessions standard audiological care (psycho-education and sleep hygiene) will be offered to another group. Both groups will be offered sound enrichment at night. In order to take account of the possible effects of clinical contact a third group will be offered 6 sessions of support without a focused tinnitus or sleep intervention. Accepted measures of sleep disturbance will be used as well as measures of tinnitus complaint. All treatment/contact will be provided at the Royal National Throat Nose & Ear Hospital. Participants will be involved in the study (inc. baseline period {2 weeks}, intervention {8 weeks} and follow-ups {4 and 20 weeks}) for 34 weeks.

The purpose of the study is to investigate the underlying central nervous mechanisms of acupuncture treatment in chronic insomnia patients, from observation changes of gray matter and functional connectivity in the default mode network and the salience network by functional magnetic resonance imaging, and combine with clinical efficacy assessment to analyze the association between the results of imaging and behavioristic.

Aim: To assess the acceptability and make estimations about the effectiveness of using self-acupressure to manage insomnia, depression, and anxiety in cancer patients undergoing chemotherapy. Study design: three-arms randomized sham-controlled trial. Participants will be assigned to the true self-acupressure group, sham acupressure group, or enhanced standard care group, with a ratio of 1:1:1 using block randomize. Participants: patients receiving chemotherapy. 114 patients will be recruited to the study. Inclusion criteria: Undergoing chemotherapy currently, Age 20 - 84 years' old, able to read and write Vietnamese, Karnofsky score ≥ 80, Insomnia Severity Index (ISI) score ≥ 11, Anxiety score measured by The Hospital Anxiety and Depression Scale (HADS) ≥ 8 and Depression score measured by HADS ≥ 8 Exclusion criteria: Patients are excluded from the trial if they are unable to understand or cooperate with study procedures, receiving other cancer treatments (e.g., radiotherapy, hormonal therapy) at the same time as receiving chemotherapy and during the period of their involvement in the trial, participating in other research studies which may have interacted with the current trial or affect insomnia, depression, anxiety perception, having difficulties or are unable to practice self-acupressure by themselves, are receiving insomnia or depression/anxiety treatment currently. Interventions Self-administered acupressure training section Participants in the true or sham self-acupressure groups will receive a self-administered acupressure training section based on their group assignment. Then, they will be requested to practice acupressure at home for 4 weeks. Patient leaflet All of the participants in three groups will receive a patient leaflet with tips to manage insomnia, depression, and anxiety. Weekly telephone reminder will be made to follow-up participants in all groups. Outcome measurement The recruitment rate, consent rate, refusal rate, attrition rate, adherence rate will be calculated. The acceptability of the intervention will be measured by the Intervention Rating Profile - 15. The ISI, The HADS, and The Functional Assessment of Cancer Therapy-General will be used to evaluate the effects of self-acupressure on the severity of insomnia, depression, anxiety. Others sleep parameters and adverse events associated with self-acupressure will be recorded.

This study will provide measures of safety and efficacy of the NightWare digital therapeutic system (iPhone + Apple watch + proprietary application) for the treatment of nightmare disorder associated with post-traumatic stress disorder (PTSD)-related sleep disturbance and the impact of improved sleep with the NightWare digital therapeutic system. The investigators hypothesize that the NightWare digital therapeutic system will significantly improve sleep quality in participants with PTSD-Related nightmares and poor sleep quality.

Insomnia has significantly negative impact on work, quality of life, psycho-somatic health on individuals and imposes substantial economic burdens on society. Mindfulness-based interventions (MBIs) have shown its efficacy in the treatment of insomnia, however the effect of online MBIs need more studies to verify. This study aims to compare the effectiveness of an online MBI named 'Mindful Living With Insomnia (MLWI)' to online CBI-I for insomnia.

This study will examine the effects of a self-help smartphone-based multi-component lifestyle medicine intervention (LM) for alleviating insomnia symptoms in a Chinese population. Since a range of lifestyle factors are related to the pathogenesis and progression of insomnia, modifying different lifestyle factors simultaneously, such as diet, exercise, stress, and sleep which are empirically supported by previous reviews, may be effective to reduce insomnia symptoms (Reid et al., 2010; Vedaa et al., 2016). Traditional Chinese nutritional values will be integrated into the smartphone application to increase the acceptability towards the intervention. A prevalence study suggested that self-help interventions are preferred due to the potential stigmatization related to mental health interventions and the high cost of mental health services in Hong Kong (Lee, Tsang, & Kwok, 2007). Nonetheless, to date, only limited self-help interventions that target lifestyle medicine for sleep-related problems are available. Through this study, we aimed to promote evidence-based patient care and improve help-seeking behaviors and access to evidence-based lifestyle interventions for insomnia.