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137 active trials for Insomnia

The Safety, Tolerability, Pharmacokinetics and Pharmacodynamics Study of HEC83518 Tablets in Chinses Healthy Subjects

Start: April 2020

Short and Long-Term Effectiveness of Existing Insomnia Therapies for Patients Undergoing Hemodialysis

Insomnia is a common and distressing symptom for patients on hemodialysis (HD), and there is evidence for a much larger impact on the health of patients. Chronic insomnia is disrupted sleep that occurs at least three nights per week and lasts at least three months. The SLEEP-HD study is a randomized open-label clinical trial to compare two types of treatment for insomnia in participants who have end-stage renal disease on HD, and who have been diagnosed with chronic insomnia. The two types of treatment involved in the study are Cognitive Behavioral Therapy for Insomnia (CBT-I) or treatment with a drug (trazodone vs placebo). 125 participants will be enrolled who are undergoing HD in two study locations (Seattle, Washington and Albuquerque, New Mexico).

Start: September 2018

Digital Behavioral Therapy for Sleep Problems

Insomnia is very common, especially in HIV population (up to 73%), and contributes to the development of other conditions such as depression, dementia, inflammation, obesity, and heart diseases. Cognitive-behavioral therapy for insomnia (CBT-I) is known to improve insomnia. However, it has never been tested in HIV-positive patients. The investigators aim to examine the Internet version of this therapy in HIV-positive patients because the availability of CBT-I is very limited while the cost is high. The investigators will test this internet version, also called digital CBT-I (dCBTI), against sleep hygiene education (SHE), a commonly prescribed set of instructions in clinical practice, in 60 HIV-positive patients with insomnia invited from the Multicenter AIDS Cohort Study (MACS) Los Angeles site. The investigators aim to test if dCBTI or SHE improves insomnia in this patient group. This trial involves a behavioral treatment that can be done from home with minimal side effects and includes neither medications nor invasive interventions. Lastly, this trial will provide important pilot data for a larger trial testing long-term effects of insomnia treatment in HIV-positive patients.

Start: March 2020

Acceptance and Commitment Therapy for Insomnia

Insomnia is a frequent complaint and is associated with impairments in physical and psychological health. Although Cognitive-Behavioral Therapy (CBT) demonstrates effective results for insomnia, there are those who do not respond to this type of intervention or present difficulties in adherence. Acceptance and Commitment Therapy (ACT) presents itself as a potentially useful intervention for the treatment of insomnia, for which, instead of focusing on controlling the symptoms, the respective approach focuses on accepting the feelings and thoughts associated, through value-based actions. The aim of this study is to evaluate the effectiveness of ACT for chronic insomnia in adults. Participants will be 150 adults aged between 18 and 59 years, diagnosed with chronic insomnia who will be randomly assigned to the ACT, CBT and wait list (WL) groups. For both groups (ACT and CBT), the intervention will be performed in six group and weekly sessions. Assessments of sleep patterns, insomnia, depression, anxiety, psychological flexibility, acceptance of sleep, beliefs about sleep, personality traits will be performed in the pre-treatment, post-treatment and six-month follow-up. After the intervention is completed, participants will respond to an inventory of compliance and satisfaction. The results will be compared using mixed ANOVA, followed by multiple comparison tests, where appropriate. For the primary and secondary outcomes, the magnitude of the effect will be calculated. The size of the effect will be calculated using the square partial eta and d of Cohen.

Start: March 2021

Nurse-Led BBTi for Post-stroke Insomnia

The current study aims to compare face-to-face and internet-based nurse-led BBTI compare to a wait-list conditions in the stroke population. This study is a parallel, three-arm, randomized controlled trial (RCT). Each participant will be randomized into one of the treatment arms; face-to-face BBTI, internet-based BBTI, and waiting-list. The BBTI, emphasizes behavioral aspects of insomnia care, arises from techniques of sleep restriction and stimulus control. The face-to-face and internet-based BBTI have equivalent content based on the standard portion. All participants will be asked to fill the online questionnaires at weeks 0 (baseline), 1 (mid-treatment), 2 (post-treatment), 4, and 12 (follow up). After the final follow-up, the waiting-list participants will be allowed to join the internet-based BBTI treatment. Our hypotheses are that patients with stroke who receive face-to-face or internet-based BBTI, compared to a wait-list condition, will experience fewer insomnia complaints.

Start: August 2021

Suvorexant on Sleep Disturbance in Patients With Chronic Insomnia and Suboptimally Controlled Type 2 Diabetes

The investigators aim to determine the effect of suvorexant on subjective total sleep time (TST) in suboptimally controlled Type 2 diabetics with chronic insomnia in a randomized placebo-controlled trial for 3 months.

Start: March 2019

THE ROLE OF MANUAL ACUPUNCTURE USING PRESS NEEDLES COMPARED WITH FILIFORM NEEDLES IN IMPROVING SYMPTOMS OF INSOMNIA AND MELATONIN HORMONE FOR HEALTHCARE WORKERS TREATING COVID-19 PATIENTS.

The purpose of this study is to compare the effectiveness of manual acupuncture between 2 types of needles in subsiding insomnia symptoms of healthcare workers who were responsible for treating COVID-19 Patients in Cipto Mangunkusumo hospital.

Start: May 2021

Solving Insomnia Electronically: Sleep Treatment for Asthma

Insomnia is commonly reported by adults with asthma. Insomnia can worsen asthma patients' quality of life and increase the risk for asthma attacks.This clinical trial will compare sleep and asthma control in adults with asthma and insomnia who receive either an internet-based intervention for insomnia or an educational video about insomnia.

Start: May 2018

Multicomponent Behavioral Sleep Intervention for Insomnia in Older Adults With Mild Cognitive Impairment

Insomnia symptoms in older adults with mild cognitive impairment represent a significant public health burden in terms of impaired quality of life, risks from untreated insomnia, and risks from pharmaceutical insomnia treatment. To address the limitations in the most effective non-pharmacological treatments for insomnia in older adults with mild cognitive impairment, a randomized pilot study will be conducted to test a brief (4 week), tablet-based, personalized, multicomponent behavioral sleep intervention for insomnia, compared to a sleep education control, in this at-risk group. The findings of the proposed project will inform future, larger scale clinical trials and may provide a novel and innovative way for older adults with mild cognitive impairment to achieve better sleep and health-related quality of life outcomes.

Start: May 2021

Efficacy of Suvorexant in Patients With Effectively Treated Restless Legs Syndrome and Persistent Chronic Insomnia

The investigators aim to determine the effect of suvorexant on actigraphically-derived total sleep time in patients with effectively treated restless legs syndrome with persistent insomnia in a two-arm, double-blind, randomized placebo-controlled crossover 2.5-month trial.

Start: June 2021

Sleep Deficiency and Stroke Outcome

Deficient sleep duration and sleep disturbances - such as insomnia, sleep disordered breathing (SDB) and restless legs syndrome (RLS)- are associated with hypertension and cardio-cerebrovascular morbidity and mortality. Several studies suggest that sleep disorders are frequent after stroke and detrimental for stroke outcome. However, more prospective studies in a large unselected sample of stroke survivors are needed to better investigate the short- and long-term consequences of sleep disturbances on mortality and occurrence of new cardio-cerebrovascular events. Also their pathophysiological mechanisms and their influence on stroke recovery should be better understood. Therefore, the aim of this study is to assess the impact of sleep deficiency and sleep fragmentation on the frequency of new cerebro- and cardiovascular events and death after stroke or transient ischemic attacks, and clinical outcome within one and two years after stroke. The working hypotheses are that stroke survivors with sleep deficiency and sleep fragmentation due to insomnia, sleep-disordered breathing or restless leg syndrome will present: (1) higher mortality from all causes and higher frequency of new cardio-/ cerebrovascular events; and (2) a less favorable clinical outcome. Outcomes will be compared between patients with and without sleep deficiency and fragmentation. Since current clinical practice in cerebrovascular patients does not sufficiently consider sleep disorders in patient's management, this study can help to bring attention to a still overlooked medical problem and change the current standard of management of stroke survivors.

Start: July 2015

A Pilot Study of Digital Cognitive Behavioral Therapy for Veterans

The proposed study is a multiple baseline design pilot study which seeks to evaluate the impact of digitally administered CBT-I, using the Sleepio platform, for the treatment of insomnia disorder among Veterans with co-morbid psychopathology. In addition, information related to acceptability and feasibility of the intervention among a Veteran sample will be obtained.

Start: February 2018

The Menopause After Cancer Study

This study will recruit women with vasomotor symptoms of menopause and a prior cancer diagnosis, for whom conventional menopausal hormone therapy (MHT) is contraindicated for any reason. This study will examine if the addition of psycho-social support and digital cognitive behavioral therapy (CBT) for insomnia to standard non-hormonal pharmacotherapy can improve quality of life for these women.

Start: June 2021

Effects of Cognitive Behavioural Therapy and Bright Light Therapy for Insomnia in Adolescents With Evening Chronotype

Insomnia is prevalent in adolescents. Together with an increase of evening preference (i.e. evening chronotype) in adolescent, sleep disturbance in adolescents are associated with a constellation of adverse outcomes. Insomnia and evening chronotype in adolescents are also found to predict the development of mental health problems and negative health-related outcomes in young adulthood. While cognitive behavioural therapy for insomnia (CBT-I) and bright light therapy were evidenced to be effective in managing sleep problems in adults, there is limited evidence to support their efficacy in children and adolescents. To address the limitations in the existing literature, this study aims to conduct a randomised controlled trial to examine the effects of CBT-I and light therapy on insomnia and mood symptoms, and other clinical and daytime symptoms, as well as overall functioning in adolescents with insomnia (particularly sleep onset insomnia) and evening chronotype.

Start: March 2020

Effects of Self-help Versus Group Cognitive Behavioural Therapy for Insomnia in Youth

Insomnia is the most prevalent sleep problem in both the general and clinical populations. Insomnia symptoms, presented as the problems initiating sleep or maintaining sleep, have been reported in association with adverse outcomes in adolescents, including an increased risk of developing depression, anxiety, interpersonal problems, somatic health problems, self-harm and suicidal ideation. Moreover, adolescent insomnia has been found to predict the development of mental health problems in young adulthood. Currently there is no medication specifically approved for use as hypnotics in children under age 18 by the US Food and Drug Administration (FDA). Although cognitive behavioural therapy for insomnia (CBT-I) has been regarded as the first-line treatment for insomnia in adults, there exists limited evidence for the efficacy of CBT-I among adolescents and young adults. Given the high prevalence and profound consequences of insomnia among youth, further research on the short-term and long-term effects of CBT-I for adolescents is warranted. To address the limitations of the existing literature, this randomised controlled trial aims to examine whether face-to-face (group-based CBT-I) versus self-help insomnia treatment benefit adolescents with insomnia, for improving sleep and other clinical and daytime symptoms as well as overall functional improvement in both the short and long term.

Start: May 2017

Online Prenatal Trial in Mindfulness Sleep Management

The aim of this study is to assess an online mindfulness intervention for pregnant women (6 weeks) for the treatment of insomnia and prevention of depression relapse in pregnancy. This mindfulness intervention will also be compared with an online intervention (6 weeks) consisting only of education about insomnia in pregnancy. The principal hypothesis is that the mindfulness intervention will be more effective than the education-only intervention.

Start: July 2019

Cereset Research In Healthcare Workers During COVID-19

The purpose of this study is to evaluate the use of Cereset Research to improve the symptoms of stress and anxiety in healthcare workers in an open label, waitlist controlled pilot clinical trial, during the period of COVID-19.

Start: July 2021

A Mixed Method Pilot Study for Patients With Mild Cognitive Impairment and Insomnia.

This study is proposed to address the research gap identified by the investigation team. The investigators are currently conducting a randomized controlled trial (RCT) to examine the effects of a new volunteer-supported model to improve cognitive function in MCI persons through the promotion of an active lifestyle. The investigators noticed that sleep problems are highly prevalent among this vulnerable group, and their motivation is low. As such, this team of investigators, which has a strong research track record and expertise in delivering psychosocial interventions, care of persons with MCI and dementia and chronic disease management using the empowerment-based educational model, developed an evidenced-based Cognitive behavioral therapy for insomnia (CBT-I) intervention featuring the empowerment approach to improve sleep quality and cognition in persons with MCI. The PI and the Co-I (D. Yu) have successfully used the empowerment model to promote self-care among patients with heart failure. Indeed, the co-investigators have extensive research and clinical experience in working with people with MCI and dementia. The Co-I (D. Yu), a nursing academician specializing in gerontology, has established an online CBT-based website (Sweet Dream) to fight against insomnia in the older population in Hong Kong and has tested the effects of an activity-based intervention for older people with sleep complaints. Another Co-I (A. Wong) is a psychologist with substantial research experience working with people with MCI and dementia. This study proposes to address a neglected area in the literature and to test the effects of an empowerment-based CBT-I for MCI persons on their sleep and cognition.

Start: May 2021

Research Evaluating Sleep & Trends for Universal Prevention

This study is designed to develop an integrated intervention to reduce alcohol and marijuana use and consequences and improve sleep among young adults with comorbid heavy episodic drinking, marijuana use, and sleep impairment.

Start: April 2021

Survivorship Sleep Program

This is a randomized pilot trial to test the feasibility and acceptability (primary outcomes) of a virtual cognitive behavioral program for insomnia for survivors of various cancer types. Secondary outcomes are to examine the preliminary effects on reducing insomnia severity from baseline to post-intervention.

Start: October 2020