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137 active trials for Insomnia

Health Promoting Work Schedules: The Effect of Abolishing Quick Returns

Introduction In shift work, quick returns refer to transitions between two shifts with less than 11 hours available rest time. In a recent report, as many as twenty-three per cent of employees in European countries reported having quick returns. Cross-sectional studies have demonstrated that quick returns are related to shorter sleep duration, fatigue, sleepiness, work-related accidents, and sickness absence. The present study is the first randomized controlled trial (RCT) to investigate the effect of abolishing quick returns for six months, compared to a work schedule that maintain quick returns during the same time frame. Methods and analysis A parallel-group cluster randomized controlled trial in a target sample of about 2700 healthcare workers at Haukeland University Hospital in Norway will be conducted. A total of 69 hospital units will be randomized to a work schedule without quick returns for six months, or continue with a schedule that includes quick returns. The primary outcome is sickness absence data retrieved from the local records kept by the hospital; secondary outcomes are questionnaire data (n ? 2700 invited) on sleep and functioning, physical and psychological health, work-related accidents, and turnover intention. For a subsample, sleep diary and sleep radar (n ? 70) data will be collected. Ethics and dissemination The study protocol was approved by the Regional Committee for Medical and Health Research Ethics in Western Norway (2020/200386). Findings from the trial will be disseminated in peer-reviewed journals and presented at national and international conferences. Exploratory analyses of potential mediators and moderators will be reported separately. User-friendly outputs will be disseminated to relevant stakeholders, unions and other relevant societal groups.

Start: January 2021

The Better Sleep for Supporters With Insomnia Study

This study will identify whether - and if so, how - tailoring would increase adoption of and benefit from an interactive internet intervention for insomnia called SHUTi (Sleep Healthy Using the Internet) for cancer caregivers. Participating caregivers' sleep and sleep-related characteristics will be characterized from a baseline assessment; then, caregivers will receive complementary and voluntary access to SHUTi. Among caregivers who choose to use SHUTi, intervention use, perceived appropriateness, and effects on sleep and quality of life will be assessed. Among caregivers who choose not to use SHUTi, reasons and barriers to using the intervention will be assessed.

Start: September 2020

Outcomes Mandate National Integration With Cannabis as Medicine for Prevention and Treatment of COVID-19

This will be a multistate, multicenter clinical study to determine the efficacy and safety of medical cannabis for a wide variety of chronic medical conditions.

Start: December 2018

Cognitive Behavioural Therapy for Insomnia for Chinese Adults: a RCT

Background: Insomnia is a common mental problem, where people experienced difficulty falling asleep, problem maintaining asleep and early morning awakening. It is highly prevalent world-wide and in Hong Kong, causing significant suffering and distress. While evidence based intervention exists, e.g. cognitive-behavioural therapy (CBT), there will not enough therapists to meet treatment demand. A more efficient delivery of treatment, e.g. internet based therapy is called for that can delivery treatment more cost efficiently by requiring lesser therapist time. Objective: This study aims at evaluating the effectiveness of CBTi (Gp) on treating Chinese insomniac adults in Hong Kong. There has been criticism that most clinical trials have been conducted with Caucasians in Western countries and little has been done with ethnic minorities, including Asians in these countries, not to mention Asians in Asian countries, e.g., Chinese in Hong Kong. Design: A two-arm parallel-group randomised controlled trial, comparing the treatment and waitlist group Method: A CBTi protocol would be developed. Approximately 60 Chinese adults with insomnia will be recruited in Hong Kong and randomised into one of the two groups (treatment vs. waitlist). The treatment last for 6 weeks, plus a 3-month follow-up period. The primary outcome measure will be Insomnia Severity Index (ISI).

Start: June 2020

The Reducing Risk Study

The present study will test an innovative mobile health adaptation of a behavioral intervention that improves sleep and mental health concerns among adolescents.

Start: November 2020

Insomnia and Sleep Disturbances in Chronic Pain Patients - Relation to Physical Activity Level and Opioid Use

Pain is one of the most common causes of healthcare contact and long-term sick leave, with negative consequences on physical and mental health. Poor sleep is common in chronic pain patients. Epidemiological studies indicate that 5-7% of patients with chronic pain are treated regularly with strong opioids. Negative side effects of pain modulating drugs on sleep quality have been reported, which may have negative influence on overall disease management in chronic pain patients. However, to date there are conflicting results regarding the effects of opioids on sleep, since the pain relieving effect of opioids seem to affect sleep positively. There is data suggesting that physical activity has positive effects on both pain perception and sleep quality (and duration). The aim of the study is to explore insomnia and characteristics of sleep in patients with chronic pain and the relationship with physical activity level and opioid use.

Start: October 2020

A Pilot Evaluation of the Insomnia Coach Mobile App

This pilot study is designed to test the feasibility, acceptability, and potential effectiveness of a mobile phone application (app) developed by the VA National Center for PTSD (VA NCPTSD) for use by Veterans with insomnia. The primary objective is to assess whether Veterans find the Insomnia Coach app to be satisfactory and feasible to use. Secondary objectives are to determine if use of the app improves subjective sleep quality and sleep parameters (e.g., sleep latency, wake after sleep onset, and total sleep time), as well as other important outcomes (e.g., daily functioning).

Start: July 2019

Targeting Sleep Homeostasis to Improve Alcohol Use Disorder Treatment Outcomes (M-STAR Study)

Insomnia is common in people who are in treatment for alcohol use disorder. It can impact both sleep quality and daytime functioning, as well as make it harder to treat the underlying alcohol use disorder. This study is looking at two types of therapy to help manage insomnia specifically for people also in treatment for alcohol use disorder.

Start: November 2020

Sleep and Pain Interventions in Women With Fibromyalgia

Insomnia affects 67-88% of chronic pain patients. SPIN II is a randomized controlled clinical trial that will compare the effects of two cognitive behavioral sleep treatments in women with fibromyalgia and insomnia. This trial will yield important information about the roles of sleep, arousal, and brain structure and function in the development and maintenance of chronic pain in women with fibromyalgia.

Start: February 2019

Cognitive Behavioral Sleep Intervention for Prevention of Type 2 Diabetes

The proposed study aims to evaluate if improving sleep could enhance the intensive lifestyle intervention for improving weight loss and glycemic control in prediabetic individuals who have insomnia with short sleep duration. A cognitive behavioral intervention for insomnia with adjustments aimed at increasing sleep duration (CBT-Sleep) will be used for this study.

Start: July 2020

Effectiveness of Healthy Habits for Hospitalized Older Adults to Optimize Rehabilitation

This study aims to evaluate behavioral interventions in conjunction with medical rehabilitation to promote functional health in patients recovering from orthopedic surgery. Half of the subjects in this study will be assigned to an intervention that meets with a study therapist to discuss implementing healthy habits. The other half of subjects will assigned to an intervention group that meets with a study therapists to discuss implementing healthy sleep habits. Both groups will undergo several physical and cognitive assessments.

Start: December 2020

Effect of Medical Marijuana on Neurocognition and Escalation of Use

This study will use a randomized controlled design to test whether patients who use medical marijuana, compared to a waitlist control group, experience a change in health outcomes (relief of symptoms, or adverse health outcomes such as new-onset symptoms of cannabis use disorders, neurocognitive impairments) or brain-based changes.

Start: July 2017

Online Treatment of Cognitive Impairment and Insomnia in Cancer Survivors

The investigators will answer the question of whether treating insomnia using Cognitive Behavior Therapy for Insomnia (CBT-I) can improve perceived cognitive impairment (PCI) in cancer survivors compared to a waitlist control group. The investigators will recruit 124 people with insomnia and cognitive complaints who have completed cancer treatment at least 6 months prior to the study.

Start: September 2019

Impact of Bed Provision and Sleep Education

Investigators will recruit up to 100 families (children aged 8-12 years and their primary caregivers) from the Philadelphia-area Beds for Kids charity program, which provides beds, bedding, and sleep education to lower-socioeconomic status (SES) children. The primary objective of this randomized controlled trial is to determine whether bed provision combined with provider-delivered sleep health education can improve sleep in children participating in the Beds for Kids program.

Start: October 2020

New Clinical Applications for Internet-based Cognitive Behavior Therapy for Insomnia and Depression

This study includes two sub-trials. Both are included in this singe registration since they have parallel inclusion of participants and have been approved by the Swedish ethics board together in one application. Trial 1 includes patients with both insomnia and major or minor depression. Participants are randomized to either a combined therapist guided Internet-CBT for insomnia and depression, or to Internet-CBT for depression with an addition of a placebo intervention for insomnia. The primary purpose is to evaluate changes in insomnia and depression severity for the combination treatment compared to the depression treatment, after treatment and at 6 and 36 months follow up. A secondary purpose is to evaluate cognitive functioning before and after treatment, as well as cost effectiveness. Recruitment is done in the Stockholm County through mass media and the Internet psychiatry clinic's regular patient recruitment. Trial 2 includes patients with insomnia who do not meet criteria for major or minor depression. All participants start therapist guided Internet-CBT for insomnia. After 4 weeks patients that are judged to be at risk of treatment failure are randomized to either continued treatment or treatment with added support intended to enhance outcome. The primary purpose is to evaluate change in insomnia severity for participants who get added support, compared to continued treatment with regular support level. A secondary purpose is to evaluate cognitive functioning before and after treatment, as well as cost effectiveness. Recruitment is done in the Stockholm County through mass media and the Internet psychiatry clinic's regular patient recruitment. NOTE: The first participants in trial 1 will be regarded as pilots, due to problems with the experimental treatment: technical issues as well as problems with the design of treatment modules. These problems were corrected when discovered. 12 participants in the experimental arm were affected by these errors. The pilot participants will not be included in the main analyses of data. This was decided upon on 31st of October 2014.

Start: January 2013

CompRest - a Comparison Between Sleep Compression and Sleep Restriction for Treating Insomnia

This study includes two consecutive sub-trials. Cognitive Behavioral Therapy (CBT) is treatment of choice for Insomnia. One of the most important treatment Components in CBT for insomnia (CBT-i) is Sleep Restriction (SR), but lately, adverse effects related to SR have been reported. A treatment method with similarities to SR is Sleep Compression (SC). SC is not as well studied as SR, but appears to have similar effects to SR but without the adverse effects. The first sub-trial thus aims at directly comparing SR and SC. The second sub-trial aims at evaluating any additional effects of CBT-i components given as an add-on treatment to a randomized selection of half participants in each original treatment arm.

Start: July 2016

Cognitive Behavioral Therapy for Insomnia (CBTi) in Patients With Mental Illness

Insomnia is common in patients with co-morbid mental illness and sleeping difficulties is a frequent complaint in most psychological disorders. Mental illness may cause sleep problems, however, sleep problems like insomnia, may also cause or exacerbate mental illness. Insomnia may aggravate symptoms of depression, anxiety and fatigue, and reduce daily functioning in patients with co-morbid insomnia and mental illness. This project aims to evaluate a course offered to patients with insomnia and mental illness at Diakonhjemmet Hospital. The course is based on cognitive behavioral therapy, a documented treatment for insomnia.

Start: August 2018

CBT for Insomnia With Anxiety and Depression

Objective to explore whether cbt-i plus is more effective and feasible for patients with insomnia complicated with anxiety and depression than the traditional cognitive behavioral therapy for insomnia. Hypothesis: cbt-i plus is superior to cbt-i in efficacy and feasibility.

Start: August 2020

Music for Sleep-onset Insomnia

The study is a randomized controlled trial evaluating the effect of bedtime music as an early intervention for sleep-onset insomnia in adults. The investigators use a randomized controlled trial design with two parallel groups. All participants receive sleep hygiene advice as standard treatment and participants in the intervention group are additionally asked to listen to a sleep playlist daily at bedtime. Subjective and objective sleep measures are evaluated before and after the 4 weeks intervention period. In addition, follow-up measures of subjective outcomes are assessed 4 weeks after the end of the intervention period.

Start: October 2020

Pharmacokinetics, Pharmacodynamics, and Safety Profile of Understudied Drugs Administered to Children Per Standard of Care (POPS)

The study investigators are interested in learning more about how drugs, that are given to children by their health care provider, act in the bodies of children and young adults in hopes to find the most safe and effective dose for children. The primary objective of this study is to evaluate the PK of understudied drugs currently being administered to children per SOC as prescribed by their treating provider.

Start: March 2020