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76 active trials for Sleep Disturbance

TRANslating Sleep Health Into QUaLity of Recovery (TRANQUiL) Study

This is a novel observational study with the overarching aim of evaluating the association between poor sleep health and poor quality of recovery in a surgical setting. It hopes to assess and optimize the perioperative sleep health of patients so significant improvements in their quality of recovery and health outcomes may be achieved.

Start: March 2021

Cannabis For Cancer-Related Symptoms

Clinical evidence is urgently needed to be able to advise patients on which cannabis-based products to take, or to avoid, in managing cancer-related symptoms. This trial was therefore designed to determine which cannabis extract combination (High THC-Low CBD, Low THC-High CBD, or Equal amounts of THC and CBD) is most effective at treating cancer related symptoms for each patient relative to placebo. Investigators propose a randomized, double-blind, N-of-1 trial to test the effectiveness of each cannabis extract combination using cannabis oils in a minimum of 120 patients on 4 cancer-related symptoms: nausea, pain, anxiety and sleep disturbance. The three active treatments will be the following cannabis oil extract combinations: High THC/Low CBD, Low THC/High CBD, and Equal amounts of THC/CBD. THC = Tetrahydrocannabinol CBD = Cannabidiol The placebo treatment will be coconut/olive oil. The overpowering flavor of the olive oil in the active oils and the placebo will effectively blind subjects. Primary objective: To identify whether there is an active cannabis extract that is more effective than placebo in managing overall cancer-related symptoms for individual subjects who completed at least 1 treatment cycle for the entire patient population represented by those individual subjects, and for subsets of that subject population defined by relevant baseline patient characteristics. Secondary objective: To identify whether there is a cannabis extract that is more effective than placebo in managing each of the 4 index symptoms (pain, nausea, anxiety and sleep disturbance) for individual subjects who completed at least 1 treatment cycle, for the entire patient population represented by those individual subjects, and for subsets of that subject population defined by relevant baseline patient characteristics. Tertiary objectives: To investigate the safety (e.g., serious adverse events) of each of the three cannabis extracts. To identify subject preference of each of the 4 oils (if any).

Start: February 2021

Stellate Ganglion Blockade to Reduce Cardiac Anxiety and PTSD Symptoms in Cardiac Arrest Survivors

This is a pilot randomized controlled trial (RCT) to gain preliminary evidence regarding the acceptability, tolerability, safety, and efficacy of a combined intervention of Stellate Ganglion Blockade (SGB) and psychoeducation on trauma symptoms and health behaviors in patients exhibiting early PTSD symptoms after cardiac arrest (CA). Primary Aim 1 (Feasibility outcomes): Gain preliminary evidence regarding the acceptability, tolerability, and safety of conducting a randomized trial that evaluates a single SGB treatment in conjunction with psychoeducation among CA patients with early PTSD symptoms. Secondary Aim 1 (Treatment-related outcomes): Test, whether SGB/psychoeducation treatment in CA patients with clinically significant PTSD symptoms is associated with reduced cardiac anxiety, PTSD symptoms, and improved health behaviors (physical activity and sleep duration), assessed objectively by a wrist-worn accelerometer for 4 weeks post-discharge.

Start: March 2021

Sleep & Postoperative Delirium in Hispanic/ Latino Patients After Cardiothoracic Surgery

The purpose of this research is to study pre-operative sleep problems and delirium in Hispanic/Latino patients after heart and lung surgery.

Start: February 2021

Electrical Vestibular Stimulation (VeNS) as a Treatment for Insomnia in Participants With a Diagnosis of PTSD

Insomnia is a common complaint among patients with post-traumatic stress disorder (PTSD) and has been associated with several further health consequences. Medications are known to be effective, and currently serve as the primary treatment for insomnia but their use is limited due to the risk of adverse events. Cognitive Behavioral Therapy (CBT-1) has also been shown to be effective and safer in the treatment of insomnia but presents its own limitations such as the time, cost, and training required. The relationship between vestibular stimulation and sleep continues to be explored, however its usefulness in the treatment of insomnia is still unknown. Vestibular stimulation itself has been shown to be safe across multiple populations. If vestibular stimulation is shown to be effective in the treatment of insomnia, it could serve as a safer alternative to medications. It could also require less cost, time, and training than CBT-1, providing a treatment option that is not only safe and effective, but broadly available to the general population. This trial therefore seeks to evaluate the efficacy of non-invasive electrical vestibular nerve stimulation (VeNS) as a method of treating insomnia in participants with a diagnosis of PTSD, as compared to a sham control.

Start: September 2021

MoodUP in Improving Psychological Outcomes Among Perinatal Women

Dramatic physiological, psychological, and social changes during the antenatal period may significantly affect a woman's psychosocial and physical conditions, thereby resulting in stress, anxiety, and depressive symptoms. Cognitive behavior therapy (CBT) is a well-established effective psychotherapy to modify thoughts, beliefs, and perceptions, as well as change the behavioral patterns under numerous conditions. However, at-risk women that need access to CBT are challenged by many issues, such as insufficient therapists, stigmatization, long waiting times, and high costs. Preventive strategies may offer a more acceptable means of addressing the problem. Internet-based CBT can help overcome some barriers to improve psychological well-being by providing a timely and efficacious intervention that is customizable, cost-effective, and flexible in terms of time and geography. Hypotheses Compared with the control group, Women who completed an internet-based CBT (MoodUP) will have significantly lower scores for stress, anxiety, and depressive symptoms immediately post-intervention and at 12 weeks post-intervention; Women who completed MoodUP will reduce the frequency of negative automatic thoughts, achieve a better sleep quality, life satisfaction, and mental health immediately post-intervention and at 12 weeks post-intervention; Women who completed MoodUP will have better client satisfaction. Approach A two-stage research design will be used for 3 years. Stage I will consist of the development and validation of MoodUP based on theoretical and empirical rationales. The development of MoodUP will be guided by a combination of the basic principles from behavioral and cognitive psychology. Essential components, teaching strategies, and technical elements of MoodUP will be established according to literature review and a meta-analysis by the principal investigator and her team. Ethical and quality standards will be assessed using the Health on the Net code of conduct and the Health-Related Website Evaluation Form, respectively. Stage II will be used to evaluate the efficacy of MoodUP among 204 antenatal at-risk women using a stratified randomized controlled trial, two-armed parallel group pretest, and repeated post-test following the Consolidated Standards of Report Trials guidelines for an internet-based intervention. Primary outcomes will be the presence and severity of antenatal stress, anxiety, and depressive symptoms using the 21-item Depression Anxiety Stress Scale. Secondary outcomes will be automatic thoughts, sleep disturbance, life satisfaction, mental well-being, and client satisfaction, as determined by the 30-item Automatic Thoughts Questionnaires, four-item Sleep Disturbance subscale of the Medical Outcomes Study Sleep Scale, the five-item Satisfaction with Life Scale, the WHO five-item Well-Being Index, and the seven-item Client Satisfaction Questionnaire, respectively. Multivariate analysis of variance with repeated measures will be used to compare the mean difference of scores in the three-time points through Wilks's lambda test. The data will be analyzed according to the intention-to-treat principle with baseline values imputed for missing follow-up data.

Start: July 2021

Electrical Vestibular Stimulation (VeNS) as a Treatment for Insomnia

Insomnia is known to be one of the most common health concerns in in the general population and has been associated with several health consequences. Medications are known to be effective, and currently serve as the primary treatment for insomnia but their use is limited due to the risk of adverse events. Cognitive Behavioral Therapy (CBT-1) has also been shown to be effective and safer in the treatment of insomnia but presents its own limitations such as the time, cost, and training required. The relationship between vestibular stimulation and sleep continues to be explored, however its usefulness in the treatment of insomnia is still unknown. Vestibular stimulation itself has been shown to be safe across multiple populations. If vestibular stimulation is shown to be effective in the treatment of insomnia, it could serve as a safer alternative to medications. It could also require less cost, time, and training than CBT-1, providing a treatment option that is not only safe and effective, but broadly available to the general population. Consequently this trial seeks to evaluate the efficacy of non-invasive electrical vestibular nerve stimulation as a method of improving sleep quality and quantity, as compared to a sham control, in patients newly diagnosed with insomnia.

Start: April 2021

Developing and Testing a Spanish-Language Intervention to Reduce Cancer-Related Sleep Disturbance

The purpose of this study is to learn about how to provide treatment to cancer survivors who have difficulty sleeping.

Start: August 2019

Art Therapy qEEG Study for Service Members With a Traumatic Brain Injury and Posttraumatic Stress Symptoms

Service members with post traumatic stress symptoms and traumatic brain injury receive 6 sessions of art therapy, which could help alleviate symptoms. In the art therapy, participants will be provided with a blank paper mache mask template and invited to alter the mask however they wish using a variety of art materials. The therapist will use the art-making process and culminating product to aid in self-reflection, reframe negative thoughts and feelings, and work through traumatic content. Prior to the session start participants will get set up with a mobile qEEG (worn like a hat and backpack). The qEEG will measure brain activity in a non-invasive way throughout the art therapy session to improve understanding of brain activity during the art therapy process.

Start: February 2021

Probiotics on Sleep Among Adults Study

The aim of this study is to determine the impact of a probiotic formulation on subjective sleep patterns. It is hypothesized that participants given the probiotics will improve their sleep patterns compared to participants receiving placebo.

Start: August 2021

CBD Oil for Reducing Emotional Impact of COVID-19

The overarching objective of the proposed project is to test the relative clinical efficacy of CBD isolate, full-spectrum CBD oil, and placebo in in reducing COVID-Induced stress, anxiety, depression, anger, and sleep disturbance.

Start: December 2020

Internet-delivered Cognitive Behaviour Therapy for Sleep Problems in ASD

This trial investigates the behavioural effects of Internet-based Cognitive behaviour therapy for insomnia (CBT-I) in adolescents with autism spectrum disorder with sleep problems. This is a randomised controlled trial.

Start: February 2021

In-Home Sleep Monitoring to Detect Suicide Risk in Veterans

This research will assess the ability of nightly objective sleep scheduling and sleep heart rate data to predict variation in suicidal ideation in U.S. military veterans identified as high-risk according to actuarial and/or clinical indicators. These data will be recorded using one of two low-cost, commercial, zero-burden, mattress actigraphic systems that enable remote, centralized, data access. Participants will be veterans accrued both from the REACH VET and local high-risk lists, a process involving collaboration with the Suicide Prevention Coordinator at the VA Palo Alto HCS. In order to minimize burden, participants will be screened by telephone, consented by mail and telephone, administered a brief admission psychometric interview by telephone, and mailed a sleep sensor system and instructions for its installation in their home. Once sleep data collection has commenced, a trained interviewer will contact the participant by telephone weekly and administer the Columbia-Suicide Severity Rating Scale. Data collection will continue for three months. The study targets a sample of 40 veterans. Longitudinal mixed effects modeling will be employed to determine whether changes in sleep scheduling and sleep heart rate predict changes in suicidal ideation.

Start: October 2020

Cognitive Behavioral Therapy for Insomnia (CBTi) in Patients With Somatic Disease

Insomnia is common with co-morbid somatic disease, e.g. rheumatic disease, cancer, heart and lung disease or gastrointestinal disorders. Pain, breathing difficulties and other symptoms of disease can worsen sleep problems and cause insomnia. In turn, insomnia may aggravate pain, fatigue and reduce quality of life in patients with somatic disorders. This project aims to evaluate a course offered to patients with insomnia and somatic disease at Diakonhjemmet Hospital. The course is based on cognitive behavioral therapy, a documented treatment for insomnia.

Start: January 2018

Online Multi-component Psychological Intervention for Prevention of Grief Disorder Due to COVID-19

This study evaluates the effectiveness of an online Multi-component psychological intervention, that is focused on providing self-support to the Mexican population for the prevention of complicated grief disorder, by reducing grief and strengthening the capacities of the person to handle losses derived from COVID-19 as well as reducing the symptoms of anxiety, depression, hopelessness, and post-traumatic stress, and increasing the quality of sleep and perception of the quality of life.

Start: December 2020

Enhancing Sleep Quality for Nursing Home Residents With Dementia

This study will improve clinical outcomes for an important, growing, and vulnerable population-nursing home (NH) residents with Alzheimer's disease or related dementias (ADRDs)-by implementing an evidence-based intervention (LOCK) to improve these residents' sleep. It will also significantly increase our understanding of how to implement and sustain nursing home interventions.

Start: February 2021

Biobehavioral Correlates of Cancer-related Cognitive Dysfunction and Its Co-occurring Symptoms

This descriptive, cross-sectional study will evaulate and fully characterize factors associated with cognitive dysfunction in Breast Cancer (BCS) and Colorectal Cancer (CRC) survivors that have cognitive concerns, and factors associated with psychoneurological symptom cluster in BCS and CRC survivors.

Start: November 2020

Impact of Bedtime Routines on Sleep and Development in Toddlers

Investigators will recruit up to 100 families (children aged 12.0 to 14.9 months and their primary caregivers) at their scheduled 12-month well child care infant visit at Temple Pediatric Care. The purpose of this randomized controlled trial is to examine the impact of implementation of a bedtime routine program, Connect, Calm, & Comfort: 3 Cs for Bedtime ZZZs, to promote better sleep and improve developmental outcomes in toddlers from primarily low-income families.

Start: November 2020

Providing Mental Health Precision Treatment

This research study is being conducted to understand if patients benefit from mobile health interventions while waiting for in-clinic mental health treatments, and to understand which patients receive the most benefit.

Start: May 2020

Functional Assessment of Ashwagandaha Root Extract During Weight Loss

Patients who are involved in a clinical protocol driven 12 week medical weight loss intervention will be randomized to receive either a placebo or 600 mg of an ashwagandha root extract. The study endpoints are primarily the patients self-reported perception of life stress and sleep quality. The working hypothesis of this study is that the addition of aschwagandha to .the medical weight loss program will improve the self-reported perception of life stress and sleep quality

Start: October 2017