1,050 Clinical Trials for Various Conditions
In order to assess the efficacy of the rhythm stabilization component of Health Rhythms' product in addressing sleep problems, investigators will recruit 128 outpatients over the age of 18, who are in early recovery (at least 2 weeks but no more than 6 months) from Alcohol Use Disorder (AUDIT-C score \>4) and are experiencing sleep problems (ISI score \>/= 10). 64 of these individuals will be randomly allocated to receive the full HealthRhythms package (sensing, trending, and stabilization) on their smartphones, while 64 will be asked to consent to sensing only. The duration of the study will be 14 weeks. The primary outcome measures of the RCT will be the ISI (Insomnia Severity Index). The investigators hypothesize that those receiving the full package will demonstrate lower levels of sleep disturbance.
Alcohol Abuse With Alcohol-Induced Sleep Disorder, Alcohol Use Disorder (AUD), Sleep Disorder, Sleep Disturbance
The current study is a prospective blinded study to collect data regarding the performance of the WP device in detecting sleep disorders. For that purpose, the WP with finger probe and chest sensor will be worn by the subject simultaneous to PSG in a sleep study at the clinical sleep lab. A PSG system will be recording the PSG data.
Sleep Disorder
Research Type: Clinical Trial Background: People with sickle cell disease (SCD) have many health challenges. Also, they often have trouble sleeping. Acceptance and commitment therapy (ACT) might help people with SCD to improve their sleep problems. Objective: To see how well ACT works in people with SCD and sleep problems and to find out how they feel about it. Eligibility: People between the ages of 18 and 55 with SCD and trouble sleeping. Design: The study is remote. Participants will not have to come to the NIH at all. They will need a device that has Bluetooth and can connect to the internet. Some participants will be in the study for 12 weeks. Others will participate for 20 weeks. Participants will video chat with an ACT coach once a week for 8 weeks. The coach will guide participants through mindfulness exercises and teach ACT ideas. Each session lasts about 45 minutes. Participants will be loaned an actigraph, a device worn on the wrist like a watch that measures and records movement. They will download a free app to upload data from the actigraph for the researchers. Participants will wear the actigraph on their nondominant wrist day and night for either 4 or 6 designated weeks. During these weeks, participants will complete a sleep diary each morning when they wake up. This takes about 2 minutes. Participants will be sent other surveys to complete from home during the study. They will answer questions about their physical and emotional health. These take 20-25 minutes. The last survey will be 4 weeks after participants finish the ACT treatment. They will answer questions about how helpful they thought ACT was and how easy or hard it was to wear the actigraph.
Sickle Cell Disease, Sickle Cell Anemia, Insomnia, Sleeplessness, Transient Insomnia, Nonorganic Insomnia, Chronic Insomnia
This is a multicenter, open-label study to evaluate the efficacy and safety of a daily single oral dose of tasimelteon in treating sleep disturbances in pediatric and adult participants with ASD.
Autism Spectrum Disorder, Sleep Disorder, Neurological Disorder, Sleep Disturbance
The objective of this protocol is to conduct a focus group to identify OSA beliefs, attitudes, and knowledge among employees in the transportation industry on shift schedules.
Obstructive Sleep Apnea
Current methods for assessing circadian timing require sampling over hours (or even up to a day) while the patient is in controlled conditions. The investigators aim to develop a method that can estimate individual circadian time with a single blood sample taken at any time of the day or night. To do this, the investigators will use two state of the art methods, a plasma proteomics-based method to identify a panel of rhythmic proteins (extending our preliminary data) and a whole blood-derived monocyte-based method using a panel of 15 transcripts (to validate and extend a recent study). We will test both methods in a series of patients with circadian rhythm sleep disorders. We will validate separately the proteomics-based biomarker and the monocyte-based transcript biomarker, and also explore whether combining them can improve the accuracy of our timing estimates. In all cases, circadian phase estimates from the biomarker panels will be compared with those derived from plasma or saliva melatonin (the current "gold-standard" circadian phase marker).
Sleep Disorders, Circadian Rhythm, Circadian Rhythm Disorders, Circadian Rhythm Sleep Disorder, Advanced Sleep Phase Syndrome (ASPS), Delayed Sleep Phase Syndrome, Sleep Wake Disorders, Sleep Disorder
The purpose of the study is to evaluate the efficacy of exogenous melatonin in improving sleep quality in HD gene carriers.
Huntington Disease
The overall goal of this project is to determine whether common sleep disturbance patterns, sleep continuity disturbance (SCD) and Sleep Fragmentation (SF), alter cerebral study drug receptor availability, drug-based analgesia, and drug abuse liability. The investigators specifically aim to: 1) evaluate whether experimental SCD and/or SF alter resting or pain-evoked receptor binding potential in brain regions associated with pain inhibition; 2) examine whether SCD and/or SF alters the analgesic response and abuse liability profile of a study medication; and 3) determine whether receptor binding potentials in brain regions of interest are associated with study medication analgesia and abuse liability. The investigators will also evaluate the extent to which associations differ by sleep condition or sex.
Sleep Disorder, Healthy
Recent findings suggest that sleep disruption may contribute to the generation and maintenance of neuropsychiatric symptoms including anxiety, depression, agitation, irritation, and apathy while treating sleep disruption reduces these symptoms. Impairments in the neural systems that support emotion regulation may represent one causal mechanism mediating the relationship between sleep and emotional distress. However, this model has not yet been formally tested within a sample of individuals with or at risk for developing Alzheimer's Disease (AD) This proposal aims to test a mechanistic model in which sleep disturbance contributes to neuropsychiatric symptoms through impairments in fronto-limbic emotion regulation function in a sample of individuals at risk for developing, or at an early stage of AD. This study seeks to delineate the causal association between sleep disruption, fronto-limbic emotion regulation brain function, and neuropsychiatric symptoms. These aims will be achieved through a mechanistic, randomized 2-arm controlled trial design. 150 adults experiencing sleep disturbances and who also have cognitive impairment with the presence of at least mild neuropsychiatric symptoms will be randomized to receive either a sleep manipulation (Cognitive Behavioral Therapy for Insomnia CBT-I; n=75) or an active control (n=75). CBT-I improves sleep patterns through a combination of sleep restriction, stimulus control, mindfulness training, cognitive therapy targeting dysfunctional beliefs about sleep, and sleep hygiene education. Neuropsychiatric symptoms, fronto-limbic functioning, and sleep disruption will be assessed at baseline and at the end of the sleep manipulation through functional Magnetic Resonance Imaging (fMRI), clinical interviews, PSG recordings, and self-report questionnaires. Neuropsychiatric symptoms (anxiety and depression) and sleep disturbance (actigraphy, Insomnia Severity Index, and sleep diaries) will be assayed at baseline and each week throughout the sleep manipulation to assess week-to-week changes following an increasing number of CBT-I sessions. Wristwatch actigraphy will be acquired from baseline to the end of the sleep manipulation at week 11. Neuropsychiatric symptoms and sleep will be assessed again at six months post-manipulation.
Alzheimer Disease, Mild Cognitive Impairment, Neuropsychiatric Symptoms, Sleep Disturbance
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.
Type 2 Diabetes Mellitus, Insomnia, Sleep Disorder, Inflammation
The objective of this K01 study was to pilot a sequential, multiple assignment, randomized trial (SMART) design to compare the impact of a sequence of sleep interventions, based on participant treatment response, to optimize sleep health in adolescents 10-18 years of age with neurodevelopmental disorders (NDDs).
Autism Spectrum Disorder, Attention Deficit Hyperactivity Disorder, Sleep Disturbance
Study Design: Ninety children with Autism Spectrum Disorder (ASD), between the ages of 2 to less than 7 years, and their parents will be recruited for this 10 week randomized clinical trial. Participants will be randomized to five individually delivered sessions of Sleep Parent Training (SPT) or five individually delivered sessions of Sleep Parent Education (SPE). Delivery of the programs will be via telehealth platform which also includes parent-child coaching in real-time. In addition to baseline, outcome measures will be collected at week 5 (midpoint of trial) and week 10 (endpoint of trial) as well as follow-up at week 16 to determine durability of treatment.
Autism Spectrum Disorder, Sleep Disturbance
Post-traumatic stress disorder (PTSD) is a common consequence of combat that can result in trauma-related hyperarousal and sleep disturbances. Poor sleep, one of the most common complaints in Veterans with PTSD, can be distressing, impair concentration and memory, and contribute to physical health conditions, such as metabolic syndrome, inflammation, and cardiovascular disease. The orexin neuropeptide system underlies both sleep and stress reactivity. Suvorexant, a drug that reduces orexin, improves sleep in civilians, but has not yet been tested in Veterans with PTSD. This study will test whether suvorexant can improve sleep disturbances and PTSD symptoms in Veterans. Suvorexant may benefit Veterans by improving sleep quickly while also reducing PTSD symptoms over the long term, and with fewer side effects that were common in previous medications used to treat these conditions. Improving Veterans' sleep and PTSD symptoms could lead to better emotional and physical well-being, quality of life, relationships, and functioning.
Sleep Initiation and Maintenance Disorders, Stress Disorders, Posttraumatic
The study aims to develop and test a user-friendly, accessible approach to sleep assessment which can function as an initial "triage" of targeted sleep conditions, such as insomnia, insufficient sleep syndrome, sleep apnea syndromes/snoring, and circadian sleep/wake disorders, within the clinical and community population. Specifically, this study will test the validity and reliability of a self-rated, digitized, and cost-effective diagnostic measure with sufficient sensitivity to accurately assess/diagnose common sleep conditions and/or risk for these conditions. Such an approach, would allow for faster assessment of common sleep conditions and disorders, and provide clinical knowledge to the individual, the physician, and if required insurance companies, as to those persons who need more immediate attention or treatment for their sleep condition.
Sleep Apnea Syndromes, Insomnia, Insufficient Sleep Syndrome, Circadian Rhythm Disorders
This randomized, double-blind, placebo-controlled trial of doxazosin will assess doxazosin's effectiveness for PTSD nightmares, subjective sleep quality, and non-nightmare PTSD symptoms in adult men and women veterans with full and partial-syndromal PTSD.
Stress Disorders, Post-Traumatic
This study seeks to characterize sleep physiology in adolescents with and without Attention deficit hyperactivity disorder (ADHD) and its relationship to differential neurocognitive and clinical outcomes within these groups.
Attention Deficit Hyperactivity Disorder
Sleep disturbance has been reported in 44-86% of children with autism spectrum disorder (ASD) and is the source of considerable stress for the affected individual and family. Sleep plays a role in development and learning processes; thus, the appropriate treatment of sleep disturbance is paramount to optimal outcomes. The empirical base for treatments to address sleep in ASD is sparse, despite wide use of pharmacologic agents such as clonidine (CLN) to target sleep disturbance. A randomized, controlled pilot investigation of CLN for sleep disturbance in children with ASD will allow investigators to evaluate the feasibility of conducting a much larger multisite trial to address the general lack of systematic data available to guide practitioners. Subjects will be 16 children, ages 6-14 years, inclusive, with sleep disturbance and ASD. This randomized double-blind, placebo-controlled (PBO), parallel groups study will test the efficacy of CLN following a brief sleep hygiene intervention. Outcome measures include: informant completed sleep questionnaires, daytime behavior questionnaires, and actigraphy. Biomarkers for medication response will include galvanic skin response and skin temperature. Side effects will be monitored throughout the study.
Autism Spectrum Disorder
The primary objective of the current study is to determine if providing cognitive-behavioral therapy of Insomnia and nightmares (CBTin) and Cognitive Processing Therapy of PTSD (CPT) results in greater PTSD and sleep symptom reduction than CPT only. A secondary objective is to determine if the sequencing of CBTl\&N before or after CPT results in differential effects on PTSD and sleep symptom reduction.
Trauma, Insomnia, Nightmares
The objective of this study is to determine if a non-invasive technique, using an innovative analysis of electrocardiogram (ECG) data, would allow for detection of respiratory events during sleep and discrimination between central and obstructive apnea. Obstructive Sleep Apnea (OSA) is the most common respiratory disturbance seen during sleep, with an estimated prevalence of 10 % in the population and is strongly associated with the development of cardiovascular disease. In patients with underlying cardiac disease, particularly in heart failure (HF), central respiratory events such as Cheyne-Stokes Respiration (CSR) are often seen during sleep. The presence of CSR is also associated with increased cardiovascular morbidity and mortality. Currently, the identification and classification of sleep related respiratory disturbances is performed during over-night sleep studies (polysomnography), which are labor-intensive, time-consuming, expensive and difficult for patients. Thus, the development of alternative techniques to assist in the identification of those events in the outpatient setting is of marked importance for widespread screening of sleep apnea.
Sleep Disorders, Sleep Apnea, Sleep Disordered Breathing
Despite research establishing the relationship between sleep disturbances and alcohol use, there is no clear understanding or model for what occurs once individuals who seek inpatient alcoholism treatment are discharged from rehabilitation facilities and attempt to integrate back into their homes and communities. The purpose of this investigation will be to characterize sleep patterns, perceptions, and beliefs throughout the process of alcohol rehabilitation. The misuse of alcohol is a global public health concern that compromises both individual and societal wellbeing, resulting in an estimated 2.5 million deaths annually. The National Institute on Alcohol Abuse and Alcoholism (NIAAA) distinguishes alcoholism by craving, loss of control, physical dependence, and tolerance (NIAAA, Alcohol Use Disorders). The relationship between alcohol use and sleep disturbances is complex and bidirectional, but sleep disturbances are common among alcoholics during phases of drinking, withdrawal, and abstinence. Outcome expectancies, behavioral capability, and self-efficacy beliefs are central constructs in the Social Cognitive Theory and will be measured directly in this study using both quantitative and qualitative methods. A mixed methods approach will be used to study the following aims: a) to assess individuals' perceptions of and experiences with sleep during alcohol rehabilitation, b) to describe sleep patterns, perceptions, and beliefs among alcohol-dependent individuals throughout the transition from a clinical research facility providing rehabilitation treatment back to the community, c) to assess whether sleep-related beliefs and/or behavior of individuals are predictive of sleep quality or relapse to drinking, and d) to assess whether sleep quality predicts relapse. Adult research participants admitted to the inpatient behavioral health unit and enrolled on to the NIAAA intramural study NCT 0010693: Assessment and Treatment of People with Alcohol Drinking Problems will be recruited for participation in this study (n=215). Sleep quality and duration will be quantitatively assessed approximately one week prior to discharge from the inpatient facility and again 4-6 weeks post-discharge. A sub-set of participants will be asked to wear actiwatches (accelerometers) to provide objective data on sleep throughout the transition from inpatient to outpatient. In addition to quantitative measures, qualitative semi-structured interviews will be conducted with a subset of 25 participants (to reach 25 completed cases) within a week of the scheduled discharge date and again four to six weeks post-discharge to assess perceptions of sleep during recovery. The proposed study will fill a gap in the literature by characterizing sleep throughout the rehabilitation process and ongoing maintenance of abstinence.
Alcoholism
This randomized phase II trial studies how well brief behavioral therapy works in improving sleep disorders in patients with stage I-III breast cancer undergoing chemotherapy. Sleep disorder counseling may reduce fatigue and insomnia as well as improve the well-being and quality of life in patients with breast cancer who are undergoing chemotherapy.
Sleep Disorder, Stage IA Breast Cancer, Stage IB Breast Cancer, Stage II Breast Cancer, Stage IIIA Breast Cancer, Stage IIIB Breast Cancer, Stage IIIC Breast Cancer
The study will evaluate the safety and efficacy of melatonin supplementation in CKD and ESRD patients with sleep disorders to reduce sleep latency times, the number of apnea/hypopneic episodes, and prolong duration in rapid eye movement (REM) sleep in CKD and ESRD patients with sleep disordered breathing.
End Stage Renal Disease, Chronic Kidney Disease, Sleep Disorder
Many women with breast cancer who are treated with aromatase inhibitor medications develop difficulty sleeping and fatigue during treatment. Some examples of aromatase inhibitor medications include anastrozole (Arimidex), exemestane (Aromasin), and letrozole (Femara). Frequently, sleeping pills do not work very well to improve sleep. Cyclobenzaprine (Flexeril) is a medication that was originally developed to treat muscle spasms. It may also improve sleep in patients with chronic pain disorders, such as fibromyalgia. In this study we are testing to see if cyclobenzaprine at bedtime will help improve sleep in women treated with aromatase inhibitors.
Sleep Initiation and Maintenance Disorders, Pain
The purpose of this study is to establish the efficacy and safety of Circadin in children with neurodevelopmental disorders and to determine the dose, this randomized, placebo-controlled study is planned to evaluate the efficacy of a double-blind, 13 week treatment period with Circadin 2/5mg in improving maintenance of sleep, sleep latency and additional parameters in children with neurodevelopmental disabilities. The efficacy and safety of Circadin 2/5 mg will continue to be assessed during an open-label extension period of 13 weeks.
Sleep Disorders
Post traumatic stress disorder (PTSD) has emerged as a significant problem among troops returning from combat zones. A majority of these veterans will report difficulty maintaining or initiating sleep. The purpose of this research will be to conduct a prospective, randomized, wait list controlled, small scale feasibility study to examine if the use of an auricular acupuncture regimen improves quality of sleep for Operation Iraqi Freedom/Operation Enduring Freedom (OIF/OEF)veterans with PTSD receiving standard PTSD treatment. Hypothesis: Objective and subjective sleep disturbances and sleep quality will be improved in OIF/OEF veterans who receive auricular acupuncture in conjunction with standard PTSD therapy or standard therapy alone.
Post Traumatic Stress Disorder, Sleep Disturbance
Autism Spectrum Disorders (ASD) are characterized by difficulties in language, social communication, and repetitive and restricted behaviors. ASD affects as many as 1 in 90-150 children. Sleep issues/insomnia is very common in children with ASD (50-80%). Insomnia has a negative impact on both the developmental and behavioral function of the child and the quality of life for the family. Causes of insomnia in children with ASD are multifactorial and can be difficult to treat effectively. Low iron stores, as manifest by low serum ferritin levels, is also common in children with ASD. Both insomnia and low iron stores are associated with Restless Legs Syndrome (RLS) and Periodic Limb Movement of Sleep (PLMS). Children with ASD often have difficulty communicating symptoms or tolerating Polysomnography (Sleep Study). This makes establishing a diagnosis of RLS or PLMS very difficult in children with ASD.
Autism Spectrum Disorder, Insomnia
This randomized phase II trial studies how well cognitive behavioral therapy and multimodal therapy works in treating sleep disturbance in patients with cancer. Cognitive behavioral therapy may help reduce sleep disturbances, fatigue, and insomnia as well as improve the well-being and quality of life of patients with cancer when given together with methylphenidate hydrochloride, therapeutic melatonin, and light therapy.
Hematopoietic and Lymphoid Cell Neoplasm, Malignant Solid Neoplasm, Sleep Disorder
Comparing two BiPAP autoSV devices in participants with complex sleep apnea and determining if the new device will treat those participants no worse than when compared to its predecessor device.
Sleep Disordered Breathing, Sleep Apnea, Central
The primary objective of this preliminary study is to estimate sleep outcome effect sizes and determine feasibility for a novel yoga treatment of insomnia in participants with post traumatic stress disorder (PTSD). Additional objectives are to evaluate relationships of sleep outcomes with measures of other PTSD symptoms, psychosocial health and possible mechanisms of action.
Post Traumatic Stress Disorder, Insomnia
This pilot clinical trial studies early brief behavioral intervention in treating sleep disturbance and improving quality of life in patients undergoing bone marrow transplant (BMT). A brief behavioral intervention may reduce symptoms of insomnia and fatigue and improve quality of life and cognitive function in patients undergoing BMT
Cognition Disorders, Fatigue, Sleep Disorders, Other Complications of Bone Marrow Transplant