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Sleep Disturbance clinical trials

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NCT ID: NCT04398082 Recruiting - Sleep Disturbance Clinical Trials

TRANslating Sleep Health Into QUaLity of Recovery (TRANQUiL) Study

TRANQUiL
Start date: March 10, 2021
Phase:
Study type: Observational

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.

NCT ID: NCT04368416 Recruiting - Aging Clinical Trials

Anxiety/Depression, Sleep and Alcohol in Elderly Anxiety/Depression, Sleep Disturbances and Alcohol Use Disorder in Elderly With Cognitive Complaints

MEM-ASA
Start date: September 22, 2020
Phase:
Study type: Observational

The goal of MEM-ASA is to investigate the prevalence of anxiety/depression, sleep disturbances and alcohol use disorder in elderly with cognitive complaints. In memory clinics of Normandy (France), all patients aged over 50 year-old are systematically questioned about anxiety, depression, sleep quality and alcohol use disorder. They also perform a neuropsychological assessment. Questionnaires are given to the patient and his/her caregiver to be filled in at home. Levels of anxiety/depression, sleep quality and alcohol consumption are related to neuropsychological performance, diagnosis and responses to the questionaires.

NCT ID: NCT04364646 Recruiting - Depression Clinical Trials

Personalized Integrated Chronotherapy for Perinatal Depression

Start date: November 2, 2020
Phase: N/A
Study type: Interventional

Perinatal depression and anxiety are common, serious, and frequently overlapping disorders that increase morbidity and mortality in new mothers (including suicide) and result in poor infant/child outcomes. Current therapies often fail to produce recovery or are poorly tolerated, and many pregnant women seek non-pharmacologic therapy or forgo treatment when non-pharmacologic options are not available. Expectant and new mothers who experience circadian rhythm dysregulation are at increased risk for perinatal depression. This Confirmatory Efficacy Clinical Trial of Non-Pharmacological Interventions for Mental Disorders R01 seeks to test whether a Personalized Integrated Chronotherapy (PIC) intervention can improve treatment outcomes for pregnant patients seeking outpatient treatment for depression, with or without anxiety. PIC is a multicomponent treatment consisting of bright light therapy, sleep phase advance, and sleep stabilization/restriction that targets the Research Domain Criteria (RDoC) constructs of circadian rhythms and sleep-wake behavior. To increase sample size and diversity and accelerate recruitment, this study will be performed at 4 sites that differ in clinical structure and that have piloted the PIC intervention. The study will enroll expectant mothers diagnosed with major depressive disorder during 3rd trimester of pregnancy. Participants will be randomized to either: (a) usual care (UC, n = 110) or (b) PIC+UC (n = 110). PIC+UC will have pregnancy and postpartum components and will be administered via a personalized approach tailored to optimize the intervention based on each patient's individual circadian and sleep timing. After a baseline assessment, PIC will be prescribed during 5 dedicated clinical visits: three during 3rd trimester of pregnancy and 2 in the postpartum period. UC will consist of medication and/or psychotherapy. UC will be quantified in both groups to evaluate differences between the PIC+UC and UC groups. Mood will be measured in both groups by blinded clinician interview and patient self-report. The safety profile of the PIC intervention will be assessed by evaluation of side effects/adverse events. Importantly, the study will also examine the target mechanisms by which PIC is hypothesized to work and test the mediation effects of the circadian targets on improvement in mood symptoms. Participants will wear wrist actigraphy/light monitors continuously during weeks 28-40 of pregnancy and postpartum weeks 2-6 to assess light exposure and to estimate sleep timing and duration. Circadian phase (measured with salivary dim light melatonin onset) will be measured at baseline during pregnancy (~30 weeks' gestation), at 36 weeks' gestation, and at postpartum week 6. Exploratory aims will examine associations between infant sleep behavior and maternal circadian rhythms and factors relevant to future dissemination of PIC. If this intervention is effective, perinatal PIC could change clinical practice and have major public health impact due to the high prevalence of perinatal depression and anxiety, the negative effects of mood disorders on mothers and their children, and the need to provide effective, novel, non-pharmacologic therapies for women with perinatal mood disorders.

NCT ID: NCT04287062 Recruiting - Sleep Disturbance Clinical Trials

Examining the Role of the Orexin System in Sleep and Stress in Persons With Opioid Use Disorder

Start date: November 20, 2020
Phase: Phase 2
Study type: Interventional

This study is designed to elucidate the role of the orexin neurotransmitter system in sleep disturbance and circadian rhythms of stress that might in turn influence relapse behaviors in persons on medication-assisted treatments (MAT) who are in early recovery from opioid use disorder (OUD). Briefly, the study will enroll recently abstinent OUD patients (N=200) maintained on either extended-release naltrexone (XR-NTX), buprenorphine, or methadone. Within each MAT group, participants will be randomized to either suvorexant or placebo. The study is expected to have a 20% treatment attrition rate which will result in N=160 completers in the entire study. Patients will be recruited from and treated at Ashley Addiction Treatment, Addiction Treatment Services at Johns Hopkins Bayview Medical Center, Man Alive, or community providers.

NCT ID: NCT04207502 Recruiting - Aging Clinical Trials

Integrating Systematic Data of Geriatric Medicine to Explore the Solution for Health Aging

Start date: September 1, 2019
Phase:
Study type: Observational

This project aims to build up the comprehensive database of geriatric medicine for local Taiwanese.

NCT ID: NCT04201392 Recruiting - Insomnia Clinical Trials

Sleep in Psychiatric Inpatients

SPIN
Start date: August 31, 2018
Phase:
Study type: Observational

Decades of research have shown that sleep disturbances are common among patients with a wide range of psychiatric disorders. Such reported sleep disturbances include disrupted sleep efficiency and continuity, sleep quality complaints, insomnia, and nightmares. While traditional models suggest that certain sleep alterations are specific for certain mental disorders, newer models assume a transdiagnostic or dimensional view of sleep disturbances in mental disorders. Findings of a recent meta-analysis support the transdiagnostic or dimensional association between sleep disorders and psychiatric conditions. Additionally, the period just prior to sleep has recently received increased clinical and research interest, with studies investigating cognitive activity and rumination prior to sleep. However, only few studies compare sleep in different psychiatric diagnoses and the characteristics of sleep in different mental disorders are still not understood well enough for concrete implications for clinical practice. This is especially true for the population of psychiatric inpatients. In this study, the outcome measures and study variables will be measured with standardised and validated questionnaires, structured clinical interview, and a commercially available Fitbit Charge 2 tracker. Participants will be recruited from the inpatient units of the Psychiatric University Hospital Zurich (PUK). Screening will be conducted by the applicant and master's students enrolled in the project, using electronic patient files at the hospital. The patients will be invited to the study by their treating physician or psychologist. Assessments will consist of one interview and filling out of questionnaires (with a 30- to 45-minute duration respectively). A sub-sample will wear fill out a sleep diary for seven consecutive nights as well as wear a Fitbit Charge 2 tracker, which they will return a week later. Each patient will receive participant reimbursement of 30 Swiss francs (CHF) for their participation in the study.

NCT ID: NCT04170049 Recruiting - Sleep Disturbance Clinical Trials

The Effects of Sensory Stimulative Activities on Sleep Performance in Elderly Adults: A Single-case Design

Start date: April 1, 2019
Phase: N/A
Study type: Interventional

Older adults have a high prevalence of sleep disturbances, which negatively and severely impact their health and quality of life. Research indicated that 43% elderly outpatients in Taiwan have used benzodiazepine, which collectively led to great medical expenditure. Non-pharmacological treatments are highly recommended as first priority for sleep disturbance in practice. Music interventions have been reported to modulate the sympathetic nervous system and to improve the elderly's sleeping performance. Proprioceptive interventions can also activate the parasympathetic nervous system, providing calming effects and significantly reducing anxiety, hyperactivity and agitation in various populations. However, the effects of these intervention on the sleep disturbances in the elderly remain unclear. The research purpose is to investigate the effects of two sensory activities that are easily executed in everyday life - auditory (e.g. listening to the music before sleeping) and proprioceptive (e.g. joint compression exercises) interventions on improving the sleep performance of the elderly. Subjective sleeping quality assessment (Pittsburgh Sleep Quality Index & Insomnia Severity Index) and objective physiological records measured by actigraphy are used as outcome measures.

NCT ID: NCT04100057 Recruiting - Alzheimer Disease Clinical Trials

Sleep Disturbance and Emotion Regulation Brain Dysfunction as Mechanisms of Neuropsychiatric Symptoms in Alzheimer's Dementia

Start date: August 31, 2021
Phase: N/A
Study type: Interventional

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.

NCT ID: NCT03970057 Recruiting - Anxiety Clinical Trials

MoodUP in Improving Psychological Outcomes Among Perinatal Women

Start date: July 1, 2021
Phase: N/A
Study type: Interventional

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, 1. 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; 2. 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; 3. 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 143 antenatal women using a 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.

NCT ID: NCT03968900 Recruiting - Smoking Clinical Trials

Racial Differences in Circadian and Sleep Mechanisms for Nicotine Dependence, Craving, and Withdrawal

Start date: January 1, 2021
Phase: N/A
Study type: Interventional

The number one preventable cause of death in the world is tobacco use. Cigarette smoking in particular, costs an estimated $300 billion due to expenses related to medical care and lost productivity. Despite similar smoking prevalence rates, blacks suffer disproportionately from smoking-related harms compared to whites.Sleep disparities such as shortened sleep duration, shorter circadian periodicity, earlier chronotype, and increased variability of sleep timing have been reported more frequently in blacks compared to whites. Given that poor sleep quality predicts relapse from smoking cessation programs, particularly among socioeconomically disadvantaged adults, sleep deficiencies and irregular timing of sleep may impact smoking craving and withdrawal symptoms over the course of the 24-hour day. Surprisingly, few studies have examined these temporal patterns of smoking and craving, and none with regard to sleep disruption, chronotype or racial disparities. A better understanding of these factors may explain heterogeneity within the smoking population, especially in minorities. Thus, the purpose of this proposal is to test the central hypothesis that the impact of chronotype and impaired sleep on cigarette usage as well as smoking dependence, urge/craving, and withdrawal depends on race.