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Sleep Wake Disorders clinical trials

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NCT ID: NCT05568381 Completed - Clinical trials for Mild Cognitive Impairment

Sleep Disturbance in MCI: A Study of a Cognitive Behavioural Therapy Digital Intervention

SUCCEED
Start date: April 20, 2023
Phase: N/A
Study type: Interventional

This study aims to determine the feasibility of a randomized-controlled trial of digital cognitive behavioural therapy for insomnia (CBT-I) for sleep and cognitive performance in older adults with MCI and insomnia symptoms (50-80 years). The trial will be completed online, and participants will be recruited from the community across Australia.

NCT ID: NCT05541692 Completed - Insomnia Clinical Trials

Efficacy of a Sleep Hygiene Toolkit for Patients in ARU

Start date: April 1, 2022
Phase: N/A
Study type: Interventional

Sleep Hygiene Study Abstract: INTRODUCTION Sleep is integral to the health of a person and can have multifaceted contributions to a person including their physical, cognitive, and psychosocial well-being. However, within a recent survey evaluating the sleep perception of patients within an acute rehabilitation unit (ARU), there was a high prevalence of reported sleep disturbances and poor sleep hygiene compared to at home (Davis et al., 2021). In addition, patients within an ARU generally have an extended length of stay-which could mean many nights of poor sleep hygiene. Given the importance of sleep in facilitating a person's health and recovery versus the challenges the hospital environment poses on patient's sleep hygiene, this study aims to examine the efficacy of a sleep hygiene toolkit provided to the patients admitted to ARU. The sleep hygiene toolkit includes multiple non-pharmaceutical resources addressing sensory stimulation and psychological and emotional needs. OBJECTIVE This study aims to evaluate the perception of sleep quality experienced by ARU patients utilizing the sleep hygiene toolkit. This study hypothesizes that with the use of a sleep hygiene toolkit, patients will report a positive impact on their sleep quality during their hospital stay. METHODOLOGY This is a within-subjects study design. All eligible participants will be given the sleep hygiene intervention administered for a period of five days. The sleep hygiene toolkit includes multiple resources including assistive devices (ie. eye masks and ear plugs), sensory-based tools (ie. aromatherapy, music, meditation, and breathing techniques), cognitive behavioral therapy (CBT) activities (ie. addressing anxiety and worry), and education and training on sleep hygiene. The visual analog scales on the Richards-Campbell Sleep Questionnaire will be used to assess patient's overall sleep perception pre- and post-intervention. CONCLUSION Given this prevalent area of need for patients admitted to ARU, occupational therapists (OT) can offer an additional way to address it. According to the Occupational Therapy Practice Framework (2020), OTs are well-equipped to provide comprehensive treatment to promote a person's sleep preparation and sleep participation. The results will determine the efficacy of a sleep hygiene toolkit for ARU patients in addressing their sleep needs-an important component in a patient's health and recovery during their hospital stay. SIGNIFICANCE OF TOPIC This study aims to highlight the barriers to successful participation in the occupation of sleep and rest for patients admitted to an acute rehabilitation unit (ARU). The creation of this sleep hygiene toolkit is to address a person's sleep preparation and sleep participation. Although sleep quality and its impact are a topic well studied, there is limited study on occupational therapy led interventions aimed to benefit the patient's sleep quality in an ARU setting.

NCT ID: NCT05511818 Completed - Sleep Clinical Trials

Radicle Rest: A Study of Cannabinoids on Sleep and Health Outcomes

Start date: September 12, 2022
Phase: N/A
Study type: Interventional

A randomized, blinded, placebo-controlled, direct-to-consumer study assessing the impact of plant derived cannabinoids on sleep and overall health outcomes

NCT ID: NCT05418283 Completed - Depressive Disorder Clinical Trials

Effects of 12-week Exercise Program on Sleep Quality and Fear of Death in Geriatric Individuals

EXDES
Start date: June 10, 2022
Phase: N/A
Study type: Interventional

The aim of this study is to determine the effect of regular aerobic exercise program on tanatophobia and sleep quality in elderly individuals, and to evaluate the relationship between sleep disorder and fear of death.

NCT ID: NCT05369715 Completed - Aerobic Exercise Clinical Trials

Diurnal Variation of Exercise on Metabolic Health

DIVA
Start date: February 11, 2022
Phase: N/A
Study type: Interventional

The main objective of this project is to study the diurnal variation of the effect of exercise on glycemic metabolism and fat oxidation in humans.

NCT ID: NCT05346588 Completed - Depression Clinical Trials

THRIVE Feasibility Trial

THRIVE
Start date: September 29, 2022
Phase: Phase 3
Study type: Interventional

To evaluate the feasibility of a pragmatic, large scale, comparative effectiveness, randomized evaluation of patient experience of intravenous propofol versus inhaled volatile anesthesia.

NCT ID: NCT05332223 Completed - Clinical trials for Chronic Heart Failure

The Epidemiology of Sleep Disordered Breathing in Patients With Congestive Heart Failure

Start date: April 15, 2022
Phase:
Study type: Observational

This research will be one of the first hospital-based studies to comprehensively evaluate the epidemiological characteristics of sleep disordered breathing (SDB) in patients with Congestive Heart Failure (CHF). This prospective, observational cohort, single center study will include all consecutive CHF outpatients from the specialized heart failure clinic in Medical Department, Hospital Taiping, Malaysia irrespective of preserved or depressed Left Ventricular Ejection Fraction (LVEF). All participants will be subjected to an attended in-laboratory polysomnogram (PSG). It is anticipated the frequency and types of SDB to be variable compared to western data as this subject remains understudied in the South East Asian population. This research utilizes PSG rather than Portable Sleep Testing (PST) as seen in preceding studies for the diagnosis of SDB to prevent underdiagnosing SDBs and clearly distinguishing Obstructive Sleep Apnea (OSA) and Central Sleep Apnea (CSA).

NCT ID: NCT05276635 Completed - Sleep Disorder Clinical Trials

Sleep Disorder Manage in Emotional Freedom Techniques vs Sleep Hygiene Education Group Therapy

Start date: January 3, 2021
Phase: N/A
Study type: Interventional

Sleep disorders are common among elderly persons, with deleterious effects on their physical and mental health. Many approaches are used to manage such disorders. Aim of the study: To compare the Emotional Freedom Techniques-Insomnia (EFT-I) and Sleep Hygiene Education (SHE) group therapy as two treatments for insomnia in a geriatric population when delivered, and their effects on sleep quality, depression, and life satisfaction.

NCT ID: NCT05253417 Completed - Insomnia Clinical Trials

The CANabidiol Use for RElief of Short Term Insomnia

CANREST
Start date: May 1, 2022
Phase: Phase 2
Study type: Interventional

This study aims to investigate the effect of 50 mg and 100 mg per day oral CBD product versus a placebo over 8 weeks on insomnia severity in adults aged 18-65 years old with insomnia symptoms.

NCT ID: NCT05247333 Completed - Constipation Clinical Trials

Implementation of a Minor Ailment Service in Community Pharmacy Practice

INDICA+PRO
Start date: October 1, 2020
Phase: N/A
Study type: Interventional

Self-care and self-medication are commonly the treatments of choice for the management of minor ailments. Minor ailments can be treated through community pharmacy using a Minor Ailment Service (MAS). The INDICA+PRO Impact Study, evaluated the clinical, economic and humanistic impact of a MAS, concluding that community pharmacies could greatly benefit the health system. Thus, the following objectives were defined for the INDICA+PRO implementation study. The primary objective is to implement a standardised MAS in usual practice in community pharmacy in Spain. The secondary objectives include an evaluation of the clinical and economic outcomes and the role and impact of two different models of change agents. A pragmatic study with an effectiveness-implementation hybrid design type 3 will be undertaken using the Framework for the Implementation of Services in Pharmacy (FISpH). The study will be carried between October 2020 and December 2022. Two type of practice change facilitators FaFa and SEFaFa. Their main function, using the Observe-Plan-Do-Study-Act process, will be to facilitate the implementation through individualised continuous support to providers of the MAS. The depth and breadth of support to pharmacist providers by each type of change agents will vary. Pharmaceutical Associations (PA) and/or Spanish Society of Community Pharmacy (SEFAC) will invite community pharmacies/pharmacists. Participating pharmacists will need to sign a commitment form. The second study population will consist of patients presenting with minor ailments or requesting a non-prescription medication. Recruitment of patients will be carried out by the pharmacist providers. The inclusion criteria will be: patients or caregivers (aged ≥18 years, or younger if they are accompanied by an adult) presenting with 31 minor ailments, grouped into five categories (respiratory, moderate pain, digestive, dermatological and other) with pre-agreed referral protocols. Other symptoms may be included at the discretion of the pharmacists. The exclusion criteria will be patients who do not provide informed consent. The patient/pharmacist intervention will consist of a MAS protocol adapted for each symptom. The consultation will be record in an electronic data capture system (SEFAC eXPERT®-) that provides a step-by-step approach with protocols and clinical information embedded. The FISpH model will be used to guide the implementation of MAS. Two types of change agents, FaFas and SeFaFas, previously trained for 18 hours, will be used to facilitate the implementation. During each of the stages (exploration, preparation, testing and operation, and initial sustainability), strategies will be used by FaFas and SeFaFas to moderate implementation factors. The impact of strategies will be evaluated. Data on pharmacy/pharmacist's provider performance and patient outcomes will be provided to pharmacist, change agents and PA and SEFAC. FaFas and SeFaFas will have a classification system for barriers and facilitators derived from the constructs in the Consolidated Framework for Implementation Research (CFIR). The classification system for implementation strategies consists of an adaptation of the facilitation activities listed by Dogherty et al. These will be documented in an electronic data capture system. FaFas will train their pharmacists (max. of 25 pharmacies) for 6 hours and subsequently provide at least monthly follow-up. The research team will provide ongoing feedback and support to the FaFas and SeFaFas through periodically, hold group meetings by video conference between the research group and all the FaFas and SeFaFas. The research group will provide formal reports on the implementation process and patient outcomes. Other forms of communication such as emails, telephone calls or WhatsApp messaging will also be available. Implementation and patient consultation process and outcome variables will be measured such as reach, fidelity and integration. Outcome service indicators will be clinical, economic and humanistic. A patient follow up will occur at a maximum of 10 days. Continuous variables will be reported using mean and standard deviation, or median and percentiles. Categorical variables will be reported using percentages. T Student's test or the ANOVA test or Kruskal-Wallis. χ2 test, Fisher's exact test or Yate's chi-squared will also be used. To determine the relationship between the dependent and the independent variables, logistic regression models will be performed including the variables with statistical significance in the bivariate model. The level of significance will be set at p <0.05. Machine learning and big data techniques are being considered for predictive modelling. The research team will only have access to de-identified data of pharmacists and patients. This study protocol has been approved by the Granada Research Ethics Committee on the 5th February 2020.