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Sleep Wake Disorders clinical trials

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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.

NCT ID: NCT05235984 Completed - Sleep Apnea Clinical Trials

Technical Feasibility Study on Screening Sleep Related Breathing Disturbances and Sleep Apnoea With Wearable Sensors

Screenbeat
Start date: July 18, 2022
Phase:
Study type: Observational [Patient Registry]

In this study the feasibility of detecting sleep apnoeas with unobtrusive wearable sensors and sounds recorded with a smartphone is studied by making an overnight recording to patients with high probability of sleep apnoeas. The data acquired with the aforementioned devices is: ECG, acceleration, bioimpedance of thorax and processed and raw audio. In data analysis phase it will be studied which combinations of these signals would enable detecting sleep apnoeas with high enough sensitivity and specificity when compared to a night polygraphy reference (Nox T3 device using airflow, breathing movements, audio, position, movement, oxygen saturation, pulse and leg EMG).

NCT ID: NCT05211063 Completed - Sleep Disorder Clinical Trials

Effects of CROCUVIS+® on Computer Vision Syndrome, Sleep and Mood Disorders

Start date: October 21, 2022
Phase: N/A
Study type: Interventional

Previous research has shown the efficacy of CROCUVIS+® dietary supplement, based on saffron extract, in the proper functioning of visual health, for example, against the development of glaucoma. The main objective of this study is to evaluate the efficacy of CROCUVIS® in computer vision syndrome, sleep and mood disorders in a sample of university students who use digital devices.

NCT ID: NCT05174104 Completed - Sleep Disorder Clinical Trials

Metabolic and Chronobiological Changes in Vestibular Rehabilitation

Start date: March 1, 2020
Phase: N/A
Study type: Interventional

The aim of the present study is to evaluate the impact of vestibular rehabilitation on metabolic aspects when evaluated by means of bioelectrical impedenzometry analysis, smart watch device and actigraphy in a group of vestibular hypofunction patients previously studied by means of video head impulse test, posturography and clinical validated scales

NCT ID: NCT05170386 Completed - Stroke Clinical Trials

Cognitive Training on Sleeping Disorders in Stroke

Start date: November 15, 2021
Phase: N/A
Study type: Interventional

Cognitive impairment and sleeping disturbance following stroke diagnosis are common symptoms that significantly affect the quality of life.

NCT ID: NCT05113654 Completed - Clinical trials for Idiopathic Pulmonary Fibrosis

Sleep Disorders in Idiopathic Pulmonary Fibrosis

Start date: April 26, 2016
Phase:
Study type: Observational

This diagnostic observational study was conducted to (1) investigate the prevalence of sleep-related breathing disorders and other sleep disorders in idiopathic pulmonary fibrosis in comparison to COPD, (2) identify characteristics of symptomatic and prognostic significance in idiopathic pulmonary fibrosis with/without sleep disorders, and (3) evaluate different tools for their ability to assess the risk of co-existing sleep disorders in idiopathic pulmonary fibrosis.

NCT ID: NCT05070143 Completed - Sleep Disorder Clinical Trials

Mini-treatment Experiments to Clarify How to Assist People to Habit Formation

Start date: October 7, 2021
Phase: N/A
Study type: Interventional

Habits impact nearly every domain of one's physical and mental health. Evidence-based psychological treatments (EBPTs) are interventions targeting psychological processes that cause and/or maintain mental illness and that have been developed and evaluated scientifically. An implicit goal of EBPTs is to disrupt unwanted habits and develop desired habits. Yet, there has been insufficient attention given to habit formation principles, theory and measures in the development and delivery of EBTPs. In preparing to conduct a 5-year R01 on this topic, the investigators are conducting this experiment to better understand habit formation. The purpose is to distill, study and clarify key concepts in habit formation before embarking on the 5-year R01. This is necessary as there is surprisingly little research to guide key decisions, particularly for the process of dismantling unwanted habits. Hence, the aim of this experiment is to compare strategies discussed in the scientific literature, which have been minimally studied, to dismantle unwanted habits. The hypothesis tested is that each of the active strategies will be superior to the no intervention group. The study is exploratory as to which of the active strategies will be most effective.

NCT ID: NCT05069285 Completed - Clinical trials for Hypnotic; Sleep Disorder

A Self-help Book for Insomnia Compared With Sleep Hygiene Advice in Patients Using Sleep Medications

Start date: May 10, 2023
Phase: N/A
Study type: Interventional

The aim is to assess whether a self-help book for insomnia will improve sleep and reduce hypnotic use among patients on sleep medications.

NCT ID: NCT05039528 Completed - Clinical trials for Obstructive Sleep Apnea

Design and Usability Testing of a Tailored Intervention About Sleep and Sleep Disorders Among Transportation Workers

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

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.

NCT ID: NCT05031793 Completed - Allergic Rhinitis Clinical Trials

Establishing the Collaborative Care Model for Pediatric Allergic Rhinitis With Sleep Disorder

Start date: February 8, 2018
Phase: N/A
Study type: Interventional

The purpose of study is to compared the impact of the integrative care clinic to ordinary western medicine among patients of moderate persistent allergic rhinitis combined with sleep disorder and establishing the collaborative care model of TCM and western medicine for pediatric allergic rhinitis with sleep disorder. Investigators invited children aged below 18 years old to the integrative care clinic as experimental group, who have persistent moderate allergic rhinitis, more than 60 scores of the OSA-18 sleep questionnaire, and can accept integrative therapy. The controlled group is patients who receive ordinary western treatment. Investigators compare these two groups by questionnaires of OSA-18,SN-5, PADQLQ,SNAP-IV, the dose of nasal corticosteroid , and polysomnography.