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Insomnia clinical trials

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NCT ID: NCT05426226 Not yet recruiting - Insomnia Clinical Trials

Effect of Low Level Light Irradiation on Insomniacs' Meridians During the First Sleep Cycle.

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

Introduction In the past, it was found that stimulating the meridians and acupoints with low-level light often had a good effect. However, for safety reasons, most instruments such as laser acupuncture devices still need to be used by medical personnel, and it is difficult to apply to insomnia patients at bed-time or the first sleep cycle, these two periods have a considerable impact on sleep quality. Therefore, the purpose of this study is to provide a safer wearable light-therapy device for Insomnia patients, so that it can be used in home sleep situations, and the improvement of subjects' sleep qualtity and meridian energy will be evaluated by PSG, HRV parameters, sleep questionnaires, and Ryodoraku value (reflects the meridian electric resistance). Methods Aim1: To evaluate whether the subjects are more relaxed by observing the changes in heart rate and meridian energy of healthy subjects after low-level light irradiating to Shenmen, Daling, Neiguan (acupoints for insomnia). We also consider the difference of light source and the skin color in experiment design. Aim2: To assess whether the insomnia patients' sleep quality has improved after applying the wearable light therapy device to subjects' bed-time (include the first sleep cycle). We use PSG, sleep questionnaires, stroop test for evaluation.

NCT ID: NCT05315986 Not yet recruiting - Insomnia Clinical Trials

Exploration of Relationships Between Sleep, Gut Health and Cognition

Start date: April 29, 2022
Phase: N/A
Study type: Interventional

Our study aims to build on emerging evidence showing relationships between gut health, sleep and brain functions. To achieve this, our study aims to test the feasibility of using non-pharmacological interventions: a psychoeducation-based intervention (enhanced sleep education - ESE) and a dietary supplement (Saffron extract), to improve sleep in older adults with insomnia complaints. Our study also aims to test the feasibility of using wearable and commercially available EEG headband technology to measure objective sleep quality in the home, which will allow for a reliable and ecologically more valid sleep research.

NCT ID: NCT05092308 Not yet recruiting - Insomnia Clinical Trials

Perspectives of Parents About Their Infants' Sleep

Start date: November 2021
Phase:
Study type: Observational

Behavioral insomnia of childhood (BIC) is a common problem in early infancy. The whole family is affected by the problem, but research usually relies only on maternal perception and report. This mixed-method study aimed to explore maternal and paternal perspectives about their child's sleep and sleep problems in early childhood. Secondly, infants' sleep will be measured objectively with actigraphy. Parental mental health, marital relationship and sleep will be evaluated in order to explore the effects on the perception of their infant's sleep.

NCT ID: NCT05078268 Not yet recruiting - Insomnia Clinical Trials

Heart Rate Variability Biofeedback as Adjunctive Therapy to Self-help CBT-I

Start date: November 20, 2021
Phase: N/A
Study type: Interventional

This study will examine the effect of Heart Rate Variability (HRV) biofeedback as adjunctive therapy to self-help Cognitive Behavioral Therapy on insomnia (CBT-I) in Chinese adult population. Heart Rate Variability Biofeedback is a therapy training aiming at increasing heart rate oscillations through real-time feedback and slow breathing training. Several literature has found that HRV biofeedback training is effective in improving HRV and improving sleep quality and sleep efficiency (Gevirtz, 2013; Lin et al., 2019). On the other hand, self-help CBT-I is well-studied in efficacy of improving cognition and behaviors and relieving insomnia (Ho et al., 2014). Rare research study HRV biofeedback as adjunctive therapy to self-help CBT-I (Lehrer, 2017). In the light of this, this study will compare the efficacy of combination of both treatments with that of CBT-I alone, examining whether HRV biofeedback's focus on psychophysiological domain can help self-help CBT-I in more significantly improving HRV and sleep quality.

NCT ID: NCT04962087 Not yet recruiting - Insomnia Clinical Trials

Health enSuite Insomnia: an App-based Treatment for Adult Chronic Insomnia

Start date: July 1, 2024
Phase: N/A
Study type: Interventional

This project consists of two independent but related randomized controlled trials. Trial 1 will focus on people who are not currently prescribed BZRA medications. Trial 2 will focus on people who have been taking BZRA medications and are initiating gradual tapering of these medications as recommended and supervised by their primary health care provider.

NCT ID: NCT04907604 Not yet recruiting - Depression Clinical Trials

European platforM to PromOte Wellbeing and HEalth in the Workplace (EMPOWER)

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

EMPOWER is a multidisciplinary research and innovation effort aiming to developing, implementing, evaluating and disseminating the effectiveness and cost-effectiveness of a modular eHealth intervention platform to promote health and well-being, reduce psychological distress, prevent common mental health problems and reduce their impact in the workplace. In collaboration with stakeholders, we will adapt existing effective interventions focused on different components (awareness and stigma, workplace conditions and psychosocial factors, stress, common mental health symptoms, early detection, comorbidity, lifestyle, and return to work) to created a combined online modular platform feasible in various workplace settings by culturally and contextually adapting it. The intervention will be implemented through a stepped wedge cluster randomized trial directed to employees and employers of small and medium sized enterprises and public agencies from three European countries (Spain, Finland and Poland) and United Kingdom. Both qualitative and quantitative methods will be used in the evaluation of the individual health outcomes, cost-effectiveness (from a social, economical, employer and employees perspective), and implementation facilitators and barriers. Implementation strategies relevant to the uptake of the EMPOWER intervention will be identified, including a realistic appraisal of barriers to uptake as well as evidence-based solutions to these barriers. Through scaling-up pre-existing effective and cost-effective interventions, EMPOWER is aimed at addressing the overarching challenges from different perspectives, including individual level (e.g., addressing stigma, mental health, well-being and lifestyles, taking into account legal, cultural and gender issues) and organizational level. The main outcomes effort will help employees, employers and policymakers in decision processes of new legal and contractual framework at EU and national level covering the new economy landscape.

NCT ID: NCT04831385 Not yet recruiting - Clinical trials for Diabetes Mellitus, Type 2

The Impact of Cognitive Behavioral Therapy for Insomnia (CBT-I) on Glycemic Control in Older Type 2 Diabetes (T2D) Comorbid With Insomnia

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

This study is a RCT aiming to use CBT-I as intervention, compared to usual care as control, to elucidate the effect of CBT-I on glycemic control, sleep quality, psychological outcomes, and cognitive function in Hong Kong Chinese older T2D comorbid with insomnia.

NCT ID: NCT04729244 Not yet recruiting - Anxiety Clinical Trials

The Study of Hemp Oil CBD for Evaluation of Efficacy and Safety in Treatment of Pain, Anxiety and Insomnia Management

Start date: September 1, 2021
Phase: Phase 1
Study type: Interventional

The investigators are looking to conduct a study looking at the effects of cannabidiol (CBD) from Hemp Oil in patients with Chronic pain, anxiety and insomnia. It is believed that CBD will improve pain anxiety and sleep quality and reduce opioid use. The study will last a total of 4 weeks and involve onsite visits in addition to weekly pain assessments.

NCT ID: NCT04728581 Not yet recruiting - Insomnia Clinical Trials

Improving Sleep After TKA Using Mirtazapine and Quetiapine

Start date: January 1, 2024
Phase: N/A
Study type: Interventional

Use of mirtazapine and quetiapine for improvement of sleep quality after TKA

NCT ID: NCT04703283 Not yet recruiting - Insomnia Clinical Trials

Self-help Lifestyle Medicine for Insomnia

Start date: March 2021
Phase: N/A
Study type: Interventional

This study will examine the effects of a self-help smartphone-based multi-component lifestyle medicine intervention (LM) for alleviating insomnia symptoms in a Chinese population. Since a range of lifestyle factors are related to the pathogenesis and progression of insomnia, modifying different lifestyle factors simultaneously, such as diet, exercise, stress, and sleep which are empirically supported by previous reviews, may be effective to reduce insomnia symptoms (Reid et al., 2010; Vedaa et al., 2016). Traditional Chinese nutritional values will be integrated into the smartphone application to increase the acceptability towards the intervention. A prevalence study suggested that self-help interventions are preferred due to the potential stigmatization related to mental health interventions and the high cost of mental health services in Hong Kong (Lee, Tsang, & Kwok, 2007). Nonetheless, to date, only limited self-help interventions that target lifestyle medicine for sleep-related problems are available. Through this study, we aimed to promote evidence-based patient care and improve help-seeking behaviors and access to evidence-based lifestyle interventions for insomnia.