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Sleep clinical trials

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NCT ID: NCT04146857 Completed - Healthy Clinical Trials

Autonomic Activity During Nap Under Hypoxia

NAPOXIA
Start date: October 30, 2019
Phase: N/A
Study type: Interventional

Sleeping under hypoxic conditions can impair cognition and autonomic nervous activity. A short daytime nap can modify these changes. Here we propose a randomized, cross-over study to evaluate the heart rate variability during a 90 min nap in a normobaric hypoxic chamber. In addition, we will investigate sleep architecture, vigilance, attention and memory.

NCT ID: NCT04145362 Completed - Sleep Clinical Trials

Sleep-wake Patterns in Preterm Infants

Start date: November 18, 2019
Phase:
Study type: Observational

The development of sleep-wake behavior is considered to be one of the most important maturation processes occurring in the first year of life. Sleep-wake behavior is related to neurobehavioral regulation of the infant and cognitive function, and gives important information about infant's health. It is suggested that the identification of sleep-wake patterns in preterm infants is critical to the detection of future disorders, early diagnosis and planning of intervention studies In this study we aimed to recruit a total of 25 premature babies born between 28 to 37 weeks of gestational age over six month in the Neonatal Intensive Care Unit of Marmara University Pendik Training and Research Hospital. Sleep wake cycles of these premature infants will be assessed at 32 weeks corrected age by actigraphy, sleep diaries, direct observation and Amplitude integrated electroencephalography (aEEG). We also aimed to investigate the maturation of sleep patterns of these infants included in the study at postconceptional 40th weeks of age, and 12th, and at 24th weeks corrected age, by sleep diaries and actigraphic measurements at their home environment. Development will be assessed by Bayley and Ages and Stages Questionnaire.

NCT ID: NCT04125355 Completed - Anxiety Clinical Trials

Care to Caregiver: The Effect of Reflexology on Sleep and Anxiety of Cancer Caregiver

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

Introduction and Aim: With the increase in life expectancy in cancer, it gains importance in the care process and the problems experienced by caregivers. However, the problems experienced by individuals caring for cancer patients are often ignored. The most common problems faced by cancer caregivers are sadness, anxiety, sleep disorders, and fatigue. Although reflexology has positive effects on sleep and anxiety in different patient groups, there is no study on its effectiveness in cancer caregivers. The aim of this study was to evaluate the effectiveness of reflexology on sleep and anxiety of caregivers. Materials and Methods: The study was conducted as a double-blind placebo-controlled design. After the groups were determined with block randomization, the reflexology investigation was applied to the experimental group for three consecutive days, while for the placebo group, the hands was moved around the foot for the same periods but no deep stimulation was applied. On the fourth day, a sociodemographic diagnostic form, state anxiety scale and Richard-Campbell Sleep Scale were administered to the participants by a blinded researcher. Data were analyzed with SPSS 25.0 package program. Written permission was obtained from the relevant ethics committee, hospital and participants to conduct the study.

NCT ID: NCT04123015 Completed - Sleep Clinical Trials

Clinical Activity During Night-shift: an Ecological Study

Start date: October 3, 2019
Phase:
Study type: Observational

A convenient sample of internal medicine residents will be observed during their nightshift work in the wards of the department of internal medicine of a university hospital. The epidemiology of night calls and emergencies, including incidence, causes, management, and prognosis, will be assessed prospectively. The impact of nightshift work on sleep, stress, quality of life, regrets, and general well being of the residents observed will be measured through completion of validated questionnaires. Quality of handoff sessions will also be assessed.

NCT ID: NCT04120363 Completed - Sleep Clinical Trials

Trial of Testosterone Undecanoate for Optimizing Performance During Military Operations

OPS II
Start date: September 23, 2019
Phase: Phase 4
Study type: Interventional

The objective of this study is to determine the effects of a single dose of testosterone undecanoate during and in recovery from simulated operational stress.

NCT ID: NCT04119778 Completed - Sleep Clinical Trials

Improving Sleep in Lung Cancer Patients: A Trial of Aerobic Exercise and Tai-chi

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

Lung cancer is one of the commonest cancers around the world. Sleep disturbances are commonly reported by lung cancer patients. Meanwhile, disturbed sleep is associated with several health problems, including shortened survival period. Thus, lung cancer imposes a substantial health burden on patients and society both locally and world widely. On top of the classical clinical therapies, additional approaches that could result in improved sleep are needed. Previous studies, including our own, have shown that physical exercise, such as aerobic walking, improves lung cancer patient's physical fitness particularly cardiovascular fitness, circadian rhythm and immune function. Another popular mode of exercise in Chinese population is tai-chi. With emphasis on breathing and concentration, tai-chi exhibits extra benefits for stress-relieving and psychological well-being. Those benefits of exercise have long been implicated for better sleep of cancer patients. The promising benefits of aerobic exercise or tai-chi, as non-pharmacological interventions, urge for need of rigorous evidence on the effectiveness of these interventions in improving sleep outcomes. However, to date, there has been no report from a randomized controlled trial (RCT) to study the effect of aerobic exercise or tai-chi on sleep of lung cancer patients. This proposed research is designed to conduct a three-arm RCT comparing aerobic exercise, tai-chi to usual care in non-small cell lung cancer patients. Recruited participants will be randomised into three groups: 1) a 16-week aerobic exercise group, 2) a 16-week tai-chi program group, and 3) a self-management control group. Aerobic exercise and tai-chi program will be conducted by certificated coaches. Life-long adherence to the practice in intervention groups is encouraged. Through this project, the investigators aim to evaluate if 1) aerobic exercise or 2) tai-chi intervention promote subjective sleep quality in lung cancer patients compared to control, as the primary outcome of this study. The investigators shall also examine if tai-chi practice can provide similar improvement in sleep quality compared with ordinary exercise. Using biomarkers including circadian rhythm, cardio-respiratory fitness, further provides objective measures for bio-physiological effectiveness of the interventions. The associations of those biological measures and psycho-social status with sleep outcomes will be further explored. Findings of this study will provide crucial information on the evidence-based practice by physical exercise or tai-chi to improve sleep of lung cancer patients. This study will also have far-reaching significance in providing important scientific evidence to policymakers to integrate physical activity into routine clinical management as an add-on treatment for lung cancer patients in Hong Kong.

NCT ID: NCT04106089 Completed - Sleep Clinical Trials

Sleep in Pediatric HSCT

Start date: November 18, 2019
Phase: N/A
Study type: Interventional

Through an aggregated N=1 randomized controlled design (each patient will serve as their own control, with the 5-day intervention period determined by randomization), the current study will test the acceptability, feasibility, and impact on sleep and supportive care engagement of protecting one 6-hour window for nighttime sleep (intervention) relative to regular vitals checks (observation only periods) during Hematopoietic Stem Cell Transplant (HSCT) recovery.

NCT ID: NCT04102345 Completed - Sleep Clinical Trials

Lavender vs Zolpidem Sleep Quality During Diagnostic PSG

Start date: September 4, 2019
Phase: Early Phase 1
Study type: Interventional

In this pragmatic, clinical study the investigators propose that lavender aromatherapy is comparable to Zolpidem (Ambien) in improving the quality of diagnostic sleep studies.

NCT ID: NCT04093271 Completed - Healthy Clinical Trials

Investigating the Efficacy of Rest-ZZZ Formula in Healthy Participants With Difficulty Falling Asleep or Staying a Sleep

Start date: September 24, 2019
Phase: Phase 1
Study type: Interventional

A randomized, double-blind, placebo-controlled, cross-over pilot study to investigate the efficacy of Rest-ZZZ in healthy participants with difficulty falling asleep or staying a sleep. The study will have 3 study periods. During each study period, eligible participants will consume either Rest-ZZZ, comparator product, or placebo for 7 days during each study period (1 product per study period), with a 1-week washout period in between each period. The primary objective is the comparison in sleep quality using a sleep quality questionnaire from pre-supplement to Day 7 between the Rest-ZZZ, comparator, and placebo. Other study outcomes include the change in quality of life, profile of mood states (POMS), and safety outcomes such as vital signs, clinical chemistry and hematological markers

NCT ID: NCT04082247 Completed - Sleep Clinical Trials

Healthy Children 2021 Study in Childcare Centers

HC2021
Start date: September 1, 2019
Phase: N/A
Study type: Interventional

In Portugal, 17.3% of children under 10 years old are overweight and 7.7% are obese. Research has shown the implementation of healthy lifestyle promotion programs and obesity prevention, however "best practices" are far from being defined. Also, the first five years of life are important for the executive functions development, namely memory, inhibition (including self-regulation) and flexibility, which includes creative thinking, thinking "outside of the box", important in problem solving. The importance of social and emotional dimensions, as well as physical health for the development of cognitive health is consensual, as sleep deprivation, low physical activity, unhealthy food may inhibit the proper development of executive functions. This project aims to evaluate the effectiveness of a healthy lifestyle promotion program on emotional, social and cognitive development and eating habits, sleep and physical activity in children between 12 and 42 months of age. A cluster randomised trial will be developed and 300 children, from 16 childcare centres will be invited to participate. Half of the childcare centres will be allocated to the control group and the other half to the intervention group. Data collection will occur before randomisation (at baseline) and after intervention. A feasibility study will be undertaken prior to the experimental study, in accordance with internationally accepted procedures. The investigators intend to implement the concept that the development of executive functions requires the combination of healthy eating, physical activity and sleep. The project will contribute with evidence-based to the cognitive, social and emotional development in children.