Clinical Research Directory

The Effect of a Daily Magnesium and Melatonin Supplement on Sleep Quality in People With Nighttime Leg Cramps

Participants are being invited to take part in a research study. Before deciding whether to take part, it is important for participants to understand why the research is being done and what it will involve. Purpose: This study will investigate whether a multi-ingredient nutritional supplement containing magnesium and melatonin can improve sleep quality in adults who experience disrupted sleep due to nighttime leg cramps. What participation involves: Participation lasts 8 weeks. Participants will be randomly assigned to take either the nutritional supplement or a placebo (inactive look-alike) every night before bed for 6 weeks. Participants will wear an Oura Ring wearable device on one finger continuously for 8 weeks throughout the study and complete short questionnaires using a smartphone app. The Oura Ring and study supplement will be sent to the participant's home address. Participants will never need to travel to a research centre; all contact with the research team will be by video call, phone, messaging, or email. How long: Total involvement will be 8 weeks, made up of a 2-week baseline period and a 6-week supplementation period. Each day, participants will complete a short app-based questionnaire (approximately 1 minute). At the end of weeks 2, 4, 6, and 8, participants will complete additional app-based questionnaires (approximately 10 minutes).

The Impact of Overnight Active Temperature Regulation on the Gut Microbiome, Inflammation, and Circadian Rhythm.

This study examines whether two continuous weeks of overnight active temperature regulation (via the Eight Sleep Pod) use affects gut microbiome composition, inflammation, and the body's daily temperature and blood pressure rhythms in postmenopausal women and age-matched men with self-reported poor sleep.

Effects of Daily Avocado Consumption on Sleep and Skin Health in Postmenopausal Females

Poor sleep quality and accelerated skin aging are common in postmenopausal women and may be linked, in part, through impaired vascular function. Avocados contain monounsaturated fats, carotenoids, vitamin E, magnesium, fiber, and other bioactive compounds that may support vascular health and, in turn, improve sleep and skin health. This randomized controlled trial will evaluate whether consuming one medium Hass avocado daily for 8 weeks improves sleep quality and skin health compared with a calorie- and fatty-acid-matched safflower oil control in postmenopausal women with poor sleep quality and overweight or obesity. The study will enroll 74 postmenopausal women aged 50-65 years who have poor habitual sleep quality. Participants will be randomly assigned to consume either one medium Hass avocado per day or 27 g of safflower oil per day for 8 weeks. Sleep will be assessed using wrist actigraphy, at-home electroencephalography, sleep diaries, and validated sleep questionnaires. Skin hydration, elasticity, barrier function, collagen, pigmentation, and wrinkles will also be assessed. Vascular function will be measured using flow-mediated dilation and blood biomarkers. The investigators expect that daily avocado consumption will improve sleep quality, skin health, and vascular function compared with the control condition and will explore whether improvements in vascular function contribute to improvements in sleep and skin health.

Improving Sleep Health for Asian Americans

Filipino Americans are at high risk of poor sleep and its adverse health consequences. The goal of this study is to test a generative AI-powered chatbot that delivers personalized, evidence-based sleep education and guidance to Filipino Americans who experience poor sleep.

Acupuncture for Sleep Fragmentation in Older Adults: A Single-Arm Pilot Study

This single-group pilot study will enroll 20 adults aged 60 years or older with persistent poor sleep. All participants will receive a standardized 6-week acupuncture program. The study will assess feasibility and preliminary changes in actigraphy-derived sleep fragmentation, self-reported sleep, brain DTI-ALPS imaging, internal jugular venous ultrasonography, and CERAD-NB word-list memory performance.

Sleep and Arterial Function in Hypertensive Patients With Poor Sleep Quality

This prospective, parallel-group randomised controlled trial evaluates whether cognitive-behavioural therapy for insomnia (CBT-I) improves arterial function and psychological and cognitive outcomes in hypertensive patients with poor sleep quality. Adults aged 18-70 with controlled hypertension and poor baseline sleep quality (sleep efficiency \<=85%) are randomised 1:1 to CBT-I (four weekly 60-minute sessions) or passive sleep education. The primary outcomes are change from baseline in pulse wave velocity and central arterial pressure at 12 months. Secondary outcomes include blood pressure, depressive symptoms, perceived stress, cognitive complaints, and sleep quality, assessed at baseline, 1, 6, and 12 months.

Psychoeducation-Supported Breathing and Relaxation for Earthquake Survivors

This randomized controlled study evaluated whether a structured program combining psychoeducation, breathing exercises, and relaxation techniques could reduce post-traumatic stress symptoms and improve sleep quality among adult earthquake survivors living in temporary accommodation in Malatya, Türkiye. A total of 90 participants were randomly assigned in equal numbers to an intervention group or a control group. The intervention group attended six face-to-face group sessions delivered twice weekly over three weeks. The program included education about trauma and stress, diaphragmatic breathing, progressive muscle relaxation, coping strategies, sleep hygiene, cognitive restructuring, positive imagery, and guidance for continued practice. The control group received no structured intervention and continued its usual daily routine. Post-traumatic stress symptoms and sleep quality were assessed before and after the intervention using the Post-Traumatic Stress Disorder Short Scale and the Pittsburgh Sleep Quality Index. The study compared changes in these outcomes between the intervention and control groups.

A Trial to Examine the Efficacy of a Supplement Gummy to Improve Sleep Quality and Quantity

This single-group trial evaluates the efficacy of FlavCity's Sleep Gummy supplement on sleep health in adults aged 20-50 who self-report issues with sleep. Forty participants will take one sleep gummy nightly (30 minutes before bed) for 7 days while wearing a Fitbit Inspire 3 sleep tracker to monitor objective sleep metrics. Participants will complete study-specific questionnaires and report sleep tracker data at Baseline, Day 1 (the day after first use), and Day 7. The study is conducted entirely virtually. Primary outcomes focus on sleep quality and quantity (including time to fall asleep, deep sleep, REM sleep, and grogginess upon waking), assessed via the validated Sleep Quality Scale (SQS) and sleep tracking biomarkers. Secondary outcomes assess participant perceptions of the product.

Effect of Magnesium Supplementation on Sleep Quality and Cognitive Function in Saudi Adults

The goal of this clinical trial was to evaluate whether magnesium citrate supplementation improved sleep quality and cognitive function in healthy Saudi adults. It also assessed the effects of magnesium on selected blood markers. The main questions it aimed to answer were: Did magnesium supplementation improve sleep quality? Did magnesium supplementation improve cognitive function? Researchers compared participants who received magnesium citrate to a control group that did not receive any intervention to evaluate its effects. Participants: Took magnesium citrate (400 mg daily) for 90 days (two capsules: one in the afternoon and one 1-2 hours before bedtime) Visited Umm Al-Qura University twice (before and after the intervention) for: Sleep quality assessment Cognitive function assessment Blood sample collection to measure serum magnesium and HbA1c The control group did not receive any supplementation during the study period.

Mechanistic Effect of Walnut Consumption on Sleep Quality

Poor sleep quality is very common in modern society. Walnuts contain many nutrients that may be helpful for sleep, including melatonin and polyphenols. Some studies show that eating foods high in melatonin and polyphenols improves sleep quality, but walnuts have not been studied specifically. This study proposes to test if eating walnuts improves sleep compared to a food that lacks these sleep-promoting factors. The investigators expect that walnut consumption for 4 days will increase melatonin levels and lead to better sleep quality compared to a high-carbohydrate, high-sugar food. The study will enroll middle-aged and older adults with sleep complaints to participate in this study. Each person will eat the two different foods for 4 days each in random order. The 4-day periods will be separated by at least 2-3 weeks. Sleep quality will be measured by questionnaire and with a wrist monitor every day. The investigators will also do a sleep study using electroencephalography (EEG) on night 3 and take measures of circadian physiology (natural body rhythms) in the laboratory on day 4 (including overnight) by measuring body temperature and blood and urine melatonin. The study findings may provide new options to improve sleep health from increased walnut consumption.

The Women Veteran's Health Mission

The purpose of this study is to evaluate the impact of a customized web-based e-health program to provide online health promotion (Missions), peer support, and social connectivity to women Veterans and their families. Primary Objective • To assess participant engagement in the program including: completion rates (%) for each 6-12 week health program (Mission) defined as completing the assessments following the intervention number of login days among those who register and drop-out rates (%) defined as those who start but do not complete the program. Secondary Objectives • To assess the impact of a web-based wellness program on health metrics including: change in body weight (lbs) sleep, and chronic pain (PROMIS 29 Questionnaire) stress (PROMIS Perceived Stress) social isolation (PROMIS Social Isolation Short Form 4a). • To determine whether there is a dose-response between the number of login days into the program and changes in health metrics.

Improving Sleep In Midlife Women

This study purpose of this study to see how consuming pistachios and completing a health intervention session a study therapist may improve sleep health in midlife women with poor sleep. Participants in this study will be asked to consume a study snack for about one month, complete a health education session with a study therapist and record information about their sleep. At baseline and after the intervention we will collect information about sleep, alertness, body composition, and blood lipids.

Effects of a Programmed Reflexology Therapy on Sleep Quality, Insomnia, Fatigue, and Heart Rate Variability Among Individuals With Poor Sleep Quality

The goal of this clinical trial is to evaluate whether a structured reflexology therapy can improve sleep, reduce insomnia severity, and alleviate fatigue in adults with poor sleep quality, and to understand how it affects autonomic nervous system function. The main questions it aims to answer are: * Can manual reflexology treatment improve sleep quality as measured by standardized sleep assessments? * Can manual reflexology influence physiological measures of autonomic function (such as heart rate and heart rate variability)? Researchers will compare the effects of a manual reflexology intervention to those of a mechanical foot massage to determine which approach is more effective in improving sleep, reducing insomnia severity, and enhancing fatigue and autonomic balance. Participants will be asked to: * Undergo weekly sessions of manual reflexology therapy for six weeks, and * Undergo weekly sessions using mechanical foot massage equipment for six weeks, with heart rate, heart rate variability, and sleep and fatigue questionnaires measured before and after each intervention period.

Effects of Circadian-Based Acupressure on Sleep Quality in Nursing Home Residents

This randomized controlled trial aims to evaluate the effectiveness of circadian-based acupressure compared with sham acupressure in improving sleep quality among nursing home residents. Additionally, the study will examine the effects of the intervention on insomnia severity, heart rate variability, and psychological distress, including depression, anxiety, and stress. A total of 80 older adults aged 60 years and above residing in a nursing home in Jakarta, Indonesia, will be randomly assigned to either the circadian-based acupressure group or the sham acupressure group. Participants in the intervention group will receive circadian-based acupressure twice daily, five days per week for four weeks, with acupoints selected and administered according to circadian meridian activity, while the control group will receive sham acupressure at non-acupuncture points with the same frequency and duration. Outcome measures will be assessed at baseline and immediately post-intervention.

Pistachio Snacking and Metabolic Flexibility

The purpose of this study is to evaluate the effects of pistachio snacking on metabolic flexibility (at rest, during exercise, and in post-exercise recovery) in healthy overweight and obese adults. Secondary goals include evaluating effects on changes in diet quality, sleep characteristics, physical activity, and hormonal health in women. In randomized order, participants will complete four days of pistachio snacking and four days of normal dietary habits (control). For both conditions, primary outcomes of resting substrate metabolism, metabolic flexibility during exercise, and post-exercise substrate metabolism will be measured pre-post intervention via indirect calorimetry. Secondary outcome of diet quality (kcal, carb, fat, protein) will be measured pre-post intervention via diet log. Exploratory outcomes of daily physical activity (steps, intensity), nightly sleep characteristics (quantity, quality, latency, efficiency), and daytime sleepiness and hunger.

Weighted Blanket in Pregnancy

Pregnancy is frequently accompanied by sleep disturbances, musculoskeletal discomfort, anxiety, and stress, which may negatively affect maternal well-being and daily functioning. Weighted blankets, which provide deep pressure stimulation, have been used as a non-pharmacological method to promote relaxation, improve sleep quality, and reduce stress and anxiety. However, their effects have not been evaluated in pregnant women. This study aims to examine the effect of weighted blanket use on lower leg cramps, sleep quality, anxiety, and stress levels among pregnant women. The trial uses a randomized, self-controlled design in which each participant completes a 14-day control period without the blanket and a subsequent 14-day intervention period using the weighted blanket. Data will be collected using validated measurement tools. The findings are expected to provide evidence for a safe, non-pharmacological supportive approach that may enhance comfort and psychological well-being during pregnancy.