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33 recruiting in FL
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Phase 3 Study of Adjunctive Treatment With Seltorexant in Adult and Elderly Participants With Major Depressive Disorder and Insomnia Symptoms

Depressive Disorder, Major

The purpose of this study is to know how well seltorexant works, and also to evaluate safety and maintenance effect of seltorexant compared with placebo as an adjunctive therapy to an antidepressant in improving depressive symptoms in participants with major depressive disorder with insomnia symptoms (MDDIS) who have had an inadequate response to current antidepressant therapy with a selective serotonin reuptake inhibitor (SSRI) or serotonin-norepinephrine reuptake inhibitor (SNRI).

Brandon, Hialeah +more, FL18โ€“74 yrsAll genders
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Treatments for Insomnia in Veterans With PTSD

Insomnia ยท PTSD

This randomized trial will compare a novel treatment, Acceptance of the Behavioral Changes to Treat Insomnia (ABC-I) to Cognitive Behavioral Therapy for Insomnia (CBT-I) among Veterans with comorbid Post-Traumatic Stress Disorder (PTSD) and insomnia disorder. ABC-I combines the behavioral components of CBT-I with components of another behavioral therapy (Acceptance and Commitment Therapy) and has been shown to improve treatment adherence. The study objectives are: 1) to evaluate the benefits of ABC-I in reducing post-traumatic stress disorder (PTSD) symptoms among Veterans with comorbid PTSD and insomnia disorder compared to CBT-I, and 2) to evaluate the effectiveness of ABC-I in improving insomnia symptoms and sleep quality among Veterans with comorbid PTSD and insomnia disorder as compared to CBT-I. Veterans with insomnia and comorbid PTSD who receive care at Sepulveda and West Los Angeles facilities will be recruited for the study. Those who pass an initial eligibility screen will be enrolled and written informed consent will be obtained. A baseline assessment will be completed that includes measures of sleep, PTSD, and quality of life. Veterans who meet all eligibility criteria will be randomly assigned to the ABC-I (n=100) or CBT-I (n=100) treatment. Both treatments will be provided in 5 one-on-one sessions by a trained instructor who is supervised by a behavioral sleep medicine specialist. All randomized participants (n=200) will have 3 follow-up assessments (post-treatment, 3-months, and 6-months after randomization). The follow-up assessments will collect information on PTSD symptoms, insomnia symptoms and sleep quality.

Miami, FL18+ yrsAll genders
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Maridebart Cafraglutide Versus Placebo in Adult Participants With Obstructive Sleep Apnea on Positive Airway Pressure Therapy

Obesity ยท Obstructive Sleep Apnea

This Phase 3 clinical trial is designed to evaluate the efficacy and safety of maridebart cafraglutide compared to placebo over a 52-week period in adults with obstructive sleep apnea (OSA) who are receiving positive airway pressure (PAP) therapy and are living with overweight or obesity.

Brandon, Palmetto Bay +more, FL18โ€“99 yrsAll genders
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Recruiting

Effect of Oxymetazoline Hydrochloride in Combination With Fluticasone Propionate on the Apnea Hypopnea Index (AHI) in Subject With Persistent Nasal Congestion and Mild Obstructive Sleep Apnea

Sleep Apnea ยท Chronic Nasal Congestion

The addition of intranasal oxymetazoline for two weeks to already instituted optimal doses of intranasal fluticasone propionate will decrease the total number of obstructive apneas and hypopneas per hour of sleep in subjects with perennial allergic or non-allergic rhinitis and mild obstructive sleep apnea who have persistent nasal congestion despite maximum doses of NGCS.

Tampa, FL18โ€“65 yrsAll genders
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Pediatric Down Syndrome Post-Approval Study

Pediatric Obstructive Sleep Apnea ยท Down Syndrome (DS)

The purpose of this Post Approval research study is to assess ongoing safety and effectiveness of the Inspire therapy in adolescents and young adults (age 13-18) with Down syndrome and severe sleep apnea. The objective of the study is to provide an ongoing safety and effectiveness assessment of the Inspire UAS System in the Pediatric Down syndrome population.

Tampa, FL13โ€“18 yrsAll genders
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Evaluating a Mat-Based Biometric Vibration System for Sleep and Daily Recovery

Healthy Adult Male and Female Volunteers

The goal of this randomized clinical trial is to learn whether a low-frequency "kinetic wellness" mat (a comfortable mat that gently vibrates) can improve stress recovery, sleep quality, mood, and attention in healthy adults ages 18-45. The main questions it aims to answer are: * After 3 weeks, does regular use of the vibrating mat increase heart rate variability (a noninvasive marker of the body's ability to recover from stress) and improve sleep, mood, perceived stress, and anxiety compared with no mat use? * Do patterns of resting brain activity (measured with EEG) and heart rate variability (HRV) change from before to after the program, and are those changes related to each other? Researchers will compare two groups: an Experimental group that uses the vibrating mat at home for 3 weeks, and a Control group that does not use the mat. Participants are randomly assigned to a group. Participants will: * Attend two lab visits (\~60 min) for questionnaires, resting heart activity (HRV) and brain activity (EEG), and a brief attention test. * On 3-4 days per week for 3 weeks: * Experimental group: use the vibrating mat for 15 minutes while recording HRV. * Control group: lie quietly for 15 minutes while recording HRV. * Both groups: record HRV for 15 minutes before bedtime and 15 minutes after waking on those same days. * Both groups: complete quick check-ins on feelings (after sessions and the next morning) and log caffeine/alcohol, exercise, and medications.

Miami, FL18โ€“45 yrsAll genders
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Recruiting

Maridebart Cafraglutide Versus Placebo in Adult Participants With Obstructive Sleep Apnea Not on Positive Airway Pressure (PAP) Therapy

Obstructive Sleep Apnea

This Phase 3 clinical trial is designed to evaluate the efficacy and safety of maridebart cafraglutide compared to placebo over a 52-week period in adults with obstructive sleep apnea (OSA) who are not on PAP therapy and are living with overweight or obesity.

Brandon, Palmetto Bay +more, FL18โ€“99 yrsAll genders
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Recruiting

SLEEP-COPE: Sleep Intervention for Oppositional Children

Insomnia Chronic ยท Oppositional Defiant Disorder

Children with Oppositional Defiant Disorder (ODD) are at risk for insomnia, arousal dysfunction, mood problems, and noncompliance. Cognitive behavioral treatment for insomnia (CBT-I) holds promise for improving insomnia and related concerns. Telehealth delivery will reduce the burden of in-person sessions, particularly in areas where there is low mental healthcare access. Telehealth CBT-I is efficacious in adults and children but has not been tested in children with ODD. The proposed trial is the next logical step - development and iterative testing of SLEEP-COPE, a brief dyadic telehealth CBT-I for children with ODD and their parents.

Tampa, FL8โ€“12 yrsAll genders
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Recruiting

Digital Dyadic Family Based Intervention to Improve Sleep in Children with ODD and Their Parents: NiteCAPP SINCC (Pilot)

Oppositional Defiant Disorder ยท Insomnia Chronic

In this proposal a brief web-based cognitive behavioral treatment for insomnia (CBT-I) for children with oppositional defiant disorder (ODD) and their parents is iteratively adapted and tested for acceptability, feasibility, and preliminary efficacy.

Tampa, FL8โ€“17 yrsAll genders
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Recruiting

CBT-I vs. MBTI for Traumatic Brain Injury (TBI)-Related Insomnia and Post-Traumatic Stress Symptoms

Traumatic Brain Injury ยท Insomnia ยท Depression

This study is a prospective two-arm, single blind randomized controlled trial design to compare the clinical effectiveness of telemedicine-delivered, 6-session, standardized cognitive behavioral therapy for insomnia (CBT-I) and mindfulness-based treatment for insomnia (MBTI) in treating insomnia symptoms and ameliorating depressive symptoms in persons with mild to moderate TBI and comorbid Post-Traumatic Stress Symptoms (PTSS) and insomnia symptoms in a 360 patients. Participants will undergo assessment (psychosocial questionnaires, neurocognitive testing, sleep monitoring) at baseline, at the end of treatment, and at 2-, 6- and 12-weeks post-treatment. The primary outcome is sleep as measured by the Insomnia Severity Index (ISI).

Eglin Air Force Base, FL18+ yrsAll genders
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Recruiting

NiteCAPP: Web-based Interventions for Insomnia in Rural Dementia Caregivers

Insomnia ยท Dementia

The goal of this project evaluate the efficacy of NiteCAPP in improving insomnia in a rural dementia caregiver sample (n of 100 caregiver and PWD dyads). We will measure both the short term (post-treatment) and long term (6 and 12 months) effects of the intervention on CG sleep, arousal, inflammation, health, mood, burden and cognitive function, and PWD sleep.

Tampa, FL18+ yrsAll genders
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Recruiting

Community Health Advocates for Motivating PAP Use in Our Neighborhoods.

Obstructive Sleep Apnea

The purpose of this research is to compare the impact of motivational enhancement therapy (MET), delivered by culturally congruent community health care workers (CHWs) versus usual care patients with previously untreated moderate-to-severe obstructive sleep apnea (OSA) on adherence to positive airway pressure (PAP) therapy.

Miami, FL18โ€“100 yrsAll genders
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Recruiting

AMAZE 4: A Research Study Investigating How Well the Medicine NNC0487-0111 Helps People With Excess Body Weight and Obstructive Sleep Apnoea Treated With Positive Airway Pressure Lose Weight and Improve Sleep Apnoea

Obesity ยท Overweight ยท Obstructive Sleep Apnoea

This study is being done to look at the efficacy and safety of NNC0487-0111 in participants with overweight or obesity, and obstructive sleep apnoea treated with positive airway pressure. There are 2 study treatments in this study taken as injections under the skin once a week. Participants will either get NNC0487-0111, (the treatment being tested) or Placebo (a treatment that has no active medicine in it) and which treatment participants get is decided by chance.

Bradenton, Naples +more, FL18+ yrsAll genders
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Recruiting

Effect of Peanut Butter on Gut and Metabolic Health

Dysbiosis

The goal of this is parallel arm, randomized clinical trial is to learn and understand the effect of daily smooth peanut butter consumption on gut and metabolic health of children age 6-13. The main objectives are: Primary Objective: To determine the prebiotic effect of daily smooth peanut butter consumption for eight weeks on gut health, including microbiome-metabolome arrays, gut epithelial/barrier function, and gut transit time, in school-aged children. Secondary Objective(s) 1. To determine the effect of daily smooth peanut butter consumption for eight weeks on metabolic and inflammatory health markers, and measures of sleep quality in school-aged children. 2. To determine the potential mechanisms and feasibility of incorporating peanut butter into the diets of school-aged children as part of healthy, personalized nutrition. Research Intervention(s): Researchers compare two groups to see if there really is an effect of daily smooth peanut butter intake on gut and metabolic health. The two groups are: 1. The 1st condition (PB) includes a normal diet supplemented daily with personalized portion of smooth PB, sandwiched between two plain unsalted saltine crackers. 2. The 2nd condition (CTL) includes a normal diet supplemented daily with an isocaloric amount of a nut-free, vegetable oil-based chocolate spread, sandwiched between two plain unsalted saltine crackers.

Tallahassee, FL6โ€“13 yrsAll genders
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