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Explore actively recruiting studies pulled live from the public ClinicalTrials.gov registry. Filter by condition and state, then check your eligibility in under a minute.

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36 recruiting in FL
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 · Overweight · 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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AMAZE 3: A Research Study Investigating How Well the Medicine NNC0487-0111 Helps People With Excess Body Weight and Obstructive Sleep Apnoea Not Treated With Positive Airway Pressure Lose Weight and Improve Sleep Apnoea

Obesity · Overweight · Obstructive Sleep Apnoea

This study is being done to look at the efficacy and safety of NNC0487-0111 in participants with excess body weight and obstructive sleep apnoea not treated with positive airway pressure lose weight and improve sleep apnoea. 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.

Miami, Naples +more, 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, FL18–100 yrsAll genders
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DReAMzz- Dronabinol and Acetazolamide Medication for Sleep Apnea (ZZ). Dose Confirmation Crossover Study for IHL-42X in Subjects With Obstructive Sleep Apnea.

Obstructive Sleep Apnea (OSA)

The goal of this randomized, double-blind, multi-dose crossover clinical trial is to determine the safety and efficacy of IHL-42X in subjects with obstructive sleep apnea. The primary endpoint is: Change in AHI4 at the end of each treatment period compared to baseline (each treatment period is 28 days). The study will consist of three separate four-way crossover dose-comparison studies each comparing three dose strengths of IHL-42X to placebo. The double-blind four-way crossover will be conducted according to a Williams design. Each of the crossover studies will test different doses of dronabinol in combination with a distinct, set dose of acetazolamide. In total, nine different combinations of dronabinol and acetazolamide formulated as IHL-42X will be tested in the study. The optimal dose strength will be selected based on safety and efficacy over a 4-week treatment period.

Brandon, Jacksonville +more, FL18–65 yrsAll genders
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A Study of Eloralintide (LY3841136) in Participants With Obstructive Sleep Apnea and Obesity or Overweight

Sleep Apnea, Obstructive · Obesity · Overweight

The purpose of the studies is to evaluate the efficacy and safety of eloralintide in participants with moderate-to-severe obstructive sleep apnea and obesity or overweight. YDAO is a master protocol designed to support two independent studies: YSA1 and YSA2. Study YSA1 will include participants who are unable or unwilling to use Positive Airway Pressure (PAP) therapy and study YSA2 will include participants who are on PAP therapy for at least 3 months at time of screening and plan to continue PAP therapy during the study. Participants will be assigned to the Intervention-Specific Appendix (ISA) that reflects their current PAP usage. Participation in the study will last about 76 weeks.

Miami, Pensacola +more, FL18+ yrsAll genders
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CBT-I vs. MBTI for Traumatic Brain Injury (TBI)-Related Insomnia and Post-Traumatic Stress Symptoms

Traumatic Brain Injury · Insomnia · 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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Treatments for Insomnia in Veterans With PTSD

Insomnia · 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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A Study of Suvorexant (MK-4305) for the Treatment of Insomnia Disorder in Participants With Opioid Use Disorder (MK-4305-098)

Insomnia

People with opioid use disorder (OUD) can have trouble falling or staying asleep. Researchers want to know if suvorexant will help people with OUD fall asleep and stay asleep. The goal of this study is to learn about the safety of suvorexant and how well people tolerate it. Researchers also want to learn if suvorexant helps people sleep longer compared to people who take placebo. A placebo looks like the study medicine but has no actual study medicine in it.

Bradenton, FL18–70 yrsAll genders
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Recruiting

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

Insomnia · 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

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

Poor Sleep Quality · Leg Cramps, Nocturnal

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).

Palm Beach Gardens, FL40–75 yrsAll genders
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Recruiting

Pediatric Down Syndrome Post-Approval Study

Pediatric Obstructive Sleep Apnea · 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, FL13–18 yrsAll genders
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Recruiting

A Study to Learn About the Monthly Dosing Study Medicine Called Berobenatide in Adults With Breathing Problems During Sleep and Overweight or Obesity Who Use a Breathing Machine (PAP) (VESPER-OSA 1)

Apnea · Sleep Disorders · Overweight and/or Obesity

This study is being done to learn about the safety and effects of a study medicine called berobenatide (bear-oh-BEN-uh-tide). The study will see if berobenatide can help adults with breathing problems during sleep (obstructive sleep apnea \[OSA\]) and overweight or obesity who use a breathing machine (positive airway pressure \[PAP\] machine). People may be able to take part if they are adults with moderate to severe OSA, have overweight or obesity, and have been using PAP therapy before joining the study. Participants will be assigned by chance to receive either berobenatide or a placebo (a treatment that looks like the study medicine but contains no active medicine). The study treatment will be given as an injection under the skin approximately once a month. Participants will receive study treatment at study sites and may administer some doses at home after receiving training. During the study, participants will attend study visits, undergo sleep studies, complete questionnaires, and have health assessments performed. Researchers will compare the effects of berobenatide and placebo on sleep apnea, body weight, and other health measures.

Bradenton, FL18+ 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 · 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, FL8–17 yrsAll genders
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Recruiting

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, FL18–74 yrsAll genders
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SLEEP-COPE: Sleep Intervention for Oppositional Children

Insomnia Chronic · 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, FL8–12 yrsAll genders
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