Clinical trials: Parasomnias
Smoking, Sleep Disturbance
Racial Differences in Circadian and Sleep Mechanisms for Nicotine Dependence, Craving, and Withdrawal
The number one preventable cause of death in the world is tobacco use. Cigarette smoking in particular, costs an estimated $300 billion due to expenses related to medical care and lost productivity.
- Conditions
- Smoking, Sleep Disturbance, Nicotine Dependence
- Trial name
- NCT03968900
- Testing
- Sleep restriction condition, Sleep extension condition
- Where
- United States
- Volunteers
- 29 people
- Sponsor
- University of Alabama at Birmingham
Sleep Disturbance, Insomnia
The SleepWell Study - Chronotherapeutic Intervention to Improve Sleep Following ACS
This two-phase pilot study will test the feasibility of a "combined chronotherapy" (CC) intervention consisting of morning bright light therapy (BLT) and evening blue light blocking (BLB), administered daily for 4 weeks in…
- Conditions
- Sleep Disturbance, Insomnia, Acute Coronary Syndrome
- Trial name
- NCT05299723
- Testing
- BLT Intervention, BLB Intervention, Sleep Hygiene Education
- Where
- United States
- Volunteers
- 19 people
- Sponsor
- Columbia University
Cancer Malignancies
Melatonin Intervention For Neurocognitive Deficits in the St. Jude Lifetime Cohort
Primary objective: 1. To examine the efficacy of melatonin treatment on neurocognitive functioning in adult survivors of childhood cancer. Secondary objectives: 1.
- Trial name
- NCT01700959
- Testing
- melatonin
- Where
- United States
- Volunteers
- 911 people
- Sponsor
- St. Jude Children's Research Hospital
Restless Legs Syndrome
Simulated Driving Study in Restless Legs Syndrome
This study was a multi center, randomized, double blind, active and placebo controlled, parallel group study to assess simulated driving performance in XP13512 treated subjects with Restless Legs Syndrome (RLS).
- Trial name
- XP083 (NCT01332318)
- Testing
- XP13512, Diphenhydramine
- Where
- United States
- Volunteers
- 130 people
- Sponsor
- XenoPort, Inc.
Restless Legs Syndrome, Ekbom Syndrome
Switching From Oral Dopamine Agonists to Rotigotine
The primary objective is to demonstrate safety and tolerability of switching patients with Restless Legs Syndrome (RLS) from an oral dopamine agonist to rotigotine.
- Conditions
- Restless Legs Syndrome, Ekbom Syndrome, Willis-Ekbom Disease
- Trial name
- SWITCH (NCT01976871)
- Testing
- Rotigotine
- Where
- United States
- Volunteers
- 21 people
- Sponsor
- John Winkelman, MD, PhD
Autism, Autism Spectrum Disorders
Treatment of Sleep Disturbances in Young Children With Autism
This study will compare the efficacy of a behavioral parent training program (PT) aimed specifically at common sleep disturbances compared to parent education (PE) program focusing on general issues related to autism.
- Trial name
- NCT01322022
- Testing
- ParentTraining, Parent Education
- Where
- United States
- Volunteers
- 40 people
- Sponsor
- University of Pittsburgh
Anxiety, Depressive Symptoms
Stepped-Care Telehealth for Distress in Cancer Survivors
Mental health issues in post-treatment adult cancer survivors are associated with multiple adverse outcomes and may represent a cancer health disparity for rural survivors.
- Conditions
- Anxiety, Depressive Symptoms, Sleep Disturbance, Recurrent Disease
- Trial name
- Telehealth (NCT03060096)
- Testing
- Severe Anxiety/depression: High Intensity Stepped Care, Moderate Anxiety/depression: Low Intensity Stepped care, Enhanced Usual Care Control
- Where
- 166 sites in United States
- Volunteers
- 68 people
- Sponsor
- Wake Forest University Health Sciences
REM Behavior Disorder, Parkinsonism
Efficacy and Tolerability of Ramelteon in Patients With Rapid Eye Movement (REM) Behavior Disorder and Parkinsonism
Parkinson's disease (PD) is the second most common neurodegenerative disorder of the elderly that affects a million patients in US. Sleep dysfunction impacts up to 90% of PD patients.
- Trial name
- NCT00745030
- Testing
- Rozerem
- Where
- United States
- Volunteers
- 3 people
- Sponsor
- Northwestern University
Parkinson Disease
Trial of Xyrem for Excessive Daytime Sleepiness and Sleep Disturbance in Parkinson's Disease (PD)
This clinical trial is designed to evaluate the safety and potential efficacy of Xyrem for the treatment of excessive daytime sleepiness (EDS) and nocturnal sleep disturbance in patients with mild to moderate Parkinson's Disease…
- Trial name
- Xyrem (NCT00641186)
- Testing
- sodium oxybate
- Volunteers
- 30 people
- Sponsor
- Baylor College of Medicine
Restless Leg Syndrome
Investigation of Efficacy of incobotulinumtoxinA (Xeomin) in Relieving Symptoms of Restless Leg Syndrome.
The purpose of this research study is to compare the safety and effectiveness of local injections of botulinum toxin A (Xeomin®) to an inactive test substance (placebo) in a medical condition called Restless Leg Syndrome.
- Trial name
- NCT01931878
- Testing
- incobotulinumtoxinA
- Where
- United States
- Volunteers
- 24 people
- Sponsor
- Yale University
Restless Legs Syndrome
Polysomnography Study Of Pregabalin And Pramipexole Versus Placebo In Patients With Restless Legs Syndrome And Associated Sleep Disturbance
The purpose of this study is to assess the efficacy and safety of pregabalin and pramipexole versus placebo in the treatment of restless legs syndrome and associated sleep disturbance.
- Trial name
- NCT00991276
- Testing
- pregabalin, pramipexole
- Where
- 41 sites in United States
- Volunteers
- 85 people
- Sponsor
- Pfizer's Upjohn has merged with Mylan to form Viatris Inc.
Restless Legs Syndrome
Study to Investigate Pharmacokinetics (PK) of Pramipexole in Pediatric Patients Who Are Individually Optimized to Stable Pramipexole Doses for the Treatment of Idiopathic Restless Legs Syndrome (RLS)
Study to determine the pharmacokinetics (PK) of pramipexole (PPX) after administration of a single dose orally (p.o.) in pediatric patients with the diagnosis of RLS
- Trial name
- NCT02231918
- Testing
- MIRAPEX® - low, MIRAPEX® - medium, MIRAPEX® - high
- Volunteers
- 26 people
- Sponsor
- Boehringer Ingelheim
Insomnia, Sleep
Frequen-ZZZ SleepPad Investigational Device POC
The investigators propose to examine the potential effects of the Frequen- ZZZ sleep pad - a noninvasive, unobtrusive appliance that generates a localized low-level electromagnetic field via radiofrequency, and that is used on…
- Conditions
- Insomnia, Sleep, Sleep Disturbance
- Trial name
- NCT05908344
- Testing
- Activated Sleep Pad system (Frequen-ZZZ), Deactivated Sleep Pad system (Frequen-ZZZ)
- Where
- United States
- Volunteers
- 10 people, healthy volunteers welcome
- Sponsor
- Kunasan Inc.
Concussion, Mild, Post-Concussion Symptoms
Bright Light Therapy for Treatment of Sleep Problems Following Mild Traumatic Brain Injury
The purpose of the research study is to understand the effectiveness of a six-week course of light exposure on cognitive functioning, mood, activity, and sleep in people that have suffered a head injury leading to a concussion.
- Conditions
- Concussion, Mild, Post-Concussion Symptoms, Sleep Problems
- Trial name
- NCT02374918
- Testing
- mTBI wavelength-1 bright light, mTBI wavelength-2 bright light, HC wavelength-1 bright light
- Where
- United States
- Volunteers
- 77 people, healthy volunteers welcome
- Sponsor
- University of Arizona
Restless Legs Syndrome
XP13512 vs. Placebo in Patients With Restless Legs Syndrome.
The primary objective of this trial is to assess the efficacy of XP13512 taken once daily compared to placebo for the treatment of patients suffering from Restless Legs Syndrome (RLS).
- Trial name
- NCT00365352
- Testing
- XP13512 600MG, XP13512 1200MG
- Volunteers
- 325 people
- Sponsor
- XenoPort, Inc.
Restless Legs Syndrome
Sifrol (Pramipexole) Onset of Action and Impact: a 12-weeks Observational Study in Patients With Primary Restless Legs Syndrome
The objectives of the Post Market Surveillance (PMS) study are to evaluate the treatment effect of pramipexole on Restless Legs Syndrome (RLS) severity as measured by International Restless Legs Rating Scale and Global Clinical…
- Trial name
- NCT00721279
- Testing
- Sifrol® (pramipexole dihydrochloride)
- Where
- 127 sites in Austria
- Volunteers
- 549 people
- Sponsor
- Boehringer Ingelheim
Restless Legs Syndrome
Long-Term Study of Gabapentin Enacarbil (GEn, XP13512) vs. Placebo in Patients With Restless Legs Syndrome.
The primary objective of this trial is to assess the maintenance of efficacy of gabapentin enacarbil (GEn, XP13512) taken once daily in the long-term treatment of patients suffering from Restless Legs Syndrome (RLS).
- Trial name
- NCT00311363
- Testing
- GEn (XP13512)
- Volunteers
- 327 people
- Sponsor
- XenoPort, Inc.
Muscle Weakness, Quadriceps Muscle Atrophy
NM Balance Regulation With ULLS and Loss of Sleep
The goal of this trial is to learn about how restricted sleep and not bearing weight on the leg affects muscle strength and posture control.
- Conditions
- Muscle Weakness, Quadriceps Muscle Atrophy, Sleep Disturbance
- Trial name
- NCT05956964
- Testing
- Sleep Restriction, Sleep Adequate
- Where
- United States
- Volunteers
- 16 people, healthy volunteers welcome
- Sponsor
- Lance Bollinger
Sleep Disturbance
Feasibility Study of Personalized Trials to Improve Sleep Quality
The purpose of this pilot study is to assess the feasibility of using N-of-1 methods in a virtual research study of melatonin intervention for poor sleep quality.
- Trial name
- NCT05349188
- Testing
- Melatonin 3 mg, Melatonin 0.5 mg
- Where
- United States
- Volunteers
- 60 people, healthy volunteers welcome
- Sponsor
- Northwell Health
Restless Legs Syndrome
Long-term Study Of Ropinirole In Restless Legs Syndrome
This is an initial placebo-controlled study followed by open treatment evaluating the effectiveness and tolerability of ropinirole long-term in patients with moderate to severe Restless Legs Syndrome.
- Trial name
- NCT00329602
- Testing
- Ropinirole
- Where
- 39 sites in Australia, Czechia and 9 more
- Volunteers
- 404 people
- Sponsor
- GlaxoSmithKline