Clinical trials: Insomnia Disorder
Insomnia, Mild Cognitive Impairment
SleepSMART for Veterans With MCI and Insomnia
Cognitive Behavioral Therapy for Insomnia (CBT-I) is the first-line treatment for chronic insomnia. However, cognitive impairments may limit progress in CBT-I for older Veterans with Mild Cognitive Impairment (MCI).
- Trial name
- SleepSMART (NCT05016960)
- Testing
- Sleep-SMART
- Where
- United States
- Volunteers
- 30 people
- Sponsor
- VA Office of Research and Development
Gulf War Illness, Insomnia
Cognitive Behavioral Therapy for Insomnia for Gulf War Illness
Sleep disturbance is a common complaint of Veterans with Gulf War Illness (GWI). Because there is clinical evidence that sleep quality influences pain, fatigue, mood, cognition, and daily functioning, this study will investigate…
- Trial name
- CBTi GWI (NCT02782780)
- Testing
- Cognitive Behavioral Therapy for Insomnia (CBTi)
- Where
- United States
- Volunteers
- 165 people
- Sponsor
- VA Office of Research and Development
Mild Cognitive Impairment, Insomnia
Multicomponent Behavioral Sleep Intervention for Insomnia in Older Adults With Mild Cognitive Impairment
Insomnia symptoms in older adults with mild cognitive impairment represent a significant public health burden in terms of impaired quality of life, risks from untreated insomnia, and risks from pharmaceutical insomnia treatment.
- Trial name
- MBSI-I (NCT04364191)
- Testing
- Multicomponent Behavioral Sleep Intervention for Insomnia, Active Control
- Where
- United States
- Volunteers
- 27 people, healthy volunteers welcome
- Sponsor
- University of Pennsylvania
Migraine, Headache
RELAXaHEAD for Headache Patients (Phase II)
The goal of this research is to assess the utility of smartphone-based progressive muscle relaxation (PMR) for the treatment of migraine and sleep.
- Conditions
- Migraine, Headache, Multiple Sclerosis, Insomnia
- Trial name
- NCT05466682
- Testing
- Smartphone-Based Progressive Muscle Relaxation Therapy (PMR), Monitored Usual Care (MUC)
- Where
- United States
- Volunteers
- 48 people
- Sponsor
- NYU Langone Health
Insomnia, Depression
A Novel Use of a Sleep Intervention to Target the Emotion Regulation Brain Network to Treat Depression and Anxiety
Several lines of evidence suggest that unhealthy sleep patterns contribute to depressive symptoms through disruption of brain networks that regulate emotional functions.
- Trial name
- NCT04424407
- Testing
- Cognitive Behavioral Therapy for Insomnia
- Where
- United States
- Volunteers
- 51 people
- Sponsor
- Stanford University
Bipolar Disorder
Ramelteon for the Treatment of Insomnia and Mood Stability in Patients With Euthymic Bipolar Disorder
The purpose of this study is to determine whether treating sleep difficulties in patients with bipolar disorder also improves their mood stability.
- Trial name
- Ram-TIME (NCT00552760)
- Testing
- Ramelteon
- Where
- United States
- Volunteers
- 90 people
- Sponsor
- Lehigh Valley Hospital
Insomnia
Improving Sleep Using Mentored Behavioral and Environmental Restructuring
The goal of this study is to test potential functional/psychosocial benefits of improved sleep using a program designed to teach nursing facility staff to improve sleep promoting strategies and environment for nursing home…
- Trial name
- SLUMBER (NCT03327324)
- Testing
- Sleep Using Mentored Behavioral and Environmental Restructuring
- Where
- United States
- Volunteers
- 110 people, healthy volunteers welcome
- Sponsor
- NYU Langone Health
Alcohol Dependence, Insomnia
Pharmacotherapy and Mechanisms of Sleep Disturbance in Alcohol Dependence
Insomnia and other sleep abnormalities are common, persistent, and associated with relapse in alcohol-dependent patients. The overall, long-term objectives of the proposed research are to investigate the neurophysiologic…
- Trial name
- MA (NCT01014533)
- Testing
- Gabapentin dispensed to subject.
- Where
- United States
- Volunteers
- 59 people, healthy volunteers welcome
- Sponsor
- Dr. Kirk Brower
Insomnia
The Efficacy of CBT-I in Alcoholics & Its Effects on Remission & Relapse
Insomnia is a highly prevalent disorder in those recovering from alcoholism. It has been associated with anxiety and depressive symptoms, as well as an increased risk of relapse back to the drinking.
- Trial name
- NCT01987089
- Testing
- Cognitive Behavioral Therapy for Insomnia (CBT-I)
- Where
- United States
- Volunteers
- 63 people
- Sponsor
- VA Office of Research and Development
Sleep Disturbance, Craving
The Efficacy of Suvorexant in Treatment of Patients With Substance Use Disorder and Insomnia: A Pilot Open Trial
Insomnia is an extremely common and poorly treated problem in patients with substance use disorders (SUD)s undergoing rehabilitation treatment in a residential facility.
- Conditions
- Sleep Disturbance, Craving, Cortisol; Hypersecretion
- Trial name
- Suvsubuse (NCT03412591)
- Testing
- Suvorexant 20 mg
- Where
- United States
- Volunteers
- 28 people
- Sponsor
- Milton S. Hershey Medical Center
Sleep Initiation and Maintenance Disorders, Depression
Improving Sleep and Psychological Functioning in People With Depression and Insomnia
This study will evaluate the safety and effectiveness of treatment with both a sleeping pill and antidepressant medication in improving sleep and psychological functioning in people with depression and insomnia.
- Trial name
- NCT00247624
- Testing
- Eszopiclone, Fluoxetine
- Where
- United States
- Volunteers
- 60 people
- Sponsor
- Wake Forest University Health Sciences
Sleep, Insomnia
Treatment of Insomnia and Glucose Metabolism
Available data suggest that obtaining adequate sleep is associated with a better ability of the body to use carbohydrates as a source of energy and a lower risk of developing diabetes.
- Conditions
- Sleep, Insomnia, Insulin Resistance
- Trial name
- NCT00724282
- Testing
- Eszopiclone
- Where
- United States
- Volunteers
- 20 people, healthy volunteers welcome
- Sponsor
- University of Chicago
Major Depressive Disorder, Insomnia
Time to Remission of Depressive Symptoms With Combined SSRI and Ramelteon
Hypothesis I: Patients in the SSRI + ramelteon treatment group will achieve remission (defined as an IDS-C30 score of 11 or less) more quickly than those in the SSRI + placebo group.
- Trial name
- TAKEDA (NCT00642694)
- Testing
- Escitalopram, Ramelteon
- Where
- United States
- Volunteers
- 29 people
- Sponsor
- University of Texas Southwestern Medical Center
Insomnia Disorder
Efficacy and Safety of ACT-541468 in Adult Subjects With Insomnia Disorder
This study evaluates the dose response of ACT-541468 on the change of WASO from baseline to Days 1 and 2, assessed by PSG.
- Trial name
- NCT02839200
- Testing
- ACT-541468 5 mg, ACT-541468 10 mg, ACT-541468 25 mg
- Where
- 35 sites in United States, Germany and 4 more
- Volunteers
- 360 people
- Sponsor
- Idorsia Pharmaceuticals Ltd.
Prostatic Neoplasms
The Effects of Castration on the Pharmacokinetics of Zolpidem After Single Dose Administration In Men With Prostate Cancer Undergoing Androgen Deprivation Therapy Compared to Normal Healthy Females
Background: Insomnia is associated with difficulty sleeping. The drug zolpidem is widely prescribed for insomnia. Women have reported worse effects from the drug than men.
- Trial name
- NCT03436745
- Testing
- Zolpidem, ECG
- Where
- United States
- Volunteers
- 12 people, healthy volunteers welcome
- Sponsor
- National Cancer Institute (NCI)
Delirium, Sleep Fragmentation
Direct Noise Reduction in the Intensive Care Units (ICU) Using Earplugs and Noise Canceling Headphones
This study seeks to examine the effects of overnight noise reduction in critically ill patients who are receiving mechanical ventilation.
- Trial name
- NCT01343095
- Testing
- Foam Earplugs, Noise Canceling Headphones
- Where
- United States
- Volunteers
- 8 people
- Sponsor
- Wake Forest University
Insomnia
A Phase III Study of Eszopiclone in Patients With Insomnia (Study SEP 190-150)
The purpose of this study is to evaluate the long-term safety of eszopiclone (2, 3 mg) in non-elderly patients with insomnia and eszopiclone (1, 2 mg) in elderly patients with insomnia.
- Trial name
- NCT00770692
- Testing
- Eszopiclone 1 mg- Elderly, Eszopiclone 2 mg- Elderly, Eszopiclone 3 mg- Non-elderly
- Where
- 34 sites in Japan
- Volunteers
- 369 people
- Sponsor
- Eisai Co., Ltd.
Insomnia, Sleep Fragmentation
Suvorexant and Sleep/Delirium in ICU Patients
Investigators will evaluate the efficacy of postoperative oral suvorexant treatment on nighttime wakefulness after persistent sleep onset (WASO) among adult cardiac surgical patients recovering in the cardiac intensive care unit…
- Conditions
- Insomnia, Sleep Fragmentation, Sleep Initiation and Maintenance Disorders, Postoperative Delirium
- Trial name
- NCT04092894
- Testing
- Suvorexant 20 mg
- Where
- 2 sites in United States
- Volunteers
- 100 people
- Sponsor
- Beth Israel Deaconess Medical Center
Sleep, Physical Activity
Effects of a Wearable Device and Social Media-Based Intervention on Physical Activity and Sleep Quality in Adults
The goal of this randomized controlled trial is to examine whether the use of a wearable device and social media based intention increases physical activity and enhance sleep quality among adults.
- Trial name
- NCT06739876
- Testing
- Wearable device-based intervention (with motivational support via social media), Wearable device-based intervention (without support)
- Where
- Taiwan
- Volunteers
- 75 people, healthy volunteers welcome
- Sponsor
- National Chung Hsing University
Nicotine Dependence, Cigarette Smoking
Smoking Cessation for Smokers With Sleep Problems
This is a pilot research study examining two types of behavioral counseling along with the nicotine patch for smoking cessation.
- Conditions
- Nicotine Dependence, Cigarette Smoking, Insomnia
- Trial name
- NCT01277887
- Testing
- Cognitive-Behavioral Counseling, Smoking Cessation Counseling
- Where
- United States
- Volunteers
- 19 people
- Sponsor
- Yale University