Clinical trials: Primary Insomnia
Primary Total Hip Arthroplasty, Primary Total Knee Arthroplasty
Total Joint Arthroplasty and Sleep
To compare non-prescription sleep aids (low-dose diphenhydramine and melatonin) to sleep hygiene education for improving postoperative sleep quality after total joint arthroplasty.
- Trial name
- NCT03968939
- Testing
- Diphenhydramine (Benadryl), Melatonin, Sleep Hygiene Education
- Where
- United States
- Volunteers
- 55 people
- Sponsor
- James A. Keeney
Primary Insomnia
Efficacy and Safety of Circadin® 2 mg in the Treatment of Primary Insomnia Patients
This is a randomised, placebo controlled study to evaluate the efficacy of a 3 week treatment period with Circadin® 2 mg in shortening sleep latency in patients with primary insomnia aged 18-80 with melatonin deficiency.
- Trial name
- NCT00397189
- Testing
- Circadin
- Where
- United Kingdom
- Volunteers
- 930 people
- Sponsor
- Neurim Pharmaceuticals Ltd.
Insomnia
A Six Week, Double-Blind Randomized, Efficacy and Safety, Sleep Lab Trial With Esmirtazapine (Org 50081) (P05707)
The purpose of this trial is to investigate the efficacy, safety and tolerability of esmirtazapine (Org 50081) compared to placebo in patients with chronic primary insomnia.
- Trial name
- NCT00506389
- Testing
- Esmirtazapine
- Volunteers
- 419 people
- Sponsor
- Merck Sharp & Dohme LLC
Insomnia
Digital Cognitive-Behavioral Therapy for Insomnia in Spanish Speaking Latinas/os (Dormir Mejor Study)
The primary objective of the proposed study is to examine the effectiveness of a culturally adapted digital program of cognitive behavioral therapy for insomnia (CBT-I) compared to minimally enhanced usual care (mEUC) on primary…
- Trial name
- NCT05353296
- Testing
- Digital cognitive behavioral therapy for insomnia (CBT-I) program, Minimally Enhanced Usual Care (mEUC), Somryst (culturally adapted)
- Where
- United States
- Volunteers
- 7 people
- Sponsor
- Columbia University
Insomnia
A 2-Part Single Dose Study to Assess the Safety, Tolerability, Pharmacokinetics, and Pharmacodynamics of E2006
Part A: The purpose of this study is to evaluate the safety and tolerability of single oral doses of E2006 administered in the morning to healthy male and female subjects.
- Trial name
- NCT01463098
- Testing
- E2006 1.0 mg, E2006 2.5 mg, E2006 5.0 mg
- Where
- 2 sites in United States
- Volunteers
- 122 people, healthy volunteers welcome
- Sponsor
- Eisai Inc.
Primary Insomnia
Sleep Loss and Mechanisms of Impaired Glucose Metabolism
The purpose of this study is to test the effects of sleep and eszopiclone, a drug that helps people sleep, on how the body processes glucose (sugar). Eszopiclone is approved by the U.S.
- Trial name
- NCT00555750
- Testing
- eszopiclone
- Where
- United States
- Volunteers
- 20 people
- Sponsor
- Brigham and Women's Hospital
Primary Insomnia
VEC-162 Study in Adult Patients With Primary Insomnia
The purpose of this study is to evaluate the efficacy and safety of a 5 week double-blind treatment period of VEC-162 as compared to placebo in male and female patients with primary insomnia.
- Trial name
- NCT00548340
- Testing
- VEC-162 20 mg, VEC-162 50 mg
- Where
- 35 sites in United States
- Volunteers
- 322 people
- Sponsor
- Vanda Pharmaceuticals
Insomnia
A Bioequivalence and Food Effect Study of SEP-190 in Japanese Healthy Subjects (Study SEP 190-102)
The purpose of this study is to investigate and evaluate the bioequivalence and food effect of SEP 190-102 in Japanese healthy subjects by assessing the pharmacokinetics parameters.
- Trial name
- NCT01055834
- Testing
- Eszopiclone 3 mg, Eszopiclone 1 mg
- Where
- Japan
- Volunteers
- 42 people, healthy volunteers welcome
- Sponsor
- Eisai Co., Ltd.
Primary Insomnia
Safety and Efficacy Study of Suvorexant in Participants With Primary Insomnia - Study B (MK-4305-029)
This is a multicenter study to test the hypothesis that suvorexant (MK-4305) is superior to placebo in improving insomnia as measured by change from baseline in: subjective total sleep time and time to sleep onset, wake time…
- Trial name
- NCT01097629
- Testing
- Suvorexant High Dose (HD), Suvorexant Low Dose (LD)
- Volunteers
- 1,020 people
- Sponsor
- Merck Sharp & Dohme LLC
Sleep Disorder, Primary Insomnia
Study of Sleep-maintenance Activity of 3 Doses of SKP-1041
SKP-1041 is a new formulation of a marketed sleeping agent called zaleplon. Zaleplon is currently available as Sonata as well as several generic formulations. Sonata and its generics induce sleep soon after ingestion.
- Trial name
- NCT00878553
- Testing
- SKP-1041 (experimental formulation of zaleplon)
- Volunteers
- 67 people
- Sponsor
- Somnus Therapeutics, Inc.
Chronic Insomnia
Enhancing Access to Insomnia (EASI) Care in VA PCMHI Clinics
This multi-site project (four VA Medical Centers) will test two approaches to improving the delivery of a behavioral insomnia treatment in the Primary Care setting to Veterans.
- Trial name
- NCT04350866
- Testing
- Expert Recommendations for Implementing Change bundle of strategies, Brief Behavioral Treatment for Insomnia
- Where
- United States
- Volunteers
- 277,920 people
- Sponsor
- VA Office of Research and Development
Primary Insomnia
A High Density EEG Comparison of Sleep Patterns in Insomnia
Insomnia, defined as a subjective report of difficulty initiating sleep, maintaining sleep, and/or non-restorative sleep, leads to significant daytime dysfunction and increased health risks.
- Trial name
- NCT01960452
- Testing
- Serial awakenings
- Where
- United States
- Volunteers
- 45 people, healthy volunteers welcome
- Sponsor
- University of Wisconsin, Madison
Insomnia, Primary Insomnia
Impact of Hyperarousal on Simple and Complex Cognitive Task Performance Among Insomnia Sufferers
The purpose of this study is to learn more about people with insomnia disorder and cognitive impairment. Cognitive impairment is difficulty with mental abilities such as thinking, knowing and remembering.
- Conditions
- Insomnia, Primary Insomnia, Chronic Insomnia
- Trial name
- NCT02290405
- Testing
- Multiple Sleep Latency Test (MSLT)
- Where
- United States
- Volunteers
- 89 people, healthy volunteers welcome
- Sponsor
- Jack Edinger, PhD
Primary Insomnia, Secondary Insomnia
An Efficacy Study of Compound LY2624803 in the Treatment of Patients With Chronic Insomnia
The purpose of this study is to compare an investigational drug (LY2624803) with placebo and with zolpidem in the treatment of outpatients with chronic insomnia.
- Trial name
- SLUMBER (NCT00784875)
- Testing
- LY2624803, zolpidem
- Where
- 49 sites in United States
- Volunteers
- 643 people
- Sponsor
- Eli Lilly and Company
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.
Sleep Disorders
Characteristics of Sleep Patterns in Young Adults With and Without Insomnia
This study will compare the symptoms, experiences, and laboratory sleep characteristics of young adults with and without insomnia.
- Trial name
- NCT00177216
- Testing
- Zolpidem, Escitalopram
- Where
- United States
- Volunteers
- 69 people, healthy volunteers welcome
- Sponsor
- University of Pittsburgh
Insomnia
A Long Term Safety Study of Suvorexant in Participants With Primary Insomnia (MK-4305-009 AM3)
This study will establish the safety and tolerability of suvorexant (MK-4305) when administered for up to 14 months. Participants will be randomized to receive suvorexant or placebo for a 12-month double-blind (DB) Treatment…
- Trial name
- NCT01021813
- Testing
- Suvorexant
- Volunteers
- 781 people
- Sponsor
- Merck Sharp & Dohme LLC
Insomnia
A Long-Term Safety and Efficacy Study of Eszopiclone in Elderly With Primary Chronic Insomnia
To evaluate the long-term safety and efficacy of eszopiclone administered for 12 weeks in elderly subjects with primary chronic insomnia.Administration of eszopiclone 2 mg daily at bedtime for 12 weeks in elderly subjects with a…
- Trial name
- NCT00386334
- Testing
- Eszopiclone
- Where
- 82 sites in United States
- Volunteers
- 388 people
- Sponsor
- Sumitomo Pharma America, Inc.
Insomnia
Implementing and Evaluating Computer-Based Interventions for Mental Health: Testing an Implementation Strategy for VA Outpatient Care
Internet-based self-help programs are personalized, self-guided interventions delivered over a computer, mobile device, or other Internet platform and focused on improving knowledge, awareness, or behavior change for a mental or…
- Trial name
- NCT03151083
- Testing
- Internet-based Self-help Insomnia Intervention
- Where
- United States
- Volunteers
- 77 people, healthy volunteers welcome
- Sponsor
- VA Office of Research and Development
Insomnia Comorbid to Psychiatric Disorder, Primary Insomnia
Sequenced Therapies for Comorbid and Primary Insomnias
Chronic insomnia is a prevalent disorder associated with increased health care costs, impaired functioning, and an increased risk for developing serious psychiatric disorders.
- Trial name
- NCT01651442
- Testing
- Behavioral Insomnia Therapy, Zolpidem, Trazodone
- Where
- 2 sites in United States, Canada
- Volunteers
- 211 people
- Sponsor
- Jack Edinger, PhD