Clinical trials: Insomnia Disorder
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
Bioequivalency Study of Zolpidem Tartrate Under Fed Conditions
The objective of this study was the bioequivalence of a Roxane Laboratories' Zolpidem Tablets, 10 mg, to Ambien® Tablets, 10 mg (Sanofi-Synthelabo Inc.) under fed conditions using a single-dose, randomized, 2-treatment, 2-period…
- Trial name
- NCT00602719
- Testing
- Zolpidem
- Where
- United States
- Volunteers
- 30 people, healthy volunteers welcome
- Sponsor
- Roxane Laboratories
Jet Lag Type Insomnia
Evaluating the Effects of Tasimelteon vs. Placebo on Jet Lag Type Insomnia
The aim of this study is to investigate tasimelteon vs. placebo on sleep in healthy individuals after a phase advance in jet lag type insomnia.
- Trial name
- NCT03373201
- Testing
- Tasimelteon
- Where
- 12 sites in United States
- Volunteers
- 320 people, healthy volunteers welcome
- Sponsor
- Vanda Pharmaceuticals
Insomnia
A Study of Suvorexant (MK-4305) for the Treatment of Insomnia Disorder in Participants With Opioid Use Disorder (MK-4305-098)
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.
- Trial name
- NCT06655883
- Testing
- Suvorexant
- Where
- 13 sites in United States
- Volunteers
- 300 people
- Sponsor
- Merck Sharp & Dohme LLC
Primary Insomnia
Adult Primary Insomnia Polysomnographic Study (0928-004)(COMPLETED)
The purpose of the study is to test the safety and effectiveness of the Investigational Drug on insomnia.
- Trial name
- NCT00094627
- Testing
- gaboxadol
- Volunteers
- 465 people
- Sponsor
- H. Lundbeck A/S
Insomnia, Major Depressive Disorder
The Exploratory Study to Investigate the Effect of Ramelteon for Insomnia Patients With Major Depressive Disorder by Using Actigraphy
The purpose of this study is to investigate exploratorily the effect of ramelteon 8 mg once daily for 8 weeks in the treatment of insomnia patients with depression by using actigraphy.
- Trial name
- NCT02669082
- Testing
- Ramelteon
- Where
- 7 sites in Japan
- Volunteers
- 26 people
- Sponsor
- Takeda
Chronic Insomnia
Safety and Efficacy of Zolpidem in the Long-Term Treatment of Insomnia
The purpose of this study is to evaluate the safety and efficacy of sublingual zolpidem during the long-term treatment of insomnia.
- Trial name
- NCT05456152
- Testing
- Sublingual Tablet
- Where
- Brazil
- Volunteers
- 358 people
- Sponsor
- EMS
Transient Insomnia
A Polysomnographic Study Of Single-Dose Gabapentin In Transient Insomnia
The purpose of this study is to assess the effect of gabapentin on polysomnographic assessments in transient insomnia induced by a sleep phase advance.
- Trial name
- NCT00674752
- Testing
- Gabapentin
- Where
- 4 sites in United States
- Volunteers
- 377 people
- Sponsor
- Pfizer's Upjohn has merged with Mylan to form Viatris Inc.
Insomnia Disorder
Digital CBT-I for Insomnia Disorder
This study will examine the effectiveness of digital CBT-I versus sleep hygiene education in reducing insomnia severity, sleep onset latency, and wake after sleep onset in those with insomnia disorder.
- Trial name
- CrEDIT (NCT05541055)
- Testing
- digital CBT-I, Sleep hygiene education
- Where
- United States
- Volunteers
- 336 people
- Sponsor
- Big Health Inc.
Insomnia, Sleep Initiation and Maintenance Disorders
Efficacy and Safety Study of Org 50081 (Esmirtazapine) in Elderly Participants (P05709)
This study was conducted to investigate the efficacy of treatment with Org 50081 (Esmirtazapine) compared to placebo in elderly participants with chronic primary insomnia.
- Conditions
- Insomnia, Sleep Initiation and Maintenance Disorders, Mental Disorders, Dyssomnias
- Trial name
- NCT00561821
- Testing
- Esmirtazapine
- Volunteers
- 538 people
- Sponsor
- Merck Sharp & Dohme LLC
Transient Insomnia
Efficacy of Ramelteon on Transient Insomnia in Healthy Adults
The purpose of this study is to evaluate the safety and efficacy of Ramelteon, once daily (QD), in healthy subjects within a sleep lab.
- Trial name
- NCT00671398
- Testing
- Ramelteon
- Where
- 12 sites in United States
- Volunteers
- 289 people, healthy volunteers welcome
- Sponsor
- Takeda
Primary Insomnia
Efficacy and Safety Study of Adipiplon, Placebo and an Active Control in Primary Insomniacs
This will be a multi-center, randomized, blinded, comparative, placebo-controlled, 4 arm crossover study in patients with primary insomnia.
- Trial name
- NCT00683436
- Testing
- Adipiplon, Ambien CR
- Where
- 9 sites in United States
- Volunteers
- 84 people
- Sponsor
- Neurogen Corporation
Insomnia, Sleep
Vestibular Nerve Stimulation to Improve Sleep
A randomized, double blind sham controlled clinical trial to evaluate the efficacy of vestibular nerve stimulation (VeNS) compared to a sham control a as a means of improving sleep as measured by ISI scores and EEG recordings The…
- Conditions
- Insomnia, Sleep, Sleep Disorders, Circadian Rhythm
- Trial name
- NCT04219566
- Testing
- VeNS
- Where
- India
- Volunteers
- 80 people, healthy volunteers welcome
- Sponsor
- Neurovalens Ltd.
Transient Insomnia
A Study of LY2624803 in Participants With Transient Insomnia
The aim of this study is to learn how different doses of LY2624803 affect sleep in healthy people. The study has four treatment periods.
- Trial name
- NCT01779830
- Testing
- LY2624803 - Capsules, Zolpidem - Tablets
- Where
- France
- Volunteers
- 32 people, healthy volunteers welcome
- Sponsor
- Eli Lilly and Company
Sleep Initiation and Maintenance Disorders
Randomised, Double-blind Study to Investigate the Safety and Efficacy of Brotizolam in Insomnia Outpatients.
To investigate the efficacy and safety of Brotizolam in the treatment of patients with insomnia in comparison with that of Estazolam
- Trial name
- NCT00347295
- Testing
- Brotizolam, Estazolam
- Where
- 8 sites in China
- Volunteers
- 253 people
- Sponsor
- Boehringer Ingelheim
Insomnia
Combined Effects of Prunus Cerasus and Apocynum Venetum On Sleep and Anxiety in Adults With Insomnia
Lay Summary: This study is about the effect of using a unique formula called Sip2Sleep®, a product currently available on the market which is a combination of montmorency tart cherry extract and Venetron® (Apocynum venetum leaf…
- Trial name
- Sip2Sleep (NCT06299488)
- Testing
- Sip2Sleep: Montmorency Cherry and Apocynum Venetum
- Where
- United States
- Volunteers
- 77 people
- Sponsor
- Lakshmi Nutraceuticals LLC
Sleep, Insomnia
Actigraphy, Wearable EEG Band and Smartphone for Sleep Staging
This study aims to evaluate the viability of the combined use of wearable and portable technologies for sleep staging. The results will be compared with polysomnography, in order to achieve clinical and diagnostic validation.
- Conditions
- Sleep, Insomnia, Sleep Apnea Syndrome, Obstructive
- Trial name
- NCT04943562
- Testing
- ACT+EEG
- Where
- 2 sites in Brazil
- Volunteers
- 96 people
- Sponsor
- SleepUp Tecnologia em Saúde Ltda
Insomnia Chronic
STATE Trial: SusTained Attention Training to Enhance Sleep - Remote
This study is a validation study to document the acceptability of the Tonic and Phasic Alertness Training (TAPAT) program in older adults with chronic late-life insomnia.
- Trial name
- STATE (NCT03604380)
- Testing
- Computerized Plasticity-Based Adaptive Cognitive Training, Active Comparator
- Where
- United States
- Volunteers
- 134 people
- Sponsor
- Posit Science Corporation
Sleep Initiation and Maintenance Disorders
Efficacy and Safety of Zolpidem-MR Administered Over a Long Term Period as Needed for Insomnia (ZOLONG)
The primary objective of the study is to evaluate the hypnotic efficacy of zolpidem-MR 12.5 mg in comparison with placebo, when administered over a long-term period, on an "as needed" basis, in patients with chronic primary…
- Trial name
- NCT00425243
- Testing
- zolpidem-MR (SL800750)
- Where
- United States
- Volunteers
- 1,025 people
- Sponsor
- Sanofi
Depressive Disorder, Major
A Study of Seltorexant Compared to Quetiapine XR as Adjunctive Therapy to Antidepressants in Adult and Elderly Participants With Major Depressive Disorder With Insomnia Symptoms Who Have Responded Inadequately to Antidepressant Therapy
The purpose of this study is to assess the efficacy of seltorexant compared with quetiapine extended-release (XR) as adjunctive therapy to an antidepressant drug in treatment response in participants with major depressive…
- Trial name
- NCT04513912
- Testing
- Seltorexant, Quetiapine XR
- Where
- 175 sites in United States, Argentina and 13 more
- Volunteers
- 757 people
- Sponsor
- Janssen Research & Development, LLC