Clinical trials: Sleep Disturbances and Insomnia
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
Diabetes Mellitus, Type 2, Insomnia
A Study of the Efficacy of Prolonged-Release Melatonin Versus Placebo in Diabetic Patients Suffering From Insomnia
Objective - Type 2 uncontrolled diabetic patients often have low endogenous melatonin and suffer from sleep disorders. The effect of a prolonged-release melatonin (PRM) formulation on glucose lipid metabolism and sleep is studied…
- Trial name
- NCT00869128
- Testing
- Circadin
- Volunteers
- 36 people
- Sponsor
- Neurim Pharmaceuticals Ltd.
Insomnia
Study of the Safety and Effectiveness of Esmirtazapine in Participants With Chronic Primary Insomnia (P05706)
The purpose of this study is to determine if esmirtazapine (Org 50081) is a safe and effective treatment for insomnia. It was anticipated that esmirtazapine would increase mean Total Sleep Time (TST) as recorded in sleep diaries…
- Trial name
- RUBY (NCT00482612)
- Testing
- Esmirtazapine
- Volunteers
- 526 people
- Sponsor
- Merck Sharp & Dohme LLC
Sleep Initiation and Maintenance Disorders
Comparison of Eplivanserin and Lormetazepam in the Treatment of Insomnia Characterized by Sleep Maintenance Difficulties
The primary objective is to compare the potential for next-day residual effects of eplivanserin 5 mg/day and lormetazepam 1 mg/day by measuring the sleepiness in the morning using the patient's sleep questionnaire during 4 weeks…
- Trial name
- DREAMS (NCT00679900)
- Testing
- eplivanserin (SR46349), lormetazepam
- Where
- 8 sites in Chile, Estonia and 6 more
- Volunteers
- 283 people
- Sponsor
- Sanofi
Insomnia
Investigation of the Efficacy and Safety of CHI-921 in Insomnia.
Insomnia is a disorder where people are having trouble sleeping and can include difficulty falling asleep, staying asleep and waking up too early, as well as having unrefreshing sleep.
- Trial name
- NCT03984604
- Testing
- CHI-921
- Where
- Canada
- Volunteers
- 21 people
- Sponsor
- Canopy Growth Corporation
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.
Sleep Initiation and Maintenance Disorders
Efficacy and Safety of M100907 on Sleep Maintenance Insomnia With a Sub-study in Stable Type II Diabetes Mellitus
The purpose of this study is to assess efficacy and safety of volinanserin in the population of patients complaining of sleep maintenance insomnia.
- Trial name
- SAMS12 (NCT00495885)
- Testing
- volinanserin (M100907)
- Where
- 16 sites in United States, Brazil and 14 more
- Volunteers
- 848 people
- Sponsor
- Sanofi
Sleep Initiation and Maintenance Disorders, Sleep Disorders
A Double-blind, Group-comparison Study Using Zolpidem (Myslee) as a Comparative Drug in Patients With Insomnia
The purpose of this study is to investigate the efficacy and safety of FK199B (Zolpidem MR Tablet) in patients with insomnia by a randomized, double-blind, group-comparison study using zolpidem (Myslee) as a comparative drug
- Trial name
- NCT00283946
- Testing
- Zolpidem MR, Zolpidem
- Where
- 8 sites in Japan
- Volunteers
- 876 people
- Sponsor
- Astellas Pharma Inc
Sleep Disorders
Insomnia and Daytime Function in Osteoarthritis
To assess the efficacy and safety of zolpidem at doses up to 10 mg compared to placebo in patients with insomnia associated with osteoarthritis
- Trial name
- NCT00530556
- Testing
- zolpidem
- Volunteers
- 170 people
- Sponsor
- Sanofi
Stress, Insomnia
A Clinical Trial of De-Stress & Snooze Gummies in Reducing Stress and Insomnia Disorder
The current study focuses on clinical validation of efficacy of nutraceutical product in management of sleep disorder. Improved sleep quality contributes significantly to cognitive function.
- Conditions
- Stress, Insomnia, Quality of Life
- Trial name
- NCT06571331
- Testing
- De-Stress & Snooze Gummies-U001, De-Stress & Snooze Gummies-I001
- Volunteers
- 60 people, healthy volunteers welcome
- Sponsor
- Herbolab India Pvt. Ltd.
Insomnia
Study of the Efficacy and Safety of Lemborexant in Subjects 55 Years and Older With Insomnia Disorder (SUNRISE 1)
This study will be conducted to demonstrate, using polysomnography, that lemborexant 10 milligrams (mg) and 5 mg is superior to placebo on objective sleep onset as assessed by latency to persistent to sleep (LPS) after the last 2…
- Trial name
- SUNRISE 1 (NCT02783729)
- Testing
- Lemborexant, Zolpidem tartrate
- Where
- 102 sites in United States, Canada and 5 more
- Volunteers
- 1,006 people
- Sponsor
- Eisai Inc.
Non Restorative Sleep, Sleep Disorder (Disorder)
Sleep Promoting Properties of a Botanical Extract in a Population Complaining From Non-Restorative Sleep (NRS)
The goal of this clinical trial is to evaluate the effect of the Botanical Extract in improving sleep symptoms of nonrestorative sleep (NRS) in healthy adults.
- Trial name
- NCT07085819
- Testing
- Botanical Extract, 125mg, Botanical Extract, 250mg, Botanical Extract, 500mg
- Where
- Ireland
- Volunteers
- 160 people, healthy volunteers welcome
- Sponsor
- Kerry Group P.L.C
Sleep Quality, Heart Rate
Apollo Remote Observational Sleep Study
The purpose of this study is to examine how Transcutaneous Vibratory Stimulation (TVS) produced by the Apollo wearable affects sleep and cardiovascular function in a diverse real-world population of Apollo users.
- Trial name
- NCT05260489
- Where
- United States
- Volunteers
- healthy volunteers welcome
- Sponsor
- Apollo Neuroscience, Inc.
Insomnia
Dose-finding Study Assessing the Efficacy, Safety, and Pharmacokinetics of Daridorexant in Subjects Aged 10 to < 18 Years With Insomnia Disorder
This study assesses the efficacy, safety, and pharmacokinetics of multiple-dose oral administration of daridorexant in pediatric subjects aged 10 to < 18 years with insomnia disorder.
- Trial name
- NCT05423717
- Testing
- Daridorexant 10 mg, Daridorexant 25 mg, Daridorexant 50 mg
- Where
- 35 sites in United States, Bulgaria and 4 more
- Volunteers
- 166 people
- Sponsor
- Idorsia Pharmaceuticals Ltd.
Insomnia Chronic
Effect of Medical Hypnosis in Virtual Reality on Insomnia Disorders
The prevalence of chronic insomnia is 13.3% in France in 2019 (8.9 million). The consequences for these people are multiple: drowsiness, memory problems, difficulty concentrating, anxiety.
- Trial name
- EMERITE (NCT04712825)
- Testing
- Cognitive-behavioural therapy, HypnoVR® device
- Where
- France
- Volunteers
- 20 people
- Sponsor
- HypnoVR
Sleep, Sleep Duration
Non-Invasive At-Home Sleep Therapy System
The goal of this clinical trial is to learn about the ability of non-invasive brain stimulation during sleep to enhance people's deep sleep and its potential benefit on memory in healthy adults via home use sleep therapy device…
- Conditions
- Sleep, Sleep Duration, Sleep Quality
- Trial name
- NCT05970276
- Testing
- Deep Sleep (N3) Enhancement with TES
- Where
- United States
- Volunteers
- 30 people, healthy volunteers welcome
- Sponsor
- Brain Electrophysiology Laboratory Company
Insomnia (moderate)
Impact of GABA Probiotic Lactiplantibacillus Plantarum Lp815 on Sleep Outcomes in Participants with Self-Reported Sleep Disturbance
The rationale for this study is to observe differences in sleep outcomes between a consumer-grade probiotic capsule called GABA Probiotic and a placebo control group.
- Trial name
- NCT06789718
- Testing
- GABA Probiotic Lactiplantibacillus plantarum Lp815 (5 Billion cfu/dose), Optional Sub-Study: Neurotransmitter Urine Test
- Where
- United States
- Volunteers
- 150 people
- Sponsor
- Verb Biotics LLC
Sleep Initiation and Maintenance Disorders
A Study to Assess the Pharmacodynamics of Lemborexant in Korean Participants With Insomnia Disorder
The primary purpose of the study is to evaluate the treatment difference between lemborexant 5 milligram (mg) (LEM5) and placebo (PBO) on latency to persistent sleep (LPS) using polysomnography (PSG) on Day 30.
- Trial name
- NCT05594589
- Testing
- Lemborexant, PBO
- Where
- 9 sites in South Korea
- Volunteers
- 65 people
- Sponsor
- Eisai Co., Ltd.
Sleep
Ultra Long-Term Sleep Monitoring Using UNEEG™ Medical 24/7 EEG™ SubQ
This study aims to evaluate the agreement between automated sleep analysis by UNEEG medical's 24/7 EEG™ SubQ device using a deep learning algorithm and the consensus score of multiple sleep technologists' manual scoring of 120…
- Trial name
- ULTS (NCT04513743)
- Testing
- 24/7 EEG™ SubQ
- Where
- Denmark
- Volunteers
- 25 people, healthy volunteers welcome
- Sponsor
- UNEEG Medical A/S
Insomnia
Open-Label Study of Bioavailability of E2006 Tablet Versus Capsule Formulations
This is a single-center, open-label, randomized crossover study being conducted in three cohorts of healthy adult subjects. Approximately 36 subjects will be randomized to one of three cohorts (approximately 12 subjects per…
- Trial name
- NCT01673880
- Testing
- E2006
- Where
- United States
- Volunteers
- 40 people, healthy volunteers welcome
- Sponsor
- Eisai Inc.