Clinical trials: Sleep Initiation and Maintenance Disorders
Transient Insomnia
A Study of Single-Dose Gabapentin in Transient Insomnia Induced by a Sleep Phase Advance
The purpose of this study is to assess the effect of gabapentin as compared to placebo on sleep, using subjective sleep measurements, in subjects with transient insomnia induced by a sleep phase advance.
- Trial name
- NCT00667108
- Testing
- Gabapentin
- Where
- 8 sites in United States
- Volunteers
- 784 people
- Sponsor
- Pfizer's Upjohn has merged with Mylan to form Viatris Inc.
Sleep, Sleep Quality
Impact of Nutritional Supplementation on Sleep Quality
This is a randomized, double-blind, placebo-controlled, 5-arm parallel-group study to evaluate the effects of 4 nutritional supplements on sleep over a 12 week period in healthy U.S. adults.
- Trial name
- NCT06935123
- Testing
- Sleep Supplements
- Where
- United States
- Volunteers
- 376 people, healthy volunteers welcome
- Sponsor
- Pharmavite LLC
Obesity, Rhinitis
Interventional Testing of Gene-environment Interactions Via the Verifomics Mobile Application
The purpose of this study is to study interactions between genes, lifestyle environmental factors like foods, nutritional supplements and non-invasive medical devices and health factors that can be measured without specialized…
- Conditions
- Obesity, Rhinitis, Rhinitis, Allergic, Respiratory Sounds
- Trial name
- NCT02758990
- Testing
- Vitamin A, Vitamin B6, Vitamin C
- Where
- United States
- Volunteers
- 16 people, healthy volunteers welcome
- Sponsor
- Verifomics LLC
Post-Concussion Symptoms, Insomnia
Neurotechnology Following Traumatic Brain Injury
This two-part study seeks to improve symptoms such as pain and sleep problems after concussion, or mild traumatic brain injury (mTBI).
- Conditions
- Post-Concussion Symptoms, Insomnia, Pain, Chronic, Depressive Symptoms
- Trial name
- Cereset (NCT03649958)
- Testing
- HIRREM-SOP or Cereset, Cereset 2x
- Where
- 2 sites in United States
- Volunteers
- 80 people
- Sponsor
- Brain State Technologies, LLC
CNS
2-Part Multiple Ascending Dose Study for Safety and Pharmacokinetics in Healthy and Elderly Subjects
This is a single-center, randomized, double-blind, placebo-controlled, sequential, multiple-dose study. The study will be conducted in two parts: Part A (6 cohorts of healthy adults receiving evening dosing) and Part B (one…
- Trial name
- NCT01673451
- Testing
- E2006
- Where
- 2 sites in United States
- Volunteers
- 24 people, healthy volunteers welcome
- Sponsor
- Eisai Inc.
Insomnia Disorder
Study to Assess the Long Term Safety and Tolerability of ACT-541468 (Daridorexant) in Adult and Elderly Subjects Suffering From Difficulties to Sleep
Study to assess the long term safety and tolerability of daridorexant in adult and elderly subjects suffering from difficulties to sleep
- Trial name
- NCT03679884
- Testing
- Daridorexant 10 mg, Daridorexant 25 mg, Daridorexant 50 mg
- Where
- 106 sites in United States, Belgium and 12 more
- Volunteers
- 804 people
- Sponsor
- Idorsia Pharmaceuticals Ltd.
Insomnia, Hepatic Impairment
Pharmacokinetics and Safety Study of YZJ-1139 in Subjects With Mild, Moderate and Normal Hepatic Impairment
Primary Objectives: To evaluate the effect of the subjects with mild (Child Pugh A), moderate (Child Pugh B) and normal hepatic impairment on the pharmacokinetics of YZJ-1139 Secondary Objectives: To evaluate the safety of a…
- Trial name
- NCT06671509
- Testing
- YZJ-1139
- Where
- China
- Volunteers
- 24 people, healthy volunteers welcome
- Sponsor
- Shanghai Haiyan Pharmaceutical Technology Co., Ltd.
Sleep Initiation and Maintenance Disorders
A Study of Lemborexant in Chinese Participants With Insomnia Disorder
The primary purpose of this study is to confirm using polysomnography (PSG) that lemborexant 10 milligram (mg) is superior to placebo on objective sleep onset as assessed by latency to persistent sleep (LPS) during the last 2…
- Trial name
- NCT04549168
- Testing
- Lemborexant
- Where
- 23 sites in China, Taiwan
- Volunteers
- 194 people
- Sponsor
- Eisai Co., Ltd.
Primary Insomnia
Adult Polysomnography Primary Insomnia Cross Over Study (0928-049)(TERMINATED)
The purpose of this study is determine whether this drug will improve your insomnia in terms of decreasing your time to fall asleep and allowing you to stay asleep longer.
- Trial name
- NCT00420810
- Testing
- MK0928 / Duration of Treatment : 8 Weeks
- Volunteers
- 138 people
- Sponsor
- H. Lundbeck A/S
Sleep Quality, Sleep Health
Clinical Study to Assess a Dietary Supplement on Sleep Health and Quality
The primary objective of this study is to evaluate the effects of a proprietary oral supplement on the sleep health and quality of people with sleep problems. It is a double-blinded placebo-controlled crossover clinical study.
- Trial name
- NCT05368909
- Testing
- Sleep Supplement
- Where
- United States
- Volunteers
- 30 people, healthy volunteers welcome
- Sponsor
- 4Life Research, LLC
Sleep Initiation and Maintenance Disorders
Radiolabel Study In Healthy Volunteers For Insomnia-Targeting Drug
The purpose of this study is to define the absorption, breakdown and excretion of a single dose of radiolabelled SB-649868 and its breakdown products by measuring their concentration in blood, urine and faeces over a 7-10 day…
- Trial name
- NCT00520663
- Testing
- 14C-SB649868
- Where
- United Kingdom
- Volunteers
- 8 people, healthy volunteers welcome
- Sponsor
- GlaxoSmithKline
Insomnia Disorder
A Study of HS-10506 in Chinese Patients With Insomnia Disorder
The primary purpose of this phase 3 study is to evaluate the safety and the efficacy of HS-10506 (change versus placebo) on latency to persistent sleep (LPS) and wakefulness after sleep onset (WASO) measured by polysomnography…
- Trial name
- NCT07587385
- Testing
- HS-10506
- Volunteers
- 732 people
- Sponsor
- Jiangsu Hansoh Pharmaceutical Co., Ltd.
Sleep Initiation and Maintenance Disorders
Efficacy and Safety of KI1001 in ≥ 55 Years Old Insomnia Patients
KI1001(Circadin®, Prolonged release tablet which contains melatonin) has showed its efficacy to improve sleep quality in over 55 years old primary insomnia patients.
- Trial name
- NCT01450228
- Testing
- KI1001
- Where
- 10 sites in South Korea
- Volunteers
- 170 people
- Sponsor
- Kuhnil Pharmaceutical Co., Ltd.
Mood, Cognitive Performance
The Effects of A Proprietary Spearmint Extract on Cognitive Performance
This study was designed to evaluate the chronic effects of a proprietary spearmint extract over 90 days of supplementation on aspects of cognitive performance (cognitive function and active reaction time), subjective mood, and…
- Conditions
- Mood, Cognitive Performance, Sleep
- Trial name
- NCT02518165
- Testing
- Proprietary spearmint extract
- Where
- United States
- Volunteers
- 142 people, healthy volunteers welcome
- Sponsor
- Kemin Foods LC
Insomnia
A Dose-Ranging, Multicenter Polysomnography Trial of PD 0200390 in Elderly Subjects With Primary Insomnia
This is a randomized, double-blind, placebo-controlled, multicenter trial with a 4-way crossover design. Elderly subjects with primary insomnia who meet screening requirements will initially be randomized into the study and…
- Trial name
- NCT00748592
- Testing
- PD 0200390
- Sponsor
- Pfizer
Insomnia
Pharmacokinetics of Suvorexant in Participants With Impaired Renal Function (MK-4305-023)(COMPLETED)
This study will investigate whether the plasma concentration-time profile and pharmacokinetics (PK) of suvorexant (MK-4305) in participants with impaired renal function are similar to those observed in healthy participants; and…
- Trial name
- NCT01059851
- Testing
- Suvorexant
- Volunteers
- 16 people, healthy volunteers welcome
- Sponsor
- Merck Sharp & Dohme LLC
Insomnia, Stress
Evaluation of the Effects of Saffron Extract on Sleep Quality and Stress
Therefore, the aim of this study was to confirm by a randomized double-blind controlled study the beneficial effects of saffron extract (Saffr'activ®) on sleep quality in subjects presenting mild to moderate sleep disorder…
- Trial name
- NCT04750681
- Testing
- Saffron
- Where
- Belgium
- Volunteers
- 66 people, healthy volunteers welcome
- Sponsor
- Comercial Quimica Masso, S.A
Sleep Initiation and Maintenance Disorders
Efficacy Study of EVT 201 in the Treatment of Elderly Patients With Daytime Sleepiness
The purpose of this study is to determine whether a compound known as EVT 201 is effective in treating elderly patients diagnosed with primary insomnia who also have moderate daytime sleepiness.
- Trial name
- NCT00401284
- Testing
- EVT 201
- Where
- 22 sites in United States
- Volunteers
- 135 people
- Sponsor
- Evotec Neurosciences GmbH
Chronic Primary Insomnia
Almorexant (ACT-078573) in Elderly Subjects With Chronic Primary Insomnia
A 2-night polysomnography / 5-way cross-over study to evaluate the effect, safety and tolerability of oral administration of almorexant (ACT 078573) in elderly subjects with primary insomnia.
- Trial name
- NCT00606593
- Where
- 21 sites in United States
- Volunteers
- 112 people
- Sponsor
- Midnight Pharma, LLC
Sleep Initiation and Maintenance Disorders
Lendormin D® Tablet (Drug Use Result Survey)
Study to investigate the safety and the efficacy in patients with insomnia, receiving Lendormin D tablet under condition of normal clinical practice.
- Trial name
- NCT02224014
- Testing
- Lendormin D tablets
- Volunteers
- 485 people
- Sponsor
- Boehringer Ingelheim