Clinical trials: Sleep Disturbances and Insomnia
INSOMNIA
A Non-inferiority Study With Two Treatment Arms Eszopiclone 3 mg Versus Zopiclone 7.5 mg - for the Treatment of Insomnia
The primary objective of the study is to determine whether eszopiclone (Eurofarma) is non-inferior to the reference drug zopiclone (Imovane®, Sanofi-Aventis) in the treatment of insomnia.
- Trial name
- Eszo (NCT01100164)
- Testing
- Eszopiclone, Zopiclone
- Where
- Brazil
- Volunteers
- 263 people
- Sponsor
- Eurofarma Laboratorios S.A.
Sleep Initiation and Maintenance Disorders, Insomnia
Effects Of GW679769 On Sleep Onset And Maintenance,And Next Day Functioning In The Elderly And Non-elderly With Primary Insomnia
This study is designed to find the optimal (best) doses of GW679769 that promote sleep onset and maintain sleep during two consecutive nights of dosing without significant next-day thinking impairment and drowsiness in subjects…
- Trial name
- NCT00280436
- Testing
- GW679769
- Where
- 26 sites in United States
- Volunteers
- 122 people
- Sponsor
- GlaxoSmithKline
Primary Insomnia
6-Month Chronic Efficacy & Safety Study of Eszopiclone in Adult Subjects With Primary Insomnia
To evaluate the long-term efficacy of eszopiclone administered for up to 6 months in subjects with primary insomnia on subjective sleep measures, compared to placebo.
- Trial name
- NCT00352144
- Testing
- Eszopiclone
- Where
- 58 sites in United States
- Volunteers
- 830 people
- Sponsor
- Sumitomo Pharma America, Inc.
Insomnia, Insomnia (Moderate)
ASV Therapy for Insomnia
This will be a single center, prospective study designed to evaluate the effect of adaptive servo ventilation therapy on insomnia severity among patients with moderate to severe chronic insomnia.
- Trial name
- NCT07011966
- Testing
- ASV therapy
- Where
- United States
- Volunteers
- 25 people
- Sponsor
- ResMed
Insomnia Disorder
A Study of Daridorexant in Chinese Patients With Insomnia Disorder
The primary purpose of this study is to assess the efficacy and safety of 50 mg daridorexant in adult and elderly chinese patients with insomnia disorder. Efficacy will be evaluated on objective and subjective sleep parameters .
- Trial name
- NCT06010693
- Testing
- Daridorexant
- Where
- 33 sites in China
- Volunteers
- 206 people
- Sponsor
- Jiangsu Simcere Pharmaceutical Co., Ltd.
Pain, Insomnia
Comparative Pharmacokinetic (PK) Study of Ibuprofen and Diphenhydramine Hydrochloride MR Tablets in Healthy Adults Under Fasting Condition
Ibuprofen and Diphenhydramine Hydrochloride Modified-Release Tablets were randomized, open, two-cycle Comparative pharmacokinetic test under double crossover and fasting condition.
- Trial name
- NCT05729555
- Testing
- Compound ibuprofen polyrelease tablets, reference 1 (R1): Ibuprofen Tablets (Motrin IB®)reference 2 (R2): Diphenhydramine Hydrochloride Tablets (Benadryl®)
- Where
- China
- Volunteers
- 16 people, healthy volunteers welcome
- Sponsor
- Overseas Pharmaceuticals, Ltd.
Sleep Initiation and Maintenance Disorders
A Study of LY2624803 in Japanese Participants With Transient Insomnia
The aim of this study is to learn how different doses of LY2624803 affect sleep in healthy Japanese participants. The study has four treatment periods.
- Trial name
- NCT01784614
- Testing
- LY2624803 - Solution, LY2624803 - Capsule
- Where
- Japan
- Volunteers
- 24 people, healthy volunteers welcome
- Sponsor
- Eli Lilly and Company
Sleep Initiation and Maintenance Disorders
Comparison of Volinanserin 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 volinanserin 2 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
- REST (NCT00788515)
- Testing
- Volinanserin (M100907), Lormetazepam
- Where
- 3 sites in France, Spain and 1 more
- Volunteers
- 33 people
- Sponsor
- Sanofi
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
Sleep Initiation and Maintenance Disorders
A Double-blind, Group-comparison P-III Study With Zolpidem MR Using Placebo and Nitrazepam in Insomnia Patients
A multicenter, randomized, double-blind, triple-dummy, group-comparison study using placebo and nitrazepam as a comparative drug.
- Trial name
- NCT00374777
- Testing
- zolpidem MR, nitrazepam
- Where
- 6 sites in Japan
- Volunteers
- 450 people
- Sponsor
- Astellas Pharma Inc
Insomnia, TBI (Traumatic Brain Injury)
Behavioral Treatment of Insomnia in Active-Duty Service Members With Traumatic Brain Injury
The objective of the study is to conduct a randomized controlled trial of Cognitive Behavioral Therapy for Insomnia (CBT-I) in a sample of active-duty sailors with a history of traumatic brain injury (TBI).
- Trial name
- CBTBI (NCT06867666)
- Testing
- In Person CBT-I, CBT-I via COAST
- Where
- United States
- Volunteers
- 168 people
- Sponsor
- Noctem, LLC
Depressive Disorder, Major
A Study to Investigate the Effect of JNJ-42847922 on Polysomnography Measures in Patients With Major Depressive Disorder With Insomnia Who Are Stably Treated With Antidepressants
The purpose of the study is to evaluate effect of JNJ-42847922 on sleep latency (latency to persistent sleep) in participants with major depressive disorder who are stably treated with selective serotonin reuptake…
- Trial name
- NCT02067299
- Testing
- JNJ-42847922
- Where
- 2 sites in Germany, Netherlands
- Volunteers
- 20 people
- Sponsor
- Janssen Research & Development, LLC
Primary Insomnia
Sleep Inducing And Maintaining Efficacy Of Circadin In Elderly Insomniacs
The aim of this placebo controlled study is to investigate the effect of 2 mg melatonin Slow Release (Circadin®) on the sleep/wake cycle in elderly insomniac out-subjects, aged 55 years or more.
- Trial name
- Neu I (NCT00816673)
- Testing
- Circadin
- Where
- France
- Volunteers
- 40 people
- Sponsor
- Neurim Pharmaceuticals Ltd.
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
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
Investigation of the Safety and Efficacy of Eszopiclone in Insomnia Patients
To investigate the safety and efficacy of administration of eszopiclone for 4 weeks in insomnia patients.
- Trial name
- NCT02452684
- Testing
- Eszopiclone
- Where
- 2 sites in Japan
- Volunteers
- 4,876 people
- Sponsor
- Eisai Co., Ltd.
Insomnia, Hepatic Insufficiency
Pharmacokinetics of Suvorexant in Participants With Hepatic Insufficiency (MK-4305-017)
This study will determine whether the plasma concentration-time profile and pharmacokinetics (PK) of suvorexant (MK-4305) in participants with moderate and mild hepatic insufficiency are similar to those observed in healthy…
- Trial name
- NCT01043926
- Testing
- Suvorexant
- Volunteers
- 16 people, healthy volunteers welcome
- Sponsor
- Merck Sharp & Dohme LLC
Sleep Initiation and Maintenance Disorders, Primary Insomnia
A Study to Compare Efficacy and Safety of Zolpidem Modified Release Formulation Versus Zolpidem in Insomnia Patients
The purpose of this study is to investigate the efficacy and safety of zolpidem MR (modified release) compared to zolpidem IR (immediate release) in patients with primary insomnia.
- Trial name
- NCT01181232
- Testing
- Zolpidem MR, Zolpidem IR
- Where
- 2 sites in Taiwan
- Volunteers
- 132 people
- Sponsor
- Astellas Pharma Inc
Sleep Initiation and Maintenance Disorders
A Study to Evaluate the Effects of GW679769 on Sleep and Cognitive Function in Subjects With Primary Insomnia
A study to investigate the effects of GW679769 on sleep and cognition. Potential subjects participate in a clinical screening visit and a two-night PSG recording session in the sleep laboratory.
- Trial name
- NCT00650871
- Testing
- GW679769
- Where
- 7 sites in United States
- Volunteers
- 48 people
- Sponsor
- GlaxoSmithKline
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.