Clinical trials: Hypnotic; Sleep Disorder
Chronic Insomnia
Safety and Efficacy of Chronic Hypnotic Use 2
This proposal will assess risks for transition from therapeutic hypnotic use to abuse in people with insomnia. The investigators will study a hypothesized at-risk sub-population, insomniacs with hyperarousal, and compare two…
- Trial name
- CIS2 (NCT02456532)
- Testing
- Zolpidem CR, Eszopiclone
- Where
- United States
- Volunteers
- 41 people, healthy volunteers welcome
- Sponsor
- Henry Ford Health System
Harmful Use of Hypnotic
Brief Intervention for Sleep Medication Misuse Among Elderly
Randomized controlled trial to evaluate effectiveness of behavioral Brief Intervention administered by General practitioners (GPs) versus business as usual on use of Z-hypnotics by elderly patients in primary care.
- Trial name
- BI-sleep (NCT06032715)
- Testing
- BI (Brief Intervention)
- Where
- Norway
- Volunteers
- 120 people
- Sponsor
- University Hospital, Akershus
Benzodiazepines Deprescribing, Sleep Problems
Improving Patient Safety by Supporting Older Adults in Managing Sleep Problems.
Among older adults (≥65 years), use of sleeping pills, such as benzodiazepines and other sedative-hypnotics, to treat sleep problems is common.
- Trial name
- BE-SAFE (NCT06584513)
- Testing
- Specific tapering plan for sleep medication, educational and cognitive behavioural therapy elements
- Where
- 6 sites in Belgium, Greece and 4 more
- Volunteers
- 470 people
- Sponsor
- Insel Gruppe AG, University Hospital Bern
Sleep Apnea, Obstructive Sleep Apnea
Continuous Positive Airway Pressure, Arousability and Links to Mechanisms in Obstructive Sleep Apnea
The study design is a randomized, controlled clinical trial to test the hypothesis that arousal threshold (ArTH) will affect how individuals with obstructive sleep apnea (OSA, Apnea-Hypopnea Index (AHI) of 10/hour of higher)…
- Trial name
- CALM-OSA (NCT07332442)
- Testing
- Eszopiclone
- Where
- United States
- Volunteers
- 250 people
- Sponsor
- Yale University
Insomnia
Photobiomodulation for Reducing Sedative-Hypnotic Use:Clinical Trial of a Light-Therapy Device
Background: Insomnia is a prevalent and growing public health issue, with one in three adults affected globally and one in five Taiwanese adults reporting significant sleep disturbances.
- Trial name
- NCT07764107
- Testing
- PBM intervention
- Volunteers
- 60 people
- Sponsor
- National Health Research Institutes, Taiwan
Insomnia Chronic, Hypnotics and Sedatives
Physical Activity Interventions for Sleep Improvement and Sedative-Hypnotic Reduction in Middle-Aged and Older Adults: Investigating the Role of Sarcopenia
Background: The prevalence of sedative-hypnotic use among middle-aged and older adults in Taiwan has continued to rise, highlighting the need to better understand the underlying factors contributing to sleep disturbances and…
- Conditions
- Insomnia Chronic, Hypnotics and Sedatives, Physical Activities
- Trial name
- NCT07896603
- Testing
- resistance training, Relaxation training
- Where
- Taiwan
- Volunteers
- 40 people
- Sponsor
- Chang Gung Memorial Hospital
Insomnia Chronic, Pain, Chronic
Clonidine is Better Than Zopiclone for Insomnia Treatment in Chronic Pain Patients
A prospective observational crossover study of 160 consenting adult patients who underwent pain management. For insomnia treatment, each patient ingested different prescribed doses of Zopiclone or Clonidine on alternate nights.
- Trial name
- NCT05277038
- Testing
- Clonidine 0.1mg pill, Clonidine 0.2mg pill, Zopiclone 3.75mg pill
- Where
- Canada
- Volunteers
- 150 people, healthy volunteers welcome
- Sponsor
- Salem Anaesthesia Pain Clinic
Sleep Initiation and Maintenance Disorders
Evaluation of the Hypnotic Properties of Zolpidem-MR 12.5 mg and Zolpidem 10 mg Marketed Product Compared to Placebo in Patients With Primary Insomnia
The primary objective is to evaluate the hypnotic efficacy of zolpidem-MR (modified release) 12.5 mg and zolpidem 10 mg marketed product in comparison with placebo in patients with primary insomnia and sleep maintenance…
- Trial name
- NCT00630175
- Testing
- zolpidem-MR (modified release), zolpidem (SL800750)
- Where
- 3 sites in United States, Australia and 1 more
- Volunteers
- 113 people
- Sponsor
- Sanofi
Sleep Initiation and Maintenance Disorders, Depression
Improving Sleep and Psychological Functioning in People With Depression and Insomnia
This study will evaluate the safety and effectiveness of treatment with both a sleeping pill and antidepressant medication in improving sleep and psychological functioning in people with depression and insomnia.
- Trial name
- NCT00247624
- Testing
- Eszopiclone, Fluoxetine
- Where
- United States
- Volunteers
- 60 people
- Sponsor
- Wake Forest University Health Sciences
Primary Insomnia
Study of the Insomnia in Patients With Low Back Pain
The purpose of this study is to examine whether insomnia due to chronic low back pain can improve with use of eszopiclone.
- Trial name
- NCT00365976
- Testing
- Eszopiclone
- Where
- United States
- Volunteers
- 58 people
- Sponsor
- Duke University
Insomnia, Attention Deficit Hyperactivity Disorder
Long Term Safety Study of Study Drug (Eszopiclone) in Children and Adolescents With ADHD -Associated Insomnia
A multicenter study to evaluate the safety of eszopiclone in children (6 11 years of age, inclusive) and adolescents (12 17 years of age, inclusive) with attention deficit/hyperactivity disorder (ADHD) associated insomnia.
- Trial name
- NCT00857220
- Testing
- eszopiclone
- Where
- 89 sites in United States
- Volunteers
- 304 people
- Sponsor
- Sumitomo Pharma America, Inc.
Sleep Apnea, Obstructive, Sleep Apnea
Comparison Between Natural Sleep Endoscopy and Drug-induced Sleep Endoscopy in Patients With Obstructive Sleep Apnea
Drug-induced sleep endoscopy (DISE) is the most used technique for identifying the obstruction site associated with obstructive sleep apnea (OSA).
- Conditions
- Sleep Apnea, Obstructive, Sleep Apnea, Sleep Apnea Syndromes, Apnea
- Trial name
- NCT04729478
- Testing
- Drug-induced sleep endoscopy, Natural sleep endoscopy
- Where
- Belgium
- Volunteers
- 40 people
- Sponsor
- ethisch.comite@uza.be
Chronic Insomnia, Hypnotic Dependence
Telepsychology for Benzodiazepines Withdrawal in Adults Suffering From Hypnotic-dependent Insomnia
Long-term use of benzodiazepines is a long-standing problem, but the optimal withdrawal modalities are not known. The main objective of this study is to compare the effectiveness of a psychological support versus a…
- Trial name
- NCT04751851
- Testing
- Medium duration withdrawal programme with ACT, Long duration withdrawal programme with ACT, Medium duration withdrawal programme without ACT
- Where
- Switzerland
- Volunteers
- 128 people
- Sponsor
- Association Nationale de Promotion des Connaissances sur le Sommeil
Insomnia
Self Help Program for Hypnotics Withdrawal in Insomniac Patients
Persistent insomnia has a high prevalence in French general population affecting between 15.8 % and 19 % of adults. In France, the disease is mainly managed by general practitioners (GP) who usually proposed intermediate…
- Trial name
- PROPERSOM (NCT02720458)
- Testing
- Standardized gradual hypnotic taper, Short-term simple self-help program
- Where
- 6 sites in France
- Volunteers
- 62 people
- Sponsor
- University Hospital, Bordeaux
Gastroesophageal Reflux
The Influence of Hypnotic Medications on Sleep Arousal and Its Effect on Gastroesophageal Reflux
This is a continuation of a study that has already been completed in the division of gastroenterology (GI) looking at the effects of sleep medication zolpidem (Ambien) on subjects with Gastroesophageal reflux disease (GERD).
- Trial name
- NCT00462137
- Testing
- Sleep Studies
- Where
- United States
- Volunteers
- 8 people
- Sponsor
- Thomas Jefferson University
Sleep Disorder (Disorder)
The Correlation Between Sleep Quality and Sleep Aid Use and Dietary Patterns
In this study, medical staff in emergency and critical care departments were investigated. It was assumed that the use of sleep aids and dietary patterns affected their sleep quality.
- Trial name
- NCT07019948
- Volunteers
- 378 people, healthy volunteers welcome
- Sponsor
- Wei XIA, PhD
Insomnia, Attention Deficit Hyperactivity Disorder
Safety & Efficacy Study of Study Drug (Eszopiclone) in Children and Adolescents With Attention-deficit/Hyperactivity Disorder - Associated Insomnia
A multi center, randomized study to evaluate the efficacy and safety of eszopiclone compared to placebo in children (6-11 years of age, inclusive) and adolescents (12-17 years of age, inclusive) with attention…
- Trial name
- NCT00856973
- Testing
- eszopiclone
- Where
- 73 sites in United States
- Volunteers
- 486 people
- Sponsor
- Sumitomo Pharma America, Inc.
Obstructive Sleep Apnea
Hypnotics to Improve Polysomnography Yield: Eszopiclone vs Ramelteon?
This study is being conducted to determine if eszopiclone is as effective as ramelteon when used as a pre-medication (sleeping pill) in sleep studies performed to diagnose and treat sleep apnea.
- Trial name
- NCT00811746
- Testing
- Rozerem (Ramelteon), Lunesta (Eszopiclone), Historical Controls
- Where
- United States
- Volunteers
- 90 people
- Sponsor
- Southern California Institute for Research and Education
Insomnia, Fibromyalgia
Suvorexant in Insomnia Co-morbid With Fibromyalgia
This study will compare sleep, pain and daytime sleepiness/fatigue in people with insomnia co-morbid with fibromyalgia while treated short-term with suvorexant 20 mg versus placebo.
- Trial name
- NCT02684136
- Testing
- suvorexant
- Where
- United States
- Volunteers
- 10 people
- Sponsor
- Henry Ford Health System
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