Clinical trials: Sleeping Efficacy
Insomnia
Study of Efficacy of WELT-IP in Insomnia (WCTP-I-B-01)
The purpose of the study was to determine safety and efficacy of WELT-IP in adult insomnia patients. WELT-IP is a cognitive behavioral therapy for insomnia (CBT-I) based digital therapeutics.
- Trial name
- NCT05822999
- Testing
- WELT-IP
- Where
- South Korea
- Volunteers
- 52 people, healthy volunteers welcome
- Sponsor
- WELT corp
Stress, Sleep
The Effectiveness of a Caralluma Fimbriata Extract on Stress, Sleep and Neurotransmitters
This is a double blind, randomised, placebo-controlled clinical trial aiming to assess the effectiveness of Caralluma fimbriata on stress, sleep and neurotransmitters in a healthy adult population.
- Trial name
- NCT05232266
- Testing
- Caralluma Fimbriata
- Where
- Australia
- Volunteers
- 129 people, healthy volunteers welcome
- Sponsor
- RDC Clinical Pty Ltd
Restless Legs Syndrome
Gabapentin Enacarbil (GSK1838262) Adult Restless Leg Syndrome (RLS) Post Marketing Commitment Study
Gabapentin enacarbil (GEn; GSK1838262; HORIZANT), at a dose of 600 mg/day, is currently approved in the United States for the treatment of adults with moderate-to-severe primary Restless Legs Syndrome (RLS).
- Trial name
- CONCORD (NCT01668667)
- Testing
- GSK1838262 600 mg, GSK1838262 450 mg, GSK1838262 300 mg
- Where
- 42 sites in United States
- Volunteers
- 501 people
- Sponsor
- XenoPort, Inc.
Restless Legs Syndrome
Efficacy and Safety of Pramipexole (PPX) in Moderate to Severe Idiopathic Restless Legs Syndrome (RLS) Patients
To evaluate safety and efficacy of pramipexole in the treatment of patients suffering from moderate to severe RLS over 6 weeks under double blinded conditions followed by a 46 week open label or double blind extension.
- Trial name
- NCT00275457
- Testing
- pramipexole
- Where
- 34 sites in Austria, Germany and 3 more
- Volunteers
- 346 people
- Sponsor
- Boehringer Ingelheim
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.
Restless Legs Syndrome
Efficacy, Safety and Tolerability of Rotigotine Nasal Spray for the Acute Treatment of RLS Symptoms
The main objective of this phase 2a proof-of-concept trial is to assess the efficacy of rotigotine nasal spray in ascending doses in subjects with idiopathic Restless Legs Syndrome.
- Trial name
- NCT00389831
- Testing
- Rotigotine Nasal Spray
- Where
- Germany
- Volunteers
- 44 people
- Sponsor
- UCB Pharma
Obstructive Sleep Apnea
Validation of Safety and Efficacy for Night Shift Therapy
The purpose of this study is to assess the accuracy of Night Shift in the detection of supine sleep and efficacy of vibro-tactile feedback in restricting supine sleep.
- Trial name
- NCT02032706
- Testing
- Deliver therapy when the supine position is detected
- Where
- United States
- Volunteers
- 36 people
- Sponsor
- Advanced Brain Monitoring, Inc.
Menopause, Hot Flashes
Randomized Evaluation of Natural Extract for Menopausal Wellness (RENEW)
This study will evaluate whether an 8-week course of a standardized herbal extract containing Shatavari and natural bio-enhancer ingredients can reduce menopausal symptoms in post-menopausal women.
- Trial name
- RENEW (NCT07834463)
- Testing
- Shatavari (Asparagus racemosus) Extract
- Where
- United States
- Volunteers
- 100 people
- Sponsor
- India Glycols Ltd
Smoking Cessation, Stress
Efficacy and Tolerability of Combination Varenicline With Hydroxyzine as a Potential Smoking Cessation Treatment
This open-label study will evaluate hydroxyzine, a first-generation antihistamine, combined with varenicline, to help smokers abstain from smoking during a 12-week trial period by diminishing the nausea, stress, anxiety, and…
- Conditions
- Smoking Cessation, Stress, Sleep Disturbance, Nausea
- Trial name
- HAVE (NCT04188106)
- Testing
- Varenicline Pill, Hydroxyzine Pill
- Where
- 2 sites in United States
- Volunteers
- 26 people, healthy volunteers welcome
- Sponsor
- Rose Research Center, LLC
Sleep Initiation and Maintenance Disorders, Alzheimer Disease
Safety and Efficacy of Suvorexant (MK-4305) for the Treatment of Insomnia in Participants With Alzheimer's Disease (MK-4305-061)
This study aims to examine the safety and efficacy of suvorexant (MK-4305) to improve sleep in individuals with Alzheimer's disease (AD).
- Trial name
- NCT02750306
- Testing
- Suvorexant
- Volunteers
- 285 people
- Sponsor
- Merck Sharp & Dohme LLC
EDS, Cataplexy
A Phase 3 Efficacy and Safety Study of HBS-301 in Participants With Narcolepsy
This is a Phase 3, multicenter, randomized, double-blind, parallel-group, placebo-controlled clinical study to assess the efficacy and safety of HBS-301 in treating excessive daytime sleepiness (EDS), cataplexy…
- Conditions
- EDS, Cataplexy, Fatigue, Narcolepsy
- Trial name
- NCT07675135
- Testing
- HBS-301
- Where
- 53 sites in United States, Canada
- Volunteers
- 258 people
- Sponsor
- Harmony Biosciences Management, Inc.
Obstructive Sleep Apnea (OSA)
Evaluating the Efficacy of PAP Therapy for Treating OSA in the Home Environment
This study will take between 4-6 months (with first patient first visit to last patient last visit expected to span 3-4 months across all study sites).
- Trial name
- NCT04744038
- Testing
- Positive Airway Pressure (PAP) Therapy
- Where
- 2 sites in United States, Australia
- Volunteers
- 108 people, healthy volunteers welcome
- Sponsor
- ResMed
Excessive Daytime Sleepiness
A Clinical Study to Evaluate the Efficacy and Safety of Pitolisant in the Treatment of EDS in Patients With OSA
The objective of this study is to demonstrate the efficacy and safety of pitolisant versus placebo during 12 weeks of the Double Blind period, to treat the Excessive Daytime Sleepiness (EDS) in patients with Obstructive Sleep…
- Trial name
- NCT05223166
- Testing
- Pitolisant
- Where
- China
- Volunteers
- 240 people
- Sponsor
- Citrine Medicine Limited
Sleep Disorders
Efficacy and Safety Assessment of ZOlpidem (Stilnox CR) in Patients With Chronic insomNIA
Primary Objective: To evaluate the efficacy and safety of the use of Stilnox CR in Mexican patients with chronic insomnia at the prescription conditions of daily practice Secondary Objective: To evaluate the satisfaction of the…
- Trial name
- NCT01024192
- Testing
- ZOLPIDEM SL800750
- Where
- Mexico
- Volunteers
- 135 people
- Sponsor
- Sanofi
Sleep Apnea, Obstructive
A Study of IBI362 in Chinese Subjects With Obstructive Sleep Apnea and BMI≥28 kg/m2
This is a multicenter, randomized, double-blind, placebo-controlled Phase III clinical study to evaluate the efficacy and safety of IBI362 in subjects with moderate-to-severe obstructive sleep apnea (OSA) and a body mass index…
- Conditions
- Sleep Apnea, Obstructive, Obesity
- Trial name
- NCT06931028
- Testing
- IBI362
- Where
- China
- Volunteers
- 260 people
- Sponsor
- Innovent Biologics (Suzhou) Co. Ltd.
Non-24-Hour Sleep-Wake Disorder
Efficacy and Safety of Tasimelteon Compared With Placebo in Totally Blind Subjects With Non-24-Hour Sleep-Wake Disorder
The purpose of this study is to evaluate the efficacy and safety of a six month double-mask treatment of tasimelteon or placebo in male and female subjects with Non-24-Hour Sleep-Wake Disorder
- Trial name
- NCT01163032
- Testing
- tasimelteon
- Where
- 28 sites in United States, Germany
- Volunteers
- 136 people
- Sponsor
- Vanda Pharmaceuticals
Obesity Hypoventilation Syndrome
AVAPS-AE Efficacy Study
The purpose of this study is to evaluate the feasibility of using of the Average Volume Assured Pressure Support (AVAPS-AE) mode versus Continuous Positive Airway Pressure (CPAP) and bilevel pressure support ventilation (PSV)…
- Trial name
- NCT01368614
- Testing
- AVAPS-AE Mode of Therapy, Respironics OnmiLab BiPAP S mode, Respironics OmniLab Advanced CPAP mode
- Where
- 2 sites in United States
- Volunteers
- 90 people
- Sponsor
- Philips Respironics
Fibromyalgia, Myofascial Pain Syndromes
Repeat of: A Study to Evaluate Efficacy and Safety of Sublingual TNX-102 SL Tablet Taken at Bedtime in Patients With Fibromyalgia
The present trial is designed to assess the safety and efficacy of TNX-102 SL 2.8 mg tablets, taken daily at bedtime after 12 weeks of treatment in patients with fibromyalgia.
- Conditions
- Fibromyalgia, Myofascial Pain Syndromes, Muscular Diseases, Nervous System Diseases
- Trial name
- RE-AFFIRM (NCT02829814)
- Testing
- TNX-102 SL Tablet, 2.8 mg
- Where
- 32 sites in United States
- Volunteers
- 51 people
- Sponsor
- Tonix Pharmaceuticals, Inc.
Insomnia, Depression
Study Of Indiplon/Placebo With Sertraline In Insomnia Co-Existing With Depression
The goal of this study is to determine whether indiplon, when administered with sertraline, improves insomnia symptoms and depressive symptoms in subjects with both insomnia and depression.
- Trial name
- NCT00232167
- Testing
- Indiplon, Sertraline
- Volunteers
- 380 people
- Sponsor
- Neurocrine Biosciences
Narcolepsy Type 1 (NT1)
A Study to Evaluate the Efficacy, Safety, and Tolerability of E2086 Compared to Placebo and Active Comparator in Adult Participants With Narcolepsy Type 1
The primary purpose of this study is to evaluate the efficacy of single oral doses of E2086 compared to placebo in the treatment of excessive daytime sleepiness (EDS) as assessed by the Maintenance of Wakefulness Test (MWT) in…
- Trial name
- NCT06462404
- Testing
- E2086, Active Comparator
- Where
- 14 sites in United States, Canada
- Volunteers
- 22 people
- Sponsor
- Eisai Inc.