Clinical trials: Sleep Wake Disorders
Transient Insomnia
A Study of the Safety of Gabapentin in a Potential Over-the-Counter Population With Occasional Sleeplessness
The purpose of this study is to assess the safety of gabapentin, as compared to placebo, in a potential over-the-counter population with reports of occasional sleeplessness
- Trial name
- NCT00666575
- Testing
- Gabapentin
- Where
- 23 sites in United States
- Volunteers
- 2,105 people
- Sponsor
- Pfizer's Upjohn has merged with Mylan to form Viatris Inc.
Restless Legs Syndrome
Dose-Response and Pharmacokinetics of Gabapentin Enacarbil (GEn [XP13512 / GSK1838262]) in Restless Legs Syndrome
The objective of the study was to generate the data necessary to determine the gabapentin exposure produced by 4 dose levels of GEn (600 mg, 1200 mg, 1800 mg, and 2400 mg) or placebo, and the corresponding relief of symptoms in…
- Trial name
- XP081 (NCT01332305)
- Testing
- GEn (XP13512/GSK1838262)
- Where
- United States
- Volunteers
- 217 people
- Sponsor
- XenoPort, Inc.
Obesity, Obstructive Sleep Apnea
Maridebart Cafraglutide Versus Placebo in Adult Participants With Obstructive Sleep Apnea on Positive Airway Pressure Therapy
This Phase 3 clinical trial is designed to evaluate the efficacy and safety of maridebart cafraglutide compared to placebo over a 52-week period in adults with obstructive sleep apnea (OSA) who are receiving positive airway…
- Trial name
- MARITIME-OSA-1 (NCT07225686)
- Testing
- Maridebart cafraglutide
- Where
- 61 sites in United States, Australia and 9 more
- Volunteers
- 250 people
- Sponsor
- Amgen
Narcolepsy, Obstructive Sleep Apnea
Evaluate Sunosi® PK in Breast Milk and Plasma of Healthy Postpartum Women Following Single Dose Oral Administration
The purpose of study JZP110-401 is to evaluate solriamfetol pharmacokinetics (PK) in the breast milk and plasma of healthy postpartum women following the administration of the drug.
- Conditions
- Narcolepsy, Obstructive Sleep Apnea, Excessive Daytime Somnolence, Excessive Sleepiness
- Trial name
- NCT05008341
- Testing
- Solriamfetol 150 mg Oral Tablet
- Where
- United States
- Volunteers
- 6 people
- Sponsor
- Axsome Therapeutics, Inc.
Sleep Disorder
Safety and Performance Study of the Electroencephalographic Recording Device and Sound Emissions
Safety and performance study of the MemoWave electroencephalographic and sound recording device to increase slow brain waves during sleep to improve memory consolidation in subjects with mild cognitive impairment
- Trial name
- MEMOWAVE (NCT04875442)
- Testing
- Memowave emitting sounds, Memowave not emitting sounds
- Where
- France
- Sponsor
- BioSerenity
Obstructive Sleep Apnea
Effectiveness and Safety of cNEP in Ethnic Japanese With Obstructive Sleep Apnea
The aim of this study is to evaluate the effectiveness and safety of cNEP (continuous negative external pressure) for the treatment of obstructive sleep apnea during two weeks of home use in subjects of Japanese ethnicity.
- Trial name
- NCT03375905
- Testing
- cNEP
- Where
- United States
- Volunteers
- 8 people
- Sponsor
- Sommetrics, Inc.
Sleep Initiation and Maintenance Disorders
Efficacy and Safety of KI1001 in the Treatment of ≥ 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
- NCT02087722
- Testing
- KI1001
- Where
- 4 sites in South Korea
- Volunteers
- 80 people
- Sponsor
- Kuhnil Pharmaceutical Co., Ltd.
Idiopathic Restless Legs Syndrome
Non-interventional Study (NIS) in Patients With Restless Legs Syndrome in Daily Practise
This non-interventional observational study is designed to gain data for Neupro® in restless legs syndrome (RLS) under real life conditions in line with the summary of product characteristics (SmPC) related to effectiveness…
- Trial name
- RLS-Practise (NCT01113710)
- Testing
- Neupro®
- Where
- 80 sites in Germany
- Volunteers
- 687 people
- Sponsor
- UCB Pharma
Obstructive Sleep Apnea, Preoperative Evaluation
Systematic Screening for Obstructive Sleep Apnea During Preoperative Consultation Using AI-preoperative Agents
The goal of this observational study is to evaluate the feasibility of a systematic screening protocol for Obstructive Sleep Apnea (OSA) during preoperative anesthesia consultations in adults aged 50 and older undergoing elective…
- Trial name
- DASCA (NCT06779682)
- Where
- France
- Volunteers
- 150 people
- Sponsor
- Intelligence Anesthesia
Insomnia
Pharmacokinetic and Safety of Ramelteon Between Adolescents With Insomnia and Healthy Adults
The purpose of this study is to determine the pharmacokinetic profile, safety, and tolerability of ramelteon in adolescents with insomnia, children with Attention Deficit Hyperactivity Disorder (ADHD) associated with insomnia and…
- Trial name
- NCT00914862
- Testing
- Ramelteon
- Where
- 2 sites in United States
- Volunteers
- 56 people, healthy volunteers welcome
- Sponsor
- Takeda
Sleep Wake Disorders, Sleep Disorders, Circadian Rhythm
Evaluating the Effects of Tasimelteon Vs. Placebo in Delayed Sleep-Wake Phase Disorder (DSWPD) and the CRY1Δ11 Variant
This is a double-blind, randomized, two-period crossover study to evaluate the efficacy and safety of a single oral dose of tasimelteon and matching placebo in male and female subjects with DSWPD and the CRY1Δ11 variant.
- Conditions
- Sleep Wake Disorders, Sleep Disorders, Circadian Rhythm, Chronobiology Disorders, Gene Mutations and Other Alterations Nec
- Trial name
- NCT06701396
- Testing
- Tasimelteon
- Where
- Turkey (Türkiye)
- Volunteers
- 60 people
- Sponsor
- Vanda Pharmaceuticals
Quality of Life, Obesity
Effect of Consumption of Pep19 on Quality of Life
Pep19 is a naturally occurring peptide (protein) that triggers loss of body fat. It has been certified Generally Recognized as Safe (GRAS) at up to 3.8 grams per day and may be included in various foods.
- Conditions
- Quality of Life, Obesity, Sleep Quality
- Trial name
- NCT06359327
- Testing
- Pep19 2 mg, Pep19 5 mg
- Where
- United States
- Volunteers
- 24 people, healthy volunteers welcome
- Sponsor
- Proteimax Biotechnology Israel LTD
Sleep Apnea, Obstructive
Safety of Ramelteon in Subjects With Mild to Moderate Obstructive Sleep Apnea
The purpose of this study is to assess the safety of ramelteon, once daily (QD), in individuals with obstructive sleep apnea.
- Trial name
- NCT00672061
- Where
- 5 sites in United States
- Volunteers
- 26 people
- Sponsor
- Takeda
Sleep Quality, Menopause
Effect of ZenRest™ Lotus Seed & Rice Germ Extract Blend on Sleep Quality in Menopausal Women
The goal of this clinical trial is to learn if ZenRest™ (Lotus Seed \& Rice Germ Extract Blend) can help improve sleep quality in menopausal women aged 40-65 with mild-to-moderate sleep complaints.
- Trial name
- NCT07678359
- Testing
- Lotus Seed & Rice Germ Extract
- Where
- United States
- Volunteers
- 60 people, healthy volunteers welcome
- Sponsor
- Nutraland USA, Inc.
Sleep Apnea
AirSense 10 AHI Validation Study
The AirSense 10 platform is able to detect respiratory events at night and report these data via telemonitoring. The accuracy of the AirSense 10 will be compared with scoring with polysomnography (PSG).
- Trial name
- NCT03043703
- Testing
- AirSense 10 AutoSet for Her
- Where
- 2 sites in Germany
- Sponsor
- ResMed
Obstructive Sleep Apnea, Obesity
UBT251 Injection Phase Ⅲ Study (OSA-NPAP)
The objective of this clinical trial is to evaluate the efficacy of investigational drug UBT251 in the treatment of moderate-to-severe obstructive sleep apnea (OSA) with obesity, as well as to assess its safety.
- Trial name
- UNISHAPE-OSA-1 (NCT07767942)
- Testing
- UBT251
- Volunteers
- 150 people
- Sponsor
- The United Bio-Technology (Hengqin) Co., Ltd.
Sleep-Disordered Breathing
Comparative Assessment of Compumedics Somfit Sleep Monitoring Device
To study whether Somfit is substantially equivalent to the existing approved devices for full polysomnography and home sleep apnea testing
- Trial name
- NCT05647746
- Testing
- Compumedics Somfit HSAT device, WatchPAT HSAT device, Compumedics Grael /E-series PSG system
- Where
- Australia
- Volunteers
- 108 people
- Sponsor
- Compumedics Limited
Sleep Disorder, Restless Legs Syndrome
Study of Istradefylline (KW-6002) for the Treatment of Restless Legs Syndrome
The primary purpose of this study is to evaluate the efficacy, safety, and tolerability of 40 mg per day of istradefylline (KW6002) in patients with Restless Legs Syndrome.
- Trial name
- NCT00199446
- Testing
- Istradefylline (KW-6002)
- Where
- United States
- Volunteers
- 160 people
- Sponsor
- Kyowa Kirin, Inc.
Menopause, Sleep Disturbance
Radicle Revive 24: A Study of Health and Wellness Products on Menopausal Health and Related Health Outcomes
A randomized, double-blind, placebo-controlled, direct-to-consumer trial assessing the impact of health and wellness products on hormonal health and associated health outcomes in women with menopausal health issues
- Conditions
- Menopause, Sleep Disturbance, Anxiety, Depression
- Trial name
- NCT06749288
- Testing
- Radicle Revive Active Study Product 4.1 Usage
- Where
- United States
- Volunteers
- 500 people, healthy volunteers welcome
- Sponsor
- Radicle Science
Sleep-disordered Breathing (SDB), Sleep Apnea
Validation of the Smart Mask V1 System and Its Measurements of SpO2 and Pulse Rate
The goal of this clinical study is to investigate a new medical device, the Smart Mask V1 System (herein 'Smart Mask'), and particularly its measurements of blood oxygen levels (SpO2) and pulse rate (PR) in healthy adults aged 18…
- Conditions
- Sleep-disordered Breathing (SDB), Sleep Apnea, Sleep Quality
- Trial name
- SMV1: PPG (NCT07086742)
- Testing
- Smart Mask V1 System
- Where
- Belgium
- Volunteers
- 53 people, healthy volunteers welcome
- Sponsor
- Pathway Medtech, LLC.