Clinical trials: Sleep Problem
Restless Legs Syndrome
A Study to Evaluate the Effect of Gabapentin on Cardiac Repolarization in Healthy Volunteers
This will be a randomized, double-blind, placebo- controlled cross-over study to investigate the effect of GEn on cardiac repolarisation parameters compared with placebo and a positive control, moxifloxacin.
- Trial name
- NCT01516372
- Testing
- GEn 1200mg, Gen 6000 mg, Moxifloxacin
- Where
- United States
- Volunteers
- 52 people, healthy volunteers welcome
- Sponsor
- XenoPort, Inc.
RLS
A PK and Safety Evaluation of HORIZANT (Gabapentin Enacarbil) in Adolescents With Moderate-to-Severe Primary RLS
The primary objective is to assess the pharmacokinetics (PK) of gabapentin following the single-dose administration of HORIZANT (Gabapentin Enacarbil) in adolescents (13 to 17 years of age) diagnosed with moderate-to-severe…
- Trial name
- RLS (NCT02633657)
- Testing
- HORIZANT 300 mg
- Where
- 4 sites in United States
- Sponsor
- XenoPort, Inc.
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.
Sleep Disorders
Clinical Trial on a Food Supplement With Melatonin and Herbal Products to Improve Sleep Quality
A randomized, double-blind, placebo-controlled clinical trial on the ability of a dietary supplement containing melatonin and herbal products to improve sleep quality in subjects with insomnia problems with a 15-day follow-up…
- Trial name
- NCT05459272
- Testing
- Aquilea Sueno Forte
- Where
- Spain
- Volunteers
- 50 people, healthy volunteers welcome
- Sponsor
- Uriach Consumer Healthcare
Restless Legs Syndrome (RLS)
Placebo-Controlled Study to Investigate the Efficacy & Safety of Injectafer in the Treatment of RLS
This will be a Phase III, double blinded, multi-center, randomized, placebo-controlled study. Eligible subjects will be randomized in a 1:1 ratio to receive Injectafer or Placebo on days 0 and 5.
- Trial name
- NCT02397057
- Testing
- Injectafer
- Where
- 19 sites in United States
- Volunteers
- 209 people
- Sponsor
- American Regent, Inc.
Insomnia
STATE Trial: SusTained Attention Training to Enhance Sleep
This study is a validation study to document the acceptability of the Tonic and Phasic Alertness Training (TAPAT) training program in older adults with chronic late-life insomnia.
- Trial name
- STATE (NCT02921074)
- Testing
- Computerized Plasticity-Based Adaptive Cognitive Training, Commercially available computerized training
- Where
- United States
- Volunteers
- 23 people
- Sponsor
- Posit Science Corporation
Narcolepsy Type 1, Narcolepsy Type 2
A Study of ORX750 in Participants With Narcolepsy and Idiopathic Hypersomnia
Narcolepsy Type 1 (NT1), Narcolepsy Type 2 (NT2), and Idiopathic Hypersomnia (IH) are rare conditions that make people feel very sleepy during the day (often referred to as excessive daytime sleepiness [EDS]).
- Conditions
- Narcolepsy Type 1, Narcolepsy Type 2, Idiopathic Hypersomnia
- Trial name
- CRYSTAL-1 (NCT06752668)
- Testing
- ORX750
- Where
- 37 sites in United States, Canada and 3 more
- Volunteers
- 248 people
- Sponsor
- Centessa Pharmaceuticals (UK) Limited
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.
Sleep Disorders, Congestion, Nasal
Exploratory Subjective Sleep Study of a Prototype Nasal Dilator
The purpose of this exploratory study is to evaluate the subjective measures of congestion and sleep quality in subjects who suffer from chronic nasal congestion and report trouble with their sleep.
- Trial name
- NCT01122849
- Testing
- Prototype Nasal Dilator, Marketed Nasal Strip
- Where
- 2 sites in United States
- Volunteers
- 61 people
- Sponsor
- GlaxoSmithKline
Insomnia (moderate)
Impact of GABA Probiotic Lactiplantibacillus Plantarum Lp815 on Sleep Outcomes in Participants with Self-Reported Sleep Disturbance
The rationale for this study is to observe differences in sleep outcomes between a consumer-grade probiotic capsule called GABA Probiotic and a placebo control group.
- Trial name
- NCT06789718
- Testing
- GABA Probiotic Lactiplantibacillus plantarum Lp815 (5 Billion cfu/dose), Optional Sub-Study: Neurotransmitter Urine Test
- Where
- United States
- Volunteers
- 150 people
- Sponsor
- Verb Biotics LLC
Narcolepsy, Sleep Apnea, Obstructive
PROVIGIL® (Modafinil) Treatment in Children and Adolescents With Excessive Sleepiness Associated With Narcolepsy or Obstructive Sleep Apnea/Hypopnea Syndrome
The primary objective of the study is to evaluate the safety and tolerability of treatment with PROVIGIL in children and adolescents with excessive sleepiness (ES) associated with narcolepsy or OSAHS (obstructive sleep…
- Trial name
- NCT00107848
- Testing
- Modafinil
- Where
- 61 sites in United States, Canada
- Volunteers
- 280 people, healthy volunteers welcome
- Sponsor
- Cephalon
Restless Legs Syndrome
An Extension Trial to Investigate Long-Term Treatment With Transdermal Rotigotine in Idiopathic Restless Legs Syndrome
This is a multicenter, open-label trial to assess safety and tolerability of rotigotine (SPM 936) in subjects with idiopathic Restless Legs Syndrome (RLS), administered at an optimal dose for up to 1 year.
- Trial name
- NCT00263068
- Testing
- Rotigotine
- Where
- United States
- Volunteers
- 279 people
- Sponsor
- UCB Pharma
Narcolepsy Type 1
A Study to Evaluate the Safety and Effectiveness of ALKS 2680 in Subjects With Narcolepsy Type 1 (ALKS 2680-201)
The purpose of this research study is to assess the safety and efficacy of ALKS 2680 compared to placebo, including whether participants taking ALKS 2680 experience a greater decrease in sleepiness and a decrease in cataplexy…
- Trial name
- Vibrance-1 (NCT06358950)
- Testing
- ALKS 2680
- Where
- 45 sites in United States, Australia and 6 more
- Volunteers
- 92 people
- Sponsor
- Alkermes, Inc.
Narcolepsy, Cataplexy
An Open Label Study of FT218 in Subjects With Narcolepsy
An Open Label Study to Evaluate Long-Term Safety and Tolerability of a Once Nightly Formulation of Sodium Oxybate for Extended-Release Oral Suspension (FT218) and the ability to switch from twice-nightly immediate release sodium…
- Conditions
- Narcolepsy, Cataplexy, Excessive Daytime Somnolence, Sleep Disorder
- Trial name
- RESTORE (NCT04451668)
- Testing
- FT218
- Where
- 29 sites in United States, Canada
- Volunteers
- 184 people
- Sponsor
- Avadel
Obstructive Sleep Apnea
Australian Clinical Study of the Apnex Medical HGNS System to Treat Obstructive Sleep Apnea
The overall goal of the study is to evaluate the safety, efficacy and therapy settings of the HGNS System for stimulating the hypoglossal nerve to help maintain an open airway in subjects with obstructive sleep apnea (OSA).
- Trial name
- NCT01186926
- Testing
- HGNS Treatment
- Volunteers
- 40 people
- Sponsor
- Apnex Medical, Inc.
Restless Legs Syndrome
Safety and Effect of Mirapex(Pramipexole) Tablet Among Korean RLS
Safety and Effect of Mirapex(Pramipexole) tablet among Korean Restless Legs Syndrome Patients: An Open-Label, Postmarketing Surveillance Study
- Trial name
- NCT01170091
- Where
- 36 sites in South Korea
- Volunteers
- 651 people
- Sponsor
- Boehringer Ingelheim
Depressive Symptoms
EVALUATION OF EFFICACY OF SAMEUP IN SUBJECTS WITH DEPRESSION SYMPTOMS: A RANDOMIZED STUDY
This study is planned to assess the efficacy of SAMEUp versus placebo after six weeks of treatment in subjects characterized by depression symptoms according to ICD-10 (International Classification of Diseases - 10th revision)…
- Trial name
- SAMEUP (NCT03932474)
- Testing
- SAMEUp
- Where
- Italy
- Volunteers
- 90 people
- Sponsor
- Nutrilinea srl
Sleep Disorders Related to Anxiety
Phytotherapy Strategy for Sleep Disorders Related to Anxiety With a Combination of Eschscholtzia and Valerian Extracts
The aim of the study is to evaluate the effect of a one-month supplementation with Phytostandard® Eschscholtzia and valerian on the Insomnia Severity Index (ISI), in insomniac so-called adjustment subjects (occasional or…
- Trial name
- NCT02981238
- Testing
- Phytostandard® Eschscholtzia / Valerian
- Where
- France
- Volunteers
- 36 people
- Sponsor
- PiLeJe
Obstructive Sleep Apnea
Adherence Risk Indicator Validation Study
While continuous positive airway pressure (CPAP) is the gold standard treatment of obstructive sleep apnea (OSA), this therapy is often discontinued or not used optimally.
- Trial name
- ARI (NCT02230085)
- Testing
- Administration of the questionnaire and monitoring of CPAP adherence
- Where
- United States
- Volunteers
- 110 people
- Sponsor
- Fisher and Paykel Healthcare
Insomnia
Brain and Heart Rhythm Responses to a Breathing-Linked Sound Application (BELL-001) in Adults With Insomnia Symptoms
The purpose of this study was to describe how brain activity and heart rhythm respond to BELL-001, a smartphone application that plays sounds linked to the user's own breathing, compared with a sham application that looks the…
- Trial name
- NCT07872007
- Testing
- BELL-001 Digital Therapeutic
- Where
- South Korea
- Volunteers
- 72 people
- Sponsor
- BELL Therapeutics Inc.