Clinical trials: Disorders of Excessive Somnolence
Prader-Willi Syndrome, Excessive Daytime Sleepiness
Impact of Bright Light Therapy on Prader-Willi Syndrome
This is a placebo controlled clinical trial to assess the utility of light therapy as a sufficient treatment for excessive daytime sleepiness in patients with Prader-Willi Syndrome
- Conditions
- Prader-Willi Syndrome, Excessive Daytime Sleepiness, Hyperphagia, Body Weight
- Trial name
- PWS-LT (NCT05939453)
- Testing
- Bright Light Therapy
- Where
- United States
- Volunteers
- 50 people
- Sponsor
- Maimonides Medical Center
Obstructive Sleep Apnea, Excessive Daytime Sleepiness
BF2.649 in Patients With OSA, Still Complaining of EDS and Refusing to be Treated by CPAP.
Multicenter randomized double blind study versus placebo during 12 weeks with at first, an escalating dose period followed by stable dose period at the selected dose.
- Trial name
- HAROSA2 (NCT01072968)
- Testing
- BF2.649
- Where
- France
- Volunteers
- 268 people
- Sponsor
- Bioprojet
Narcolepsy Type 1
Clinical and Neurophysiological Characteristics of Narcolepsy
The study is the first attempt in post-Soviet Russian history to collect and analyze the existing available data of narcolepsy cohort in order to get prove characteristics of narcolepsy in Russia according to known data.
- Trial name
- NCT05375890
- Testing
- no intervention
- Where
- 11 sites in Russia
- Volunteers
- 89 people
- Sponsor
- I.M. Sechenov First Moscow State Medical University
Healthy Subjects, Kleine-Levin Syndrome
Brain Scintigraphy in Normal Versus Kleine-Levin Syndrome Subjects
The investigators perform neuropsychological tests and brain scintigraphy in 30 healthy subjects. These results will be compared with data obtained out of episode in patients with Kleine-Levin syndrome (KLS).
- Trial name
- SCINTIK (NCT02337023)
- Testing
- Brain scintigraphy with injection of Neurolite® (ECD)
- Where
- France
- Volunteers
- 56 people, healthy volunteers welcome
- Sponsor
- Assistance Publique - Hôpitaux de Paris
Obstructive Sleep Apnea
Effect of CPAP on Blood Pressure in Excessively Sleepy Obstructive Sleep Apnea Subtype
The primary objective of this study is to determine the longer-term (6 months) effect of CPAP therapy on change in 24-hour mean blood pressure (24hMBP) in OSA subjects with the excessively sleepy symptom subtype.
- Trial name
- NCT05742360
- Testing
- CPAP therapy
- Where
- 2 sites in United States
- Volunteers
- 227 people
- Sponsor
- Ohio State University
Excessive Sleepiness, Shift Work Sleep Disorder
Safety/Efficacy Study With Armodafinil (CEP-10953) in Treatment of Excessive Sleepiness Associated With Chronic SWSD
The primary objective of this study is to determine whether treatment with Armodafinil (CEP-10953) is more effective than placebo treatment for patients with excessive sleepiness associated with chronic shift work sleep disorder…
- Trial name
- NCT00080288
- Testing
- Armodafinil 150 mg/day
- Volunteers
- 254 people
- Sponsor
- Cephalon
Excessive Sleepiness, Parkinson Disease
A 4-Week Study of the Safety, Efficacy, and Pharmacokinetics of JZP-110 [(R)-2-amino-3-phenylpropylcarbamate Hydrochloride] in Subjects With Parkinson's Disease and Excessive Sleepiness
This study is a 4-week, multicenter, randomized, double-blind, placebo-controlled, ascending dose, 4-period crossover study designed to evaluate the safety, tolerability, efficacy, and PK of JZP-110 (75, 150, and 300 mg) in the…
- Trial name
- NCT03037203
- Testing
- JZP-110
- Where
- 25 sites in United States
- Volunteers
- 66 people
- Sponsor
- Jazz Pharmaceuticals
Parkinson Disease
Bright Light Therapy for Non-motor Symptoms in Parkinson's Disease
This is a randomized placebo- and active-controlled trial for assessing the efficacy of bright light therapy for sleep and mood symptoms in patients with Parkinson's disease
- Trial name
- NCT05524961
- Testing
- Bright light therapy, Inactivated negative ion generator
- Where
- Hong Kong
- Volunteers
- 69 people
- Sponsor
- Chinese University of Hong Kong
Narcolepsy
Body Weight Regulation in Patients With Narcolepsy
This study will measure energy expenditure (the rate at which the body burns calories), physical activity and caloric intake in people with narcolepsy to learn more about how the risk of becoming overweight or diabetic may be…
- Trial name
- NCT00283894
- Where
- United States
- Volunteers
- 30 people, healthy volunteers welcome
- Sponsor
- National Institute of Diabetes and Digestive and Kidney Diseases (NIDDK)
Excessive Daytime Sleepiness, Narcolepsy
Extension Study of the Safety and Efficacy of Armodafinil in the Treatment of Patients With Excessive Sleepiness
A 12 Month, Open-Label, Flexible Dosage Extension Study of the Safety and Efficacy of Armodafinil (CEP-10953) in the Treatment of Patients with Excessive Sleepiness Associated with Narcolepsy, Obstructive Sleep Apnea/Hypopnea…
- Conditions
- Excessive Daytime Sleepiness, Narcolepsy, Obstructive Sleep Apnea/Hypopnea Syndrome, Chronic Shift Work Sleep Disorder
- Trial name
- NCT00228553
- Testing
- Armodafinil 100 to 250 mg/day
- Where
- 100 sites in United States, Australia and 5 more
- Volunteers
- 743 people
- Sponsor
- Cephalon
Narcolepsy
Study of MK-6552 in Participants With Narcolepsy Type 1 (MK-6552-004)
The purpose of this study was to evaluate the safety, efficacy, pharmacokinetics (PK), and pharmacodynamics (PD) of MK-6552 in participants with Narcolepsy Type 1 (NT1).
- Trial name
- NCT06179407
- Testing
- MK-6552
- Where
- 5 sites in United States
- Volunteers
- 9 people
- Sponsor
- Merck Sharp & Dohme LLC
Narcolepsy, Idiopathic Hypersomnia
A Study Evaluating the Efficacy and Safety of Xywav Expanded Dosing vs Placebo in Participants With Narcolepsy or IH
The purpose of this study is to evaluate the efficacy and safety of expanded Xywav dosing regimens in adult participants with narcolepsy or idiopathic hypersomnia (IH).
- Trial name
- XYRISE (NCT07625280)
- Testing
- Xywav
- Where
- 15 sites in United States
- Volunteers
- 120 people
- Sponsor
- Jazz Pharmaceuticals
Narcolepsy
A Phase 3 Study to Evaluate the Efficacy and Safety of Samelisant in Patients With Narcolepsy (AWAKE)
The primary objective of this study is to evaluate the effect of Samelisant on excessive daytime sleepiness (EDS) after 12 weeks of treatment.
- Trial name
- NCT07540364
- Testing
- Samelisant
- Where
- United States
- Volunteers
- 240 people
- Sponsor
- Suven Life Sciences Limited
Narcolepsy Type 1, Hypnagogic Hallucinations
Imagery Control Therapy and Lucid Dreaming for REM-Related Symptoms in Narcolepsy
This randomized controlled trial evaluated the efficacy of a cognitive behavioral intervention based on lucid dreaming training and imagery control therapy for reducing REM-related symptoms in patients with narcolepsy type 1.
- Conditions
- Narcolepsy Type 1, Hypnagogic Hallucinations, Sleep Paralysis, REM Sleep Intrusion Symptoms
- Trial name
- ICLDR-NAR Tria (NCT07609537)
- Testing
- Cognitive Behavioral Therapy for Narcolepsy (CBT-NAR) With Lucid Dreaming and Imagery Control Therapy, Sleep Hygiene Education and Structured Clinical Follow-up
- Where
- Colombia
- Volunteers
- 98 people
- Sponsor
- Institute of Behavioral Sleep Medicine, Colombia
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.
Idiopathic Hypersomnia
Sodium Oxybate in Idiopathic Hypersomnia
this study evaluates of the efficacy of sodium oxybate on excessive daytime sleepiness using Epworth sleepiness scale over 8 weeks compared to placebo
- Trial name
- SODHI (NCT03597555)
- Testing
- Sodium Oxybate Oral Solution 500 MG/ML
- Where
- France
- Volunteers
- 48 people
- Sponsor
- University Hospital, Montpellier
Narcolepsy 1, Kleine-Levin Syndrome
Microglial Activation in Narcolepsy Type 1 and Kleine-Levin Syndrome: Positron Emission Tomography (PET) Study in [18F] DPA-714
Type 1 narcolepsy (NT1) is a chronic sleep disorder caused by the selective and irreversible loss of neurons from the hypothalamus, which synthesizes a neurotransmitter: hypocretin (Hcrt) / orexin.
- Trial name
- NARCOGLIE (NCT03754348)
- Testing
- PET scan with tracer injection [18F] DPA-714
- Where
- France
- Volunteers
- 78 people
- Sponsor
- University Hospital, Montpellier
Narcolepsy
Discovering Factors in Narcolepsy Patients' Clinical Research Experiences
An observational trial can provide a platform for patients to share experiences and perspectives on living with narcolepsy, which can inform the development of new treatments and support programs.
- Trial name
- NCT05870735
- Volunteers
- 500 people
- Sponsor
- Power Life Sciences Inc.
Narcolepsy, Excessive Sleepiness
Study Assessing Effects of JZP-110 on Driving Performance in the Treatment of Excessive Sleepiness in Narcolepsy
This trial is a randomized, double-blind, placebo-controlled, crossover study to evaluate the effect of JZP-110 on driving performance in subjects with excessive sleepiness due to narcolepsy.
- Trial name
- NCT02806908
- Testing
- JZP-110
- Where
- Netherlands
- Volunteers
- 24 people
- Sponsor
- Jazz Pharmaceuticals
Obstructive Sleep Apnea, Hypopnea
Armodafinil (CEP-10953) in Treatment of Excessive Sleepiness Associated With Obstructive Sleep Apnea/Hypopnea Syndrome(OSAHS)
The primary objective of this study is to determine whether treatment with Armodafinil (CEP-10953) is more effective than placebo treatment for patients with excessive sleepiness associated with obstructive sleep apnea/hypopnea…
- Trial name
- NCT00078325
- Testing
- Armodafinil 250 mg/day, Armodafinil 150 mg/day
- Volunteers
- 395 people
- Sponsor
- Cephalon