Clinical trials: Disorders of Excessive Somnolence
Narcolepsy
The Effect of Caffeine on the Narcoleptic Patients
Caffeine may be playing a beneficial role in patients with narcolepsy. However, the relationship between caffeine and its effects on narcoleptic patients has not been examined, and it is also unclear whether caffeine provides a…
- Trial name
- NCT02832336
- Testing
- Vivarin, Fiber
- Where
- Saudi Arabia
- Volunteers
- 16 people
- Sponsor
- King Saud University
Narcolepsy With Cataplexy, Excessive Daytime Sleepiness
Pitolisant to Assess Weekly Frequency of Cataplexy Attacks and EDS in Narcoleptic Patients (HARMONY CTP)
Double blind, randomized, parallel groups study of Pitolisant versus placebo, in narcoleptic patients experiencing EDS, and cataplexy (minimum of 3 complete or partial cataplexy attacks per week).
- Trial name
- NCT01800045
- Testing
- Pitolisant
- Where
- Hungary
- Volunteers
- 103 people
- Sponsor
- Bioprojet
Parkinson's Disease
Efficacy and Safety of BF2.649 in Excessive Daytime Sleepiness (EDS) in Parkinson's Disease
To compare the efficacy of BF2.649 over placebo (12 week Double-Blind Phase) and assess the long term safety and the efficacy maintenance(9 months Open-Label Extension Phase) of BF2.649 in the improvement of excessive daytime…
- Trial name
- HARPS1 (NCT01036139)
- Testing
- BF2.649 (pitolisant)
- Where
- France
- Volunteers
- 268 people
- Sponsor
- Bioprojet
Sleepiness, Daytime
Effects of Litebook EDGE™ Phototherapy on Academic Performance and Brain Activity
As children pass through puberty the timing of their sleep-wake cycle shifts and they experience a strong urge to stay up and awaken late.
- Trial name
- LiteBook (NCT05383690)
- Testing
- LED bright light treatment device
- Where
- United States
- Volunteers
- 26 people, healthy volunteers welcome
- Sponsor
- Mclean Hospital
Bipolar Disorder, Insomnia
Mindfulness Therapy on Disrupted Sleep in Bipolar Disorder
The investigators propose to investigate the efficacy of a brief (4-session) Body Scan (BS) meditation intervention for individuals with bipolar I disorder with insomnia (i.e. difficulties falling or staying asleep).
- Conditions
- Bipolar Disorder, Insomnia, Hypersomnia, Sleep Problems
- Trial name
- NCT01764035
- Testing
- Body Scan (BS) Meditation Intervention, Brief Supportive Psychotherapy (SP)
- Where
- United States
- Volunteers
- 48 people
- Sponsor
- Massachusetts General Hospital
Excessive Sleepiness
Study of the Effect of Armodafinil Treatment in Healthy Subjects With Excessive Sleepiness Associated With Jet Lag Disorder
This is a randomized, double-blind, placebo-controlled, parallel-group study of armodafinil and placebo treatment in healthy subjects with excessive sleepiness associated with jet lag disorder.
- Trial name
- NCT00758498
- Testing
- armodafinil
- Where
- 4 sites in United States
- Volunteers
- 427 people, healthy volunteers welcome
- Sponsor
- Cephalon
Narcolepsy With Cataplexy
A Study of the Efficacy and Safety of JZP-258 in Subjects With Narcolepsy With Cataplexy
This is a double-blind, placebo-controlled, randomized-withdrawal, multicenter study of the efficacy and safety of JZP-258.
- Trial name
- NCT03030599
- Testing
- JZP-258
- Where
- 25 sites in United States, Belgium and 4 more
- Volunteers
- 201 people
- Sponsor
- Jazz Pharmaceuticals
Idiopathic Hypersomnia
A Study of TAK-360 in Adults With Idiopathic Hypersomnia
Idiopathic Hypersomnia (IH) is a condition where people feel extremely sleepy during the day, especially in the morning, even if they sleep a lot at night.
- Trial name
- NCT06812078
- Testing
- TAK-360
- Where
- 29 sites in United States, France and 4 more
- Volunteers
- 96 people
- Sponsor
- Takeda
Narcolepsy, Excessive Daytime Sleepiness
A Phase 1, Single Dose Study of JZP-386 to Evaluate Safety, Pharmacokinetics and Pharmacodynamics
This study is being conducted to evaluate the safety, tolerability, blood distribution and effectiveness single ascending doses of JZP-386 compared to doses of Xyrem® and placebo.
- Trial name
- NCT02215499
- Testing
- Sodium Oxybate, JZP-386
- Where
- United Kingdom
- Volunteers
- 28 people, healthy volunteers welcome
- Sponsor
- Concert Pharmaceuticals
Narcolepsy Type 1
Evaluation of the Effectiveness of a Physical Activity Program on the Severity of Narcolepsy
Narcolepsy Type 1 (NT1) is a rare chronic neurological disorder resulting from the selective loss of hypocretin neurons. Patients with NT1 suffer from excessive daytime sleepiness, disrupted nighttime sleep, and cataplexy…
- Trial name
- NARCOSPORT (NCT05460052)
- Testing
- Physical activity training program, Weekly phone call., Personalized training plan.
- Where
- France
- Volunteers
- 30 people
- Sponsor
- Hospices Civils de Lyon
Obstructive Sleep Apnea
Bright Light Therapy for Residual Daytime Symptoms Associated With Obstructive Sleep Apnea
Sleep apnea is one of the most common chronic condition among US military Veterans, causing sleepiness, reduced psychomotor vigilance and depression, which undermine daytime functioning and quality of life.
- Trial name
- NCT04299009
- Testing
- Bright light therapy glasses
- Where
- United States
- Volunteers
- 15 people
- Sponsor
- VA Office of Research and Development
D012893, Sleep Disorder
Prevalence of Sleep Disturbances in Elderly People Hospitalized in Medicine, Psychiatry and Rehabilitation Departments: TOPASE Prospective Study, RIPH 3
Objectives and evaluation criteria: The main objective of this study is to evaluate changes in sleep quality in patients aged 60 and over since their admission to a medical, psychiatric or medical and rehabilitation ward in one…
- Trial name
- TOPASE (NCT06659575)
- Where
- 10 sites in France
- Volunteers
- 104 people
- Sponsor
- University Hospital, Angers
Narcolepsy Type 1, Hypersomnolence
Mind-wandering and Predictive Processes in Narcolepsy: a Putative Mechanism Through Covert REM Intrusions
Mind wandering is a state in which attention turns away from the external environment or current task to focus on internal thoughts (past experiences, future events, planned actions...).
- Conditions
- Narcolepsy Type 1, Hypersomnolence, Idiopathic Hypersomnia
- Trial name
- NARCOWANDERING (NCT06457945)
- Testing
- ASRT, Questionnaires, Electrophysiological recordings
- Where
- France
- Volunteers
- 180 people
- Sponsor
- Hospices Civils de Lyon
Obstructive Sleep Apnea (OSA), Insomnia
Validating the Use of a Subjectively Reported Sleep Vital Sign
Sleep disorders are commonly under-recognized in the primary care setting and available screening tools are often are limited. The study inestigators hypothesize that the use of a novel subjective sleep vital sign (VS) will…
- Conditions
- Obstructive Sleep Apnea (OSA), Insomnia, Restless Leg Syndrome (RLS), Hypersomnia Type; Sleep Disorder
- Trial name
- SVS (NCT03018912)
- Testing
- Sleep VS
- Where
- United States
- Volunteers
- 1,260 people, healthy volunteers welcome
- Sponsor
- Kaiser Permanente
Myotonic Dystrophy, Type 1 (DM1), Myotonic Dystrophy
Safety, Tolerability and Pharmacokinetics of ERX-963 in Adults With Myotonic Dystrophy Type 1
Participants in this study will receive two treatments, placebo and ERX-963, on different days in a randomized fashion. The primary purpose of this study is to investigate the safety and tolerability of ERX-963 in participants…
- Trial name
- NCT03959189
- Testing
- ERX-963
- Where
- 4 sites in United States
- Volunteers
- 12 people
- Sponsor
- Expansion Therapeutics, Inc.
Sleep Disturbance
Bonafide Sleep Supplement for Menopausal Women With Sleep Complaints
This open-label study was designed to evaluate whether a daily dietary sleep supplement could improve sleep quality and related daytime well-being in menopausal women aged 40 to 65 with sleep complaints.
- Trial name
- NCT07839312
- Testing
- S-Adenosyl Methionine (SAMe), Propyl Gallate, Gamma-Aminobutyric Acid (GABA), L-Theanine, and Magnesium Glycinate
- Where
- United States
- Volunteers
- 111 people, healthy volunteers welcome
- Sponsor
- Bonafide Health
Hypersomnia
Disentangling the Role of Depression in Hypersomnia
Individuals who have disorders of hypersomnolence (excessive sleepiness) often report symptoms of depression. The goal of this study is to further understand of the relationship between depression and hypersomnia by examining…
- Trial name
- NCT05850676
- Testing
- Sleep study
- Where
- United States
- Volunteers
- 54 people
- Sponsor
- University of Pennsylvania
Narcolepsy
A Safety and Effectiveness Study of a Single Dose of JNJ-17216498 in Patients With Narcolepsy
The purpose of this study is to evaluate the safety and effectiveness of JNJ-17216498 compared to modafinil and placebo in patients with narcolepsy, with and without cataplexy.
- Trial name
- NCT00424931
- Testing
- JNJ-17216498, Modafinil
- Where
- 16 sites in United States
- Volunteers
- 16 people
- Sponsor
- Alza Corporation, DE, USA
Sleep Deprivation, Depression
Work Hour Reductions, Medical Errors, and Intern Well-Being at Providence St. Vincent Medical Center Intensive Care Unit
The purpose of this study is to determine whether reducing intern work hours and eliminating extended shifts in the intensive care unit will reduce prescribing errors and improve intern well-being.
- Trial name
- NCT00996320
- Testing
- Reduced work hour schedule
- Where
- United States
- Volunteers
- 22 people, healthy volunteers welcome
- Sponsor
- Providence Health & Services
Endometriosis, Sleep
Sleep Quality, Daytime Sleepiness and Insomnia in Patients With Endometriosis: a Case-control Study.
This study included women referred to two academic centres for the diagnosis and treatment of endometriosis (cases) and women referred to our Institutions because of routine gynaecologic consultations (controls).
- Trial name
- NCT02027142
- Testing
- Pittsburgh Sleep Quality Index., Epworth sleepiness scale., Insomnia Severity Index.
- Where
- 2 sites in Italy
- Volunteers
- 290 people
- Sponsor
- IRCCS Azienda Ospedaliera Universitaria San Martino - IST Istituto Nazionale per la Ricerca sul Cancro, Genoa, Italy