Clinical trials: Disorders of Excessive Somnolence
Narcolepsy
A Study of the Safety and Effectiveness of ADX-N05 in the Treatment of Excessive Daytime Sleepiness
This is a study to evaluate the safety and effectiveness of ADX-N05 compared to placebo in the treatment of excessive daytime sleepiness in adults with narcolepsy.
- Trial name
- NCT01485770
- Testing
- ADX-N05
- Where
- 10 sites in United States
- Volunteers
- 33 people
- Sponsor
- Jazz Pharmaceuticals
Down Syndrome, Obstructive Sleep Apnea Syndrome
Down Syndrome and Continuous Positive Pressure Therapy
The purpose of this study is to evaluate the efficacy and tolerability of Continuous Positive Pressure for SAOS in Down Syndrome patients.
- Trial name
- Morphee (NCT00394290)
- Testing
- Continuous Positive Pressure
- Where
- France
- Volunteers
- 31 people
- Sponsor
- Institut Jerome Lejeune
Idiopathic Hypersomnia
A Phase 3 Efficacy and Safety Study of HBS-301 in Participants With Idiopathic Hypersomnia (IH)
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 adult participants (ages ≥18 years) with idiopathic hypersomnia (IH).
- Trial name
- NCT07500090
- Testing
- HBS-301 tablet
- Where
- 42 sites in United States, Canada
- Volunteers
- 248 people
- Sponsor
- Harmony Biosciences Management, Inc.
Sleep Initiation and Maintenance Disorders, Circadian Rhythm Sleep Disorders
Light Exposure to Treat Sleep Disruption in Older People
The purpose of this study is to test whether shifts in the timing of the biological clock to a later hour (phase delay shifts of the human circadian system) can be produced in response to four successive evenings of light…
- Conditions
- Sleep Initiation and Maintenance Disorders, Circadian Rhythm Sleep Disorders, Hypersomnia
- Trial name
- NCT00427323
- Testing
- light exposure
- Where
- United States
- Volunteers
- 60 people, healthy volunteers welcome
- Sponsor
- National Institute on Aging (NIA)
Narcolepsy, Amyloid Pathology
Narcolepsy Protect Against Alzheimer's Disease?
Links between orexin and amyloid processes have been underlined recently. During the Alzheimer's process an upregulation of the orexin mechanism has been observed.
- Trial name
- PROTECMAN (NCT03378453)
- Testing
- PET-scan18F-AV-45
- Where
- France
- Volunteers
- 38 people
- Sponsor
- University Hospital, Montpellier
Dementia, Sleep Apnea
Effect of Treating Sleep Apnea on Cognition in Patients With Dementia
The purpose of this study is to determine whether treating sleep apnea with continuous positive airway pressure would result in improvements in cognition in patients with Alzheimer's disease.
- Trial name
- NCT00477828
- Testing
- Continuous positive airway pressure
- Where
- United States
- Volunteers
- 61 people, healthy volunteers welcome
- Sponsor
- University of California, San Diego
Narcolepsy, Obstructive Sleep Apnea (OSA)
Study of Psychological, Sociological and Professional Factors Associated With Maintenance of Wakefulness Test
The predictors of objective impaired alertness assessed by Maintenance of Wakefulness Tests (MWT) are poorly understood. Identifying such predictors are essential from a clinical point of view and from a pathophysiological…
- Trial name
- STAYAWAKE (NCT06586138)
- Testing
- STAI (State-Trait Anxiety Inventory) Scale : Psychological inventory of 20 self-report items on a 4-point scale
- Where
- France
- Volunteers
- 103 people
- Sponsor
- Hospices Civils de Lyon
Narcolepsy, Cataplexy Narcolepsy
Clinical Outcomes in Narcolepsy and Cataplexy: An Evaluation of Reboxetine Treatment (CONCERT)
CONCERT (Clinical Outcomes in Narcolepsy and Cataplexy: An Evaluation of Reboxetine Treatment) is a Phase 2, double-blind, randomized, placebo-controlled, crossover, multicenter trial of AXS-12 in patients with narcolepsy.
- Conditions
- Narcolepsy, Cataplexy Narcolepsy, Excessive Sleepiness
- Trial name
- CONCERT (NCT03881852)
- Testing
- AXS-12 (Reboxetine)
- Where
- 14 sites in United States
- Volunteers
- 21 people
- Sponsor
- Axsome Therapeutics, Inc.
Narcolepsy
"Twelve-week Study of the Safety and Efficacy of JZP-110 in the Treatment of Excessive Sleepiness in Narcolepsy"
This trial is a 12-week, randomized, double-blind, placebo controlled, multicenter, 4-treatment parallel group study of the safety and efficacy of JZP-110 in the treatment of excessive sleepiness in adult subjects with narcolepsy.
- Trial name
- NCT02348593
- Testing
- JZP-110
- Where
- 60 sites in United States, Canada and 4 more
- Volunteers
- 239 people
- Sponsor
- Jazz Pharmaceuticals
Parkinson's Disease
Circadian Rhythms and Sleep-Wake Cycles in Parkinson's Disease
Disruption of sleep and alertness is one of the most disabling non-motor symptoms of Parkinson's disease (PD). Mechanisms leading to impaired sleep and alertness in PD are not well understood, and treatment options remain…
- Trial name
- NCT01742182
- Testing
- Light exposure
- Where
- United States
- Volunteers
- 70 people, healthy volunteers welcome
- Sponsor
- Massachusetts General Hospital
Idiopathic Hypersomnia, Excessive Daytime Sleepiness
A Long-Term Safety and Effectiveness Study to Evaluate Pitolisant in Adult Patients With Idiopathic Hypersomnia
The primary objective of this study is to assess the long-term safety and effectiveness of pitolisant in patients with idiopathic hypersomnia (IH) who completed the Double-Blind Randomized Withdrawal Phase of study HBS-101-CL-010.
- Trial name
- NCT05458128
- Testing
- Pitolisant
- Where
- 32 sites in United States
- Volunteers
- 119 people
- Sponsor
- Harmony Biosciences Management, Inc.
Dementia, Alzheimer Disease
The Music, Sleep and Dementia Study
The specific aims of this studyare to examine the 1) feasibility; 2) acceptability; and 3) preliminary efficacy of a tailored music intervention in home-dwelling older adults with dementia suffering from sleep disruption.
- Conditions
- Dementia, Alzheimer Disease, Circadian Rhythm Disorders, Circadian Rhythm Sleep Disorder
- Trial name
- NCT04157244
- Testing
- Tailored music listening intervention
- Where
- United States
- Volunteers
- 32 people, healthy volunteers welcome
- Sponsor
- University of Pennsylvania
Hypersomnia
Importance of Sleep Deprivation in Differential Diagnosis of Primary Hypersomnia (Actisom dépistage)
7 to 14 days actimetry recording in order to exclude sleep deprivation just before hospitalisation for differential diagnosis of hypersomnia
- Trial name
- Actisom (NCT03459300)
- Where
- France
- Volunteers
- 100 people
- Sponsor
- Centre d'Investigation Clinique et Technologique 805
Dementia With Lewy Bodies
"Pilot Study of Armodafinil in Patients With Dementia With Lewy Bodies"
This research study is to examine the effects of the study medication Armodafinil in patients with dementia with Lewy bodies (DLB).
- Trial name
- NCT01023672
- Testing
- Armodafinil
- Where
- United States
- Volunteers
- 20 people
- Sponsor
- Mayo Clinic
Healthy, Narcolepsy
A Clinical Study of MK-6552 and Modafinil in Healthy Men (MK-6552-005)
The goal of this study is to learn what happens to MK-6552 in a person's body over time. Researchers will compare what happens to levels of MK-6552 in people's blood when it is taken with and without modafinil.
- Trial name
- NCT06665230
- Testing
- MK-6552, Modafinil
- Where
- United States
- Volunteers
- 12 people, healthy volunteers welcome
- Sponsor
- Merck Sharp & Dohme LLC
Narcolepsy
A Study of HBS-201 (Pitolisant Delayed-release)
The purpose of this study is to assess the tolerability of HBS-201 when starting at a therapeutic dose in adult participants with narcolepsy.
- Trial name
- NCT07051252
- Testing
- HBS-201
- Where
- 15 sites in United States
- Volunteers
- 46 people
- Sponsor
- Harmony Biosciences Management, Inc.
Parkinson Disease, Sleep Disorders
Clock and Narcolepsy Genetic Variants and the Effects of Stalevo® (Levodopa/Carbidopa/Entacapone) on Sleep Disorders in Parkinson's Disease
The purpose of this study is to investigate the genetic variants of clock and narcolepsy genes that determine the therapeutic effects of Stalevo® on the quality of sleep in patients with Parkinson's Disease.
- Trial name
- NCT02452606
- Testing
- Stalevo®
- Where
- South Korea
- Volunteers
- 100 people
- Sponsor
- Asan Medical Center
Wakefulness Disorder, Narcolepsy
Hypersomnia in the Paediatric Population
This is a 36-month, multicentric, cross-sectional study involving a paediatric population aged 6 to 17 years. Three groups will be included: Group A: children from the general population with no complaints of sleepiness; Group B…
- Conditions
- Wakefulness Disorder, Narcolepsy, Idiopathic Hypersomnia
- Trial name
- SOMNO-PED (NCT07766343)
- Testing
- Sleepness and wakeness scale, Polysomnography, Actimetry
- Where
- France
- Volunteers
- 760 people, healthy volunteers welcome
- Sponsor
- University Hospital, Montpellier
Sleep, Slow-wave Sleep, Sleep Enhancement, Sleep Optimization, Sleep Inertia
Association Between Slow Wave Activity and Sleep Inertia
Observational study: The goal of this observational study is to learn about the association between slow wave activity before awakening and post-awakening psychomotor vigilance task in time-fixed, 2-hour, simulated night naps in…
- Conditions
- Sleep, Slow-wave Sleep, Sleep Enhancement, Sleep Optimization, Sleep Inertia, Night Shift Work
- Trial name
- NCT07409883
- Testing
- Nap intervention
- Where
- Thailand
- Volunteers
- 28 people, healthy volunteers welcome
- Sponsor
- Mahidol University
Narcolepsy
A Patient-Centric, Prospective, Observational, Non-Interventional Switch Study of XYWAV in Narcolepsy
The rationale for the patient-centric, prospective, observational, non-interventional study design of JZP258-402 is to evaluate the transition experience of participants with narcolepsy treated with oxybate and to examine the…
- Trial name
- NCT04803786
- Testing
- Transition from Xyrem to Xywav
- Where
- United States
- Volunteers
- 110 people
- Sponsor
- Jazz Pharmaceuticals