Clinical trials: Disorders of Excessive Somnolence
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
A Web-based Observational Study of Patient-reported Outcomes in Adults With Narcolepsy
Nexus is a collaboration between academic institutions, advocacy and industry to answer important questions about narcolepsy. It is a web-based observational study of patient-reported outcomes in adult patients with narcolepsy…
- Trial name
- NCT02769780
- Where
- United States
- Volunteers
- 1,500 people
- Sponsor
- Jazz Pharmaceuticals
Sleep Apnea, Obstructive, Sleep Apnea Syndromes
Continuous Positive Airway Pressure (CPAP) After Adenotonsillectomy in Children
Obstructive sleep-disordered breathing (SDB) affects 2-3% of children and may lead to problems with nighttime sleep and daytime behavior, learning, sleepiness, and mood.
- Conditions
- Sleep Apnea, Obstructive, Sleep Apnea Syndromes, Child Behavior Disorders, Attention Deficit Disorder With Hyperactivity
- Trial name
- NCT01554527
- Testing
- CPAP treatment, No CPAP treatment
- Where
- United States
- Volunteers
- 120 people
- Sponsor
- University of Michigan
Narcolepsy Without Cataplexy, Idiopathic Hypersomnia
Clarithromycin Mechanisms in Hypersomnia Syndromes
The purpose of this study is to evaluate a medication called clarithromycin for treating sleepiness in narcolepsy and idiopathic hypersomnia.
- Conditions
- Narcolepsy Without Cataplexy, Idiopathic Hypersomnia, Narcolepsy With Cataplexy
- Trial name
- NCT04026958
- Testing
- Clarithromycin
- Where
- United States
- Volunteers
- 83 people
- Sponsor
- Emory University
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.
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
Evaluation of Academic and Professional Trajectories of Narcoleptic Patients
Narcolepsy is a chronic, disabling condition characterized by excessive daytime sleepiness and, in some patients, falls in muscle tone related to emotions (cataplexies). It often begins in childhood or in young adults.
- Trial name
- NARCOWORK (NCT03173378)
- Testing
- Questionnaires
- Where
- France
- Volunteers
- 149 people, healthy volunteers welcome
- Sponsor
- Hospices Civils de Lyon
Idiopathic Hypersomnia
a Chronobiological Treatment Combining Evening Melatonin and Morning Light Therapy in Idiopathic Hypersomnia: a Prospective, Double Bind, Randomized, Placebo-controlled -Trial
Idiopathic hypersomnia (IH) is a chronic disabling disorder characterized by excessive daytime sleepiness (EDS), prolonged nighttime sleep and sleep inertia.
- Trial name
- HyperChrono (NCT06252571)
- Testing
- - Melatonin - Active light ttherapy
- Where
- France
- Volunteers
- 72 people
- Sponsor
- University Hospital, Strasbourg, France
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
COPD
Comparing Fluticasone-salmeterol in Chronic Obstructive Pulmonary Disease (COPD) and Sleep
Fluticasone (Advair), an inhaled corticosteroid and salmeterol, a long-acting beta agonist, are approved for use in the management of COPD.
- Trial name
- NCT00731770
- Testing
- Advair 250, Advair 250 - matched
- Where
- United States
- Volunteers
- 10 people
- Sponsor
- Milton S. Hershey Medical Center
Narcolepsy, Excessive Daytime Sleepiness
Efficacy and Safety Study of BF2.649 in the Treatment of Excessive Daytime Sleepiness in Narcolepsy
The objective of this study is to evaluate the efficacy and safety of BF2.649 administered by individual titration in narcoleptic patients with excessive daytime sleepiness (EDS)
- Conditions
- Narcolepsy, Excessive Daytime Sleepiness, Cataplexy, Sleep Disorders
- Trial name
- Harmony1 (NCT01067222)
- Testing
- BF2.649, Modafinil
- Where
- Switzerland
- Volunteers
- 110 people
- Sponsor
- Bioprojet
Sleep Apnea, Hypersomnia
Patient Outcomes in Unattended and In- Lab Polysomnography
This randomized controlled study will directly evaluate whether unattended polysomnography (level 2 sleep study) in individuals referred for sleep apnea or hypersomnia, including those with comorbidities of insomnia and…
- Trial name
- NCT05230394
- Testing
- Attended Polysomnography in the Lab, Unattended Polysomnography in the Home
- Where
- Canada
- Volunteers
- 194 people, healthy volunteers welcome
- Sponsor
- Cerebra Medical
Narcolepsy Type 1, Narcolepsy Type 2
A Long-term Extension Study of ORX750 in Participants With Narcolepsy and Idiopathic Hypersomnia
This study is a long-term extension (LTE) of the parent Study ORX750 0201, and will provide long-term open-label safety, tolerability, and efficacy of ORX750 in participants with narcolepsy type 1 (NT1), narcolepsy type 2 (NT2)…
- Conditions
- Narcolepsy Type 1, Narcolepsy Type 2, Idiopathic Hypersomnia
- Trial name
- NCT07096674
- Testing
- ORX750
- Where
- 24 sites in United States, Canada and 2 more
- Volunteers
- 90 people
- Sponsor
- Centessa Pharmaceuticals (UK) Limited
Pregnancy Related, Narcolepsy
WAKIX® (Pitolisant) Pregnancy Registry
The WAKIX (pitolisant) Pregnancy Registry is a US-based, prospective, observational cohort study designed to evaluate the association between pitolisant exposure during pregnancy and subsequent maternal, fetal, and infant…
- Trial name
- NCT05536011
- Testing
- Pitolisant, Comparator Products
- Where
- United States
- Volunteers
- 1,329 people
- Sponsor
- Harmony Biosciences Management, Inc.
Narcolepsy, Narcolepsy Type 1
Decreasing Nightmares in Adults With Narcolepsy
The purpose of this clinical trial is learn whether a behavioral (non-medication) treatment can reduce nightmares in adults with narcolepsy. All participants will receive the treatment and will complete three assessments.
- Conditions
- Narcolepsy, Narcolepsy Type 1, Narcolepsy With Cataplexy, Narcolepsy Without Cataplexy
- Trial name
- DAWN (NCT06383806)
- Testing
- Imagery Rehearsal Therapy (IRT)
- Where
- United States
- Volunteers
- 80 people
- Sponsor
- University of Utah
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
Long COVID, Long COVID-19
RECOVER-SLEEP: Platform Protocol, Appendix_A (Hypersomnia)
The platform protocol is designed to be flexible so that it is suitable for a range of study settings and intervention types. Therefore, the platform protocol provides a general protocol structure that can be shared by multiple…
- Conditions
- Long COVID, Long COVID-19, Hypersomnia
- Trial name
- NCT06404099
- Testing
- Modafinil, Solriamfetol
- Where
- United States
- Volunteers
- 361 people
- Sponsor
- Duke University
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
Sleep-wake Disturbances in Motor-phase Parkinson's Disease
Study of the Symptomatic Effects of Nocturnal Sodium Oxybate in Parkinson's Disease
Sleep wake disturbance is a common problem in Parkinson's disease patients and so far the therapeutic possibilities for symptomatic relief are limited.
- Trial name
- PD-Xyrem (NCT02111122)
- Testing
- Sodium Oxybate
- Where
- Switzerland
- Volunteers
- 16 people
- Sponsor
- Christian Baumann
Narcolepsy, Idiopathic Hypersomnia
Cardiovascular and Cognitive Implications of Central Disorders of Hypersomnolence and Their Treatments
This is an observational study evaluating patients diagnosed with narcolepsy or idiopathic hypersomnia that have been prescribed a new/different hypersomnia treatment.
- Trial name
- NCT05371483
- Testing
- 24-hour Ambulatory Blood Pressure Monitoring, Oculo-Cognitive Addition Test (OCAT)
- Where
- United States
- Volunteers
- 100 people
- Sponsor
- Mayo Clinic