Clinical trials: Drowsiness
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
Obstructive Sleep Apnea
"Six-week Study of the Safety and Efficacy of JZP-110 in the Treatment of Excessive Sleepiness in OSA"
This trial is a 6-week, double-blind, placebo-controlled, randomized-withdrawal, multicenter study of safety and efficacy of JZP-110 in the treatment of excessive sleepiness in adult subjects with OSA.
- Trial name
- OSA (NCT02348619)
- Testing
- JZP-110
- Where
- 30 sites in United States, Finland and 3 more
- Volunteers
- 174 people
- Sponsor
- Jazz Pharmaceuticals
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.
Idiopathic Hypersomnia
A Multicenter Study of the Efficacy and Safety of JZP-258 in the Treatment of Idiopathic Hypersomnia (IH) With an Open-label Safety Extension
This is a study of the efficacy and safety of JZP-258, an oxybate mixed-salts oral solution being developed as a low sodium alternative product for Xyrem.
- Trial name
- NCT03533114
- Testing
- JZP-258
- Where
- 63 sites in United States, Belgium and 6 more
- Volunteers
- 154 people
- Sponsor
- Jazz Pharmaceuticals
Partial Epilepsy
Randomized Controlled Trial to Assess Effects of Lacosamide on Sleep and Wake in Adults With Focal Epilepsy
Sleepiness and fatigue are the most common complaints of people with epilepsy and can have a negative impact on quality of life. Though unproven, these problems are often blamed on anti-seizure medications.
- Trial name
- NCT01190098
- Testing
- Lacosamide
- Where
- United States
- Volunteers
- 59 people
- Sponsor
- The Cleveland Clinic
Narcolepsy With Cataplexy, Narcolepsy Without Cataplexy
Efficacy and Safety of Pitolisant in Pediatric Narcoleptic Patients With or Without Cataplexy, Double-blind Study Followed by a Prolonged Open-label Period
The purpose of this multicenter double blind study is to assess efficacy and safety of Pitolisant versus placebo in paediatric Narcoleptic patients with or without cataplexy.
- Trial name
- NCT02611687
- Testing
- pitolisant
- Where
- 11 sites in Finland, France and 3 more
- Volunteers
- 110 people
- Sponsor
- Bioprojet
Narcolepsy
Trial of Xyrem® (Sodium Oxybate) for the Treatment of Narcolepsy
This is a long-term, open-label, extension of the OMC-SXB-7 trial. Participants from the OMC-SXB-7 open-label trial may be entered without any requirement as to length of participation in that trial.
- Trial name
- NCT00132873
- Testing
- Xyrem (sodium oxybate) oral solution
- Where
- Canada
- Volunteers
- 59 people
- Sponsor
- Jazz Pharmaceuticals
Narcolepsy
A Study to Evaluate Safety, and Efficacy of SUVN-G3031 (Samelisant) in Patients With Narcolepsy With and Without Cataplexy
This study is of an investigational drug called SUVN-G3031 (Samelisant) as a possible treatment for narcolepsy with cataplexy or narcolepsy without cataplexy.
- Trial name
- SUVN-G3031 (NCT04072380)
- Testing
- SUVN-G3031
- Where
- 41 sites in United States, Canada
- Volunteers
- 190 people
- Sponsor
- Suven Life Sciences Limited
Nocturia, Daytime Sleepiness
Cross-over Study of Armodafinil Treatment of Daytime Sleepiness Associated With Treated Nocturia
The objective of the study is to evaluate armodafinil as a wakefulness-promoting therapy as a means of improving residual daytime sleepiness in patients with treated nocturia.
- Trial name
- NCT02151253
- Testing
- Armodafinil
- Where
- United States
- Volunteers
- 81 people
- Sponsor
- Duke University
Insomnia, Blindness
Melatonin for Circadian Sleep Disorders in the Blind
This research project consists of a three part study with five embedded sub studies. The first study phase identifies "body rhythms" of sleepiness/wakefulness and of melatonin levels for each subject (including sub-study 1).
- Conditions
- Insomnia, Blindness, Daytime Sleepiness
- Trial name
- NCT00911053
- Testing
- Melatonin, Regular Sleep Schedule, Light
- Where
- United States
- Volunteers
- 59 people
- Sponsor
- Oregon Health and Science University
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
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 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
Parkinson Disease
Safety and Efficacy of THN102 in Patients With Parkinson's Disease and Excessive Daytime Sleepiness
This is a randomized, placebo-controlled, 3-way cross-over phase IIa trial comparing two dose levels of THN102 to placebo in patients suffering from Parkinson's disease associated with excessive daytime sleepiness.
- Trial name
- NCT03624920
- Testing
- THN102 Dosage A, THN102 Dosage B, THN102 Dosage C
- Where
- 34 sites in United States, Czechia and 3 more
- Volunteers
- 77 people
- Sponsor
- Theranexus
Narcolepsy
Safety and Efficacy of THN102 on Sleepiness in Narcoleptic Patients
This Phase 2 study is a 8-site, double-blind, randomised, placebo-controlled, 3-way cross-over trial, involving 3 treatments with Modafinil 300 mg or the combination drug THN102 (Modafinil/Flecainide 300 /3 mg…
- Trial name
- NCT02821715
- Testing
- THN102 300/3, THN102 300/27
- Where
- 8 sites in Belgium, France
- Volunteers
- 51 people
- Sponsor
- Theranexus
Fatigue
SleepTrackTXT Feasibility and Pilot Study
Aim 1: To determine if real-time assessments of perceived sleepiness and fatigue using text-messaging impacts an emergency medicine clinician's Attitudes, Perceived Norms, Self-Efficacy, Alertness Habits, Perceived Importance of…
- Trial name
- SleepTrackTXT (NCT02063737)
- Testing
- Text-message assessments only, Text-message interventions for high level fatigue
- Where
- United States
- Volunteers
- 100 people, healthy volunteers welcome
- Sponsor
- University of Pittsburgh
Obstructive Sleep Apnea
"Twelve-week Study of the Safety and Efficacy of JZP-110 in the Treatment of Excessive Sleepiness in OSA"
This trial is a 12 week, randomized, double-blind, placebo controlled, multicenter, 5-arm parallel group study of safety and efficacy of JZP-110 in the treatment of excessive sleepiness in adult subjects with OSA.
- Trial name
- OSA (NCT02348606)
- Testing
- JZP-110
- Where
- 59 sites in United States, Canada and 3 more
- Volunteers
- 476 people
- Sponsor
- Jazz Pharmaceuticals
Seasonal Allergic Rhinitis
Fluticasone Furoate Treatment of Daytime Somnolence and Cognitive Performance in Seasonal Allergic Rhinitis
The hypothesis is that treating hay fever patients who had daytime sleepiness and slowed thinking because of the hay fever will improve when treated with an effective anti-hay fever medication, an intranasal steroid, that is will…
- Trial name
- NCT00997620
- Testing
- Fluticasone furoate Nasal Spray 110 mcg
- Volunteers
- 40 people, healthy volunteers welcome
- Sponsor
- Western Sky Medical Research
Excessive Sleepiness, Shift-work Disorder
Clinical Trial of Solriamfetol for Excessive Sleepiness Related to Shift Work Disorder
In this research study the investigators want to learn more about whether the medication Solriamfetol improves daytime sleepiness in workers who start work at very early times (between 3 and 6am).
- Trial name
- NCT04788953
- Testing
- Solriamfetol Oral Tablet
- Where
- United States
- Volunteers
- 84 people, healthy volunteers welcome
- Sponsor
- Charles A. Czeisler, PhD, MD
Idiopathic Hypersomnia
A Phase 3 Study to Assess the Safety and Efficacy of Pitolisant in Adult Patients With Idiopathic Hypersomnia
The primary objective of this study is to evaluate the safety and efficacy of pitolisant compared with placebo in treating excessive daytime sleepiness (EDS) in participants with idiopathic hypersomnia (IH) age ≥18 years.
- Trial name
- NCT05156047
- Testing
- Open-label Pitolisant, Double-blind Pitolisant
- Where
- 58 sites in United States
- Volunteers
- 214 people
- Sponsor
- Harmony Biosciences Management, Inc.