Clinical trials: Sleep Problems
Obstructive Sleep Apnea
AD109 Dose Finding in Mild to Moderate OSA
This is a randomized, 3-period, placebo-controlled, crossover, phase 2 clinical study to examine the efficacy and safety of 2 doses of AD109 vs placebo in patients with mild obstructive sleep apnea.
- Trial name
- NCT04631107
- Testing
- AD109 dose1- A, AD109 dose2- B
- Where
- 3 sites in United States
- Volunteers
- 32 people
- Sponsor
- Apnimed
Insomnia Disorder
Study to Evaluate the Effect of 2 Dosage Strengths of Lemborexant (E2006) on a Multiple Sleep Latency Test in Participants With Insomnia Disorder
This is a single-dose, randomized, placebo-controlled, 3-way crossover study of 2 dosage strengths of lemborexant (5 mg and 10 mg) in participants with insomnia disorder.
- Trial name
- NCT02350309
- Testing
- Lemborexant 5 mg, Lemborexant 10 mg, Flurazepam 30 mg
- Where
- 2 sites in United States
- Volunteers
- 69 people
- Sponsor
- Eisai Inc.
Obstructive Sleep Apnea Syndrome
Brain Oxygenation and Hemodynamics During Sleep in Obstructive Sleep Apnea Sufferers
The goal of this trial is to assess the performance of the OxiplexTS-an absolute near-infrared oximeter-as an instrument to measure brain oxygenation and hemodynamics in sleep medicine as well as in the broader field of…
- Trial name
- NIRS-OSAS (NCT00591591)
- Testing
- OxiplexTS
- Where
- 4 sites in United States
- Volunteers
- 309 people, healthy volunteers welcome
- Sponsor
- ISS, Inc.
Restless Legs
Intravenous Iron Metabolism in Restless Legs Syndrome
Double-blind, placebo-controlled, entitled: "Intravenous Iron Metabolism in Restless Legs Syndrome
- Trial name
- RLS (NCT00685815)
- Testing
- Ferric Carboxymaltose (FCM)
- Where
- United States
- Volunteers
- 12 people
- Sponsor
- American Regent, Inc.
Obesity Hypoventilation Syndrome
AVAPS-AE Efficacy Study
The purpose of this study is to evaluate the feasibility of using of the Average Volume Assured Pressure Support (AVAPS-AE) mode versus Continuous Positive Airway Pressure (CPAP) and bilevel pressure support ventilation (PSV)…
- Trial name
- NCT01368614
- Testing
- AVAPS-AE Mode of Therapy, Respironics OnmiLab BiPAP S mode, Respironics OmniLab Advanced CPAP mode
- Where
- 2 sites in United States
- Volunteers
- 90 people
- Sponsor
- Philips Respironics
Parenting Practices, Self Efficacy
Evaluation Study of Talk Parenting Skills
After development of the prototype Bedtime Routine module of the Talk Parenting program, the investigators will evaluate its feasibility and initial efficacy in a within-subjects pre-post design study.
- Conditions
- Parenting Practices, Self Efficacy, Stress, Child Behavior
- Trial name
- NCT04633434
- Testing
- The Talk Parenting Skill for Alexa
- Where
- United States
- Volunteers
- 98 people, healthy volunteers welcome
- Sponsor
- Oregon Research Behavioral Intervention Strategies, Inc.
Insomnia
VEC-162 Study in Healthy Adult Volunteers in a Model of Insomnia
The purpose of this study is to determine the safety and efficacy of VEC-162 compared to placebo to improve sleep parameters in a model of insomnia.
- Trial name
- NCT00291187
- Testing
- 20 mg VEC-162, 50 mg VEC-162, 100 mg VEC-162
- Where
- 19 sites in United States
- Volunteers
- 411 people, healthy volunteers welcome
- Sponsor
- Vanda Pharmaceuticals
Obstructive Sleep Apnea, Central Sleep Apnea
Comparison of SomnaPatch With Polysomnography in Sleep Disordered Breathing
The purpose of this study is to evaluate the accuracy of Somnarus diagnostic technology for diagnosis of sleep apnea in human subjects.
- Conditions
- Obstructive Sleep Apnea, Central Sleep Apnea, Mixed Sleep Apnea, Cheyne-Stokes Respiration
- Trial name
- NCT02034175
- Testing
- SomnaPatch, Polysomnography
- Where
- 3 sites in United States
- Volunteers
- 190 people
- Sponsor
- Somnarus Inc
Narcolepsy
A Study of the Safety and Effectiveness of ADX-N05 for Excessive Daytime Sleepiness in Subjects With Narcolepsy
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
- NCT01681121
- Testing
- ADX-N05
- Where
- 28 sites in United States
- Volunteers
- 93 people
- Sponsor
- Jazz Pharmaceuticals
Sleep Apnea, Obstructive
Comparison Study of the ICON™ Auto Series With and Without SensAwake™ and ThermoSmart™ and Conventional Continuous Positive Airway Pressure in Obstructive Sleep Apnea Patients
A total of 216 patients will be randomized into a partially single blind, randomized, parallel-arm trial to determine whether the ICON™ AT with SensAwake™ and ThermoSmart™ can improve therapy adherence when compared to standard…
- Trial name
- NCT01517763
- Testing
- Conventional CPAP Therapy, Fixed pressure ICON™ without ThermoSmart™, Auto ICON™ with SensAwake™ and ThermoSmart™
- Where
- United States
- Volunteers
- 32 people
- Sponsor
- Fisher and Paykel Healthcare
Sleep Disordered Breathing
Evaluation of Software Enhancements to the Respironics BiPAP autoSV Device Compared to BiPAP S/T Device
This study is being undertaken to collect data from Respironics, Inc's BiPAP autoSV3 and compare with data from Respironics, Inc's BiPAP S/T device, to confirm that the algorithms in the BiPAP autoSV3 device can safely and…
- Trial name
- SV3-ST (NCT01241604)
- Testing
- BiPAP S/T, BiPAP Auto SV3
- Where
- United States
- Volunteers
- 11 people, healthy volunteers welcome
- Sponsor
- Philips Respironics
Primary Insomnia
Almorexant (ACT 078573) in Adult Subjects With Chronic Primary Insomnia
A polysomnography study to evaluate the effect, safety and tolerability of oral administration of almorexant (ACT 078573) in adult subjects with primary insomnia.
- Trial name
- RESTORA 1 (NCT00608985)
- Testing
- almorexant, zolpidem
- Where
- 91 sites in Australia, Austria and 18 more
- Volunteers
- 709 people
- Sponsor
- Midnight Pharma, LLC
Obstructive Sleep Apnea
Sleep Apnea Study in Adults Using DreamPort-Eclipse and a Traditional Nasal Mask
The Randomized Controlled Trial of Bleep DreamPort-Eclipse Study is a two-arm, randomized, prospective, non-blinded study to assess the effectiveness of the novel CPAP human interface design to improve leak, AHI, and pressure…
- Trial name
- NCT05818540
- Testing
- Eclipse novel CPAP mask, ResMed P-10 mask
- Where
- United States
- Volunteers
- 173 people, healthy volunteers welcome
- Sponsor
- Bleep, LLC
Restless Legs Syndrome
Study to Investigate Pharmacokinetics (PK) of Pramipexole in Pediatric Patients Who Are Individually Optimized to Stable Pramipexole Doses for the Treatment of Idiopathic Restless Legs Syndrome (RLS)
Study to determine the pharmacokinetics (PK) of pramipexole (PPX) after administration of a single dose orally (p.o.) in pediatric patients with the diagnosis of RLS
- Trial name
- NCT02231918
- Testing
- MIRAPEX® - low, MIRAPEX® - medium, MIRAPEX® - high
- Volunteers
- 26 people
- Sponsor
- Boehringer Ingelheim
Chronic Insomnia, Adults
A Multicenter, Randomized, Double-blind, Placebo-controlled, Parallel-group, Bayesian Adaptive Randomization Design, Dose Response Study of the Efficacy of E2006 in Adults and Elderly Subjects With Chronic Insomnia
This is a multicenter, multiple dose, randomized, double-blind, placebo-controlled, parallel-group, Bayesian adaptive, dose response study in subjects with chronic insomnia.
- Conditions
- Chronic Insomnia, Adults, Elderly
- Trial name
- NCT01995838
- Testing
- E2006
- Where
- 29 sites in United States
- Volunteers
- 291 people
- Sponsor
- Eisai Inc.
Narcolepsy
An Interventional Safety Switch Study (Segue Study) of XYWAV in Narcolepsy
The rationale for the interventional, open-label, single-arm design of JZP258-401 is to evaluate the clinical experience in participants with narcolepsy transitioning treatment from Xyrem to XYWAV.
- Trial name
- NCT04794491
- Testing
- JZP-258
- Where
- 28 sites in United States
- Volunteers
- 62 people
- Sponsor
- Jazz Pharmaceuticals
Obstructive Sleep Apnea
CPAP In-home Assessment USA
The study is to evaluate the product reliability, therapy effectiveness and user feedback of a Continuous Positive Airway Pressure (CPAP) device in-home for up to 6 months.
- Trial name
- NCT02809859
- Testing
- Fisher & Paykel Healthcare CPAP Device
- Where
- 4 sites in United States
- Volunteers
- 139 people
- Sponsor
- Fisher and Paykel Healthcare
Apnea, Sleep
Radiofrequency Ablation for Multi-level Obstructive Sleep Apnea: A Single-arm, Multicenter Study
The United States is currently experiencing an increase in the incidence and prevalence of obstructive sleep apnea (OSA). With prevalence in middle-aged adults of 2 to 4% of the population, untreated OSA has been implicated in…
- Trial name
- NCT02349893
- Testing
- RFA treatment
- Where
- 6 sites in United States
- Volunteers
- 56 people
- Sponsor
- Olympus Surgical Technologies Europe
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
Restless Legs Syndrome (RLS)
Randomized, Placebo-controlled Trial of Ferric Carboxymaltose in RLS Patients With Iron-deficiency Anemia
Treatment Phase I and II Primary Objective: To evaluate the efficacy and safety of FCM (750 mg dose x 2) for treatment of Restless Legs Syndrome (RLS) in patients with iron-deficiency anemia (IDA).
- Trial name
- NCT02826681
- Testing
- Injectafer® (Ferric Carboxymaltose - FCM)
- Where
- 8 sites in United States
- Volunteers
- 70 people
- Sponsor
- American Regent, Inc.