Clinical trials: Dyssomnia
Primary Insomnia
Sleep Laboratory Study to Investigate the Safety and Efficacy of Neu-P11 in Primary Insomnia Patients
This is a phase II study. It is conducted using a randomized, double-blind, 3-arm placebo controlled, parallel group design. Eligible patients will be randomized in a 1:1:1 ratio to receive Neu-P11 20 mg, Neu-P11 50 mg or placebo…
- Trial name
- NCT01489969
- Testing
- Neu-P11
- Where
- 9 sites in United States
- Volunteers
- 137 people
- Sponsor
- Neurim Pharmaceuticals Ltd.
Sleep Disordered Breathing
User Preference/Validation Evaluation of the New Philips Respironics Positive Airway Pressure Application
This pilot study is intended to evaluate the acceptance and performance of the DreamMapper application and the Therapist Assist educational tool in naïve patients with Obstructive Sleep Apnea who have been prescribed Positive…
- Trial name
- NCT03748264
- Testing
- Standard of Care, DreamMapper Application, DreamMapper Application with Therapist Assist
- Where
- 5 sites in United States
- Volunteers
- 62 people, healthy volunteers welcome
- Sponsor
- Philips Respironics
Restless Legs Syndrome
Clinical Evaluation of Ropinirole IR (Immediate Release) Tablets in Patients Who Are Diagnosed With Symptomatic Restless Legs Syndrome (RLS) Associated With Chronic Kidney Disease (CKD) Managed With Haemodialysis (Including Haemofiltration and Haemodiafiltration)
This is a multicenter, placebo controlled, parallel group, double-blind, randomized comparison study to evaluate the efficacy and safety of ropinirole IR tablets orally administered for 12 weeks in patients with symptomatic…
- Trial name
- NCT00996944
- Testing
- Ropinirole immediate release (IR)
- Where
- 19 sites in Japan
- Volunteers
- 34 people
- Sponsor
- GlaxoSmithKline
Obstructive Sleep Apnea
Study to Predict the Benefits of First-line Humidification Use and Comparison of the Effect of ThermoSmart™ and no Humidification on Adherence
This study aims to investigate the benefits of using first line heated humidification. The primary objective of this research is to determine the effect of high levels of humidification delivered by ThermoSmart™ on CPAP…
- Trial name
- NCT01742949
- Testing
- Heated humidification (ThermoSmart), No Humidification
- Where
- 4 sites in France
- Volunteers
- 40 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 Snoring, Sleep Apnea
Study Will Test the Theory That Training With the Facial-Flex Exercise Device Will Improve Snoring in Patients
The study will test the hypothesis that training with the Facial-Flex exercise device for six weeks will improve snoring in patients with primary snoring or very mild sleep apnea.
- Trial name
- NCT01554904
- Testing
- Facial-Flex
- Where
- United States
- Volunteers
- 18 people, healthy volunteers welcome
- Sponsor
- Facial Concepts, Inc.
Obstructive Sleep Apnea
A Development Study to Evaluate a Full-Face Mask for the Treatment of Obstructive Sleep Apnea
This investigation is designed to evaluate the comfort, ease of use and performance of a trial nasal mask for the treatment of Obstructive Sleep Apnea (OSA) in the home environment.
- Trial name
- NCT03272763
- Testing
- F&P Toffee mask
- Where
- United States
- Volunteers
- 38 people
- Sponsor
- Fisher and Paykel Healthcare
Obstructive Sleep Apnea (OSA)
Safety and Tolerability of Gefapixant (MK-7264) in Participants With Obstructive Sleep Apnea (MK-7264-039)
The purpose of this study is to assess the safety and tolerability of multiple dose administration of gefapixant (MK-7264) in participants with moderate to severe obstructive sleep apnea (OSA).
- Trial name
- NCT03882801
- Testing
- Gefapixant
- Where
- 5 sites in United States, Belgium
- Volunteers
- 24 people, healthy volunteers welcome
- Sponsor
- Merck Sharp & Dohme LLC
Restless Legs Syndrome
A Study of Rotigotine Patch in Adolescent Subjects With Restless Legs Syndrome of Unknown Cause
The purpose of this study is to demonstrate the efficacy of rotigotine against placebo in adolescent subjects with idiopathic Restless Legs Syndrome (RLS) over a 12-week maintenance period and to investigate the safety and…
- Trial name
- NCT03728933
- Testing
- Rotigotine 1 milligram/24 hours, Rotigotine 2 milligram/24 hours
- Where
- United States
- Volunteers
- 23 people
- Sponsor
- UCB Biopharma SRL
Restless Legs Syndrome
Iron Sucrose In The Treatment of Restless Legs Syndrome: Safety of Three Dose Regimens as Evaluated by Clinical Assessments
Non-randomized open label Phase II clinical trial in which subjects meeting criteria for RLS were assigned to 1 of 3 treatment cohorts.
- Trial name
- NCT00895232
- Testing
- Cohort I, Cohort II, Cohort III
- Volunteers
- 21 people
- Sponsor
- American Regent, Inc.
Obstructive Sleep Apnea
TheraPAP Equivalence Crossover Study
The present study, TheraEquivalence, is a Phase 2 crossover study designed to examine the efficacy and safety of TheraPAP (TPAP) vs. CPAP alone in the treatment of OSA.
- Trial name
- NCT06238362
- Testing
- TPAP, CPAP
- Where
- United States
- Volunteers
- 50 people
- Sponsor
- SleepRes Inc.
Insomnia
A Six Week, Double-Blind Randomized, Efficacy and Safety, Sleep Lab Trial With Esmirtazapine (Org 50081) (P05707)
The purpose of this trial is to investigate the efficacy, safety and tolerability of esmirtazapine (Org 50081) compared to placebo in patients with chronic primary insomnia.
- Trial name
- NCT00506389
- Testing
- Esmirtazapine
- Volunteers
- 419 people
- Sponsor
- Merck Sharp & Dohme LLC
Sleep Disordered Breathing, Congestion, Nasal
To Characterize the Performance of the Nasal Dilator Strip in Lowering Nasal Resistance During Sleep, Promoting Nasal Route Breathing and Reducing the Signs and Symptoms of Sleep Disordered Breathing in a Group of Chronic Nocturnal Nasal Congestion Sufferers Who Report Trouble With Their Sleep.
To characterize the performance of the nasal dilator strip in lowering nasal resistance during sleep, promoting nasal route breathing and reducing the signs and symptoms of sleep disordered breathing in a group of chronic…
- Trial name
- NCT03105297
- Testing
- Prototype nasal dilator strip, No strip
- Where
- Australia
- Volunteers
- 91 people
- Sponsor
- GlaxoSmithKline
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 Apnea Syndromes
Sleep Disordered Breathing and Chronic Pain
The purpose of this study is to evaluate positive pressure in patients with chronic pain taking opioid medications who have sleep disordered breathing.
- Trial name
- NCT01457014
- Testing
- servo ventilation auto, Continuous positive airway pressure, servo ventilation manual
- Where
- 4 sites in United States
- Volunteers
- 88 people
- Sponsor
- Philips Respironics
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
Sleep Disordered Breathing, Sleep Apnea, Central
Evaluation of Software Enhancements to the Respironics BiPAP Auto Servo Ventilation (AutoSV) Device
This study is being undertaken to collect data from Respironics Inc's BiPAP Auto Servo Ventilation 3 (autoSV3) and compare with data from Respironics, Inc's BiPAP autoSV2, to confirm that the algorithms in the BiPAP autoSV3…
- Trial name
- AUTOSV3 (NCT00720213)
- Testing
- Respironics BiPAP autoSV2, Respironics BiPAP autoSV3
- Where
- 5 sites in United States
- Volunteers
- 44 people, healthy volunteers welcome
- Sponsor
- Philips Respironics
Obstructive Sleep Apnea
FAST as a Treatment for Obstructive Sleep Apnea
The objective of this study is to assess the feasibility and safety of tongue suspension using the Siesta Medical Encore Tongue Suspension System for the treatment of obstructive sleep apnea (OSA).
- Trial name
- FAST (NCT01611779)
- Testing
- Encore Tongue Suspension System
- Where
- United States
- Volunteers
- 5 people
- Sponsor
- Siesta Medical, Inc.
Healthy
Next-Day Residual Effects of Gabapentin, Diphenhydramine and Triazolam on Simulated Driving Performance in Normal Volunteers
This study will examine the next-day residual effects of a nighttime dose of gabapentin 250 mg, diphenhydramine citrate 76 mg and triazolam 0.5 mg compared to placebo and each other on simulated driving performance in normal…
- Trial name
- NCT01888497
- Testing
- Gabapentin, Diphenhydramine citrate, Triazolam
- Where
- 4 sites in United States
- Volunteers
- 59 people, healthy volunteers welcome
- Sponsor
- Pfizer's Upjohn has merged with Mylan to form Viatris Inc.
Obstructive Sleep Apnea
SleepFlexTM Treatment of Obstructive Sleep Apnea
The purpose of this study is to evaluate the safety and effectiveness of the SleepFlex program for treatment of mild to moderate OSA
- Trial name
- NCT04726514
- Testing
- SleepFlex
- Where
- United States
- Volunteers
- 10 people
- Sponsor
- Berendo Scientific, LLC