Clinical trials: Parasomnia
Obstructive Sleep Apnea
Comparison of Auto-Adjusting Positive Airway Pressure Devices
Little is understood about how different auto-adjusting PAP devices operate. The purpose of this evaluation is to compare two devices in a randomised two night PSG trial.
- Trial name
- NCT02357706
- Testing
- APAP A (ResMed AirSense AutoSet), APAP B (Apex iCH Auto)
- Where
- Germany
- Volunteers
- 20 people
- Sponsor
- ResMed
Major Depressive Disorder, Insomnia
A Study to Evaluate the Safety, Tolerability, and Efficacy of SAGE-217 Compared to Placebo in Adult Participants With Comorbid Major Depressive Disorder (MDD) and Insomnia
This study is a randomized, double-blind, placebo-controlled study of the safety, tolerability, and efficacy of SAGE-217 compared to placebo in adult participants with comorbid major depressive disorder (MDD) and insomnia.
- Trial name
- NCT03771664
- Testing
- SAGE-217
- Where
- 28 sites in United States
- Volunteers
- 87 people
- Sponsor
- Biogen
Excessive Sleepiness
Efficacy and Tolerability of Armodafinil in Adults With Excessive Sleepiness Associated With Shift Work Disorder
The primary objective of the study is to determine whether armodafinil treatment is more effective than placebo treatment in patients with excessive sleepiness associated with shift work disorder (SWD) by measuring improved…
- Trial name
- NCT01080807
- Testing
- Armodafinil
- Where
- 63 sites in United States
- Volunteers
- 385 people
- Sponsor
- Cephalon
Insomnia
A Study of Zolpidem Tartrate Sublingual Tablet in Adult Patients With Insomnia
The purpose of the study is to evaluate sleep onset following administration of zolpidem tartrate sublingual tablet (Intermezzo) versus placebo in adult insomnia patients.
- Trial name
- NCT00466193
- Testing
- zolpidem tartrate sublingual tablet
- Where
- United States
- Volunteers
- 295 people
- Sponsor
- Transcept Pharmaceuticals
Obstructive Sleep Apnea
Patient Perception Questionnaire Validation
Validation of the patient perception questionnaire relating to CPAP use
- Trial name
- NCT02067000
- Testing
- Obstructive Sleep Apnea
- Where
- United States
- Volunteers
- 217 people
- Sponsor
- Fisher and Paykel Healthcare
Sleep, Sleep Disorders Not Due to A Substance or Known Physiological Condition
Feasibility, Effectiveness and Efficacy of the PowerSleep Device
The purpose of this study is test the effectiveness of the PowerSleep auditory stimulation device on sleep quality and daytime functioning in individuals who have insufficient sleep.
- Trial name
- NCT02797678
- Testing
- Powersleep
- Where
- 4 sites in United States
- Volunteers
- 62 people
- Sponsor
- Philips Respironics
Obstructive Sleep Apnea
Field Usability Study of Eclipse Mask
The study is designed to assess the usability of a novel CPAP human interface compared to a traditional nasal mask. Human subjects will interact with two different CPAP interfaces including a traditional CPAP mask and the 2nd…
- Trial name
- NCT05559047
- Testing
- Eclipse mask
- Where
- 3 sites in United States
- Volunteers
- 70 people, healthy volunteers welcome
- Sponsor
- Bleep, LLC
Sleep Apnea
Modified AutoSet Device vs Existing AutoSet Device, the Assessment of Efficacy and Subjective Comfort of the Treatment.
The purpose of this study is to determine if the performance of the modified AutoSet device is equivalent or better than the existing AutoSet device (VPAP Auto) in the efficacy of the treatment and the subjective comfort.
- Trial name
- NCT00906958
- Testing
- Nexus Flow Generator, VPAP Flow Generator 25
- Where
- Australia
- Volunteers
- 20 people
- Sponsor
- ResMed
Diabetes Mellitus Type 2
GLYCOSA Study:Effect of PAP Treatment on Glycemic Control in Patients With Type 2 Diabetes
Obstructive Sleep Apnea (OSA) and type 2 diabetes mellitus are two prevalent medical conditions with significant associated cardiovascular and cerebrovascular morbidity and mortality.
- Trial name
- NCT00509223
- Testing
- Positive Airway Pressure therapy, Lifestyle counseling
- Where
- 15 sites in United States, Australia and 1 more
- Volunteers
- 416 people
- Sponsor
- ResMed
Myotonic Dystrophy 1, Excessive Daytime Sleepiness
Safety and Efficacy of Pitolisant on Excessive Daytime Sleepiness and Other Non-Muscular Symptoms in Patients With Myotonic Dystrophy Type 1
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 patients with Myotonic Dystrophy Type 1 ages 18 to 65 years.
- Trial name
- NCT04886518
- Testing
- Pitolisant Oral Tablet
- Where
- 13 sites in United States, Canada
- Volunteers
- 30 people
- Sponsor
- Harmony Biosciences Management, Inc.
Central Sleep Apnea
Post Approval Study of the remedē System
Prospective, single arm cohort study to evaluate the long-term safety, long-term effectiveness, and survival rate in subjects implanted with the remedē System.
- Trial name
- NCT03425188
- Where
- 17 sites in United States, Germany
- Volunteers
- 53 people
- Sponsor
- Respicardia, Inc.
Obstructive Sleep Apnea
DeVilbiss AutoAdjust With SmartFlex Comparative Study
There will be equivalent therapeutic effectiveness between SmartFlex and standard modes when using the DeVilbiss AutoAdjust device.
- Trial name
- NCT01203956
- Testing
- SmartFlex, Standard
- Where
- 2 sites in United States
- Volunteers
- 28 people
- Sponsor
- DeVilbiss Healthcare LLC
Cheyne-Stokes Respiration, Sleep Apnea, Central
Bipap Automatic Servo Ventilation (autoSV) Advanced in Central Apnea Patients
Pilot study testing the Bipap autoSV Advanced Algorithm during full night, in-lab polysomnography (PSG) and 3 months at home on patients with Central Sleep Apnea, Hunter Cheyne Stokes Respiration, or Complex Sleep Apnea.
- Trial name
- NCT01199042
- Testing
- BiPAP autoSV Advanced
- Where
- 3 sites in United States
- Volunteers
- 29 people
- Sponsor
- Philips Respironics
Insomnia
Fifty Two Week Extension Trial of Org 50081 (Esmirtazapine) in the Treatment of Insomnia (P05708)
This trial is a 52-week, open-label extension trial to investigate safety and to explore efficacy of Org 50081 (Esmirtazapine) in participants who completed Protocol 176001 (P05706) (NCT00482612) or 176002 (P05707) (NCT00506389).
- Trial name
- NCT00610675
- Testing
- Org 50081
- Volunteers
- 346 people
- Sponsor
- Merck Sharp & Dohme LLC
Insomnia
Driving Performance After Middle of the Night Administration of 3.5 mg Zolpidem Tartrate Sublingual Tablet
A study in healthy volunteers of the next morning driving performance after middle-of-the-night dosing of 3.5 mg zolpidem tartrate sublingual tablet, a sleep aid.
- Trial name
- NCT01106859
- Testing
- zopiclone, zolpidem tartrate sublingual tablet
- Where
- Netherlands
- Volunteers
- 40 people, healthy volunteers welcome
- Sponsor
- Transcept Pharmaceuticals
Restless Legs Syndrome
Simulated Driving Study in Restless Legs Syndrome
This study was a multi center, randomized, double blind, active and placebo controlled, parallel group study to assess simulated driving performance in XP13512 treated subjects with Restless Legs Syndrome (RLS).
- Trial name
- XP083 (NCT01332318)
- Testing
- XP13512, Diphenhydramine
- Where
- United States
- Volunteers
- 130 people
- Sponsor
- XenoPort, Inc.
Sleep Apnea
Mapping for Acute Transvenous Phrenic Nerve Stimulation Study
The Mapping for Transvenous Phrenic Nerve Stimulation Study (MAPS) is being conducted to evaluate the feasibility of transvascular stimulation of phrenic nerves via an electrophysiology (EP) catheter advanced into the great veins.
- Trial name
- MAPs (NCT01981590)
- Testing
- Stimulating the phrenic nerve intravenously using high frequency electrical pulses using an EP catheter connected to external pulse stimulator.
- Where
- 2 sites in Netherlands, Sweden
- Volunteers
- 15 people
- Sponsor
- Medtronic BRC
Excessive Daytime Sleepiness, Narcolepsy
A Study Of A Novel Compound For Excessive Daytime Sleepiness Associated With Narcolepsy
Histaminergic agents are known to be involved with the sleep/wake cycle. This compound is a histaminergic agent which therefore may improve alertness and awakeness in patients with excessive daytime sleepiness (EDS) associated…
- Trial name
- NCT01006122
- Testing
- PF-03654746
- Where
- 21 sites in United States
- Volunteers
- 95 people
- Sponsor
- Pfizer
Obstructive Sleep Apnea, Obesity
Obstructive Sleep Apnea Master Protocol GPIF: A Study of Tirzepatide (LY3298176) in Participants With Obstructive Sleep Apnea
The purpose of this study is to evaluate the effect and safety of tirzepatide in participants with moderate to severe obstructive sleep apnea and obesity who are both unwilling or unable to use Positive Airway Pressure (PAP)…
- Trial name
- SURMOUNT-OSA (NCT05412004)
- Testing
- Tirzepatide
- Where
- 58 sites in United States, Australia and 8 more
- Volunteers
- 469 people
- Sponsor
- Eli Lilly and Company
Obstructive Sleep Apnea (OSA), Post-Traumatic Stress Disorder (PTSD)
Comparison Study Using APAP With and Without SensAwake in Patients With OSA and PTSD
The purpose of this research is to examine the application of AutoCPAP with and without SensAwake in subjects with OSA and Post-Traumatic Stress Disorder (PTSD), and evaluate whether patients achieve better sleep quality and…
- Trial name
- NCT02549508
- Testing
- AutoCPAP with SensAwake On, AutoCPAP with SensAwake Off
- Where
- United States
- Volunteers
- 85 people
- Sponsor
- Fisher and Paykel Healthcare